tag:theconversation.com,2011:/us/topics/vaccine-research-6196/articlesVaccine research – The Conversation2021-11-03T11:23:09Ztag:theconversation.com,2011:article/1687082021-11-03T11:23:09Z2021-11-03T11:23:09ZWhy vaccine doses differ for babies, kids, teens and adults – an immunologist explains how your immune system changes as you mature<figure><img src="https://images.theconversation.com/files/429805/original/file-20211102-19-1cqiw40.jpg?ixlib=rb-1.1.0&rect=0%2C896%2C5503%2C4032&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Many vaccine formulations are tweaked for patients of different ages.</span> <span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/news-photo/student-andy-melgar-checks-in-with-emt-alfonso-deza-after-news-photo/1327357664">Mario Tama via Getty Images</a></span></figcaption></figure><p>Human beings are born pretty helpless, with a lot of developing to do. And just as you must learn such skills as how to walk, so must your immune system learn to defend against infections. As time passes, your immune system matures through different stages, much the way you advanced from crawling to standing, walking and running.</p>
<p>This process is one of the reasons scientists study the immune response to a vaccine in different age groups, and why, for example, the COVID-19 vaccines need to be tested separately in children ages 5-11 and those 12-16. Doctors want to use the vaccine dose that provides the best protection with the fewest side effects. And that’s going to depend on how the immune system is working based on how developed it is – something you can’t really tell from the outside.</p>
<p><a href="https://directory.hsc.wvu.edu/Profile/56680">I’m an immunologist</a>, and here’s the way I explain to my pediatric and adult patients how vaccines work in people of all different ages. </p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/429806/original/file-20211102-29191-vtodoe.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="baby at mother's breast" src="https://images.theconversation.com/files/429806/original/file-20211102-29191-vtodoe.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/429806/original/file-20211102-29191-vtodoe.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=454&fit=crop&dpr=1 600w, https://images.theconversation.com/files/429806/original/file-20211102-29191-vtodoe.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=454&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/429806/original/file-20211102-29191-vtodoe.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=454&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/429806/original/file-20211102-29191-vtodoe.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=571&fit=crop&dpr=1 754w, https://images.theconversation.com/files/429806/original/file-20211102-29191-vtodoe.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=571&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/429806/original/file-20211102-29191-vtodoe.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=571&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
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<span class="caption">A newborn’s immune system still has a lot to learn and relies on supports from mom.</span>
<span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/photo/close-up-of-mother-breastfeeding-baby-boy-while-royalty-free-image/1203911366?adppopup=true">Paulo Sousa/EyeEm via Getty Images</a></span>
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<h2>Two halves of the immune system</h2>
<p>The immune maturing process starts shortly after birth.</p>
<p>When you’re born, your main immune protection comes via antibodies your mother shared through the placenta and breast milk. They provide what’s called passive immunity. <a href="https://doi.org/10.3389/fimmu.2020.595297">Newborns’ adaptive immune system</a> – the part of your immune system that will make your own antibodies – isn’t really up and running yet. The process gets started right away, but it can take years for the adaptive immune system to reach full maturity.</p>
<p>Luckily you’re also born with what’s called the <a href="https://www.ncbi.nlm.nih.gov/books/NBK279396/">innate immune system</a> – and it lasts throughout your life. It doesn’t need to learn in order to fight off infections and promote health as the adaptive immune system does. Without the innate immune system people would get sick a lot faster and more often.</p>
