tag:theconversation.com,2011:/id/topics/vaccine-manufacturing-52323/articlesVaccine manufacturing – The Conversation2022-08-11T15:25:00Ztag:theconversation.com,2011:article/1880942022-08-11T15:25:00Z2022-08-11T15:25:00ZMonkeypox vaccines: what’s available and why they aren’t a silver bullet<figure><img src="https://images.theconversation.com/files/477187/original/file-20220802-19-wlgzm.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">A dose of Imvanex vaccine used to protect against Monkeypox virus.</span> <span class="attribution"><span class="source">Lex van Lieshout/ANP/AFP via Getty Images</span></span></figcaption></figure><p><em>In July 2022 the World Health Organization <a href="https://theconversation.com/monkeypox-world-health-organization-declares-it-a-global-health-emergency-heres-what-that-means-186518">declared the recent current monkeypox outbreak</a> a global health emergency. Since the start of the year thousands of cases have been reported from over 80 countries. The <a href="https://www.who.int/news/item/23-07-2022-second-meeting-of-the-international-health-regulations-(2005)-(ihr)-emergency-committee-regarding-the-multi-country-outbreak-of-monkeypox">current outbreak</a> is unlike any previous ones. Infections are happening in non-endemic countries outside of Africa. And the pattern is of sustained person-to-person transmission. But there has also been an increase in the number of cases in countries in west and central Africa where the disease is endemic. The current outbreak monkeypox virus strain has a relatively low mortality <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2395797/">compared to other strains</a>. If other strains escape Africa the problem is going to be far more challenging. The Conversation Africa spoke to virologist Anna-Lise Williamson about monkeypox vaccines and best way forward for African countries.</em> </p>
<hr>
<h2>Are there vaccines against Monkeypox? How effective are they?</h2>
<p>The monkeypox virus is related to variola virus which caused smallpox and so the smallpox vaccines also protected from monkeypox. But these early smallpox vaccines are no longer commercially available because the disease was certified as eradicated in 1980 and so <a href="https://www.who.int/health-topics/smallpox#tab=tab_1">vaccination stopped</a>. </p>
<p>For a long time monkeypox was rare because of the cross-protection provided by the smallpox vaccine.</p>
<p>There are now two types of vaccine available. </p>
<p>The first is based on a replicating vaccinia virus and formed the basis of the smallpox virus <a href="https://www.who.int/news-room/feature-stories/detail/the-smallpox-eradication-programme---sep-(1966-1980)">eradication campaigns</a>. This required one immunisation and gave protection for life. </p>
<p>These vaccines are not regarded as very safe because they can have serious side effects. In some cases 1 to 2 people per million vaccinated died of <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1069029/">vaccine complications</a>. </p>
<p>This was acceptable in the days of smallpox because about <a href="https://www.who.int/teams/health-product-and-policy-standards/standards-and-specifications/vaccine-standardization/smallpox#:%7E:text=Two%20forms%20of%20the%20disease,most%20prominent%20on%20the%20face.">30% of people</a> who got the disease died from it. </p>
<p>The vaccine faces additional challenges in the era of HIV. People with certain immunodeficiency diseases, <a href="https://www.nejm.org/doi/10.1056/NEJM198703123161106?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub%20%200pubmed">including HIV</a>, can’t receive this type of vaccine.</p>
<p>The second vaccine is based on an attenuated form of vaccinia virus called modified vaccinia Ankara (MVA) which cannot complete its replication cycle in humans. This is a very safe vaccine. But protection does not last as long as the conventional vaccines based on replicating vaccinia virus. </p>
<p>It is marketed in the US as <a href="https://www.fda.gov/vaccines-blood-biologics/jynneos">Jynneos</a> and in Europe as <a href="https://www.ema.europa.eu/en/medicines/human/EPAR/imvanex">Imvanex</a>. It requires two immunisations. Both are made by Bavarian Nordic.</p>
<p>As far as I am aware it is uncertain how long people remain protected from infection. </p>
<h2>How widely available are the vaccines?</h2>
<p>The MVA based vaccine – which is the safest vaccine – appears to be in very <a href="https://www.science.org/content/article/there-s-shortage-monkeypox-vaccine-could-one-dose-instead-two-suffice">short supply</a>. According to <a href="https://healthpolicy-watch.news/exclusive-china-monkeypox-bavarian-nordics/">newspaper articles</a> Bavarian Nordic are not able to produce the vaccines at present. </p>
<p>There are stockpiles of the vaccinia virus replicating vaccines. But they can’t be rolled out in countries with a high prevalence of HIV without extensive management ensuring HIV-positve people do not get it. South Africa is an example.</p>
<h2>Vaccines are key to controlling a number of diseases. Is this true for monkeypox too?</h2>
<p>Vaccines are the only way to control monkeypox once you have outbreak as we’re <a href="https://theconversation.com/monkeypox-this-is-an-entirely-new-spread-of-the-disease-184085">currently seeing</a> in the US and several European countries. </p>
<p>The problem is the cost. Countries have to weigh up the cost of vaccinating everybody versus the cost of treating the disease.</p>
<p>The cost/benefit analysis is different for each country. The scenarios will look very different depending on whether you’re sitting in London or in Lagos. Vaccinating high risk populations is a possible strategy to stop the spread of the disease.</p>
<p>Nigeria has been managing monkeypox outbreaks for some time. But the strategy has not relied on vaccines because, from their viewpoint, it wouldn’t be cost effective. You’d have to vaccinate a lot of people for it to be effective. It obviously makes sense to make sure there’s good disease surveillance. </p>
<p>There is also an antiviral drug, tecovirimat <a href="https://www.cdc.gov/poxvirus/monkeypox/treatment.html">(TPOXX)</a> that has been developed for smallpox and works for treating monkeypox. However this is not available in Africa and so Africa needs to manufacture drugs for the continent. </p>
<p>For developed countries, it makes sense to do contact tracing and to identify high risk communities. And then to vaccinate at-risk populations. This is true particularly if you can’t change people’s behaviour.</p>
<h2>What’s the longer term solution for African countries?</h2>
<p>African countries must start making the vaccines that they need. For example there’s a vaccine – a recombinant vaccine based on MVA – in final trials that addresses both monkeypox and respiratory syncytial virus (RSV). RSV kills <a href="https://www.thelancet.com/journals/langlo/article/PIIS2214-109X(20)30251-5/fulltext">millions of children</a> in Africa every year. If you could vaccinate against both at the same time that may be cost effective.</p>
<p>I belong to <a href="https://africacdc.org/download/partnerships-for-african-vaccine-manufacturing-pavm-framework-for-action/">Partnerships for African Manufacturing</a>, an initiative that’s pushing for local production capacity.</p>
<p>But it’s hard. We have virtually no expertise. And it requires a great deal of work to set up manufacturing capability. </p>
<p>And it’s going to cost money. Those who have money to invest need to do that.</p>
<p>After the <a href="https://www.cdc.gov/flu/pandemic-resources/2009-h1n1-pandemic.html">flu pandemic in 2010</a> everyone said African countries should manufacture flu vaccines. Africa didn’t get any vaccines until the pandemic had ended – a forerunner to the COVID situation.</p>
<p>The danger is that the issue just disappears again and nothing gets done. We must try and keep some momentum in place so we can look after ourselves for next pandemic.</p><img src="https://counter.theconversation.com/content/188094/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Anna-Lise Williamson receives funding from TIA, SAMRC and NRF.</span></em></p>Countries have to weigh up the cost of vaccinating everybody versus the cost of treating the disease.Anna-Lise Williamson, Professor in Vaccinology, Institute of Infectious Disease and Molecular Medicine, University of Cape TownLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1883992022-08-11T10:28:56Z2022-08-11T10:28:56ZMonkeypox: demand for vaccines is outstripping supply – this is what’s causing the shortages<figure><img src="https://images.theconversation.com/files/478708/original/file-20220811-5117-k495hz.jpg?ixlib=rb-1.1.0&rect=0%2C0%2C3594%2C2392&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">The smallpox vaccine is currently being used to protect against monkeypox.</span> <span class="attribution"><a class="source" href="https://www.shutterstock.com/image-photo/doctor-researcher-scientist-hand-blue-glove-1396494821">PhotobyTawat/ Shutterstock</a></span></figcaption></figure><p>Over <a href="https://www.cdc.gov/poxvirus/monkeypox/response/2022/world-map.html">30,000 cases</a> of monkeypox have been reported in more than 80 countries worldwide in 2022. Most are in countries that have never previously reported monkeypox. While monkeypox is not as <a href="https://www.gov.uk/guidance/monkeypox">transmissible</a> as many respiratory infections (such as COVID-19), it’s still important to curb the spread.</p>
<p>One way to control spread is by <a href="https://www.gov.uk/government/publications/monkeypox-vaccination-resources/protecting-you-from-monkeypox-information-on-the-smallpox-vaccination">vaccinating vulnerable people</a>. Fortunately, we already have vaccines which are <a href="https://www.gov.uk/government/publications/smallpox-and-vaccinia-the-green-book-chapter-29">very effective</a> at preventing monkeypox. But as case numbers continue to rise, reports are emerging that <a href="https://www.science.org/content/article/there-s-shortage-monkeypox-vaccine-could-one-dose-instead-two-suffice">demand for vaccines</a> is <a href="https://www.ft.com/content/1d9f678b-33d0-480d-b5d7-f5cbc9c41141">outstripping supply</a> in many parts of the world currently seeing an outbreak, including <a href="https://www.nytimes.com/2022/08/05/health/monkeypox-vaccine-hiv.html">the US</a>, <a href="https://www.theguardian.com/world/2022/aug/10/uk-will-run-out-of-monkeypox-vaccine-in-10-to-20-days">UK</a> and <a href="https://www.reuters.com/world/europe/europe-consider-dose-sparing-increase-monkeypox-vaccine-who-seeks-trials-2022-08-10/">Europe</a>.</p>
<h2>Vaccine supply</h2>
<p>There are a number of reasons why we are seeing shortages of the vaccine used to protect against monkeypox. Broadly, it’s due to chronic weaknesses in our global vaccine manufacturing and distribution systems, which make it especially difficult to supply the vaccines needed to protect against new infections and outbreaks.</p>
<p>The vaccine currently being used to protect against monkeypox is the smallpox vaccine, which works because the monkeypox virus is so closely related to smallpox.</p>
<p>Until now, the smallpox vaccine has been a niche product because it’s not been needed since smallpox was <a href="https://www.who.int/health-topics/smallpox">eradicated</a> in 1980. Pharmaceutical companies can’t afford to manufacture vast numbers of doses just in case, and few governments can justify buying a vaccine that isn’t used. This means the vaccines currently being administered are from <a href="https://www.phe.gov/about/sns/Pages/products.aspx">emergency stockpiles</a> that were created to respond to an accidental (or deliberate) release of smallpox.</p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/monkeypox-qanda-how-do-you-catch-it-and-what-are-the-risks-an-expert-explains-183606">Monkeypox Q&A: how do you catch it and what are the risks? An expert explains</a>
</strong>
</em>
</p>
<hr>
<p>As such, there are limited stocks and production capacity globally, so demand is rapidly outstripping supply. Even the US, with one of the largest smallpox vaccine stockpiles, recently ordered <a href="https://www.hhs.gov/about/news/2022/07/01/hhs-orders-2-point-5-million-more-doses-jynneos-vaccine-for-monkeypox-preparedness.html">2.5 million additional doses</a> in response to the monkeypox outbreak. But there are reports that the factory in Denmark which makes the world’s only smallpox vaccine approved for monkeypox is <a href="https://healthpolicy-watch.news/exclusive-china-monkeypox-bavarian-nordics/">temporarily closed</a>, which may further impact the world’s ability to source more vaccine doses. And unfortunately, transferring production to other facilities is not straightforward. </p>
<p>One particular problem for vaccine manufacturers is that it’s hard to predict when or where big outbreaks of infections may happen. Of course, there are some infections that we know consistently require a regular supply of vaccines – such as the influenza virus. But while <a>1 billion influenza vaccines</a> are produced globally each year, it still takes <a href="https://www.cdc.gov/flu/prevent/vaccine-selection.htm">approximately six months</a> from picking the most important new strains to manufacturing and rolling out jabs.</p>
<p>So even with vaccines in high demand, it isn’t simple to manufacture more doses. This is why we are <a href="https://100days.cepi.net/">still striving</a> to innovate ways to rapidly produce new vaccines affordably and at a very large scale.</p>
<p>Vaccines are inherently complicated to make. Because they are made from relatively fragile and complex biological materials (such as a virus), the product has to be exactly right every time. If the formula changes even slightly, it might not work as well – or even increase the risk of side-effects. </p>
<p>Adding to this challenge is the fact that different vaccine products may be manufactured by different methods. For example, the equipment needed to produce a viral vaccine (such as the smallpox vaccine used against monkeypox) will be very different to that used to make COVID-19 RNA vaccines. It’s also slow and expensive to test any necessary modifications or improvements that may be needed to make a vaccine safer and more effective. </p>
<figure class="align-center ">
<img alt="Glass vials arranged in a row move through a conveyer belt, where they are filled with the vaccine." src="https://images.theconversation.com/files/478711/original/file-20220811-15-y3tft6.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/478711/original/file-20220811-15-y3tft6.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=338&fit=crop&dpr=1 600w, https://images.theconversation.com/files/478711/original/file-20220811-15-y3tft6.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=338&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/478711/original/file-20220811-15-y3tft6.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=338&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/478711/original/file-20220811-15-y3tft6.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=424&fit=crop&dpr=1 754w, https://images.theconversation.com/files/478711/original/file-20220811-15-y3tft6.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=424&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/478711/original/file-20220811-15-y3tft6.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=424&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">It isn’t just as easy as making more vaccines to meet demand.</span>
<span class="attribution"><a class="source" href="https://www.shutterstock.com/image-illustration/3d-render-pharmaceutical-manufacture-background-glass-2115129506">wacomka/ Shutterstock</a></span>
</figcaption>
</figure>
<p>Surprisingly, even some simple processes common to all vaccines and other medicines – such as filling doses into vials for distribution to patients – still have a mismatch of capacity. Vaccines are usually manufactured in different locations to <a href="https://www.thechemicalengineer.com/news/volunteers-publish-guide-to-help-public-understand-fill-and-finish-and-drug-product-release/">packaging facilities</a>, raising logistical hurdles (such as strictly controlled refrigeration requirements) that can further delay distribution. These facilities are used for many different medicines and are usually fully booked years in advance; schedules that are still recovering from COVID-19 disruptions may now be experiencing urgent changes to package the smallpox vaccine from stockpiles. </p>
<p>It also isn’t just a case of developing new monkeypox vaccines that are easier to manufacture. Even with major recent scientific progress, it would take many months to develop a safe and effective new vaccine. For monkeypox, it’s far quicker and simpler to use the existing smallpox vaccine.</p>
<h2>What can be done?</h2>
<p>Smallpox vaccine production is likely to be increased to meet demand. But until this happens, many countries will have to make best use of what supplies they can access, and rely on other strategies to help curb the virus’s spread.</p>
<p>The most effective way to prevent monkeypox causing further harm is by using an integrated, locally led public health response – vaccines are just one part of this. Testing and contact tracing is vital. If enough infected people in a region can be identified and supported to isolate while they’re infectious, transmission can be blocked.</p>
<p>Given the vaccine shortages, we expect that people don’t need two vaccine doses to be protected against monkeypox. This is why vaccinating the most at-risk groups with <a href="https://www.gov.uk/government/publications/monkeypox-vaccination-resources/monkeypox-waiting-for-your-vaccination">one dose now</a>, paired with other public health measures, is the most effective strategy for curbing the spread of monkeypox – especially while vaccine supplies are limited. Second doses can be administered to maximise immunity when supplies do become available.</p>
<p>The current monkeypox outbreak is yet another reminder of the importance of investing in global health, and ensuring there’s more equal access to vaccines and other medical interventions that can help prevent the spread of harmful diseases.</p><img src="https://counter.theconversation.com/content/188399/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Alexander Edwards does not work for, consult, own shares in or receive funding from any company or organisation that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.</span></em></p>Chronic weaknesses in our global vaccine manufacturing and distribution systems may broadly be to blame.Alexander Edwards, Associate Professor in Biomedical Technology, University of ReadingLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1821472022-05-15T20:15:16Z2022-05-15T20:15:16ZAustralia risks relying on Pfizer and Moderna for its COVID vaccines. 3 ways to break free<figure><img src="https://images.theconversation.com/files/460499/original/file-20220429-26-ut9yfa.jpg?ixlib=rb-1.1.0&rect=14%2C0%2C3180%2C1992&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">
</span> <span class="attribution"><a class="source" href="https://www.shutterstock.com/image-vector/coronavirus-vaccine-affordability-people-want-buy-1908778336">Shutterstock</a></span></figcaption></figure><p>The rapid development and deployment of COVID vaccines has been one of the greatest achievements of the pandemic.</p>
<p>However, Australia <a href="https://www.mja.com.au/journal/2022/217/2/covid-19-vaccines-boosters-and-mandates-building-mission-economy-not-rentier">risks relying on</a> COVID vaccines from two main companies – Pfizer and Moderna – and that’s a problem.</p>
<p>While the need for COVID vaccines is not going away anytime soon, we need to shape the market to drive more competition for better access to improved vaccines.</p>
<p>Here’s what Australia needs to do to break free from an effective duopoly dominating the local market, especially when many of us are likely to <a href="https://www.health.gov.au/initiatives-and-programs/covid-19-vaccines/getting-your-vaccination/booster-doses">need boosters</a>.</p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/covid-vaccination-recommendations-evolve-over-time-who-is-due-for-which-dose-now-181779">COVID vaccination recommendations evolve over time. Who is due for which dose now?</a>
</strong>
</em>
</p>
<hr>
<h2>How did we get here?</h2>
<p>When COVID finally broke out at scale in Australia late last year, the vaccines (and high levels of adult vaccination) worked extremely well to reduce deaths and severe illness.</p>
<p>Since January 1 this year, there have been <a href="https://ourworldindata.org/coronavirus/country/australia">more than</a> 5.9 million confirmed COVID infections nationwide, but about 5,300 deaths.</p>
<p>Yet current vaccines aren’t 100% effective at protecting against infection; new viral variants (<a href="https://theconversation.com/why-are-there-so-many-new-omicron-sub-variants-like-ba-4-and-ba-5-will-i-be-reinfected-is-the-virus-mutating-faster-182274">and sub-variants</a>) continue to emerge; protection via <a href="https://www1.racgp.org.au/newsgp/clinical/booster-protection-wanes-after-four-months-what-do">vaccination</a> and <a href="https://theconversation.com/how-long-does-protective-immunity-against-covid-19-last-after-infection-or-vaccination-two-immunologists-explain-177309">prior infection wanes</a> quite quickly, meaning reinfection is becoming more common and booster shots may remain part of the landscape for some time to come.</p>
<p>Meanwhile, <a href="https://www.sciencedirect.com/science/article/pii/S0140673622003282?via%3Dihub">vaccine inequity</a> remains an unresolved problem. This has led to a situation where rich countries, such as Australia, are giving booster shots where some <a href="https://www.sciencedirect.com/science/article/pii/S0140673622008170?via%3Dihub">poorer countries</a> don’t even have enough vaccine for first doses.</p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/how-australias-fickleness-on-covid-vaccines-is-perpetuating-global-vaccine-inequity-165001">How Australia's fickleness on COVID vaccines is perpetuating global vaccine inequity</a>
</strong>
</em>
</p>
<hr>
<h2>Pfizer and Moderna, but not much else</h2>
<p>In <a href="https://www.mja.com.au/journal/2022/217/2/covid-19-vaccines-boosters-and-mandates-building-mission-economy-not-rentier">a recent article</a> in the Medical Journal of Australia, we outline the need to break free from the handful of powerful players still dominating Australia’s COVID vaccine market.</p>
<p>While the number of <a href="https://covid19.trackvaccines.org/agency/who/">approved COVID vaccines</a> <a href="https://en.wikipedia.org/wiki/List_of_COVID-19_vaccine_authorizations">is growing</a> around the world, Australia largely still relies on only two, namely vaccines from Pfizer and Moderna.</p>
<p>The AstraZeneca and Novavax vaccines are only rarely <a href="https://www.health.gov.au/initiatives-and-programs/covid-19-vaccines/advice-for-providers/clinical-guidance/clinical-recommendations">used as boosters</a> if <a href="https://www.health.gov.au/initiatives-and-programs/covid-19-vaccines/approved-vaccines/novavax">no other vaccines</a> are suitable.</p>
<p>More than <a href="https://www.health.gov.au/sites/default/files/documents/2022/05/covid-19-vaccine-rollout-update-11-may-2022.pdf">95% of Australian adults</a> have received two doses of COVID vaccine already. So future requirements are primarily for boosters and child vaccines. Australia, therefore, continues to face an effective duopoly.</p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/462361/original/file-20220511-22-9sko2m.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="Middle-aged lady smiling with bandaid on upper arm" src="https://images.theconversation.com/files/462361/original/file-20220511-22-9sko2m.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/462361/original/file-20220511-22-9sko2m.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/462361/original/file-20220511-22-9sko2m.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/462361/original/file-20220511-22-9sko2m.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/462361/original/file-20220511-22-9sko2m.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/462361/original/file-20220511-22-9sko2m.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/462361/original/file-20220511-22-9sko2m.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=503&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">Future supplies of COVID vaccines will be used for booster shots and children.</span>
<span class="attribution"><a class="source" href="https://www.shutterstock.com/image-photo/portrait-mature-female-smiling-after-getting-1927590569">Shutterstock</a></span>
</figcaption>
</figure>
<h2>The power of patents</h2>
<p>This effective duopoly further reinforces the already considerable power these manufacturers hold via the intellectual property rights to their vaccines.</p>
<p>These vaccine patents are protected by the World Trade Organization under the Agreement on Trade-Related Aspects of Intellectual Property Rights (or <a href="https://www.wto.org/english/tratop_e/trips_e/trips_e.htm">TRIPS</a>). This prevents international competitors from replicating patented technologies. </p>
<p>These patent rights allow companies to earn higher profits (or “economic rents”) than if their technologies were freely available to allow open competition.</p>
<p><div data-react-class="Tweet" data-react-props="{"tweetId":"1523962841178558469"}"></div></p>
<p>The intellectual property dimensions of COVID vaccines have been controversial. </p>
<p>Pfizer and Moderna have continued <a href="https://peoplesvaccine.org/resources/media-releases/pharma-companies-make-1000-dollars-per-second/">to make extraordinary profits</a> from COVID vaccines.</p>
<p>Yet Moderna found itself <a href="https://www.ipwatchdog.com/2022/03/31/nihs-fight-ownership-modernas-covid-19-patent-highlights-hazards-business-collaborations/id=148040/">in dispute</a> with the United States government, conceding <a href="https://www.nytimes.com/2021/12/17/us/moderna-patent-nih.html?msclkid=2baf60f6d0f511ec9526396a701fee1f">US government employees</a> had directly developed several technologies key to the Moderna vaccine (not to mention years of publicly-funded basic research). </p>
<p>Moderna has also <a href="https://www.npr.org/sections/goatsandsoda/2021/10/19/1047411856/the-great-vaccine-bake-off-has-begun">resisted sharing</a> the formulation of its vaccine to allow key middle-income countries to manufacture it.</p>
<p>Meanwhile, Pfizer has negotiated <a href="https://www.citizen.org/article/pfizers-power/?eType=EmailBlastContent&eId=9b708ddb-d34d-4dfa-95e4-d4d672a82a1b">advantageous</a> and <a href="https://www.theguardian.com/uk-news/2021/dec/05/wall-of-secrecy-in-pfizer-contracts-as-company-accused-of-profiteering">secretive</a> vaccine contracts with governments, shifting liability and risk onto governments and controlling nations’ ability to redistribute stock between themselves. </p>
<p>High-income countries have <a href="http://aftinet.org.au/cms/Civil-society-organisations-urge-Australia-to-oppose-ineffective-TRIPS-proposal">consistently resisted</a> or watered down <a href="https://docs.wto.org/dol2fe/Pages/SS/directdoc.aspx?filename=q:/IP/C/W688.pdf&Open=True">calls for a TRIPS waiver</a>, which would have allowed global sharing of manufacturing technologies. </p>
<p><a href="https://journals.plos.org/globalpublichealth/article?id=10.1371%2Fjournal.pgph.0000427">Critics argue</a> the opponents of a TRIPS waiver are largely concerned about avoiding setting any precedents that might allow the profits of Big Pharma to be limited in future.</p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/why-a-leaked-wto-solution-for-a-covid-patent-waiver-is-unworkable-and-wont-make-enough-difference-for-developing-countries-179642">Why a leaked WTO 'solution' for a COVID patent waiver is unworkable and won't make enough difference for developing countries</a>
</strong>
</em>
</p>
<hr>
<h2>What should Australia do next?</h2>
<p>In Australia, the reality that current COVID vaccines only partially prevent transmission leaves us dependent on this effective duopoly for ongoing boosters. Boosters also remain mandated for people in <a href="https://www.health.gov.au/initiatives-and-programs/covid-19-vaccines/information-for-aged-care-providers-workers-and-residents-about-covid-19-vaccines/residential-aged-care-workers">many occupations</a>.</p>
<p>Australia can escape this captive vaccine market in three steps.</p>
<p><strong>1. Approve more vaccines</strong></p>
<p>Australia needs to expand the supply of new COVID vaccines by actively assisting a wider range of manufacturers to bring their products to the Therapeutic Goods Administration for approval. This would increase competition for boosters and stimulate the development and supply of more effective “sterilising” vaccines (ones that prevent viral transmission).</p>
<p>Meanwhile, Australia must extract maximum value from all existing vaccine contracts, and insist upon full freedom to transfer supplies to our regional neighbours.</p>
<p><strong>2. Push for patent reform</strong></p>
<p>Australia should use its influence to vigorously drive a TRIPS waiver at the World Trade Organization. It should also explore strategic options with a coalition of partners to consider how the current global intellectual property regime could be rapidly reformed or, if necessary, circumvented. </p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/3-ways-to-vaccinate-the-world-and-make-sure-everyone-benefits-rich-and-poor-155943">3 ways to vaccinate the world and make sure everyone benefits, rich and poor</a>
</strong>
</em>
</p>
<hr>
<p><strong>3. Set up domestic, not-for-profit capability</strong></p>
<p>Australia should institute an economic “mission” to establish publicly-owned, not-for-profit vaccine and essential pharmaceuticals research, development and manufacturing infrastructure and capability in Australia. This would serve domestic and wider regional needs for COVID and beyond. </p>
<p>Sadly, the Australian government’s recent agreement with Moderna for the company to establish <a href="https://theconversation.com/new-facility-to-be-built-in-victoria-to-produce-mrna-vaccines-173674">mRNA manufacturing here</a> is <em>not</em> such an example. It may risk entrenching existing power. The agreement is also <a href="https://www.abc.net.au/radionational/programs/sciencefriction/moderna-mrna-australia-covid-pharmaceutical-profits-business/13849344">still secret</a>. </p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/new-facility-to-be-built-in-victoria-to-produce-mrna-vaccines-173674">New facility to be built in Victoria to produce mRNA vaccines</a>
</strong>
</em>
</p>
<hr>
<p>In an increasingly insecure world of growing disruptions – ecological and health crises, fracturing supply chains and heightened military tensions – Australia can provide a safe and resilient vaccine and pharmaceutical manufacturing capability to protect the health of Australians and our neighbours. </p>
<p>However, old models that privilege shareholders, via excess profits and intellectual property protection, will not deliver this new vision.</p>
<hr>
<p><em><a href="https://www.deakin.edu.au/about-deakin/people/sithara-wanni-arachchige-dona2">Sithara Dona</a>, an associate research fellow at Deakin University, co-authored the research mentioned in this article.</em></p><img src="https://counter.theconversation.com/content/182147/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Martin Hensher has received an honorarium from Novartis SA (Brazil) for a lecture delivered to the Novartis Access 2021 conference. He is a member of the South Australian Health Performance Council and a board member of Glenview Community Services, Tasmania (a not-for-profit aged care provider).</span></em></p>Boosters and vaccinating children mean we’re relying on two pharmaceutical companies to supply Australia’s COVID vaccines. That needs to change.Martin Hensher, Henry Baldwin Professorial Research Fellow in Health System Sustainability, University of TasmaniaLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1826832022-05-10T13:45:08Z2022-05-10T13:45:08ZMaking COVID vaccines in Africa: advances and sustainability issues<figure><img src="https://images.theconversation.com/files/462011/original/file-20220509-18-mj9lv0.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">GettyImages</span> </figcaption></figure><p>The history of vaccine manufacturing capacity in Africa dates back to 1881, when Egypt’s <a href="https://www.vacsera.com/">Vacsera company</a> was established. Before the COVID pandemic was <a href="https://www.who.int/director-general/speeches/detail/who-director-general-s-opening-remarks-at-the-media-briefing-on-covid-19---11-march-2020">declared</a>, there were eight African countries that, to our knowledge, had a record of vaccine manufacturing facilities (see the map). They were: Algeria, Egypt, Morocco and Tunisia (North Africa); Nigeria and Senegal (West Africa); Ethiopia (East Africa); and South Africa. </p>
<p>Between them they had 14 facilities.</p>
<iframe src="https://flo.uri.sh/visualisation/9497187/embed" title="Interactive or visual content" class="flourish-embed-iframe" frameborder="0" scrolling="no" style="width:100%;height:700px;" sandbox="allow-same-origin allow-forms allow-scripts allow-downloads allow-popups allow-popups-to-escape-sandbox allow-top-navigation-by-user-activation" width="100%" height="400"></iframe>
<div style="width:100%!;margin-top:4px!important;text-align:right!important;"><a class="flourish-credit" href="https://public.flourish.studio/visualisation/9497187/?utm_source=embed&utm_campaign=visualisation/9497187" target="_top"><img alt="Made with Flourish" src="https://public.flourish.studio/resources/made_with_flourish.svg"> </a></div>
<p>Few were involved from end to end (discovery, fill and finish, pack and distribute) production process. Instead, the focus was largely on the late stage of production process – fill and finish as well as pack and distribution. </p>
<p>It’s therefore not surprising that Africa’s vaccine manufacturing capacity has been limited. The facilities supply less than <a href="https://www.nature.com/articles/d41586-021-01048-1">1% of vaccines needed</a> for the continent. </p>
<p>Before the COVID pandemic, efforts to address the challenge of limited vaccine production on the continent yielded little success. The pandemic clearly exposed the limited capacity to manufacture vaccines. African countries were among the last in the world to begin rolling out <a href="https://www.afro.who.int/news/supply-bottleneck-financial-challenges-fuel-delays-africas-covid-19-vaccine-rollout">COVID vaccines</a>. This was largely due to limited access to vaccines and funding constraints.</p>
<p>As a result key stakeholders on the continent were joined by <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8640685/">international partners</a>, to advocate for the urgent and rapid establishment of COVID vaccines manufacturing capacity on the continent.</p>
<h2>The urgency around manufacturing capacity</h2>
<p><a href="https://reliefweb.int/report/world/vaccine-nationalism-hoarding-putting-us-all-risk-secretary-general-tells-world-health">Vaccines nationalism and hoarding</a> were topical issues in 2021. In a telling statement issued by the UN secretary general in October 2021, COVID vaccines nationalism and hoarding were hampering the global response to the pandemic, putting everyone at risk of the devastating impacts of the disease, including emergence of the <a href="https://www.un.org/press/en/2021/sgsm20986.doc.htm">SARS-COV-2 variants of concern</a>. It did not make public health sense to have a few high income countries with <a href="https://www.weforum.org/agenda/2021/01/what-is-vaccine-nationalism-coronavirus-its-affects-covid-19-pandemic/">excess supply</a> of COVID-19 vaccines while low income countries had nothing. </p>
<p>Once COVID vaccines began to be approved – the first was <a href="https://www.who.int/news/item/31-12-2020-who-issues-its-first-emergency-use-validation-for-a-covid-19-vaccine-and-emphasizes-need-for-equitable-global-access">Pfizer/BioNTech</a> – there was high demand for rapid deployment to vaccinate <a href="https://cdn.who.int/media/docs/default-source/immunization/covid-19/strategy-to-achieve-global-covid-19-vaccination-by-mid-2022.pdf">70% of the global population</a>. Demand outstripped the supply. The <a href="https://www.gavi.org/covax-facility">COVAX</a> facility, a global collaboration to accelerate development and equitable access to COVID vaccines, was established. Despite this, high income countries used their financial muscle to secure almost all available supply of <a href="https://www.oecd.org/coronavirus/policy-responses/coronavirus-covid-19-vaccines-for-developing-countries-an-equal-shot-at-recovery-6b0771e6/">COVID vaccines</a>. Developing countries, including those on the continent, were left at the back of the queue. </p>
<p>African countries failed to secure the vaccines they needed. As a result, pressure began to mount on the leaders of African countries to develop local COVID vaccine manufacturing capacity.</p>
<p>In April 2021, the African Union Commission and Africa Centres for Disease Control hosted a <a href="https://africacdc.org/news-item/african-union-and-africa-cdc-launches-partnerships-for-african-vaccine-manufacturing-pavm-framework-to-achieve-it-and-signs-2-mous/">two-day high-level summit</a> to discuss the issue. The outcome of the summit was a framework for action prepared by the Partnerships for African Vaccine Manufacturing. At the same time, there were <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8640685/">willing partners</a> to support COVID vaccine manufacturing capacity in Africa, both within Africa and outside Africa.</p>
<h2>A logical approach to solving the problem</h2>
<p>The logical start for the continent was to use existing vaccine manufacturing capacity. Ten of the 14 existing manufacturing facilities were front runners in launching COVID vaccine production. Nine out of the 10 started production (late stages) of COVID vaccines in 2021. </p>
<p>Encouragingly, five new facilities from five more countries (Ghana, Kenya, Uganda, Rwanda and Botswana) are being set up to produce COVID vaccines. Some of the new facilities will start production of COVID vaccines as early as 2022. This is an incredible achievement. </p>
<p>The map provides an encouraging picture and it would be tempting to say that Africa will no longer be at the back of the queue in accessing COVID vaccines. On completion of the set up of all (15) COVID vaccines manufacturing facilities on the continent, Africa will be well positioned to produce other vaccines too. </p>
<p>A pertinent issue is the sustainability of the facilities. Demand and market for locally produced vaccines will be critical for the sustainability of the 15 COVID vaccines manufacturing facilities in Africa.</p>
<p>There’s a salutary lesson in the example provided by Aspen Pharmacare, the South African based vaccines manufacturing plant. It was the first on the continent to enter a non-binding <a href="https://www.aspenpharma.com/2020/11/02/aspen-announces-agreement-with-johnson-johnson-to-manufacture-investigational-covid-19-vaccine-candidate/">agreement</a> with J&J’s Janssen to manufacture COVID vaccines. </p>
<p>At the time of the agreement in 2021, J&J’s COVID vaccine ticked many boxes in terms of suitability for deployment on the continent. The plan was that all the vaccines manufactured at the plant would be distributed on the continent. But by May 2022, Aspen had not received orders to supply the COVID vaccines to the continent, possibly due to the changing dynamics of COVID vaccines supply in 2022 – supply appears to be greater than the demand. </p>
<p>Without demand for the vaccines, Aspen’s COVID vaccines manufacturing facility is at risk of closure. Key stakeholders such as Africa CDC and the South African government have called for African countries to place orders with Aspen. </p>
<p>While the problem of establishing COVID vaccines manufacturing capacity appears to have been partly resolved, a bigger problem lies ahead – sustaining the facilities on the continent.</p><img src="https://counter.theconversation.com/content/182683/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Benjamin Kagina receives funding from Wellcome and Bill & Melinda Gates Foundation. In the past, Benjamin has received unconditional educational grants from the pharmaceutical sector. </span></em></p>Before the COVID pandemic, efforts to address the challenge of limited vaccine production on the continent yielded little success.Benjamin Kagina, Senior Research Officer & Co-Director, Vaccines For Africa Initiative, Faculty of Health Sciences, University of Cape TownLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1746052022-01-10T03:44:56Z2022-01-10T03:44:56ZWhy has my child’s vaccination been cancelled? We’re reliant on overseas supply and a complex logistics network<figure><img src="https://images.theconversation.com/files/439941/original/file-20220110-13-gd4wmt.jpg?ixlib=rb-1.1.0&rect=0%2C22%2C5058%2C2589&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">
</span> <span class="attribution"><span class="source">Shutterstock</span></span></figcaption></figure><p>Reports of GPs <a href="https://www.abc.net.au/radionational/programs/breakfast/child-vaccine-appointments-delayed-or-cancelled/13700424">cancelling</a> or postponing COVID vaccine appointments for 5-11 year olds are piling up, with desperate parents expressing anger and fear about how their as-yet unvaccinated children will fare as Omicron case numbers explode.</p>
<p><div data-react-class="Tweet" data-react-props="{"tweetId":"1479256529991651333"}"></div></p>
<p>Federal COVID-19 Task Force Commander Lieutenant General John Frewen <a href="https://www.health.gov.au/news/lieutenant-general-john-frewens-interview-on-sunrise-on-10-january-2022">said</a> on Monday:</p>
<blockquote>
<p>Supply isn’t the issue; we’ve got enough vaccines. The real challenge now is just getting the distribution to where the demand is greatest. </p>
</blockquote>