<p>The innate immune system starts with your skin and mucous membranes. Should any germs get past those physical barriers, it has enzymes just waiting to break down foreign organisms. Beyond that there are specialized cells looking for anything that is not you in order to kill intruders, while other cells called phagocytes gobble up invaders.</p>
<p>So the innate immune system is <a href="https://www.forbes.com/sites/fionamcmillan/2019/02/26/the-immune-systems-first-responders-are-smarter-than-we-thought/?sh=5fdc40261d82">your body’s first responder</a>. It buys you a bit of time. Then your adaptive immune system comes in and joins the fight.</p>
<p>When you become immunized via a vaccine or infection, your adaptive immune system starts actively making antibodies of your own. They’re proteins that act like suction cups and stick to viruses or bacteria to help the body get rid of the germs faster and prevent the infection from spreading. Antibodies are specialized to recognize and take down a particular intruder.</p>
<p>The adaptive immune system can learn a new infection or recall one that it has not seen in a long time.</p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/429808/original/file-20211102-29670-eqps6i.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="frozen vaccine vials" src="https://images.theconversation.com/files/429808/original/file-20211102-29670-eqps6i.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/429808/original/file-20211102-29670-eqps6i.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/429808/original/file-20211102-29670-eqps6i.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/429808/original/file-20211102-29670-eqps6i.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/429808/original/file-20211102-29670-eqps6i.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/429808/original/file-20211102-29670-eqps6i.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/429808/original/file-20211102-29670-eqps6i.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>
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<span class="caption">The dose that works for adults might not be appropriate for youngsters of different ages.</span>
<span class="attribution"><a class="source" href="https://newsroom.ap.org/detail/VirusOutbreakBiden/d89b46b600de4f7d9f834aa4901fb24c/photo?boardId=d7f2514f50804466b15dfb81ed00d9cd&st=boards&mediaType=audio,photo,video,graphic&sortBy=&dateRange=Anytime&totalCount=52&currentItemNo=0">AP Photo/Francisco Seco</a></span>
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<h2>Vaccines account for immune development</h2>
<p>In the same way an infant will learn to walk even if you don’t secure the stairways and pool areas for them, your immune system can learn to squelch an invading virus without a vaccine – but the chance of injury is much greater. </p>
<p>Vaccines work by triggering the creation of antibodies that will recognize a specific germ and work to fight it off in a safer manner than getting the infection for the first time without it. How well a vaccine works is a combination of how many antibodies you produce in response to it, how effective they are and the safety of the vaccine.</p>
<p>When researchers work to fine-tune the dosage of a vaccine for different age groups, they need to be aware of what parts of the immune system are online and what parts aren’t fully active in people at each developmental stage. This is part of the reason some vaccines – <a href="https://theconversation.com/kids-arent-just-littler-adults-heres-why-they-need-their-own-clinical-trials-for-a-covid-19-vaccine-162821">such as for COVID-19</a> – <a href="https://theconversation.com/the-fda-authorizes-pfizers-covid-19-vaccine-for-children-ages-5-to-11-a-pediatrician-explains-how-the-drug-was-tested-for-safety-and-efficacy-169907">get tested and approved on different schedules</a> for adults, teens, kids and babies.</p>
<p>A number of vaccines for infants are given as a series – meaning they get the same kind of shot several times over the course of a few months. A baby’s adaptive immune system is prone to being forgetful or not listening at this age – the same way a baby falters as it tries to stand and walk. With each exposure, every aspect of the immune system <a href="https://doi.org/10.1038/cr.2009.139">gets stronger and better</a> at defending against the would-be infection.</p>