<p>South Australia’s health deputy chief executive Don Frater, however, has reportedly <a href="https://indaily.com.au/news/2022/01/10/sa-health-reveals-shortfall-of-vaccines-for-children/">said</a> that state has “more demand than what we have supply”.</p>
<p>The child’s dose comes in different vials to the adult dose, with <a href="https://www.ncirs.org.au/safety-side-effects-allergies-and-doses-covid-19-pfizer-vaccine-5-11-year-olds-explained">different packaging</a>.</p>
<p>The rollout of the Pfizer vaccine for children has come at a difficult time, from a logistics perspective. Many GPs have said “delivery delays” are behind the need to reschedule appointments.</p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/australia-may-miss-out-on-several-covid-vaccines-if-it-cant-make-mrna-ones-locally-148996">Australia may miss out on several COVID vaccines if it can't make mRNA ones locally</a>
</strong>
</em>
</p>
<hr>
<h2>What might be behind the delays?</h2>
<p>This is a specialised product, which needs to be stored in special freezers <a href="https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-submit-covid-19-vaccine-stability-data">at -80°C</a>, and obviously needs to be transported in a certain way. </p>
<p>There are a lot of steps in the transport process – from the supplier overseas to the shipping service bringing them to Australia, from their landing spot in the country, to specialised storage, to individual GPs.</p>
<p>Each of those steps require staff on the ground to ensure the system works – and many workers in this system are likely being affected by Omicron.</p>
<p>The same staffing issues resulting in <a href="https://theconversation.com/supermarket-shortages-are-different-this-time-how-to-respond-and-avoid-panic-174529">empty supermarket shelves</a> could be affecting the vaccine distribution network too. </p>
<p>Thousands of drivers, administration staff, packers and logistics planners could be furloughed, off sick or in isolation because a household member is.</p>
<p><div data-react-class="Tweet" data-react-props="{"tweetId":"1479356503849332738"}"></div></p>
<p>The rollout of the 5-11 year old vaccination program, timed in an effort to get kids vaccinated before school starts, also comes hot on the heels of the Christmas and New Year break; even without Omicron, it’s possible staffing numbers across the supply chain and logistics network are still yet to return to pre-Christmas levels.</p>
<p>There have been <a href="https://twitter.com/Leighma03/status/1479403027517755392">anecdotal reports</a> of <a href="https://twitter.com/Leighma03/status/1479403027517755392">some</a> people having their booster appointments being cancelled too, so it seems it is not only 5-11 year olds who are affected.</p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/safety-side-effects-allergies-and-doses-the-covid-19-pfizer-vaccine-for-5-11-year-olds-explained-173323">Safety, side effects, allergies and doses. The COVID-19 Pfizer vaccine for 5-11 year olds explained</a>
</strong>
</em>
</p>
<hr>
<p>It’s hard to know how widespread the issue is. Frewen told Sunrise on Monday</p>
<blockquote>
<p>if you’re having trouble at the moment, maybe with your normal healthcare provider, your GP, then please do try pharmacies, maybe try one of the state and territory clinics as they come online. </p>
</blockquote>
<p>He <a href="https://twitter.com/RNBreakfast/status/1480285219496202240">told</a> RN Breakfast that: </p>
<blockquote>
<p>We will have more than enough vaccines for every kid to have their first dose before the end of the year.</p>
</blockquote>
<p>This must be very frustrating for people who have tried to get in early and are keen to have their children vaccinated as soon as possible.</p>
<p>Clearly, something has fallen over somewhere in the distribution. It would be good to have some clarity from government and industry on exactly where the systemic problems are and what’s being planned to address them.</p>
<h2>Domestic production of mRNA vaccines</h2>
<p>The Therapeutic Goods Administration (TGA) only just provisionally approved the use of Pfizer’s COMINARTY COVID vaccine for people aged 5-11 years on <a href="https://www.tga.gov.au/covid-19-vaccines-undergoing-evaluation">December 3</a>.</p>
<p>Moderna’s application for the use of SPIKEVAX COVID vaccine for children under age 12 is still <a href="https://www.tga.gov.au/covid-19-vaccines-undergoing-evaluation">under evaluation</a>, according to the TGA.</p>
<p>Hopefully, once that is approved, parents of children in the 5-11 year old age bracket will have more choice on where and how they can get their child vaccinated.</p>
<p>Both Pfizer and Moderna’s COVID vaccines are mRNA vaccines, and experts have long called for a boost in domestic mRNA manufacturing capacity so Australia is less reliant on overseas supplies.</p>
<p>Promisingly, Moderna and the Australian government late last year <a href="https://www.biopharma-reporter.com/Article/2021/12/14/Moderna-to-build-mRNA-vaccine-manufacturing-facility-in-Australia">announced</a> an in-principle agreement to build a mRNA manufacturing facility in Victoria. The site will hopefully be up and running by 2024, according to media <a href="https://www.abc.net.au/news/2021-12-14/moderna-to-be-first-mrna-vaccine-made-in-australia/100697324">reports</a>. </p>
<p>That’s something to be celebrated, and domestic manufacturing would hopefully mean a shorter and less complex supply chain with less opportunity for difficulties in future. But it does highlight it would have been good to have something worked out earlier. </p>
<p>It would also be prudent for the government to consider what it might take to lure Pfizer to develop mRNA manufacturing capability in Australia. You could argue, from a market point of view, it could be strategic for Moderna to have a manufacturing competitor here in Australia too. </p>
<p>If we are serious about building our biotechnology sector in Australia, then having monopoly of just one player in the country might not be ideal.</p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/supermarket-shortages-are-different-this-time-how-to-respond-and-avoid-panic-174529">Supermarket shortages are different this time: how to respond and avoid panic</a>
</strong>
</em>
</p>
<hr>
<img src="https://counter.theconversation.com/content/174605/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Archa Fox receives funding from the Australian Research Council. She is a member of the Australia New Zealand RNA Production Consortium that has lobbied for establishment of onshore mRNA vaccine manufacturing in Australia</span></em></p>We’re reliant on overseas supply - and the many moving parts of delivery. Each of those parts require staff on the ground – and many workers in this system are likely being affected by Omicron.Archa Fox, Associate Professor and ARC Future Fellow, The University of Western AustraliaLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1729432021-12-02T22:03:12Z2021-12-02T22:03:12ZHow can scientists update coronavirus vaccines for omicron? A microbiologist answers 5 questions about how Moderna and Pfizer could rapidly adjust mRNA vaccines<figure><img src="https://images.theconversation.com/files/435121/original/file-20211201-21-17k49im.jpg?ixlib=rb-1.1.0&rect=0%2C23%2C7940%2C5880&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Some vaccines use mRNA to make copies of the triangular red spike proteins to induce immunity.</span> <span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/photo/covid-19-viruses-attaching-to-cell-illustration-royalty-free-image/1307405789?adppopup=true">Juan Gaertner/Science Photo Library via Getty Images</a></span></figcaption></figure><p><em>If the omicron variant of the coronavirus is different enough from the original variant, it’s possible that existing vaccines won’t be as effective as they have been. If so, it’s likely that companies will need to update their vaccines to better fight omicron. Deborah Fuller is a <a href="https://scholar.google.com/citations?user=eNprtJEAAAAJ&hl=en&oi=ao">microbiologist who has been studying mRNA and DNA vaccines</a> for over two decades. Here she explains why vaccines might need to be updated and what that process would look like.</em></p>
<h2>1. Why might vaccines need to be updated?</h2>
<p>Basically, it’s a question of whether a virus has changed enough so that antibodies created by the original vaccine are no longer able to recognize and fend off the new mutated variant.</p>
<p>Coronaviruses use spike proteins to attach to <a href="https://theconversation.com/what-is-the-ace2-receptor-how-is-it-connected-to-coronavirus-and-why-might-it-be-key-to-treating-covid-19-the-experts-explain-136928">ACE-2 receptors on the surface of human cells and infect them</a>. All mRNA COVID-19 vaccines work by giving instructions in the form of mRNA that direct cells to <a href="https://theconversation.com/how-do-mrna-vaccines-work-and-why-do-you-need-a-second-dose-5-essential-reads-157198">make a harmless version of the spike</a> protein. This spike protein then induces the human body to produce antibodies. If a person is then ever exposed to the coronavirus, these antibodies bind to the coronavirus’s spike protein and thus interfere with its ability to infect that person’s cells. </p>
<p>The omicron variant contains a new <a href="https://www.who.int/news/item/26-11-2021-classification-of-omicron-(b.1.1.529)-sars-cov-2-variant-of-concern">pattern of mutations to its spike protein</a>. These changes could disrupt the ability of some – but probably not all – of the antibodies induced by the current vaccines to <a href="https://doi.org/10.1038/s41586-021-04005-0">bind to the spike protein</a>. If that happens, the vaccines could be less effective at preventing people from getting infected by and transmitting the omicron variant.</p>
<h2>2. How would a new vaccine be different?</h2>
<p>Existing mRNA vaccines, like those made by Moderna or Pfizer, code for a <a href="https://www.cdc.gov/coronavirus/2019-ncov/vaccines/different-vaccines/mrna.html">spike protein from the original strain of coronavirus</a>. In a new or updated vaccine, the mRNA instructions would encode for the omicron spike protein.</p>
<p>By swapping out the genetic code of original spike protein for the one from this new variant, a new vaccine would induce antibodies that more effectively bind the omicron virus and prevent it from infecting cells. </p>
<p>People already vaccinated or previously exposed to COVID-19 would likely need only a single booster dose of a new vaccine to be protected not only from the new strain but <a href="https://doi.org/10.1038/d41586-021-02795-x">also other strains that may be still in circulation</a>. If omicron emerges as the dominant strain over delta, then those who are unvaccinated would only need to receive 2-3 doses of the updated vaccine. If delta and omicron are both in circulation, people would likely get a combination of the current and updated vaccines.</p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/435122/original/file-20211201-28-lmhzff.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="A diagram showing how DNA becomes mRNA which becomes proteins." src="https://images.theconversation.com/files/435122/original/file-20211201-28-lmhzff.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/435122/original/file-20211201-28-lmhzff.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=470&fit=crop&dpr=1 600w, https://images.theconversation.com/files/435122/original/file-20211201-28-lmhzff.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=470&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/435122/original/file-20211201-28-lmhzff.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=470&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/435122/original/file-20211201-28-lmhzff.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=591&fit=crop&dpr=1 754w, https://images.theconversation.com/files/435122/original/file-20211201-28-lmhzff.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=591&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/435122/original/file-20211201-28-lmhzff.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=591&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">By changing the mRNA sequence in a vaccine, researchers can change the antibody producing protein it encodes for to better match new variants.</span>
<span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/illustration/protein-syntesis-schematic-illustration-royalty-free-illustration/1298189974?adppopup=true">Alkov/iStock via Getty Images</a></span>
</figcaption>
</figure>
<h2>3. How do scientists update a vaccine?</h2>
<p>To make an updated mRNA vaccine, you need two ingredients: the genetic sequence of the spike protein from a new variant of concern and a DNA template that would be used to build the mRNA.</p>
<p>In most organisms, DNA provides the instructions for making mRNA. Since researchers have already <a href="https://covariants.org/variants/21K.Omicron">published the genetic code for the omicron spike protein</a>, all that’s left to do is make a DNA template for the spike protein that would be used to produce the mRNA part of new vaccines. </p>
<p>To do this, researchers mix DNA templates with synthetic enzymes and four molecular building blocks that make mRNA – G, A, U and C for short. The enzymes then build an mRNA copy of the DNA template, a process called transcription. Using this process, it takes only minutes to produce a batch of the mRNA for vaccines. Researchers then place the mRNA transcripts within <a href="https://www.genome.gov/about-genomics/fact-sheets/COVID-19-mRNA-Vaccine-Production">fatty nanoparticles that protect the instructions</a> until they are safely delivered into cells in your arm.</p>
<h2>4. How long until a new vaccine might be ready?</h2>
<p>It takes only three days to generate the DNA template needed to make a new mRNA vaccine. Then it would take about a week to produce sufficient doses of the mRNA vaccine for testing in the lab and another six weeks to perform the pre-clinical tests on human cells in test tubes to make sure a new vaccine works as it should.</p>
<p>So <a href="https://doi.org/10.1038/d41586-021-00241-6">within 52 days</a>, scientists could have an updated mRNA vaccine ready to plug into the manufacturing process and begin producing doses for a human clinical trial. That trial would likely require at least another few weeks for a total of around 100 days to update and test a new vaccine.</p>
<p>While that trial is going on, manufacturers could start switching their current process to making a new vaccine. Ideally, once the clinical trial is complete – and if the vaccine gets authorized or approved – a company could immediately start rolling out doses of a new vaccine.</p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/435124/original/file-20211201-25-9dj61a.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="Dozens of vaccine vials on a table." src="https://images.theconversation.com/files/435124/original/file-20211201-25-9dj61a.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/435124/original/file-20211201-25-9dj61a.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/435124/original/file-20211201-25-9dj61a.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/435124/original/file-20211201-25-9dj61a.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/435124/original/file-20211201-25-9dj61a.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/435124/original/file-20211201-25-9dj61a.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/435124/original/file-20211201-25-9dj61a.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=503&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">Both Moderna and Pfizer have made statements saying that they could have updated vaccines ready for trials in fewer than 100 days.</span>
<span class="attribution"><a class="source" href="https://newsroom.ap.org/detail/APTOPIXVirusOutbreakBrazil/66429176b01146408b7757600b8c55c4/photo?Query=covid%20vaccine%20vials&mediaType=photo&sortBy=&dateRange=Anytime&totalCount=697&currentItemNo=38">AP Photo/Bruna Prado</a></span>
</figcaption>
</figure>
<h2>5. Does an updated vaccine need full clinical trials?</h2>
<p>It’s currently not clear how much clinical data would be required to get FDA approval or authorization for an updated COVID-19 vaccine. However, all the ingredients would be the same in a new vaccine. The only difference would be a few lines of genetic code that would ever so slightly change the shape of the spike protein. From a safety perspective, an updated vaccine is essentially identical to the already tested vaccines. Because of these similarities, clinical testing may not need to be as extensive as what was needed for the first-generation COVID-19 vaccines.</p>
<p>At a minimum, clinical trials for updated vaccines would likely require safety testing and confirmation that an updated vaccine <a href="https://www.technologyreview.com/2021/01/13/1016098/moderna-variant-coronavirus-vaccine-update/">induces antibody levels</a> on par with the response of the original vaccine against the original, beta and delta strains. If these are the only requirements, then researchers would enroll only hundreds – not tens of thousands – of people to obtain the clinical data needed. </p>
<p>[<em>The Conversation’s science, health and technology editors pick their favorite stories.</em> <a href="https://theconversation.com/us/newsletters/science-editors-picks-71/?utm_source=TCUS&utm_medium=inline-link&utm_campaign=newsletter-text&utm_content=science-favorite">Weekly on Wednesdays</a>.]</p>
<p>One important thing to note is that if vaccine manufacturers decide to update their vaccines for the omicron variant, it wouldn’t be their first time making this kind of change.</p>
<p>A previous variant, B.1.351, emerged in October 2020 and was <a href="https://www.cdc.gov/coronavirus/2019-ncov/science/science-briefs/scientific-brief-emerging-variants.html">sufficiently resistant to then-current vaccines to warrant updating them</a>. Manufacturers quickly responded to the potential threat by developing an updated mRNA vaccine to match this variant and performed clinical trials to <a href="https://www.nih.gov/news-events/news-releases/nih-clinical-trial-evaluating-moderna-covid-19-variant-vaccine-begins">test the new vaccine</a>. Fortunately, this variant did not become the dominant variant. But if it had, vaccine manufacturers <a href="https://doi.org/10.1038/d41586-021-02854-3">would have been ready to roll out an updated vaccine</a>.</p>
<p>If it turns out that omicron – or any future variant, for that matter – warrants a new vaccine, companies have already completed the dress rehearsals and are ready to meet the challenge.</p><img src="https://counter.theconversation.com/content/172943/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Deborah Fuller is co-founder of Orlance, Inc, a biotechnology company developing a needle free technology to deliver RNA and DNA vaccines. She also serves as a scientific advisor for HDT Bio, a biotechnology company developing RNA vaccines for COVID19 and other infectious diseases. She receives funding supporting basic and translational research in RNA and DNA vaccines from the National Institutes of Health.</span></em></p>The new omicron variant of coronavirus has a number of mutations that may require manufacturers to update vaccines. The unique attributes of mRNA vaccines make updating them fast and easy.Deborah Fuller, Professor of Microbiology, School of Medicine, University of WashingtonLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1621102021-07-06T15:00:16Z2021-07-06T15:00:16ZWhy Africa’s push to make vaccines should look further than COVID-19<figure><img src="https://images.theconversation.com/files/405100/original/file-20210608-130350-1ba9vr4.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">South African President Cyril Ramaphosa, Deputy president David Mabuza, Health Minister Dr Zweli Mkhize visiting the Aspen Pharmacare sterile manufacturing facility. </span> <span class="attribution"><span class="source">Lulama Zenzile/Die Burger/Gallo Images via Getty Images</span></span></figcaption></figure><p>It’s unlikely that vaccine manufacturing will offer Africa a quick fix for COVID-19. Countries on the continent are grappling with a diverse array of challenges. These include vaccine hesitancy, supply bottlenecks and a lack of operational funding and human resources to administer jabs. </p>
<p>Still, the political will to boost local manufacturing of vaccines is rising across the globe, including in Africa – and has never been this high.</p>
<p>The reason is simple. COVID-19 has shown that regions and countries take care of their own people first when crises hit. Africa wants to be able to do the same. To do so, the continent must seize new opportunities to fast-track the development of vaccine manufacturing capacity and to boost regulatory processes.</p>
<p>In 2020, about 40 African countries participated in a World Health Organisation (WHO) <a href="https://www.who.int/director-general/speeches/detail/director-general-s-opening-remarks-for-panel-is-africa-ready-to-finance-its-own-vaccine">training marathon</a> to build manufacturing capacity.
All 54 countries on the continent also supported Ethiopia’s recently passed resolution to the <a href="https://healthpolicy-watch.news/us-backs-trips-waiver-to-strip-vaccines-of-patent-protection-as-wha-pushes-local-vaccine-capacity/">74th World Health Assembly</a>, focused on strengthening local production of medicine and health technology. At the recent <a href="https://www.g20.org/the-global-health-summit-ended-with-the-signing-of-the-rome-declaration.html">G20 Global Health Summit</a>, the European Commission also announced a new initiative on manufacturing in Africa, backed by €1 billion. </p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/trips-waiver-us-support-is-a-major-step-but-no-guarantee-of-covid-19-vaccine-equity-160638">TRIPS waiver: US support is a major step but no guarantee of COVID-19 vaccine equity</a>
</strong>
</em>
</p>
<hr>
<p>That’s critical because manufacturing vaccine doesn’t come cheap. Success will depend heavily on support – in cash and in kind – from developed countries. It takes hundreds of millions of dollars to produce a <a href="https://www.thelancet.com/journals/langlo/article/PIIS2214-109X(18)30346-2/fulltext">new vaccine</a>. </p>
<p>There is hope for relaxation of <a href="https://theconversation.com/trips-waiver-us-support-is-a-major-step-but-no-guarantee-of-covid-19-vaccine-equity-160638">intellectual property rights</a>. These are necessary to open the way to local manufacturing of existing vaccines. </p>
<p>But the production process for new vaccines can take as long as five to 10 years. The typical vaccine roadmap begins with exploratory research, followed by pre-clinical and clinical safety and efficacy testing on animals and humans – and regulatory reviews and approvals for licensing. Only then can the manufacturing process begin.</p>
<p>This requires a significant body of skills. Local expertise in areas such as research and development, regulatory expertise and quality assurance must be strengthened too. </p>
<h2>Local manufacturing</h2>
<p>It will take several more years before countries are fully prepared to manufacture new vaccines to the scale of contributing significantly to global output. Therefore, governments should adopt a longer-term view that prioritises the most urgent health challenges in the region. This vision must be about manufacturing vaccine generally, rather than COVID-19 vaccines specifically.</p>
<p>Africa has <a href="https://www.nature.com/articles/d41586-021-01048-1">54 countries</a> and 1.2 billion people, but produces only 1% of all the vaccines it administers. The continent also faces a heavy burden of disease. Over <a href="https://www.who.int/news-room/fact-sheets/detail/malaria#:%7E:text=Disease%20burden&text=cases%20in%202018.-,The%20estimated%20number%20of%20malaria%20deaths%20stood%20at%20409%20000,all%20malaria%20cases%20and%20deaths">90%</a> of the world’s malaria deaths and <a href="https://www.afro.who.int/health-topics/hivaids">70%</a> of all people living with HIV are in Africa.</p>
<p>So far, the continent has only a few producers of vaccines. Statutes signed between the government of Senegal and the Institut Pasteur in <a href="https://www.avmi-africa.org/manufacturers/#1490181278853-496b3000-e3fc">2009</a> allowed the country to manufacture yellow fever vaccines. There are <a href="https://www.avmi-africa.org/manufacturers/#1490181277540-254a2bb0-9973">six other vaccine manufacturing institutes</a>. One is <a href="https://www.vacsera.com/">VACSERA </a>in Egypt, the oldest vaccine manufacturer in Africa. Egypt is slated to complete the production of <a href="https://egyptindependent.com/egypt-to-produce-40-million-doses-of-sinovac-vaccine-in-2021/">40 million</a> doses of China’s Sinovac COVID-19 vaccine domestically by the end of 2021. In South Africa, the pharmaceutical company<a href="https://www.aspenpharma.com/"> Aspen</a> will be manufacturing doses of the <a href="https://www.reuters.com/article/uk-health-coronavirus-safrica-johnson-jo-idUSKBN2BO5IA">Johnson & Johnson</a> COVID-19 vaccine under licence.</p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/vaccine-production-in-south-africa-how-an-industry-in-its-infancy-can-be-developed-153204">Vaccine production in South Africa: how an industry in its infancy can be developed</a>
</strong>
</em>
</p>
<hr>
<p>Most local companies engage only in packaging and labelling, and occasionally fill-and-finish steps. But it’s noteworthy that there are about <a href="https://www.afro.who.int/news/what-africas-vaccine-production-capacity">80 sterile injectables facilities</a> on the continent. These produce a broad range of fill-and-finish sterile solutions and emulsions including anaesthetics, eye drops and multi-drug resistant tuberculosis vaccines. Significant financial commitment would be required to transform them into fully integrated manufacturing facilities. But these operations have built solid track records with partners and suppliers that will benefit expansion plans.</p>
<h2>Integrating policies</h2>
<p>Africa’s segmented markets, and often small economies, are at odds with the fact that vaccines are mostly produced in large quantities to keep prices down. They require large markets for sustainability. Regulatory bodies that meet international standards are also lacking, presenting a further hurdle.</p>
<p>Integrating national and regional policies and strategies would in effect increase the size of the overall market. All countries could then benefit, regardless of the size of their economy.</p>
<p>More integration will drive agreement on the manufacturing of products in high demand in Africa. It will also expand market access, and help avoid costly duplication. But most importantly, it will help ensure sustainability because most African countries’ markets are too small to support their own manufacturing. </p>
<p>African countries must make better use of regional economic integration platforms such as the <a href="https://www.ecowas.int/">Economic Community of West African States</a>, the <a href="https://www.comesa.int/">Common Market for Eastern and Southern Africa</a>, and the new <a href="https://au.int/en/cfta">African Continental Free Trade Agreement</a>, all of which offer great opportunities. </p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/africas-free-trade-area-offers-great-promise-but-only-if-risks-are-managed-with-resolve-161535">Africa's free trade area offers great promise. But only if risks are managed with resolve</a>
</strong>
</em>
</p>
<hr>
<p>The <a href="https://www.un.org/africarenewal/magazine/november-december-2020/afcfta-africa-readying-free-trade-come-january-2021">African Continental Free Trade Area</a>, for example, aims to reduce all trade costs – it will eliminate 90% of tariffs – and enable Africa to integrate further into global supply chains. Cutting red tape and simplifying customs procedures will bring significant income gains. </p>
<p>Strong regulatory capacity and oversight is another building block for vaccine production and product safety. Countries must strengthen their regulatory systems to ensure that all medical products are of the highest quality, and that local manufacturers maintain international standards. This is why it’s critical for member states to urgently ratify the treaty to support the creation of the <a href="https://au.int/en/pressreleases/20200205/african-medicine-agency-ama-treaty">African Medicines Agency</a>. To date, <a href="https://au.int/en/pressreleases/20210507/republic-guinea-deposits-instrument-ratification-african-medicines-agency-ama">seven</a> of the required 15 African Union member states have ratified the treaty.</p>
<p>The World Health Organisation, where I am the regional advisor for vaccine research and regulation in the Africa region, works with member states and partners towards local vaccine manufacture.</p>
<p>In Ethiopia, for example, we are working closely with the Ministry of Health. We’re conducting a feasibility study in respect of the potential for high-standard manufacturing of vaccines. We’re also developing cost estimates for a road map to success.</p>
<p>Ethiopia, home to the second biggest population on the continent, had to pay a hefty US$707 million to procure routine vaccines between 2016 to 2020. That’s an enormous financial burden and sends a very clear message about the urgency for local manufacturing.</p>
<h2>Looking forward</h2>
<p>Africa is facing <a href="https://www.dw.com/en/coronavirus-digest-who-says-africa-urgently-needs-20-million-vaccine-doses/a-57695529">delays in accessing life-saving vaccines</a> for COVID-19. The continent may experience similar delays in the future. The continent faces significant and enduring <a href="https://www.hsph.harvard.edu/news/features/africa-cdc-head-is-driving-a-new-public-health-agenda-on-the-continent/#:%7E:text=March%2012%2C%202020%20%E2%80%93%20Africa%20faces,growing%20burden%20of%20chronic%20diseases">public health threats</a>, including measles, rotavirus, yellow fever and Ebola.</p>
<p>To manage these public health threats, Africa needs its own capacity for vaccine development and production so that it can immunise for childhood diseases and help control outbreaks of highly infectious diseases – including COVID-19.</p><img src="https://counter.theconversation.com/content/162110/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Bartholomew Dicky Akanmori is Regional Adviser for Vaccine Research and Regulation in the WHO Regional Office for Africa. </span></em></p>Vaccine manufacturing doesn’t come cheap. It depends heavily on support from developed countries. It also requires much more than relaxing intellectual property rights and a desire for vaccine equity.Bartholomew Dicky Akanmori, Professor Emeritus of Immunology, University of GhanaLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1627782021-06-21T14:12:56Z2021-06-21T14:12:56ZA COVID-19 vaccine plant in Africa? This is what it would take to build one<figure><img src="https://images.theconversation.com/files/406671/original/file-20210616-3629-1s8oacg.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Staff members work at a COVID-19 vaccine-producing plant of Sinovac in Beijing.</span> <span class="attribution"><span class="source">Zhang Yuwei/Xinhua via Getty</span></span></figcaption></figure><p>The COVID-19 crisis has <a href="https://www.nature.com/articles/d41586-020-02774-8?faodatalab=2020-10-06-2">revived discussions</a> on <a href="https://discovery.ucl.ac.uk/id/eprint/10044381/1/Local%20Production%20of%20Pharmaceuticals.pdf">localising vaccine manufacturing to the African region</a> to reduce the dependence on imports. </p>
<p>The fact that Africa is lagging so far behind on the COVID-19 vaccination compared with Europe and North America has highlighted the importance of the issue. Most African countries depend on the WHO-sponsored <a href="https://www.who.int/initiatives/act-accelerator/covax">COVAX</a> scheme, which buys COVID-19 vaccines from manufacturers by pooling demand, thus enhancing their bargaining power. It also offers discounts for least developed countries.</p>
<p>However, the scheme is <a href="https://foreignpolicy.com/2021/04/21/covax-africa-vaccine-rollout-coronavirus-pandemic/">underfunded</a> and <a href="https://blogs.lse.ac.uk/globalhealth/2020/12/14/12-days-of-global-health-power-and-the-reproduction-of-global-inequalities/">competes with national authorities</a> procuring vaccines directly from the manufacturers, and thus lacking a secure supply. Moreover, the supply shortage became worse when the <a href="https://www.economist.com/business/2021/03/03/a-billion-plus-covid-19-shots-in-2021-can-serum-institute-do-it">Serum Institute of India</a>, previously the main supplier to COVAX, <a href="https://www.ft.com/content/5f38b956-9eaf-4026-99ee-b7887e38dd16">focused on domestic needs</a> when the pandemic spread in India.</p>
<p>So what would actually be needed to localise vaccine manufacturing in Africa?</p>
<p>I argue that the main constraints are not patents but time, knowledge transfer and capital. To overcome these constraints, a broad co-operation of many partners is necessary.</p>
<h2>What’s in place</h2>
<p>Several companies have announced their intention to produce COVID-19 vaccines in Africa. These include <a href="https://www.aspenpharma.com/2020/11/02/aspen-announces-agreement-with-johnson-johnson-to-manufacture-investigational-covid-19-vaccine-candidate/">Aspen</a> in South Africa and <a href="https://www.timeslive.co.za/news/south-africa/2021-03-18-cape-town-company-to-manufacture-covid-19-vaccine/">Saidal</a> in Algeria. </p>
<p>Expertise related to other types of vaccines also exists, for example, in the <a href="http://www.pasteur.sn/institut/">Institut de Pasteur de Dakar</a>. However, most of these plants focus on the final stages of the value chain, filling vials and packaging. Across Africa, <a href="https://www.spotlightnsp.co.za/2021/05/24/in-depth-what-will-it-take-to-actually-make-mrna-vaccines-in-sa/">competences</a> related to earlier stages of the value chain are very limited.</p>
<p>A <a href="https://link.springer.com/article/10.1057/s42214-021-00103-y">key challenge</a> for local manufacturers of vaccines – and drugs more generally – is competition from India. Indian companies have developed pharma competences, especially in generic medicines and <a href="https://theconversation.com/india-is-key-for-global-access-to-a-covid-19-vaccine-heres-why-144772">vaccines</a>, and benefit from a large domestic market.</p>
<p>National health services in developing economies thus face a basic dilemma: <a href="https://link.springer.com/article/10.1057/s42214-021-00103-y">should they import pharmaceuticals from India, or should they procure from local companies that operate at higher costs?</a>.</p>
<p>As most healthcare providers operate under tight budget constraints, they typically opt for imports.</p>
<p>Thus, local companies in Africa would find it very challenging to be cost-competitive in the longer run when the current worldwide scarcity of COVID-19 vaccines is overcome as new plants become operational around the world.</p>
<p>What are the key obstacles an African vaccine hub would have to overcome?</p>
<h2>Constraints</h2>
<p><strong>Time:</strong> It takes time to design and build a manufacturing plant, to obtain all the regulatory approvals, and to establish quality control processes. A particular challenge is that vaccines are living, genetic organisms, consisting of large and complex molecules that require complex biologic processes for their creation, which need to be grown organically.</p>
<p>Moreover, manufacturing depends on supply chains for ingredients and materials, which in this industry generally are global. Globally, supply chains for COVID-19 vaccines have been hampered by <a href="https://www.washingtonpost.com/business/2021/02/18/vaccine-fat-lipids-supply/">manufacturing bottlenecks, monopolised supply</a>, <a href="https://theconversation.com/the-world-is-hungry-for-mrna-covid-vaccines-like-pfizers-but-were-short-of-vital-components-159143">patents</a> and even <a href="https://www.zeit.de/zustimmung?url=https%3A%2F%2Fwww.zeit.de%2Fwirtschaft%2F2021-05%2Fcorona-impfstoffe-patent-aufhebung-globaler-sueden-gerechtigkeit-faq">export bans</a>. In addition, <a href="https://www.oecd.org/coronavirus/policy-responses/using-trade-to-fight-covid-19-manufacturing-and-distributing-vaccines-dc0d37fc/">national trade barriers</a> within the region can increase the costs of sourcing critical inputs.</p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/the-world-is-hungry-for-mrna-covid-vaccines-like-pfizers-but-were-short-of-vital-components-159143">The world is hungry for mRNA COVID vaccines like Pfizer's. But we're short of vital components</a>
</strong>
</em>
</p>
<hr>
<p>Given all these constraints, a potential new plant in Africa would not be operational in 2021, and would not help solve the immediate need for vaccines now. Yet, vaccine building vaccine competences is a goal with longer-term benefits.</p>
<p><strong>Knowledge transfer:</strong> Building and operating a <a href="https://www.nature.com/articles/s41565-020-0737-y">vaccine plant requires state-of-the-art knowledge</a> – especially for new types of vaccine such as <a href="https://www.cdc.gov/coronavirus/2019-ncov/vaccines/different-vaccines/mrna.html">mRNA</a>, including how to build and operate a plant, and how to control its quality. Such knowledge is typically <a href="https://pubsonline.informs.org/doi/abs/10.1287/orsc.5.1.14">tacit</a> and held by people and teams involved in the research and development. Thus, <a href="https://pubsonline.informs.org/doi/abs/10.1287/orsc.1080.0412?casa_token=U5J-gZvpPiQAAAAA:PWePgefCbeu6ia4mgxUvRRcKEYSzyXqJx5AfTRnb4Ud3fecyu4cUXEb00dJsWH2NceD9JDAUn7o">it needs to be shared by direct interpersonal interaction</a>; it cannot be obtained by reading patents or other public sources.</p>
<p>This contrasts with drugs, for example, that can be reverse engineered, <a href="https://issues.org/covid-vaccines-development-distribution-patenting-shadlen/">enabling generic manufacturers to develop and scale up production</a> without collaboration of the patent holder.</p>
<p>Thus, new manufacturers of vaccines need to acquire and absorb a lot of knowledge, which practically cannot be done (at least not in a timely fashion) without <a href="https://issues.org/covid-vaccines-development-distribution-patenting-shadlen/">direct collaboration with those who hold the knowledge</a>. At the same time, <a href="https://www.frontiersin.org/articles/10.3389/fpubh.2019.00056/full">national regulatory authorities need to address their capability gaps</a>.</p>
<p><strong>Investment capital:</strong> Big investment projects with revenues far in the future need risk capital to finance the construction. The first question any investor – be they an aid organisation or a private investor – will ask is: what is the demand for your product when you are ready to go to market?</p>
<p>Operating costs in Africa are likely to be higher due to lesser scale of the operation, and more complex logistics. Thus, an investor would be concerned that the plant is not price-competitive in normal situations – that is without the current global shortage of vaccines in 2021.</p>
<p>This concern can be addressed by advance purchase commitments, preferably with up-front payment (that’s how the UK and the US <a href="https://www.politico.eu/article/the-key-differences-between-the-eu-and-uk-astrazeneca-contracts/">secured their early lead in vaccine supply</a>). </p>
<p>As the likely buyers mostly are state-related agencies, such as national health systems, they would have to sign purchase agreements. Ideally, several national health systems would cooperate to contract one manufacturer in the region to enable scale of the operation. Yet, they might be reluctant to commit given the prospect (albeit uncertain) that imported vaccines might be available at a cheaper price in two to three years.</p>
<p>Once, national health systems – or other potential buyers – have indicated their commitments, there may also be an opportunity for effective development aid. Donors may for example subsidise the purchase agreements. Or, development banks may take equity in the new plant and share the risk of the operation.</p>
<p><strong>Intellectual property rights:</strong> A waiver or a compulsory licence for key technology, including ingredients and materials, would help lower costs. But it would need to be valid over the operating lifetime of the plant. In other words, a waiver “until the end of the pandemic” is of little help.</p>
<p>The World Trade Organisation’s <a href="https://link.springer.com/article/10.1057/s42214-020-00079-1">TRIPs agreement in principle allows countries to impose compulsory licensing</a> in cases of national emergencies. However, a recent review study has shown that this possibility <a href="https://link.springer.com/article/10.1057%2Fs42214-020-00068-4">is rarely used</a> – the requirements are too complex, <a href="https://theconversation.com/how-to-get-covid-19-vaccines-to-poor-countries-and-still-keep-patent-benefits-for-drugmakers-158384">especially for countries without local manufacturing capacity</a>. </p>
<p>Reform of the TRIPS agreement would help, notably by simplifying compulsory licensing, or by reducing the scope and length of intellectual property rights. At a minimum, this would strengthen the bargaining power of local players engaging with the global industry.</p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/how-to-get-covid-19-vaccines-to-poor-countries-and-still-keep-patent-benefits-for-drugmakers-158384">How to get COVID-19 vaccines to poor countries – and still keep patent benefits for drugmakers</a>
</strong>
</em>
</p>
<hr>
<h2>Overcoming the constraints</h2>
<p>Local vaccine manufacturing in Africa is both feasible and desirable because it helps Africa to respond to future pandemics. To achieve that, a broad regional partnership with substantial up-front commitments is necessary.</p>
<p>First, to enable efficient scale of operation, national authorities across the region need to collaborate to coordinate health sector procurement, regulation and quality control of the medicines, and trade policies.</p>
<p>Second, owners of the technology should be part of the partnership, not only to facilitate the transfer of tacit knowledge but also to ensure quality control. <a href="https://www.ft.com/content/2db9e21f-881d-4da2-8394-3ec732024581">BioNTech</a>, for example, has stated that it is willing to engage in this type of collaboration.</p>
<p>Third, development organisations may support such ventures by bringing partners together, co-funding advance purchase agreements, and perhaps by investing in the plant itself.</p>