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<a href="https://images.theconversation.com/files/429732/original/file-20211102-54176-3uy4s0.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="chart listing vaccination schedule for young children" src="https://images.theconversation.com/files/429732/original/file-20211102-54176-3uy4s0.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/429732/original/file-20211102-54176-3uy4s0.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=293&fit=crop&dpr=1 600w, https://images.theconversation.com/files/429732/original/file-20211102-54176-3uy4s0.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=293&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/429732/original/file-20211102-54176-3uy4s0.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=293&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/429732/original/file-20211102-54176-3uy4s0.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=369&fit=crop&dpr=1 754w, https://images.theconversation.com/files/429732/original/file-20211102-54176-3uy4s0.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=369&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/429732/original/file-20211102-54176-3uy4s0.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=369&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
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<span class="caption">Some vaccines need to be given multiple times.</span>
<span class="attribution"><a class="source" href="https://www.cdc.gov/vaccines/schedules/easy-to-read/child-easyread.html">CDC National Center for Immunization and Respiratory Diseases</a>, <a class="license" href="http://creativecommons.org/licenses/by/4.0/">CC BY</a></span>
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<p>After 4 years of age and through younger adult life, your immune system tends to be <a href="https://doi.org/10.1016/j.jaci.2018.02.017">more responsive and less prone to forgetting</a>. It’s not a coincidence that this is when people tend to <a href="https://www.uhhospitals.org/Healthy-at-UH/articles/2018/04/allergies-and-age">gain most of their allergies</a>. For the COVID-19 Pfizer vaccine, researchers found that kids ages 5 to 11 had a similar immune and safety response at <a href="https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-announce-positive-topline-results">one-third the dose</a> used for those ages 12 and up.</p>
<p>Scientists tend to start with patients between ages 18 and 55 years old when studying vaccines. Their adult immune systems have matured and they can be counted on to reliably report any adverse reactions. Seeing what happens in the adult age group also helps physicians predict what might occur when a vaccine is administered to others and be on the lookout for these side effects in the younger age groups.</p>
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<p>Around age 55 or so, the adaptive immune system <a href="https://doi.org/10.1098/rspb.2014.3085">starts to become weaker again and forgetful</a>, in some ways more like the infant’s developing system. Luckily vaccine boosters can provide a quick refresher for these older patients – like helping protect them from accidental falls after a lifetime having mastered walking and running.</p>
<p>In the end, vaccines provide the safest environment for the immune system to learn, and tweaking the dosages for different age groups helps ensure that each patient gets just what’s necessary to get the job done.</p><img src="https://counter.theconversation.com/content/168708/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Brian Peppers 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>First CDC signed off on a COVID-19 vaccine for adults, then teens. Now US children ages 5 to 11 are officially eligible for shots. Here’s the science on why each group needs to be considered separately.Brian Peppers, Assistant Professor of Pediatric and Adult Allergy/Immunology, West Virginia UniversityLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1603452021-05-07T00:54:46Z2021-05-07T00:54:46ZWhat’s the Valneva COVID-19 vaccine, the French shot that’s supposed to be ‘variant proof’?<figure><img src="https://images.theconversation.com/files/399120/original/file-20210506-14-ssjrin.jpg?ixlib=rb-1.1.0&rect=0%2C4%2C1000%2C658&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-photo/valneva-covid19-vaccine-concept-finger-pointing-1950918379">mundissima/www.shutterstock.com</a></span></figcaption></figure><p>A COVID-19 vaccine from French company Valneva has yet to complete clinical trials. But it has <a href="https://www.news.com.au/national/australia-in-talks-with-french-firm-valneva-about-importing-vaccine/news-story/bcd4d56629b5469311b1d9a5db6edcc3">caught the eye</a> of governments in the UK, <a href="https://twitter.com/ReutersWorld/status/1388201550938529799">Europe</a> and Australia. </p>
<p>One of the vaccine’s main selling points is its apparent ability to mount a more general immune response against SARS-CoV-2, the virus that causes COVID-19, rather than rely on the <a href="https://theconversation.com/revealed-the-protein-spike-that-lets-the-2019-ncov-coronavirus-pierce-and-invade-human-cells-132183">spike protein</a> to do this.</p>
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<p>This means the vaccine is more likely to be effective against the type of virus variants we’ve already seen emerging, and may emerge in the future. <a href="https://www.scmp.com/news/world/europe/article/3131661/french-firms-more-variant-proof-coronavirus-vaccine-could-help">Some reports</a> describe it as “<a href="https://medium.com/technicity/phase-3-trials-on-a-new-variant-proof-vaccine-begin-9f52225e7350">variant proof</a>”. </p>
<p>The hope is vaccines using this technology would be able to provide protection for longer, rather than keep being reformulated to get ahead of these new variants.</p>
<h2>How does it work?</h2>
<p>Valneva’s vaccine, called VLA2001, is based on tried and tested vaccine technology. It’s the technology used in the vaccine against <a href="https://www.jstor.org/stable/24858956">poliovirus</a> and in some types of <a href="https://www.cdc.gov/flu/prevent/quadrivalent.htm">flu vaccines</a>. And the company already has a commercially available <a href="https://preventje.com/hcp/what-is-ixiaro/">Japanese encephalitis</a> vaccine based on the same technology.</p>
<p>VLA2001 uses an <a href="https://www.who.int/news-room/feature-stories/detail/the-race-for-a-covid-19-vaccine-explained">inactivated version of the whole virus</a>, which cannot replicate or cause disease.</p>
<p>The virus is inactivated using a chemical called <a href="https://pubchem.ncbi.nlm.nih.gov/compound/beta-Propiolactone">beta-propiolactone or BPL</a>. This is <a href="https://www.tandfonline.com/doi/full/10.1586/erv.12.38">widely used</a> to inactivate other viruses for vaccines. It was even used to make <a href="https://www.liebertpub.com/doi/full/10.1089/vim.2010.0028?casa_token=jNYegUijdDkAAAAA%3AQfR_VQ4OjQeI70ajPwgEZb_2lWASqd2Mm5xMcj9aDKYOS0FFAB344DzrqW7g-lmaTeKDW-T8oJI">experimental versions</a> of vaccines against SARS-CoV, the virus that caused <a href="https://www.cdc.gov/sars/about/fs-sars.html">SARS (severe acute respiratory syndrome)</a>.</p>
<p>This type of inactivation is expected to preserve the structure of the viral proteins, as they would occur in nature. This means the immune system will be presented with something similar to what occurs naturally, and mount a strong immune response.</p>
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Read more:
<a href="https://theconversation.com/from-adenoviruses-to-rna-the-pros-and-cons-of-different-covid-vaccine-technologies-145454">From adenoviruses to RNA: the pros and cons of different COVID vaccine technologies</a>
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<p>After being inactivated, the vaccine would be highly purified. Then, an adjuvant (an immune stimulant) is added to induce a strong immune response.</p>
<p>VLA2001 isn’t the first inactivated vaccine against COVID-19. Leading COVID-19 inactivated vaccines, such as those developed by Sinopharm and Bharat Biotech, have been <a href="https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine-tracker.html">approved for use</a> in China and received emergency approval in other countries, including India.</p>
<p>However, VLA2001 is the only COVID-19 vaccine candidate using whole inactivated virus in clinical trials in the UK and in mainland Europe.</p>
<h2>What are the benefits we know so far?</h2>
<p>This approach to vaccine development presents the immune system with all of the structural components of the SARS-CoV-2 virus, not just the spike protein, as many other COVID-19 vaccines do. </p>
<p>So Valneva’s vaccine is thought to produce a more broadly protective immune response. That is, antibodies and cells of the immune system are able to recognise and neutralise more pieces of the virus than just the spike protein. </p>
<p>As a result, Valneva’s vaccine could be more effective at tackling emerging COVID-19 virus variants and, if approved, play a useful role as a booster vaccine. </p>