<p>Policy makers may help creating such partnerships by simplifying compulsory licensing rules. In contrast, a time-limited patent waiver would achieve little.</p><img src="https://counter.theconversation.com/content/162778/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Klaus Meyer does not work for, consult, own shares in or receive funding from any company or organisation that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.</span></em></p>Local companies in Africa would find it very challenging to be cost-competitive in the longer run when the current worldwide scarcity of COVID-19 vaccines is overcome.Klaus Meyer, Professor of International Business, Ivey Business School, Western UniversityLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1606852021-05-11T21:22:54Z2021-05-11T21:22:54ZCanada is virtue signalling while waffling on global access to COVID-19 vaccines<figure><img src="https://images.theconversation.com/files/400122/original/file-20210511-13-1tuqssl.jpg?ixlib=rb-1.1.0&rect=237%2C26%2C3233%2C2365&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Anita Anand, Canada's minister of public services and procurement, opens a box with some of the first 500,000 of the two million AstraZeneca COVID-19 vaccine doses that Canada secured last March through a deal with the Serum Institute of India. </span> <span class="attribution"><span class="source">THE CANADIAN PRESS/Carlos Osorio - POOL</span></span></figcaption></figure><p>Based on public statements, it’s easy to come to the conclusion that Canada is working to improve global access to COVID-19 vaccines.</p>
<p>This quote comes from an <a href="https://www.washingtonpost.com/opinions/2020/07/15/international-community-must-guarantee-equal-global-access-covid-19-vaccine/">opinion piece</a> in the <em>Washington Post</em> on July 15, 2020; the lead author, none other than Prime Minister Justin Trudeau:</p>
<blockquote>
<p>“…we must urgently ensure that vaccines will be distributed according to a set of transparent, equitable and scientifically sound principles. Where you live should not determine whether you live, and global solidarity is central to saving lives and protecting the economy.”</p>
</blockquote>
<p>The person being quoted here in early May of this year is <a href="https://www.theglobeandmail.com/politics/article-trudeau-wont-state-position-on-covid-19-vaccine-patent-waiver-as/">Mary Ng</a>, the International Trade Minister in Trudeau’s cabinet:</p>
<blockquote>
<p>“The work we have been doing and the leadership we have been providing is very much about removing all barriers to vaccine access, whether it be production or supply chain or export restrictions…We’re trying to remove all barriers to access to vaccines.”</p>
</blockquote>
<p>But despite what Trudeau and Ng said, Canada is not doing all that it can to improve access. Far from it.</p>
<h2>Virtue signalling with little action</h2>
<p>Canada has <a href="https://www.bnnbloomberg.ca/canada-has-reserved-more-vaccine-doses-per-person-than-anywhere-1.1533041">signed contracts for enough vaccine doses</a> to inoculate every woman, man and child in Canada four times. Canada is <a href="https://globalnews.ca/news/7777450/biden-covid-vaccine-canada-help/">accepting vaccine donations</a> from the United States and also <a href="https://www.cbc.ca/news/politics/covax-first-shipment-canada-1.5979777">purchasing vaccines from COVAX</a> (COVID-19 Vaccines Global Access — a mechanism mainly designed to ensure that low- and middle-income countries can access vaccines). </p>
<p>Over one-third of Canadians have <a href="https://health-infobase.canada.ca/covid-19/vaccination-coverage/">received at least one dose of vaccine</a> as of May 7, compared to <a href="https://www.dw.com/en/coronavirus-africas-vaccination-rollout-off-to-slow-start/a-57242006">vaccination rates of under two per cent in Africa</a>. Back in January, Canada <a href="https://www.theglobeandmail.com/world/article-canada-rejects-who-request-for-immediate-vaccine-donations-to-lower/">refused to donate any vaccines</a> and that position has not changed since.</p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/400123/original/file-20210511-13-1wx018t.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="A person in a reflective vest and a face mask examining a crate with a COVAX label" src="https://images.theconversation.com/files/400123/original/file-20210511-13-1wx018t.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/400123/original/file-20210511-13-1wx018t.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/400123/original/file-20210511-13-1wx018t.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/400123/original/file-20210511-13-1wx018t.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/400123/original/file-20210511-13-1wx018t.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/400123/original/file-20210511-13-1wx018t.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/400123/original/file-20210511-13-1wx018t.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=503&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">A shipment of COVID-19 vaccines distributed by the COVAX Facility arrives in Abidjan, Ivory Coast, last February.</span>
<span class="attribution"><span class="source">(AP Photo/ Diomande Ble Blonde)</span></span>
</figcaption>
</figure>
<p>This pattern of virtue signalling about access to medicines and then doing nothing has a long tradition in Canada.</p>
<p>Back in the late 1990s, the South African government was trying to improve access to drug treatment for the staggering <a href="https://academic.oup.com/ije/article/31/1/37/655915">22 per cent of the population that was HIV positive</a>. At that time, triple therapy — the three-drug cocktail used to treat HIV — <a href="https://www.msf.org/untangling-web-antiretroviral-price-reductions-14th-edition">cost over US $10,000 per person per year</a>, effectively putting it out of reach of the vast majority of South Africans. </p>
<p>South Africa wanted to encourage the use of low-cost generic drugs. The response from 39 drug companies, backed by the United States, was to take South Africa to court. Canada’s position? We <a href="http://jmcti.org/2000round/build-in-agenda/service/S_CSS_W_046.pdf">supported access but we also supported the intellectual property rights of the drug companies</a>.</p>
<h2>C-TAP, COVAX and the WTO TRIPS waiver</h2>
<p>Fast forward to the present and COVID-19. In May 2020, the World Health Organization launched the <a href="https://www.who.int/news-room/detail/29-05-2020-international-community-rallies-to-support-open-research-and-science-to-fight-covid-19">COVID-19 Technology Access Pool</a>, or C-TAP, an initiative to accelerate and broaden global access to COVID-19 vaccines under development at the time, as well as treatments and diagnostics. </p>
<p>C-TAP has the <a href="https://www.who.int/initiatives/covid-19-technology-access-pool/endorsements-of-the-solidarity-call-to-action">endorsement of 40 countries</a>. But not Canada. No pharmaceutical company has contributed to C-TAP. <a href="https://www.statnews.com/pharmalot/2020/05/28/who-voluntary-pool-patents-pfizer/">Pfizer CEO Albert Bourla said</a>: “At this point in time, I think it’s nonsense, and… it’s also dangerous.”</p>
<figure class="align-center ">
<img alt="A policeman standing on a skip with crates of vaccine." src="https://images.theconversation.com/files/400125/original/file-20210511-23-x2rlm8.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/400125/original/file-20210511-23-x2rlm8.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/400125/original/file-20210511-23-x2rlm8.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/400125/original/file-20210511-23-x2rlm8.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/400125/original/file-20210511-23-x2rlm8.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/400125/original/file-20210511-23-x2rlm8.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/400125/original/file-20210511-23-x2rlm8.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=503&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">A Malawian policeman guards AstraZeneca COVID-19 vaccines after the shipment arrived in March at the Kamuzu International Airport in Lilongwe, Malawi.</span>
<span class="attribution"><span class="source">(AP Photo/Thoko Chikondi, File)</span></span>
</figcaption>
</figure>
<p>COVAX is designed to give poor countries enough vaccine for 20 per cent of their population, but it is <a href="https://www.devex.com/news/covax-facility-seeks-an-additional-2b-for-covid-19-vaccines-99671">$2 billion short</a> of even achieving that modest objective.</p>
<p>In the face of the failure of C-TAP and in order to supplement what COVAX could do, back in October 2020 India and South Africa asked the World Trade Organization to <a href="https://www.barrons.com/articles/the-arguments-against-sharing-covid-19-intellectual-property-dont-add-up-51620056595">suspend the protection of intellectual property</a>.</p>
<p>The request included patent rights, technical know-how and undisclosed data for COVID-19 products for the duration of the pandemic. This is known as the TRIPS (Trade-Related Aspects of Intellectual Property Rights) waiver. The objective was to free up unused worldwide capacity to increase the production of vaccines and other products necessary for the prevention and treatment of COVID-19.</p>
<p>As many <a href="https://www.theglobeandmail.com/business/commentary/article-suspending-covid-19-vaccine-patents-is-morally-correct-but-wont-move/">commentators have pointed out</a>, if the waiver is approved by the WTO (and approval requires consensus among all its 159 members), nothing will change overnight. It will take many months and possibly even longer to ramp up vaccine production. </p>
<p>But that increased capacity is going to be needed. It is increasingly looking like we might require <a href="https://www.nationalgeographic.com/science/article/why-annual-covid-19-boosters-may-become-the-norm">yearly booster shots for COVID-19</a> as variants multiply. That’s almost six billion doses of vaccine a year for people 15 years and older, <a href="https://www.barrons.com/articles/the-arguments-against-sharing-covid-19-intellectual-property-dont-add-up-51620056595">almost double the current capacity to produce vaccines</a>. </p>
<p>Moreover, when drug companies think that the pandemic is over, they are going to raise prices dramatically. Pfizer currently charges US$19.50 per dose, but chief financial officer Frank D’Amelio said that <a href="https://www.fiercepharma.com/pharma/pfizer-eyes-higher-covid-19-vaccine-prices-after-pandemic-exec-analyst">Pfizer’s normal price for vaccines is $150 to $175</a>.</p>
<h2>Canada’s position on intellectual property</h2>
<p>To the amazement of just about everyone, the Biden administration just announced that the U.S. is going to <a href="https://www.cnn.com/2021/05/05/politics/vaccine-patent-waivers/index.html">support the waiver</a> for COVID-19 vaccines.</p>
<p>Canada? Just like the South Africa situation, we neither support nor oppose the waiver. The Canadian government will take part in talks at the WTO about the waiver, but won’t say which side it will be taking. </p>
<figure class="align-center ">
<img alt="A motorcade of police cars and a truck." src="https://images.theconversation.com/files/400126/original/file-20210511-23-1cxa0na.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/400126/original/file-20210511-23-1cxa0na.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=418&fit=crop&dpr=1 600w, https://images.theconversation.com/files/400126/original/file-20210511-23-1cxa0na.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=418&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/400126/original/file-20210511-23-1cxa0na.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=418&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/400126/original/file-20210511-23-1cxa0na.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=525&fit=crop&dpr=1 754w, https://images.theconversation.com/files/400126/original/file-20210511-23-1cxa0na.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=525&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/400126/original/file-20210511-23-1cxa0na.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=525&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">A police escort follows the shipment carrying just under 300,000 doses of the single-shot Johnson & Johnson COVID-19 vaccine, which is developed by the Janssen Pharmaceutical Companies, at Pearson International Airport in Toronto on April 28.</span>
<span class="attribution"><span class="source">THE CANADIAN PRESS/Nathan Denette</span></span>
</figcaption>
</figure>
<p>Canada’s position for months has been that it was “<a href="https://www.theglobeandmail.com/politics/article-trudeau-wont-state-position-on-covid-19-vaccine-patent-waiver-as/">merely asking questions about the patent waiver proposal, rather than opposing it</a>.” But in a <a href="https://patentdocs.typepad.com/files/2021-03-05-phrma-letter.pdf">letter to the U.S. government</a> back in March from the Pharmaceutical Research and Manufacturers of America, Canada was listed as one of the countries standing with the U.S. in opposing the waiver.</p>
<p>Canada is <a href="https://www.theglobeandmail.com/politics/article-canada-to-take-part-in-talks-over-vaccine-patent-waivers-but-wont/">currently negotiating with drug companies over vaccine delivery schedules</a> and is still in a battle with them about changes to <a href="http://innovativemedicines.ca/pmprb-regulations-delayed/">how prices for patented drug will be determined</a>. </p>
<p>Innovative Medicines Canada (IMC), the lobby group for the multinational companies, not surprisingly has come out strongly against the waiver. <a href="http://innovativemedicines.ca/innovative-medicines-canada-cautions-covid-19-trips-ip-waiver/">In a statement</a> a few days after the U.S. announced its position, IMC said the “proposed waiver of TRIPS IP protections would be a disappointing step that will create greater uncertainty and unpredictability in the production, quality, and availability of COVID-19 vaccines worldwide.” </p>
<p>How much is fear of further angering the pharmaceutical industry playing into Canada’s position on the waiver?</p>
<p>When it comes to standing up for access to medicines versus standing up for intellectual property rights, for Canada, plus ça change, plus c’est la même chose; the more things change, the more they stay the same.</p><img src="https://counter.theconversation.com/content/160685/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>In 2017-2020, Joel Lexchin received payments for being on a panel at the American Diabetes Association, for talks at the Toronto Reference Library, for writing a brief in an action for side effects of a drug for Michael F. Smith, Lawyer and a second brief on the role of promotion in generating prescriptions for Goodmans LLP and from the Canadian Institutes of Health Research for presenting at a workshop on conflict-of-interest in clinical practice guidelines. He is currently a member of research groups that are receiving money from the Canadian Institutes of Health Research and the Australian National Health and Medical Research Council. He is a member of the Foundation Board of Health Action International and the Board of Canadian Doctors for Medicare. He receives royalties from University of Toronto Press and James Lorimer & Co. Ltd. for books he has written. </span></em></p>Despite some public virtue signalling, the Canadian government is not doing all it can to improve global access to COVID-19 vaccines. Canada has yet to announce its position on the WTO patent waiver.Joel Lexchin, Professor Emeritus of Health Policy and Management, York University, Emergency Physician at University Health Network, Associate Professor of Family and Community Medicine, University of TorontoLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1591432021-04-27T20:06:09Z2021-04-27T20:06:09ZThe world is hungry for mRNA COVID vaccines like Pfizer’s. But we’re short of vital components<p>Given the AstraZeneca COVID-19 vaccine is no longer recommended for under-50s following news of very rare <a href="https://theconversation.com/what-is-thrombocytopenia-the-rare-blood-condition-possibly-linked-to-the-astrazeneca-vaccine-158522">blood clots</a>, Australia is looking to other vaccines to plug the gap.</p>
<p>Pfizer’s mRNA vaccine will become the mainstay of the rollout, with <a href="https://www.abc.net.au/news/2021-04-09/national-cabinet-astrazeneca-covid-vaccine-clots-rollout/100058440">40 million doses</a> expected to arrive before year’s end.</p>
<p>But Australia isn’t the only country eager to get its hand on this vaccine.</p>
<p>Skyrocketing demand coupled with shortages of vital components is leading to bottlenecks in the supply chain of this and other mRNA vaccines, delaying vaccine supplies.</p>
<p>The Victorian government also <a href="https://www.premier.vic.gov.au/victoria-ready-lead-new-vaccine-manufacturing">announced last week</a> it would provide A$50 million to set up local manufacturing of mRNA vaccines in Australia. It’s feasible supply chain issues could also impact local manufacturing of mRNA vaccines.</p>
<p>So what are the missing supplies for making mRNA vaccines?</p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/what-is-mrna-the-messenger-molecule-thats-been-in-every-living-cell-for-billions-of-years-is-the-key-ingredient-in-some-covid-19-vaccines-158511">What is mRNA? The messenger molecule that's been in every living cell for billions of years is the key ingredient in some COVID-19 vaccines</a>
</strong>
</em>
</p>
<hr>
<h2>The shortages slowing mRNA vaccine production</h2>
<p><strong>1. mRNA manufacturing and capping</strong></p>
<p>Manufacturing mRNA vaccines is kind of like making a car, with an assembly line and many steps. Each step needs to lead to the next and flow smoothly to make the final product. </p>
<p>COVID mRNA vaccine manufacturing starts with making the “messenger RNA”, the instructions that tell our cells to make the coronavirus’ spike proteins. The mRNA is produced in reactor vessels, where protein enzymes track along a DNA template and copy that DNA sequence into RNA form.</p>
<p>The first shortage is in sterile, single-use plastic bags which sit inside the metal reactor vessels used for making the mRNA, almost like a bin liner. Several suppliers of these plastic liners are <a href="https://www.ft.com/content/b2f4f9cf-af80-428f-a198-2698ceb4c701">ramping up production</a> so it’s anticipated this shortage won’t last too long.</p>
<p>The second main shortage relates to “capping” the mRNA at one end. Capping involves adding a chemical molecule to the mRNA which stops the mRNA breaking down too quickly and helps our cells use the mRNA to make protein. Early on during the worldwide upscaling of mRNA manufacturing, rumours abounded that the enzymes and raw materials to make the mRNA cap were running short, given related enzymes used for COVID tests were also in <a href="https://cen.acs.org/analytical-chemistry/diagnostics/Shortage-RNA-extraction-kits-hampers/98/web/2020/03">short supply</a>. </p>
<p>However, while only a few players <a href="https://uk.finance.yahoo.com/news/nucleotides-market-growth-trends-covid-110900508.html?guccounter=1&guce_referrer=aHR0cHM6Ly93d3cuZ29vZ2xlLmNvbS5hdS8&guce_referrer_sig=AQAAAHT9TQqVB65s3GM9IfZB93re88kb9pAnF6V9n4h1Rhk94u1Z0MM8FHyv_Hao6EidhHEhNe-99VRZtPIQ3t740xsXDzkmY4xGJTFOzUAAmORJi9iEdE9bZPu_2Bl-_DYImw1mPOlwiUfv6njekNtkUa0EQ-puKgT5pcmwx7sUgtbM">dominate the field</a>, this doesn’t seem to be a bottleneck now. But it does still remain one of the most costly parts of the mRNA <a href="https://bioprocessintl.com/sponsored-content/ask-the-expert-high-yield-mrna-production-from-plasmid-to-highly-purified-product/">production process</a>.</p>
<p><strong>2. Lipids in nanoparticles</strong></p>
<p>The main bottleneck right now is the supply of some of the lipids making the nanoparticles that protect the mRNA and deliver it into our cells.</p>
<p>One lipid in particular, a so-called “cationic lipid”, wraps around the mRNA and then releases it inside the cell. Several chemical synthesis steps are required to make these cationic lipids, and prior to COVID only a handful of manufacturers worldwide were making these, and only on a <a href="https://www.washingtonpost.com/business/2021/02/18/vaccine-fat-lipids-supply/">fairly small scale</a>. </p>
<p>Upscaling this production of cationic lipids has been even harder than setting up the mRNA production. Currently, four companies — Croda/Avanti, CordenPharma, Evonik and Merck — are the <a href="https://cen.acs.org/business/outsourcing/Lipids-unsung-COVID-19-vaccine/99/web/2021/02">main manufacturers</a> of these lipids.</p>
<p>As an indication of how serious this shortfall in lipids is, in December 2020 former US President Donald Trump invoked the Defense Production Act to <a href="https://www.ft.com/content/3c21ae81-3504-4d11-8784-c1b67458a0ca">assist Pfizer in accessing</a> more lipids. </p>
<h2>Why do we have these shortages?</h2>
<p>The reasons for these shortages are complex. In most cases, demand has outstripped supply. In some cases, some countries or companies have been stockpiling some of these components. “Operation Warp Speed”, initiated by the Trump administration to speed up COVID vaccine development, used its financial clout <a href="https://www.medicalcountermeasures.gov/barda/influenza-and-emerging-infectious-diseases/coronavirus/pharmaceutical-manufacturing-in-america/">throughout 2020</a> to buy up and secure many vaccine components including vials and lipids. This has put the vaccine manufacturers based in the United States in a good position, including Moderna and several Pfizer sites.</p>
<p>For some materials, the reason for the shortfall is simply that they’re hard to make. The bespoke cationic lipids are chemically synthesised in ten steps that all have to performed under strict quality control. Even if the equipment is ready, setting up such a manufacturing process <a href="https://cen.acs.org/business/outsourcing/Lipids-unsung-COVID-19-vaccine/99/web/2021/02">takes months</a>.</p>
<p><div data-react-class="Tweet" data-react-props="{"tweetId":"1362554064735768578"}"></div></p>
<h2>How could these shortages impact future mRNA manufacturing in Australia?</h2>
<p>When Victoria’s <a href="https://www.abc.net.au/news/2021-04-21/victoria-to-develop-mrna-covid19-vaccine-facilities/100083372">new mRNA manufacturing facility</a> comes online, hopefully in the next 12-24 months, some of these global shortages may still be plaguing the worldwide supply chains. This shouldn’t stop our efforts on that front as raw material supplies are rapidly increasing. </p>