<p>Valneva’s vaccine can be stored at <a href="https://valneva.com/research-development/covid-19-vla2001/">standard cold-chain conditions (2-8°C)</a> and is expected to be given as two shots.</p>
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Read more:
<a href="https://theconversation.com/uk-south-african-brazilian-a-virologist-explains-each-covid-variant-and-what-they-mean-for-the-pandemic-154547">UK, South African, Brazilian: a virologist explains each COVID variant and what they mean for the pandemic</a>
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<h2>How about results from clinical trials?</h2>
<p><a href="https://clinicaltrials.gov/ct2/show/NCT04671017?term=valneva&draw=3&rank=5">According to</a> <a href="https://valneva.com/press-release/valneva-reports-positive-phase-1-2-data-for-its-inactivated-adjuvanted-covid-19-vaccine-candidate-vla2001/">the company</a>, no safety concerns or serious adverse events were associated with VLA2001 in early-stage clinical trials. </p>
<p>VLA2001 was given as a low, medium or high dose in these trials with <a href="https://clinicaltrials.gov/ct2/show/NCT04671017?term=valneva&draw=3&rank=5">all participants</a> in the high-dose group generating antibodies to the virus spike protein. </p>
<p>One measure of immune response in the high-dose group after completing the two doses indicated antibody levels were, after two weeks, at least as high as those seen in patients naturally infected with SARS-CoV-2.</p>
<p>Interestingly, VLA2001 induced immune responses against a number of virus proteins (including the spike protein) across all participants, an encouraging sign the vaccine can provide broad protection against COVID-19.</p>
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<p>The vaccine has since advanced to <a href="https://valneva.com/press-release/valneva-initiates-phase-3-clinical-trial-for-its-inactivated-adjuvanted-covid-19-vaccine-candidate-vla2001/">phase 3 clinical trials</a> in the UK. The trial, which started in April 2021, will compare its safety and efficacy <a href="https://www.globenewswire.com/news-release/2021/04/21/2214528/0/en/Valneva-Initiates-Phase-3-Clinical-Trial-for-its-Inactivated-Adjuvanted-COVID-19-Vaccine-Candidate-VLA2001.html">with the AstraZeneca vaccine</a>. </p>
<p>The phase 3 trial is expected to be completed by the northern hemisphere’s <a href="https://www.bloomberg.com/news/articles/2021-04-29/a-french-biotech-says-inactivated-vaccines-are-the-way-to-fight-covid-variants">autumn this year</a>. And if successful, would be submitted for regulatory approval after that.</p>
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<strong>
Read more:
<a href="https://theconversation.com/a-single-vaccine-to-beat-all-coronaviruses-sounds-impossible-but-scientists-are-already-working-on-one-156373">A single vaccine to beat all coronaviruses sounds impossible. But scientists are already working on one</a>
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<h2>Who’s interested?</h2>
<p>Despite phase 3 clinical trials only just starting, the UK government has <a href="https://www.news.com.au/national/australia-in-talks-with-french-firm-valneva-about-importing-vaccine/news-story/bcd4d56629b5469311b1d9a5db6edcc3">pre-ordered</a> more than <a href="https://valneva.com/press-release/valneva-announces-uk-government-exercise-of-option-for-40-million-doses-of-its-inactivated-adjuvanted-covid-19-vaccine/">100 million doses</a> of the vaccine from Valneva, with the option of buying more down the track. If trials prove successful and pass regulatory approval, this means the vaccine could be used as a booster in time for this year’s northern hemisphere’s winter.</p>
<p>Australia <a href="https://www.news.com.au/national/australia-in-talks-with-french-firm-valneva-about-importing-vaccine/news-story/bcd4d56629b5469311b1d9a5db6edcc3">has confirmed</a> it’s also in talks with Valeneva about importing the vaccine. Some countries in Europe are also <a href="https://www.reuters.com/world/europe/exclusive-some-eu-nations-still-want-valneva-covid-19-vaccine-deal-sources-2021-04-30/?taid=608c4f0e12d1d500012373d2&utm_campaign=trueAnthem:+Trending+Content&utm_medium=trueAnthem&utm_source=twitter">reportedly keen</a> to strike a deal.</p>
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<p>As new cases of COVID-19 increase globally, we’ll continue to see new viral variants emerge that threaten to escape the protection existing vaccines offer.</p>