<p>Australia should also do more manufacturing of small molecule active pharmaceutical ingredients, that is, the <a href="https://www.who.int/medicines/areas/quality_safety/quality_assurance/DefinitionAPI-QAS11-426Rev1-08082011.pdf">biologically active component in each drug</a>, including lipids and other building blocks of mRNA. Australia imports over 90% of its <a href="https://www.afr.com/politics/federal/australia-dangerously-dependent-on-medical-imports-20200217-p541ej">drugs from overseas</a>. Making active pharmaceutical ingredients is important, not just for COVID vaccines but more generally.</p>
<p><div data-react-class="Tweet" data-react-props="{"tweetId":"1384681558687236098"}"></div></p>
<p>Australia nearly ran out of some essential drugs, <a href="https://thenewdaily.com.au/news/2020/05/02/coronavirus-shortage-medications/">like ventolin</a>, in the early days of the COVID-19 crisis. This was due to both Australians’ panic buying, as well as COVID-hit Chinese factories slowing down their manufacturing, leading to a lack of access to these ingredients for our most <a href="https://thenewdaily.com.au/news/2020/05/02/coronavirus-shortage-medications/">commonly used drugs</a>. The added benefits of locally based manufacturing of active pharmaceutical ingredients is we’d be part of the solution when components are in short supply in future. </p>
<p>Australia also has a very strong research community in mRNA and nanomedicine. There are several world-leading groups working on creating better lipid nanoparticles for the delivery of mRNA and other medical products.</p>
<p>Having access to local manufacturing capability of active pharmaceutical ingredients would therefore transform the ability of Australian researchers to lead the way in developing the next blockbuster medical technology based on mRNA or nanoparticle delivery.</p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/3-mrna-vaccines-researchers-are-working-on-that-arent-covid-157858">3 mRNA vaccines researchers are working on (that aren't COVID)</a>
</strong>
</em>
</p>
<hr>
<img src="https://counter.theconversation.com/content/159143/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Archa Fox receives funding from the Australian Research Council and the National Health and Medical Research Council of Australia. She is the President of the RNA Network of Australia and a Director of the International RNA Society.</span></em></p><p class="fine-print"><em><span>Pall Thordarson receives funding from the Australian Research Council (ARC), The University of New South Wales, Australian Research Data Commons (ARDC - NCRIS), NSW Health, Cancer Australia and the Kids Cancer project, and the Cooperative Research Centres Projects (CRC-P) scheme with backing from industry partners Genesys Electronic Design and CSL. Pall has been asked to give advise to several organisation and companies that are interest in RNA manufacturing in Australia.</span></em></p>Skyrocketing demand coupled with shortages of vital components is leading to bottlenecks in the supply chain of Pfizer’s and other mRNA vaccines.Archa Fox, Associate Professor and ARC Future Fellow, The University of Western AustraliaPall Thordarson, Professor, Chemistry, UNSW SydneyLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1583002021-04-01T20:07:11Z2021-04-01T20:07:11ZWhy Johnson & Johnson throwing out 15 million COVID-19 vaccine doses shouldn’t scare you<figure><img src="https://images.theconversation.com/files/393200/original/file-20210401-21-1aa4vgp.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Vaccine production staff demonstrate operations at a facility in Germany.</span> <span class="attribution"><a class="source" href="https://newsroom.ap.org/detail/VirusOutbreakGermanyVaccineManufacturing/5d45624961da484aaf748f5e5e0859db/photo">AP Photo/Michael Probst</a></span></figcaption></figure><p>Human errors at a manufacturing plant forced Johnson & Johnson to throw out <a href="https://www.politico.com/news/2021/03/31/johnson-johnson-vaccine-15-million-ruined-478776">15 million doses</a> of its COVID-19 vaccine – enough to vaccinate 7% of the U.S. adult population. </p>
<p>The New York Times, which first reported the loss on March 31, 2021, called it “<a href="https://www.nytimes.com/2021/03/31/world/johnson-and-johnson-vaccine-mixup.html?smtyp=cur&smid=tw-nytimes">a major embarrassment</a>” for the vaccine-maker and its subcontractor, Emergent BioSolutions.</p>
<p>But while errors with an impact of that magnitude sound shocking, they’re also a reminder that the U.S. vaccine manufacturing process has strict quality control measures designed to catch these problems before they reach the public.</p>
<p>Vaccine manufacturing is complex, with many potential points for errors. As an expert in <a href="https://scholar.google.com/citations?user=cpd3_bYAAAAJ&hl=en">health care operations</a> and the <a href="https://papers.ssrn.com/sol3/papers.cfm?abstract_id=3797192">COVID-19 vaccine rollout</a>, I closely follow vaccine manufacturing and approval processes. The multiple layers of quality checks by the producer and external inspectors throughout the process are essential to protect public health.</p>
<h2>Checking the vaccines, and checking them again</h2>
<p>After authorizing a vaccine, the U.S. Food and Drug Administration must <a href="https://www.historyofvaccines.org/content/articles/vaccine-development-testing-and-regulation">approve and regularly inspect</a> each vaccine manufacturing facility. </p>
<p>Before each batch of vaccines is released by the FDA, it undergoes rigorous and extensive testing to ensure vaccine safety. In the case of COVID-19 vaccines, manufacturers are required to submit the results of each quality control test for each batch of vaccines <a href="https://www.fda.gov/media/144412/download">48 hours</a> prior to its distribution. This stringent quality control process has led to what the FDA describes as the <a href="https://www.fda.gov/files/vaccines,%20blood%20&%20biologics/published/Ensuring-the-Safety-of-Vaccines-in-the-United-States.pdf">safest vaccine supply</a> in U.S. history.</p>
<p>The quality control process is also how <a href="https://www.jnj.com/johnson-johnson-statement-on-u-s-covid-19-vaccine-manufacturing">Johnson & Johnson discovered</a> defects within the batch of 15 million doses at the Emergent BioSolutions facility. </p>
<p>The Baltimore plant was one of several <a href="https://www.hhs.gov/about/news/2020/06/01/hhs-adds-628-million-contract-emergent-biosolutions-secure-manufacturing-capacity-operation-warp-speed.html">contracted by the federal government</a> in 2020 to help vaccine-makers ramp up production. The facility was still awaiting authorization from the FDA to deliver the vaccines for U.S. use when the problems were discovered. As standard practice, Johnson & Johnson said it had <a href="https://www.jnj.com/johnson-johnson-statement-on-u-s-covid-19-vaccine-manufacturing">specialists at the facility</a> to check safety and quality. The Washington Post reported that workers at the facility in late February <a href="https://www.washingtonpost.com/business/2021/03/31/vaccine-johnson-johnson-emergent/">mixed up</a> the ingredients for the AstraZeneca and Johnson & Johnson vaccines both being produced there, throwing the entire batch into question. The FDA had <a href="https://apnews.com/article/virus-vaccine-johnson-and-johnson-emergent-biosolutions-d9edd171f8013e17c0be8b13a6db7fed">previously flagged quality control concerns</a> at Emergent’s Baltimore plant related to its testing of a potential treatment for anthrax, according to the records obtained by the Associated Press. </p>
<p>All vaccine manufacturing plants – domestic and international – require authorization from the FDA before they can supply vaccines to the U.S. population. The Johnson & Johnson vaccines currently used in the U.S. were manufactured in Johnson & Johnson’s own <a href="https://www.cbsnews.com/news/quality-control-issues-force-johnson-johnson-to-scrap-doses-of-covid-19-vaccine/">facility in the Netherlands</a>. </p>
<figure class="align-center ">
<img alt="A worker looks closely at a series of packaged syringes" src="https://images.theconversation.com/files/393202/original/file-20210401-23-1oxoflc.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/393202/original/file-20210401-23-1oxoflc.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/393202/original/file-20210401-23-1oxoflc.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/393202/original/file-20210401-23-1oxoflc.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/393202/original/file-20210401-23-1oxoflc.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/393202/original/file-20210401-23-1oxoflc.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/393202/original/file-20210401-23-1oxoflc.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=503&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">Quality control for the COVID-19 vaccines includes checking the vials, syringes and every other part of the vaccine process.</span>
<span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/news-photo/in-this-photograph-taken-on-september-2-a-worker-checks-news-photo/1228416934">Sajjad Hussain/AFP via Getty Images</a></span>
</figcaption>
</figure>
<p>The U.S. government’s Operation Warp Speed has also been involved in quality control. At one point, it deployed <a href="https://www.gao.gov/assets/gao-21-319.pdf">16 Department of Defense personnel</a> to two manufacturing sites to fill gaps in the quality control workforce so production could continue.</p>
<p>After vaccines have been distributed, the Centers for Disease Control and Prevention continues to <a href="http://dx.doi.org/10.15585/mmwr.mm7008e3">monitor for any problems in patients</a>.</p>
<p>[<em>Get the best of The Conversation, every weekend.</em> <a href="https://theconversation.com/us/newsletters/weekly-highlights-61?utm_source=TCUS&utm_medium=inline-link&utm_campaign=newsletter-text&utm_content=weeklybest">Sign up for our weekly newsletter</a>.]</p>
<h2>How much time goes into quality checks?</h2>
<p>The U.S. learned years ago how crucial quality control checks and independent verification are for vaccine safety. In 1955, the <a href="https://theconversation.com/the-great-polio-vaccine-mess-and-the-lessons-it-holds-about-federal-coordination-for-todays-covid-19-vaccination-effort-152806">polio vaccine rollout</a> led to <a href="https://www.statnews.com/2020/12/07/covid-19-vaccine-safety-lessons-paul-meier-polio/">40,000 vaccine-induced polio infections</a>.</p>
<p>Flu vaccine-maker <a href="https://www.sanofi.com/en/your-health/flu-vaccine-a-race-against-the-clock">Sanofi says it now spends about 70%</a> of its production time on quality checks, and its vaccines are checked again by health officials once they’re shipped from the facility.</p>
<p>The new mRNA technology used by COVID-19 vaccine-makers Moderna and Pfizer is somewhat <a href="http://doi.org/10.1208/s12249-020-01744-7">less challenging</a> because it doesn’t involve live virus, as traditional flu vaccines do. Pfizer says it spends <a href="https://www.usatoday.com/in-depth/news/health/2021/02/07/how-covid-vaccine-made-step-step-journey-pfizer-dose/4371693001/">more than half</a> of its production time on assuring the quality of each batch. </p>
<h2>Manufacturing improvements are also crucial</h2>
<p>Manufacturing process improvement is just as important as thorough quality testing, because errors do happen.</p>
<p>In 2020, <a href="https://apnews.com/article/international-news-oxford-coronavirus-pandemic-883e783962dc562a99864b4b63de9897">AstraZeneca</a> revealed that a manufacturing error led to one-and-a-half – instead of two – doses of its vaccine being given to nearly 3,000 study patients. That error clouded its study results and <a href="https://www.newyorker.com/news/daily-comment/why-there-is-so-much-confusion-about-the-astrazeneca-vaccine">delayed</a> the U.S. approval process by months.</p>
<p>The Biden administration has asked Johnson & Johnson to <a href="https://www.politico.com/news/2021/03/31/johnson-johnson-vaccine-15-million-ruined-478776">step up</a> its supervision of Emergent’s production process. </p>
<p>The incident shows that the industry has work to do to minimize manufacturing errors. Yet, I would argue that the public has every reason to remain confident in the rigorous quality control process that prevents bad vaccines from circulating and ensures vaccine safety.</p><img src="https://counter.theconversation.com/content/158300/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Tinglong Dai does not work for, consult, own shares in or receive funding from any company or organization that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.</span></em></p>Vaccine manufacturing is complex, with lots of potential points for errors. But it also has extensive quality control checks and approvals.Tinglong Dai, Associate Professor of Operations Management & Business Analytics, Johns Hopkins Carey Business School, Johns Hopkins University School of NursingLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1554302021-02-18T14:08:16Z2021-02-18T14:08:16ZHow are COVID-19 vaccines made? An expert explains<p><em>Editor’s note: <a href="https://theconversation.com/profiles/anne-moore-1152821">Anne Moore</a> is a senior lecturer in biochemistry and cell biology at University College Cork and a specialist in vaccine development. We spoke to her for <a href="https://theconversation.com/coronavirus-vaccine-whats-getting-in-the-way-of-the-global-rollout-the-conversation-weekly-podcast-155432">episode 3 of The Conversation Weekly podcast</a> on vaccine manufacturing.</em></p>
<iframe src="https://player.acast.com/60087127b9687759d637bade/episodes/how-patent-laws-get-in-the-way-of-global-vaccine-rollout?theme=default&cover=1&latest=1" frameborder="0" width="100%" height="110px" allow="autoplay"></iframe>
<p><em>Below are excerpts from our conversation that have been edited for length and clarity.</em></p>
<h2>First, are all the vaccines the same?</h2>
<p>No. Different COVID-19 vaccines use different technologies, or “platforms”. The most conventional one is the inactivated vaccine. It contains dead virus. Because the virus is still whole, it has all of the parts, in the correct shape, that can stimulate a response from the immune system – what we call the antigens. The immune response can be against multiple antigens.</p>
<p>The <a href="https://www.bbc.co.uk/news/world-asia-china-55212787">Chinese vaccines</a> – from Sinovac and Sinopharm – are the main ones using this platform. It’s a great technology, it works for some human and veterinary vaccines. The same approach was used for <a href="https://www.gavi.org/vaccineswork/what-are-whole-virus-vaccines-and-how-could-they-be-used-against-covid-19">seasonal flu vaccines</a> some years ago.</p>
<p>Then there are the viral-vectored vaccines, such as the <a href="https://www.bbc.co.uk/news/health-55302595">Oxford/AstraZeneca vaccine</a> and the <a href="https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(21)00191-4/fulltext">Sputnik V vaccine</a> from Russia’s Gamaleya Institute. This is where you take a harmless virus, such as a virus that gives you a cold, and you alter it so that it can infect one cell, but can’t reproduce and go on to infect other cells. </p>
<p>You then get that virus to carry the gene for a protein of interest, such as the spike protein of SARS-CoV-2, with the DNA sequence for the spike protein combined into the virus’s DNA. The virus is thus a vehicle for bringing the genetic instructions on how to make the spike protein into the body.</p>
<figure class="align-center ">
<img alt="SARS-CoV-2, with its spike proteins on its exterior coloured orange" src="https://images.theconversation.com/files/384725/original/file-20210217-21-1no6we3.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/384725/original/file-20210217-21-1no6we3.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=337&fit=crop&dpr=1 600w, https://images.theconversation.com/files/384725/original/file-20210217-21-1no6we3.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=337&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/384725/original/file-20210217-21-1no6we3.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=337&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/384725/original/file-20210217-21-1no6we3.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=424&fit=crop&dpr=1 754w, https://images.theconversation.com/files/384725/original/file-20210217-21-1no6we3.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=424&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/384725/original/file-20210217-21-1no6we3.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=424&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">The spike proteins (orange) are some of the virus’s most recognisable antigens, so are a good target for the immune system.</span>
<span class="attribution"><a class="source" href="https://www.shutterstock.com/image-illustration/sarscov2-coronavirus-virus-which-causes-covid19-1688912314">Kateryna Kon/Shutterstock</a></span>
</figcaption>
</figure>
<p>When you vaccinate someone with this harmless virus, it infects cells. The cells then read the gene the virus is carrying and start producing the spike protein, and the immune system mounts a response against this. And because the body recognises that there’s a virus present, the response it mounts is very strong to the protein of interest and also to the viral vector.</p>
<p>The final vaccines authorised are the new kids on the block, the <a href="https://theconversation.com/how-mrna-vaccines-from-pfizer-and-moderna-work-why-theyre-a-breakthrough-and-why-they-need-to-be-kept-so-cold-150238">nucleic acid vaccines</a> from Pfizer/BioNTech and Moderna. These are just a sequence of RNA wrapped up in a lipid droplet to stop it being degraded in the body and help it get inside a cell. RNA is a really sensitive little molecule and is chopped up very easily and quickly if not protected. Once the RNA gets into a cell, again, it instructs the cell to make the SARS-CoV-2 spike protein for the immune system to respond to.</p>
<h2>So how do you make these vaccines?</h2>
<p>It depends on the platform. For viral-vectored vaccines, you take some of your harmless cold virus after you have added the spike protein DNA to it and grow it in a cell culture. Although the virus has been altered so it can’t reproduce in the body, it can still replicate in the specially designed cells in this cell culture.</p>
<p>You’ll then have this bulking up of the virus over the course of a few days, anywhere from four litres of cell culture up to maybe 20, 30 litres. Really high-scale production can be carried out in steel tanks – the manufacturing environment can look a bit similar to a super-clean, sterile brewery. You have to make sure that your cells are in the best environment possible for them to live and to allow the virus to grow. This requires monitoring many environmental factors in and around the cell culture – temperature, oxygen and CO₂ levels, acidity and so on.</p>
<p>You end up with this liquid that is full of the virus that you’re interested in. But it’s also full of materials that you don’t want. So then you have what we call downstream processing, where you’re purifying the virus vaccine away from all of the other components that you’re not interested in. </p>
<p>That downstream process is very important and is highly controlled and evaluated. It involves a lot of filtration and chromatography. At the end you have to have a very safe sterile product that contains only what you want. </p>
<p>There are multiple steps, and at each stage you’re taking samples and running experiments to show that you’re purifying your product as you go along. Even though it can take only a few days to grow a batch of virus, it can take a long time to purify it and prove that it’s pure, sterile and is what you say it is. The vaccine will only be released when you can prove that it’s the exact purity, sterility and composition that you’re claiming.</p>
<p>For inactivated vaccines, the process is similar. You grow up litres of the virus itself. And then you kill it in a specific way so that you maintain the structure of that dead virus. And then you take that and you inject it into people.</p>
<h2>But making an mRNA vaccine is different?</h2>
<p>Yes, with the nucleic acid vaccines you don’t have any cells. You don’t need any vats to grow anything in. You use a machine, a synthesiser, to add each nucleic acid onto the next in the right sequence so that you end up with the full-length RNA sequence that encodes the spike protein.</p>
<p>Then you have to take that and mix it with your little lipid droplets. You mix these components together in a very controlled way so that you’ve produced these tiny little droplets that are at the nanometre scale, with your RNA on the inside, covered by these lipids.</p>
<p>And again, you have to analyse them and show that they meet a very tight specification of size and what they’re composed of and be able to prove the quality of your product.</p><img src="https://counter.theconversation.com/content/155430/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Anne Moore has, in the past, received funding from grant-awarding authorities and through collaborative research work with small and medium vaccine companies.</span></em></p>While some of the authorised COVID-19 vaccines are grown, others are built.Anne Moore, Senior Lecturer in Biochemistry and Cell Biology, University College CorkLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1554322021-02-18T12:34:16Z2021-02-18T12:34:16ZCoronavirus vaccine: what’s getting in the way of the global rollout? – The Conversation Weekly podcast<p>In this week’s episode of <a href="https://theconversation.com/uk/topics/the-conversation-weekly-98901">The Conversation Weekly</a> podcast, we hear about an ongoing battle to relax intellectual property rules around coronavirus vaccines and new research on why China is closing down coal-fired power stations faster in some places than others. </p>