<p>Already, we are seeing vaccines from companies <a href="https://www.theguardian.com/world/2021/may/05/tweaked-moderna-vaccine-neutralises-covid-variants-in-trials">such as</a> <a href="https://investors.modernatx.com/news-releases/news-release-details/moderna-announces-positive-initial-booster-data-against-sars-cov">Moderna</a> and <a href="https://www.wsj.com/articles/covid-19-vaccines-targeting-multiple-strains-are-in-the-works-11615374007">Novavax</a> begin to reformulate their spike protein-based vaccines to get ahead of emerging variants.</p>
<p>So Valneva’s vaccine, with the potential to elicit a more broadly protective immune response, may prove to be a useful tool to combat the rise of the virus and its mutations. However, whether the vaccine is really “variant proof” or merely less affected by emerging variants remains to be seen.</p><img src="https://counter.theconversation.com/content/160345/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Adam Taylor receives funding from the Australian National Health and Medical Research Council. </span></em></p>It sounds too good to be true, a vaccine that can protect against future virus variants. But governments around the world are keen to learn more.Adam Taylor, Early Career Research Leader, Emerging Viruses, Inflammation and Therapeutics Group, Menzies Health Institute Queensland, Griffith UniversityLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1443322020-08-12T12:00:59Z2020-08-12T12:00:59ZA COVID-19 vaccine needs the public’s trust – and it’s risky to cut corners on clinical trials, as Russia is<figure><img src="https://images.theconversation.com/files/352381/original/file-20200811-20-179mzzz.jpg?ixlib=rb-1.1.0&rect=187%2C22%2C743%2C551&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">On Aug. 11, Russian President Vladimir Putin announced that a coronavirus vaccine developed in the country has been registered for use.</span> <span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/news-photo/photo-shows-vials-of-vaccine-called-gamcovidvac-in-moscow-news-photo/1228002428?adppopup=true">Russian Health Ministry/Handout/Anadolu Agency via Getty Images</a></span></figcaption></figure><p>Russia’s announcement that a <a href="https://www.politico.com/news/2020/08/11/russia-coronavirus-vaccine-putin-daughter-393455">fast-tracked COVID-19 vaccine</a> is registered there, with plans for quick distribution in the general population this fall, is being <a href="https://www.nature.com/articles/d41586-020-02386-2">condemned by scientists worldwide</a>.</p>
<p>Findings from scientific studies of this vaccine, named “Sputnik V,” are not available. Large safety and efficacy trials <a href="https://sputnikvaccine.com/about-vaccine/clinical-trials/">are only now getting underway</a>. But despite only two months of preliminary testing in people, Russian President Vladimir Putin called the vaccine “<a href="https://www.bbc.com/news/world-europe-53735718">quite effective</a>” and it’s <a href="https://www.bloomberg.com/news/articles/2020-08-11/putin-says-russia-has-registered-world-s-first-covid-19-vaccine">received regulatory approval</a>.</p>
<p>In other places, notably the <a href="https://www.weforum.org/agenda/2020/06/vaccine-development-barriers-coronavirus/">United States, China and the European Union</a>, even as <a href="https://www.nationalgeographic.com/science/health-and-human-body/human-diseases/coronavirus-vaccine-tracker-how-they-work-latest-developments-cvd/">researchers rush to develop vaccines</a>, they continue to publish studies of these vaccines at a more measured pace than is happening in Russia.</p>
<p>As an <a href="https://scholar.google.com/citations?user=RNembkwAAAAJ&hl=en&oi=ao">epidemiologist who studies vaccine hesitancy and vaccine-preventable disease</a>, I’m concerned about this news from Russia. After essential workers and high-risk groups are vaccinated, I would want to be among the first in line for an approved COVID-19 vaccine, but the medical research system must make sure any vaccine is safe and effective before distributing it to the population at large.</p>
<h2>Clinical trials have a valuable role</h2>
<p>Before any drug, vaccine or medical device is licensed for use in the general population, it needs to go through <a href="https://www.historyofvaccines.org/content/articles/vaccine-development-testing-and-regulation">several rounds of large-scale testing</a>. These studies are designed to make sure the intervention is safe and effective, and to understand what the appropriate dosage will be.</p>