<iframe src="https://player.acast.com/60087127b9687759d637bade/episodes/how-patent-laws-get-in-the-way-of-global-vaccine-rollout?theme=default&cover=1&latest=1" frameborder="0" width="100%" height="110px" allow="autoplay"></iframe>
<p><iframe id="tc-infographic-561" class="tc-infographic" height="100" src="https://cdn.theconversation.com/infographics/561/4fbbd099d631750693d02bac632430b71b37cd5f/site/index.html" width="100%" style="border: none" frameborder="0"></iframe></p>
<p>While some of the world’s richest countries are racing ahead with large-scale programmes to vaccinate their populations, for <a href="https://theconversation.com/covid-19-vaccines-how-and-when-will-lower-income-countries-get-access-152718">much of the developing world</a>, the first doses of the vaccines remain a long way off. </p>
<p>For the past few months, a group of countries has been pushing for the intellectual property rules around coronavirus vaccines to be waived temporarily, arguing this would help expand supply and push down costs. But a small group of countries – many of them home to the companies which hold the patents for those vaccines that have been licensed – are trying to block it. The issue is likely to be discussed at the World Trade Organization’s General Council in early March. </p>
<p>Ronald Labonté, Distinguished Research Chair in Globalization and Health Equity at the School of Epidemiology and Public Health, University of Ottawa, explains what the push for the waiver is all about. He says what it really comes down to is that these countries “don’t want to touch the intellectual property rights regime” of the specific “TRIPS” agreement that regulates it, which he says “is so profitable to the patent holding pharmaceutical industry”.</p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/dummys-guide-to-how-trade-rules-affect-access-to-covid-19-vaccines-152897">Dummy's guide to how trade rules affect access to COVID-19 vaccines</a>
</strong>
</em>
</p>
<hr>
<p>We also hear from Mosoka Fallah, Lecturer at the School of Public Health, College of Health Sciences at the University of Liberia, who explains what the situation is like on the ground in West Africa. He’s part of a group advocating for more equitable access to COVID-19 vaccines, including more funding for the Covax facility which is procuring vaccines for developing countries.</p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/no-country-is-an-island-collective-approach-to-covid-19-vaccines-is-the-only-way-to-go-153200">No country is an island: collective approach to COVID-19 vaccines is the only way to go</a>
</strong>
</em>
</p>
<hr>
<p>And Anne Moore, Senior Lecturer in Biochemistry and Cell Biology, at University College Cork in Ireland, explains some of the processes behind making a coronavirus vaccine, and the huge scramble to rededicate those facilities are licensed to do so. You can read her <a href="https://theconversation.com/how-are-covid-19-vaccines-made-an-expert-explains-155430">article on vaccine manufacturing here</a>. </p>
<p>In our second story this week we hear about new research on why – and where – China is decommissioning hundreds of coal-fired power stations. While China has set an ambitious target for net zero carbon emissions by 2060, Hao Tan, Associate Professor at the University of Newcastle in Australia, says that’s only part of the reason why coal-fired power stations are closing at a faster rate in the east of the country. He explains what this shift means for the wider region, and <a href="https://theconversation.com/forget-about-the-trade-spat-coal-is-passe-in-much-of-china-and-thats-a-bigger-problem-for-australia-153300">those countries that export coal to China</a>. </p>
<p>And we finish this week’s episode with some reading recommendation on the historic child sex abuse scandal rocking France from Clea Chakraverty, politics and society editor at The Conversation in France.</p>
<p>The Conversation Weekly is produced by Mend Mariwany and Gemma Ware, with sound design by Eloise Stevens. Our theme music is by Neeta Sarl.</p>
<p>News clips in this episode from <a href="https://www.youtube.com/watch?v=vlOMghih_sM">Global News</a>, <a href="https://www.youtube.com/watch?v=HNIViibimVU">eNCA</a>, <a href="https://www.youtube.com/watch?v=GUT68PWyX0U">DW News</a>, <a href="https://www.youtube.com/watch?v=FGwPiKxmpDI">WTO</a>, <a href="https://www.youtube.com/watch?v=PZ8kdVFbQ_A">Arirang News</a>, <a href="https://www.youtube.com/watch?v=leuFqY4L0_c">Reuters</a>, <a href="https://www.youtube.com/watch?v=V7bRzgOc5hY">United Nations</a> and <a href="https://www.youtube.com/watch?v=jnh9SZ2YzEU">Sky News Australia</a>.</p>
<p>A transcript of this episode is <a href="https://theconversation.com/how-patent-laws-get-in-the-way-of-the-global-coronavirus-vaccine-rollout-155494">available here</a>. </p>
<p><em>You can listen to The Conversation Weekly via any of the apps listed above, our <a href="https://feeds.acast.com/public/shows/60087127b9687759d637bade">RSS feed</a>, or find out how else to <a href="https://theconversation.com/how-to-listen-to-the-conversations-podcasts-154131">listen here</a>.</em></p><img src="https://counter.theconversation.com/content/155432/count.gif" alt="The Conversation" width="1" height="1" />
Plus new research on why China is closing down coal-fired power stations. Listen to episode 3 of The Conversation Weekly.Gemma Ware, Head of AudioDaniel Merino, Associate Breaking News Editor and Co-Host of The Conversation Weekly PodcastLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1547922021-02-08T19:28:20Z2021-02-08T19:28:20ZThe roots of Canada’s COVID-19 vaccine shortage go back decades<figure><img src="https://images.theconversation.com/files/382868/original/file-20210207-16-47psnp.jpg?ixlib=rb-1.1.0&rect=70%2C37%2C3470%2C2408&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">A health-care worker prepares a dose of the Pfizer-BioNTech COVID-19 vaccine at a UHN COVID-19 vaccine clinic in Toronto on Thursday, January 7, 2021. </span> <span class="attribution"><span class="source">THE CANADIAN PRESS/Nathan Denette</span></span></figcaption></figure><p>As of Feb. 5, Canada had administered <a href="https://ourworldindata.org/covid-vaccinations">2.7 COVID-19 vaccination doses per 100 people compared to 61.7 for Israel and 16.2 for the United Kingdom</a>. By contrast, Canada has <a href="https://www.theglobeandmail.com/canada/article-getting-the-jab-done-when-can-canadians-expect-to-get-a-covid-19/">signed contracts with seven different companies for a total of 234 million doses</a> with options for tens of millions more. </p>
<p>What’s going on?</p>
<p>To understand the problem, we need to go back to the 1980s. At that time, the government-owned Connaught Labs was producing vaccines here in Canada and decision-making was in the public realm. But <a href="https://www.thestar.com/opinion/contributors/2020/03/11/the-public-lab-that-could-have-helped-fight-covid-19-pandemic.html">Connaught was partially privatized</a> and then finally allowed to be sold to the French company Merieux (now part of Sanofi) by the Conservative government of Brian Mulroney. </p>
<p>Fast forward to the 2000s, when Québec-based vaccine manufacturer <a href="https://www.theglobeandmail.com/life/health-and-fitness/health/conditions/how-vaccines-became-big-business/article572731/">IAF BioChem</a> went through a couple of sales and ended up being owned by GlaxoSmithKline (GSK).</p>
<p><a href="https://www.canadianhealthpolicy.com/products/canada---s-vaccine-development-capacity-and-the-federal-government---s-management-of-covid-19.html">Sanofi and GSK still make vaccines in Toronto and Ste-Foy</a>, but decisions about what vaccines to produce are not in Canadian hands. </p>
<h2>Unheeded warnings</h2>
<figure class="align-right ">
<img alt="Close-up of a man at a microphone" src="https://images.theconversation.com/files/382865/original/file-20210207-24-gi1ni9.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=237&fit=clip" srcset="https://images.theconversation.com/files/382865/original/file-20210207-24-gi1ni9.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=891&fit=crop&dpr=1 600w, https://images.theconversation.com/files/382865/original/file-20210207-24-gi1ni9.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=891&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/382865/original/file-20210207-24-gi1ni9.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=891&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/382865/original/file-20210207-24-gi1ni9.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=1120&fit=crop&dpr=1 754w, https://images.theconversation.com/files/382865/original/file-20210207-24-gi1ni9.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=1120&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/382865/original/file-20210207-24-gi1ni9.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=1120&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">Dr. David Naylor, then Dean of Medicine at the University of Toronto, is seen in Halifax in September 2003 at the Annual Conference of Federal, Provincial and Territorial Ministers of Health discussing his report on a Canadian centralized centre for disease control.</span>
<span class="attribution"><span class="source">(CP PHOTO/Scott Dunlop)</span></span>
</figcaption>
</figure>
<p>It didn’t have to be that way. After the SARS outbreak in 2003, the report <a href="https://www.phac-aspc.gc.ca/publicat/sars-sras/pdf/sars-e.pdf"><em>Learning from SARS</em></a> led by Dr. David Naylor recommended that Canada develop a “national vaccine strategy” and prioritize the security of our vaccine supply. We got another warning about the need for a secure and steady supply of vaccines with the H1N1 pandemic of 2009 when there were <a href="https://www.theglobeandmail.com/opinion/article-canadas-vaccine-legacy-influenza-polio-and-covid-19/">production delays at the GSK plant in Ste-Foy</a>. </p>
<p>Nobody seems to have been paying attention. As a result, when the COVID-19 pandemic started, Canada was left with few options.</p>
<h2>COVID-19 response</h2>
<p>Canada’s first attempt to ensure domestic production was a deal with the <a href="https://www.theglobeandmail.com/politics/article-canada-china-vaccine-collaboration-began-to-fall-apart-days-after/">Chinese manufacturer CanSino Biologics</a> in May 2020. Had that deal gone ahead, it would have involved trials at the Canadian Centre for Vaccinology at Dalhousie University and, if successful, subsequent domestic manufacturing. But within days of the agreement being announced, there were already troubles as the Chinese delayed sending the seed material for the vaccine and, ultimately, it never arrived.</p>
<p>Efforts to secure a domestically made supply then turned to <a href="https://www.theglobeandmail.com/canada/article-president-of-montreal-company-pnuvax-says-ottawa-passed-on-its-offer/">upgrading the National Research Council (NRC) facility in Montréal</a> and subsequently building an entirely new plant at a total cost of $170 million. In doing so, the government bypassed providing PnuVax, a biopharmaceutical company also located in Montréal, with any of the <a href="https://pm.gc.ca/en/news/news-releases/2020/04/23/prime-minister-announces-new-support-covid-19-medical-research-and">$600 million from Industry Canada’s Strategic Innovation Fund</a> earmarked for the research or development of COVID-19 vaccines and therapies. </p>
<p>PnuVax had been renovated in 2012 to meet Health Canada standards and according to <a href="https://www.theglobeandmail.com/canada/article-feds-passed-over-private-option-with-plans-to-produce-covid-19-vaccine/">sources cited by the <em>Globe and Mail</em></a>, the company could have been ready to produce millions of doses of a COVID-19 vaccine by the end of 2020.</p>
<figure class="align-center ">
<img alt="Trudeau and two scientists, all in white lab coats and face masks, in a lab" src="https://images.theconversation.com/files/382866/original/file-20210207-22-1hihk43.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/382866/original/file-20210207-22-1hihk43.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=436&fit=crop&dpr=1 600w, https://images.theconversation.com/files/382866/original/file-20210207-22-1hihk43.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=436&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/382866/original/file-20210207-22-1hihk43.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=436&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/382866/original/file-20210207-22-1hihk43.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=548&fit=crop&dpr=1 754w, https://images.theconversation.com/files/382866/original/file-20210207-22-1hihk43.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=548&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/382866/original/file-20210207-22-1hihk43.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=548&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">Prime Minister Justin Trudeau, left, with scientists Anja Rodenbrock, centre, and Stephane Lanthier during a visit to the National Research Council’s Human Health Therapeutics Research Centre facility in Montréal on Aug. 31, 2020.</span>
<span class="attribution"><span class="source">THE CANADIAN PRESS/Graham Hughes</span></span>
</figcaption>
</figure>
<p><a href="https://www.theglobeandmail.com/canada/article-feds-passed-over-private-option-with-plans-to-produce-covid-19-vaccine/">Prime Minister Justin Trudeau</a> initially said the NRC facility would be up and running by November 2020 and producing 250,000 doses a month. However, in early February, Trudeau admitted that the <a href="https://www.theglobeandmail.com/opinion/article-canadas-vaccine-procurement-efforts-have-been-shrouded-in-unjustified/">NRC plant wouldn’t be ready until the summer of 2021</a>, and with the need to outfit the facility for the Novavax vaccine and subsequent Health Canada inspections, there won’t be any vaccine coming from there until the end of 2021.</p>
<p>The failure of the CanSino deal and the delay in building the new NRC facility left Canada reliant on foreign sources of vaccine. The contracts for the vaccine were negotiated based on advice provided by the <a href="https://nrc.canada.ca/en/corporate/covid-19-vaccine-task-force">18 member COVID-19 Vaccine Task Force</a> set up by the NRC in June 2020. </p>
<p>Both the co-chairs of the task force have <a href="https://theconversation.com/canadas-covid-19-vaccine-task-force-needs-better-transparency-about-potential-conflicts-of-interest-147323">conflicts of interest with companies producing the vaccines</a> and the terms of the contracts are being kept secret. Among other things, we don’t know what price Canada is paying for each vaccine, what the timeline for delivery is, whether there are penalties for delays and how the contracts are being enforced, if at all. </p>
<p>Complicating things even further, the <a href="https://www.theglobeandmail.com/politics/article-drug-makers-resist-ottawas-pleas-for-more-covid-19-vaccines-before/">contracts focused on large-scale delivery starting in April 2021</a> because of uncertainty back in the summer about when vaccines would be available.</p>
<h2>Delayed deliveries</h2>
<p>Now Canada is facing delays in vaccine delivery from both Pfizer and Moderna, the companies making the only two vaccines approved in Canada so far. The <a href="https://www.theglobeandmail.com/politics/article-pfizer-vaccine-delays-are-longer-than-expected-ottawa-says/">Pfizer plant in Belgium</a>, where our vaccine comes from, is being retooled to increase production while the <a href="https://globalnews.ca/news/7619692/canada-covid-vaccine-moderna-shipments/">exact reasons for the Moderna delay are unclear</a>. Moderna is shipping its vaccine to Canada through Belgium. (Both companies and the federal government have promised that the amounts scheduled for delivery by the end of March will be honoured.)</p>
<figure class="align-center ">
<img alt="A large empty room with tables set up with vaccination supplies and biohazard bins." src="https://images.theconversation.com/files/382867/original/file-20210207-14-1ht9a7x.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/382867/original/file-20210207-14-1ht9a7x.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=457&fit=crop&dpr=1 600w, https://images.theconversation.com/files/382867/original/file-20210207-14-1ht9a7x.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=457&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/382867/original/file-20210207-14-1ht9a7x.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=457&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/382867/original/file-20210207-14-1ht9a7x.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=575&fit=crop&dpr=1 754w, https://images.theconversation.com/files/382867/original/file-20210207-14-1ht9a7x.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=575&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/382867/original/file-20210207-14-1ht9a7x.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=575&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">Toronto’s Mass Vaccination Clinic is shown on Jan. 17, 2021.</span>
<span class="attribution"><span class="source">THE CANADIAN PRESS/Frank Gunn</span></span>
</figcaption>
</figure>
<p>On top of having no domestic production and the delays, Canada is facing vaccine nationalism from other countries. <a href="https://www.theglobeandmail.com/politics/article-biden-upholds-us-first-vaccine-policy-shutting-door-on-canada-for-now/">U.S. President Joe Biden</a> is sticking to an America-first position and not allowing the Pfizer plant in Michigan or the Moderna plant in New Hampshire to export any of their vaccines to Canada until all Americans have been vaccinated. </p>
<p>The <a href="https://www.politico.eu/article/eu-brandishes-export-ban-to-claim-dibs-on-vaccine-astrazeneca-pfizer/">European Union is also threatening to block the export of vaccines</a> possibly affecting exports from Belgium, as it too is confronting delays in being able to vaccinate its citizens.</p>
<p>One response from Canada to all of this is to <a href="https://www.cbc.ca/news/canada/covax-explainer-canada-backlash-1.5902072">claim 1.9 million doses of the yet-to-be-approved AstraZeneca vaccine from COVAX</a>, a facility primarily set up to ensure that low- and middle-income countries will have access to vaccines. Canada is the <a href="https://www.cbc.ca/radio/asithappens/as-it-happens-thursday-edition-1.5900864/february-4-2021-episode-transcript-1.5902999">second-largest country donor to COVAX</a> and is entitled to claim vaccines from COVAX, but is doing so when, as of Feb. 3, <a href="https://www.cnn.com/2021/02/05/africa/vaccine-race-africa-intl/index.html">only four African countries have started vaccinating their citizens</a>. </p>
<p>In <a href="https://www.cbc.ca/radio/asithappens/as-it-happens-thursday-edition-1.5900864/february-4-2021-episode-transcript-1.5902999">an interview on CBC’s <em>As It Happens</em></a>, Karina Gould, Canada’s minister of international development, defended Canada’s move, a made-in-Canada form of vaccine nationalism.</p>
<p>Ensuring that Canadians would receive an effective vaccine quickly was never going to be a sure thing; there was always plenty of opportunity for something to go wrong. But the uncertainty involved has been compounded by a lack of government planning in the past, secrecy, a lack of international co-operation and poor government decision-making. Let’s hope we do better when the next pandemic comes around.</p><img src="https://counter.theconversation.com/content/154792/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>In 2017-2020, Joel Lexchin received payments for being on a panel at the American Diabetes Association, for talks at the Toronto Reference Library, for writing a brief in an action for side effects of a drug for Michael F. Smith, Lawyer and a second brief on the role of promotion in generating prescriptions for Goodmans LLP and from the Canadian Institutes of Health Research for presenting at a workshop on conflict-of-interest in clinical practice guidelines. He is currently a member of research groups that are receiving money from the Canadian Institutes of Health Research and the Australian National Health and Medical Research Council. He is a member of the Foundation Board of Health Action International and the Board of Canadian Doctors for Medicare. He receives royalties from University of Toronto Press and James Lorimer & Co. Ltd. for books he has written. </span></em></p>Behind Canada’s current COVID-19 vaccine shortage is a decades-long tale of unheeded warnings, missed opportunities and dismantled resources that was never going to end well.Joel Lexchin, Professor Emeritus of Health Policy and Management, York University, Emergency Physician at University Health Network, Associate Professor of Family and Community Medicine, University of TorontoLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1523512021-01-14T21:58:57Z2021-01-14T21:58:57ZCOVID-19 vaccine rollout: Why a mask and social distancing are still needed, even if you get the shot<figure><img src="https://images.theconversation.com/files/378201/original/file-20210112-17-wx7619.jpg?ixlib=rb-1.1.0&rect=0%2C496%2C4086%2C2521&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Health-care workers wait in line at a COVID-19 vaccine clinic in Toronto on Jan. 7, 2021. </span> <span class="attribution"><span class="source">THE CANADIAN PRESS/Nathan Denette</span></span></figcaption></figure><p>It was a long struggle to adopt a new normal of wearing face masks, maintaining physical distance, handwashing and on-and-off lockdowns. Then, with the approval of two vaccines, came the expectation that the world will soon be cured of COVID-19, and that we all will resume our old normal life. But — not so fast. We must hold on to our new normal for a bit longer.</p>
<p><a href="http://doi.org/10.1056/NEJMoa2034577">Pfizer/BioNTech</a> and <a href="http://doi.org/10.1056/NEJMoa2035389">Moderna</a> each announced in November 2020 that their mRNA-based vaccines have close to a 95 per cent efficacy rate (the efficiency with which the vaccines prevent a severe illness from COVID-19). These first vaccines were <a href="https://www.modernatx.com/modernas-work-potential-vaccine-against-covid-19">developed in record time</a>, and also mark the first time mRNA (messenger ribonucleic acid) is being used for vaccination purposes. </p>
<p>However, a number of factors, such as those related to the nature of these two vaccines, our compliance with the non-pharmaceutical preventive measures (face masks, physical distancing, handwashing, isolation and quarantine) and the enormous task of vaccinating a large portion of the population, challenge our expectations of a quick end to this pandemic.</p>
<h2>Rollout challenges</h2>
<p>For vaccination to work and achieve herd immunity — the point at which it becomes impossible for the virus to find susceptible hosts to sustain its transmission — more than 70 per cent of the population has to be vaccinated. Dr. Anthony Fauci <a href="https://www.vox.com/coronavirus-covid19/2020/12/15/22176555/anthony-fauci-covid-19-vaccine-herd-immunity-goal">recently put the vaccination rate</a> to a necessary level of 85 per cent and above! </p>
<p>Both vaccines face several challenges that hamper a quick vaccine rollout here in Canada and around the world, including: </p>
<ol>
<li>The capacity of each pharmaceutical company to produce the number of vaccine doses needed to reach 70 per cent of the population; and </li>
<li>The logistics of distributing the vaccines and administering the vaccine shots far and wide. </li>
</ol>
<figure class="align-right ">
<img alt="Gloved hands filling a syringe from a vial" src="https://images.theconversation.com/files/378203/original/file-20210112-21-a30e3y.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=237&fit=clip" srcset="https://images.theconversation.com/files/378203/original/file-20210112-21-a30e3y.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=780&fit=crop&dpr=1 600w, https://images.theconversation.com/files/378203/original/file-20210112-21-a30e3y.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=780&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/378203/original/file-20210112-21-a30e3y.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=780&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/378203/original/file-20210112-21-a30e3y.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=980&fit=crop&dpr=1 754w, https://images.theconversation.com/files/378203/original/file-20210112-21-a30e3y.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=980&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/378203/original/file-20210112-21-a30e3y.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=980&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">A health-care worker prepares a dose of the Pfizer-BioNTech COVID-19 vaccine at a COVID-19 vaccine clinic in Toronto on Jan. 7, 2021. The vaccine requires two doses, several weeks apart.</span>
<span class="attribution"><span class="source">THE CANADIAN PRESS/Nathan Denette</span></span>
</figcaption>
</figure>
<p>In addition, both Pfizer/BioNTech and Moderna vaccines require a two-dose regimen to reach the reported efficacy rate, adding to the total number of doses needed to reach herd immunity. Hence, the demand for these vaccines is bound to stress the resources and the industrial capacities of both companies. </p>
<p>Indeed, Pfizer early on reported <a href="https://www.fiercepharma.com/pharma/pfizer-facing-various-challenges-covid-19-vaccine-manufacturing-dosing-feds">challenges in meeting the production</a> of the ordered vaccine doses, and Moderna <a href="https://www.forbes.com/sites/greatspeculations/2020/12/10/can-moderna-rise-to-the-manufacturing-challenge/?sh=3b39e4f15c77">has no record of drug production</a> in the past, although it is working with other companies around the world to meet the production demand. </p>
<p>Furthermore, both vaccines require freezing temperatures for storage and distribution, making their speedy and wide distribution a challenge. These conditions are more critical in the case of the Pfizer/BioNTech vaccine; its requirement of the ultra-freezing temperature to maintain its stability makes the distribution to remote areas almost impossible. The special delivery conditions for the mRNA vaccines make the <a href="https://www.theglobeandmail.com/canada/article-canadas-strained-health-system-faces-struggle-to-inoculate-millions/">administration of the shots</a> a nightmare in terms of the need for a large number of specialized vaccination stations and personnel.</p>
<p>These challenges have contributed to the low daily rate of <a href="https://www.cnn.com/2020/12/30/health/us-uk-israel-covid-vaccinations/index.html">10 vaccination shots per 100,000 population per day</a> in Canada in December. We need about 88,000 shots per day for the rest of 2021 to vaccinate as much as 85 per cent of the Canadian population (with a single shot). The current distribution and vaccination rates in Canada are bound to leave many high-risk population groups vulnerable to COVID-19. Hence, abiding to the current preventive measures remains paramount.</p>
<h2>Transmission, immunity and the unvaccinated</h2>
<p>As we celebrate the arrival of these two novel vaccines, other factors that are worth mentioning may hamper the return to our old normal life. </p>
<p>First, at this time, we do not have evidence that the mRNA vaccines <a href="https://nationalpost.com/news/world/who-chief-scientist-not-confident-vaccines-prevent-transmission">limit the transmission of the virus</a>. </p>
<p>Second, we do not know how long one remains immune to COVID-19 after being vaccinated. </p>
<p>Third, the population aged 16 and younger is left out of the current vaccination program due to a lack of data on safety and impact. Yet those aged 19 and younger now <a href="https://health-infobase.canada.ca/covid-19/epidemiological-summary-covid-19-cases.html">account for around 16 per cent of COVID-19 cases in Canada</a>.</p>
<figure class="align-center ">
<img alt="Masked people on the street" src="https://images.theconversation.com/files/378205/original/file-20210112-19-ihovxr.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/378205/original/file-20210112-19-ihovxr.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=404&fit=crop&dpr=1 600w, https://images.theconversation.com/files/378205/original/file-20210112-19-ihovxr.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=404&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/378205/original/file-20210112-19-ihovxr.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=404&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/378205/original/file-20210112-19-ihovxr.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=508&fit=crop&dpr=1 754w, https://images.theconversation.com/files/378205/original/file-20210112-19-ihovxr.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=508&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/378205/original/file-20210112-19-ihovxr.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=508&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">People wear face masks as they walk along a street in Montréal on Dec. 13, 2020. Masks will still be needed to help prevent the spread of COVID-19 as the vaccine is administered in the coming months.</span>
<span class="attribution"><span class="source">THE CANADIAN PRESS/Graham Hughes</span></span>
</figcaption>
</figure>
<p>On the other hand, there is a real risk that with the current vaccine rollout there will be an increase in transmission contacts due to the perception of vaccine-acquired immunity and the notion that vaccination will prevent transmission. Continued compliance with the non-pharmaceutical preventive measures is essential, especially when many are experiencing <a href="https://theconversation.com/covid-19-caution-fatigue-why-it-happens-and-3-ways-to-prevent-it-150837">COVID-19 fatigue</a> and most people have gotten used to the idea that other diseases can be stopped with a single pill or shot. </p>
<p>Indeed, the continuous spread of COVID-19 in Canada shows that many do not comply with the preventive measures and lockdown guidelines. The percentage of people who test positive for COVID-19, called the <a href="https://health-infobase.canada.ca/covid-19/epidemiological-summary-covid-19-cases.html">positivity rate, is now at 4.3 per cent</a>. </p>
<figure class="align-center ">
<img alt="Red social distancing marking on a floor" src="https://images.theconversation.com/files/378206/original/file-20210112-19-12aowcj.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/378206/original/file-20210112-19-12aowcj.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/378206/original/file-20210112-19-12aowcj.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/378206/original/file-20210112-19-12aowcj.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/378206/original/file-20210112-19-12aowcj.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/378206/original/file-20210112-19-12aowcj.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/378206/original/file-20210112-19-12aowcj.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=503&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">A social distancing sticker on the floor of a hallway at Willingdon Elementary School in Montréal, on Aug. 26, 2020. Social distancing will likely still be part of life for the next few months.</span>
<span class="attribution"><span class="source">THE CANADIAN PRESS/Paul Chiasson</span></span>
</figcaption>
</figure>
<p>A recent mathematical model evaluated the impact of vaccine efficacy and coverage in preventing future COVID-19 outbreaks. It predicts a possible increased risk of outbreaks during the vaccination of the population. <a href="https://liam.lab.yorku.ca/files/2021/01/The-minimal-vaccine-efficacy-required.pdf?x26585">This preliminary study</a>, called a <a href="https://theconversation.com/in-the-rush-for-coronavirus-information-unreviewed-scientific-papers-are-being-publicized-152912">preprint, has yet to be “peer reviewed,”</a> formally vetted by other scientists. </p>
<p>The predicted risk was based on the assumption that a person who believed they were immune might increase their potential transmission contacts through increased social and economic activities, as well as through lack of compliance with pharmaceutical preventive measures such as masks and social distancing.</p>
<p>The study showed that the risk of outbreaks depends on the efficacy rate and coverage of the vaccines, and the compliance with the non-pharmaceutical prevention measures. It predicts an increase in the size of the outbreak when vaccination coverage is high, the vaccine efficacy is low and the compliance with masks, social distancing and other non-pharmaceutical prevention measures is low. </p>
<p>Canada and many other countries are <a href="https://www.cbc.ca/news/canada/toronto/covid-19-ontario-december-29-vaccine-reopen-1.5856296">contemplating a single dose vaccination regimen</a> to reach as many people as quickly as they can with the doses that they have in hand. However, the single dose mRNA <a href="https://www.sciencemediacentre.org/expert-reaction-to-phase-3-results-for-the-pfizer-biontech-bnt162b2-mrna-covid-19-vaccine/">vaccine efficacy rate is much lower than two doses: about 50 per cent to 70 per cent</a>. </p>
<p>Under these high coverage/low vaccine efficacy conditions, continued public education about the potential risks of not complying with non-pharmaceutical preventive measures, in the midst of a pandemic and a challenging en masse vaccine rollout, is crucial to keep the COVID-19 spread under control.</p>
<h2>Is there an end?</h2>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/378207/original/file-20210112-19-g19m9o.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="A crumpled blue face mask on the ground" src="https://images.theconversation.com/files/378207/original/file-20210112-19-g19m9o.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/378207/original/file-20210112-19-g19m9o.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=418&fit=crop&dpr=1 600w, https://images.theconversation.com/files/378207/original/file-20210112-19-g19m9o.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=418&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/378207/original/file-20210112-19-g19m9o.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=418&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/378207/original/file-20210112-19-g19m9o.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=525&fit=crop&dpr=1 754w, https://images.theconversation.com/files/378207/original/file-20210112-19-g19m9o.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=525&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/378207/original/file-20210112-19-g19m9o.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=525&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">A discarded face mask on the ground in Montréal.</span>
<span class="attribution"><span class="source">THE CANADIAN PRESS/Graham Hughes</span></span>
</figcaption>
</figure>
<p>The approval of the two mRNA vaccines and the start of vaccination of high-risk population groups in Canada certainly has made the light at the end of the tunnel seem brighter. However, until most of the population gets vaccinated with vaccines of high efficacy, compliance with the non-pharmaceutical prevention measures remains critical to curb the spread of COVID-19 and save lives. We must be patient with the vaccine’s effect on herd immunity and persist with preventive practices even when the current lockdowns end and our economy reopens.</p><img src="https://counter.theconversation.com/content/152351/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Jianhong Wu receives funding from the Canadian 2019 Novel Coronavirus (COVID-19) Rapid Research Funding Opportunity</span></em></p><p class="fine-print"><em><span>Dasantila Golemi-Kotra does not work for, consult, own shares in or receive funding from any company or organisation that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.</span></em></p>Rollout of COVID-19 vaccines has begun. But getting the jab doesn’t mean abandoning masks, distancing and handwashing. Here’s why the current preventive measures must continue post-vaccine.Dasantila Golemi-Kotra, Professor, Biology, York University, CanadaJianhong Wu, Professor and Canada Research Chair in Industrial and Applied Mathematics, York University, CanadaLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/943802018-04-16T13:56:05Z2018-04-16T13:56:05ZWhy manufacturing a key vaccine in South Africa is so important<figure><img src="https://images.theconversation.com/files/214304/original/file-20180411-560-1i1h6z9.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">
</span> <span class="attribution"><span class="source">Shutterstock</span></span></figcaption></figure><p>South Africa has been <a href="https://www.facebook.com/dstgovza/posts/10156279130712959">granted a licence</a> to manufacture one of the world’s most important vaccines. It’s the first time the country will be able to do so since the mid 1990s, and is news that will result in many positive spin-offs for the country.</p>
<p>The hexavalent vaccine <a href="https://www.news-medical.net/drugs/Hexaxim.aspx">Hexaxim</a> is used to vaccinate children against six life-threatening infectious diseases: diphtheria, tetanus, acellular pertussis (whooping cough), inactivated polio, Haemophilus influenza type b and hepatitis B. It is a vital component of South Africa’s <a href="http://www.nicd.ac.za/assets/files/NICD_Vaccine_Booklet_D132_FINAL.pdf">expanded programme on immunisation</a> and more than 3 million children are vaccinated every year. There are 14 vaccines administered between the ages of 0 and 2 years; four of these are Hexaxim. As a result of this programme, the number of children under the age of five that have died has significantly dropped. In 2013, it sat at 47 409 children, down from 89 418 in 2005.</p>
<p>In the late 1980s and early 1990s the country produced some of its own vaccines. But this capacity disappeared in the mid-1990s; the State Vaccine Institute and the South African Vaccine Producer, both run by the national health department, closed down because they weren’t operating at the required levels of manufacturing practice.</p>
<p>The department considered exiting vaccine manufacture entirely. But it was persuaded to enter into a partnership where a private company was mandated to upgrade the old State Vaccine Institute in exchange for a monopoly on vaccine supply. After years of negotiation and capacity building this partnership with – the Biovac Institute – has finally been given <a href="https://www.facebook.com/dstgovza/posts/10156279130712959">the go ahead</a>. It will manage vaccine research and development, manufacturing and supply. </p>
<p>Local vaccine manufacture has several foreseeable benefits. These include decreased cost and increased availability and the capability to provide vaccines to the region. The local manufacturing process can also spur economic growth.</p>
<h2>The cost factor</h2>
<p>Manufacturing vaccines locally establishes a strategic capability in a sector which is prone to shortages and price fluctuations. These realities often have severe consequences for public health. For example earlier this year, newborns in South Africa <a href="https://www.iol.co.za/dailynews/vaccine-shortage-risks-life-12993215">could not be vaccinated against tuberculosis</a> due to a shortage of the Bacillus Calmette-Guérin (BCG) vaccine.</p>
<p>Vaccines are supplied into a global market from a relatively small number of sites. Manufacturing problems, mostly linked to issues of quality and safety, do occur and not infrequently affect the supply of vaccines to lower value markets.</p>
<p>In South Africa the vaccines that form part of the extended programme on immunisation vaccines are a big budget item for the National and Provincial Departments of Health. </p>
<p>When the Biovac Institute was established the <a href="https://health-policy-systems.biomedcentral.com/articles/10.1186/s12961-018-0303-3">annual cost of vaccines</a> was only R188 million. This cost has since grown to R1.75 billion. Hexaxim accounts for 37% of the expenditure. About 3 million doses of the vaccine are procured each year. These are imported directly by the Biovac Institute in single vials and then distributed to the clinics and hospitals. </p>
<p>Being able to manufacture these doses locally using imported antigens will enable Biovac to achieve, at least in part, one of its core objectives: to “ensure a domestic capacity in vaccine production that will enable the South African health authorities to respond to disease outbreak emergencies”. Over the medium term, <a href="https://www.sciencedirect.com/science/article/pii/S0264410X17307703">local manufacture</a> will also save an estimated 15% of the cost as compared to international procurement, depending on the actual vaccine and capacity utilisation of the manufacturing facility. </p>
<p>Local manufacture creates jobs, grows the economy and reduces the pressure on foreign exchange. </p>
<p>The details of the technology transfer agreement under which the institute will be making Hexacim are not yet publicly available. But it will be surprising if the deal does not allow South Africa to supply other countries in the Southern African Development Community and even sub-Saharan Africa with locally manufactured product. In this way it will be able to generate income. </p>
<h2>A long time coming</h2>
<p>Reaching this milestone has been a slow process. When the public private partnership was formed, it was thought that all of the core objectives would be reached within five years. </p>
<p>But the difficulties of building local skills, raising the finance and installing the infrastructure were under-estimated. Even the initial steps, which involved establishing sufficient absorptive capacity in the institute, took more time and expense that was originally anticipated.</p>
<p>The initiative had been costly for the public sector. Under the agreements of the partnership, the institute received a premium of about <a href="https://health-policy-systems.biomedcentral.com/articles/10.1186/s12961-018-0303-3">13%</a> on the wholesale price of the vaccine. This amounted to more than R1.1 billion between 2004 to 2016. These funds have been used to support the procurement, build the infrastructure, undertake research and development, and facilitate the technology transfer process.</p>
<p>Although this may seem a high price, a recent <a href="https://health-policy-systems.biomedcentral.com/articles/10.1186/s12961-018-0303-3">evaluation</a> of the partnership showed that a positive value for money had been achieved. It argued that South Africa had not overpaid for its vaccines and that overall the institute had been of significant public benefit.</p>
<p>What it shows though is that public sector procurement is a powerful means of achieving local economic development. South Africa has not been very successful with this approach to date. </p>
<p>The institute’s achievement shows that such partnerships are possible. But it also shows that they require a long term commitment by both parties to resolve the problems and constraints which arise when the objectives are implemented.</p>
<p>Although other means are possible, the institute supports this approach to localisation and suggests one strategy by which South Africa could reach its targets of economic growth and diversification.</p><img src="https://counter.theconversation.com/content/94380/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>David Walwyn works at the University of Pretoria and receives funding from the National Research Foundation as a rated researcher. This research was not sponsored by any organisation or company which could benefit from the article. He does not consult for, or own shares, in any organisation mentioned in the article </span></em></p>Manufacturing one of the world’s most important vaccines will have several benefits for South Africa.David Richard Walwyn, Professor of Technology Management, University of PretoriaLicensed as Creative Commons – attribution, no derivatives.