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<p>Under normal conditions, the research required to bring a vaccine to market <a href="https://doi.org/10.1186/s12961-020-00571-3">can take decades</a>. For example, before the HPV vaccine was <a href="https://www.cdc.gov/mmwr/preview/mmwrhtml/mm5920a4.htm">licensed in the U.S. in 2006</a>, a phase III clinical trial <a href="https://doi.org/10.1016/S0140-6736(09)61248-4">enrolled 18,644 participants in 2004-2005</a>, a phase II clinical trial had <a href="https://doi.org/10.1016/S0140-6736(04)17398-4">enrolled 1,113 participants in 2000</a>, and the laboratory studies that led to a vaccine candidate had been <a href="https://doi.org/10.2147/tcrm.2006.2.3.259">published in the early 1990s</a>.</p>
<p>In the face of the coronavirus pandemic, scientists around the globe are focusing their efforts on developing a COVID-19 vaccine. <a href="https://www.knowablemagazine.org/article/health-disease/2020/getting-covid-19-vaccine-quickly-and-safely">They’re working at an</a> <a href="https://theconversation.com/what-needs-to-go-right-to-get-a-coronavirus-vaccine-in-12-18-months-136816">unprecedented pace to move through the necessary clinical trials</a> to end up with a safe and effective vaccine. One of the most time-consuming parts of clinical trials is enrolling participants, and pharmaceutical companies have <a href="https://doi.org/10.1186/s12961-020-00571-3">sped up this process</a> by lining up volunteers early, obtaining important baseline data from them even before a vaccine candidate is available.</p>
<figure>
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<figcaption><span class="caption">Here’s how drugs are tested and approved in the U.S.</span></figcaption>
</figure>
<h2>Problems if the vaccine is released too early</h2>
<p>Carefully conducted clinical trials are necessary to identify any problems with the vaccine. For example, studies of a new type of measles vaccine in the early 1990s found that it was <a href="https://apps.who.int/iris/bitstream/handle/10665/228552/WER6748_357-361.PDF">detrimental to baby girls</a>, and so it was never licensed to the general population. The existing measles or measles-mumps-rubella vaccine available in the U.S. and other countries is <a href="https://www.cdc.gov/vaccinesafety/vaccines/mmr/mmr-studies.html">highly safe and effective</a>. </p>
<p>It could also be that the vaccine is not effective in some categories of people. Phase I and II clinical trials have small sample sizes and may not include individuals from high-risk groups. For example, a recently published phase II clinical trial of a COVID-19 vaccine <a href="https://doi.org/10.1016/S0140-6736(20)31605-6">excluded obese people, those with chronic diseases and pregnant women</a>. However, these are all groups that should be able to get the vaccine in the future. More studies, including phase III trials, are necessary to discover if the vaccine works in the general population. Preliminary results should be <a href="https://www.reuters.com/article/us-health-coronavirus-vaccines-explainer/when-will-a-coronavirus-vaccine-be-ready-idUSKCN2571H2">available by the end of 2020</a>.</p>
<p>The concern is that by introducing the vaccine early, without adequate testing of safety, effectiveness and dosing, the population may be presented with a vaccine which is not safe or not effective, and with little information on which vaccine schedule is best.</p>
<p>Food and Drug Administration Commissioner Dr. Stephen Hahn has said the FDA <a href="https://www.mercurynews.com/2020/08/10/commissioner-fda-wont-cut-corners-on-covid-19-vaccine/">will not “cut corners”</a> in approving a COVID-19 vaccine in the U.S. despite an accelerated program, <a href="https://abcnews.go.com/Politics/public-health-experts-scientists-confident-vaccine-process-criticism/story?id=72216320">dubbed Operation Warp Speed</a>.</p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/352382/original/file-20200811-14-292m13.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="archival photo of packing vials of polio vaccine into boxes" src="https://images.theconversation.com/files/352382/original/file-20200811-14-292m13.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/352382/original/file-20200811-14-292m13.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=492&fit=crop&dpr=1 600w, https://images.theconversation.com/files/352382/original/file-20200811-14-292m13.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=492&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/352382/original/file-20200811-14-292m13.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=492&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/352382/original/file-20200811-14-292m13.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=619&fit=crop&dpr=1 754w, https://images.theconversation.com/files/352382/original/file-20200811-14-292m13.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=619&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/352382/original/file-20200811-14-292m13.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=619&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">In 1956, boxes of polio vaccine were rushed for delivery, but only after clinical trials concluded and it was approved by the FDA.</span>
<span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/news-photo/indianapolis-in-at-the-eli-lilly-and-company-plant-in-the-news-photo/514874700?adppopup=true">Bettmann via Getty Images</a></span>
</figcaption>
</figure>
<h2>Rushing to market</h2>
<p>But is there ever an ethical reason to release a vaccine early, even without going through all phases of clinical trials?</p>
<p>Although it would be wonderful to get a vaccine into the population quickly, there could be substantial downsides if researchers and manufacturers cut corners. Imagine a vaccine that often had serious side effects that weren’t caught in small trials before it was widely administered.</p>
<p>[<em>Research into coronavirus and other news from science</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-corona-research">Subscribe to The Conversation’s new science newsletter</a>.]</p>
<p>An untested vaccine wouldn’t just harm the people vaccinated. If negative perceptions about the safety or efficacy of a COVID-19 vaccine spread throughout the population, it could limit how many people are willing to get the shot and perpetuate disease transmission.</p>
<p>Trust in vaccination programs is crucial. Russia, in fact, provides an important historical example. In the 1990s, trust in the country’s public health system rapidly decreased, and rates of diphtheria-tetanus-pertussis vaccination fell as a result. A large outbreak of <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2640235/?tool=pmcentrez&report=abstract">diphtheria then spread through eastern Europe</a>, leaving over 4,000 people dead.</p>
<p>Hasty rollout of a COVID-19 vaccine could prime people not only to not trust the COVID-19 vaccine, but also to doubt vaccination and public health systems as a whole. </p>
<p>Vaccinations should be developed by impartial scientists and evaluated by nonpartisan government officials. By cutting red tape, procedures can be prioritized and sped up, but they must not be skipped.</p><img src="https://counter.theconversation.com/content/144332/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Abram L. Wagner receives funding from the NIH and NSF. </span></em></p>As Russia fast tracks a coronavirus vaccine, scientists worry about skipped safety checks – and the potential fallout for trust in vaccines if something ends up going wrong.Abram L. Wagner, Research Assistant Professor of Epidemiology, University of MichiganLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1430472020-07-21T12:12:19Z2020-07-21T12:12:19ZRussian cyberthreat extends to coronavirus vaccine research<figure><img src="https://images.theconversation.com/files/348428/original/file-20200720-92332-1dragjf.jpg?ixlib=rb-1.1.0&rect=0%2C8%2C5463%2C3628&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Who are in the hoodies?</span> <span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/photo/group-of-hooded-hackers-shining-through-a-digital-royalty-free-image/682344086">BeeBright/iStock/Getty Images Plus</a></span></figcaption></figure><p>A Russian cyberespionage group that hacked into election networks before the 2016 U.S. presidential election is now attempting to steal coronavirus vaccine information from researchers in the U.S., U.K. and Canada. The governments of those three countries <a href="https://thehill.com/policy/national-security/507744-russian-hackers-return-to-spotlight-with-vaccine-research-attack">issued a warning on July 16</a> saying that the group known as APT29 or “Cozy Bear” is targeting vaccine development efforts. The group, which is <a href="https://www.theguardian.com/world/2020/jul/16/russian-state-sponsored-hackers-target-covid-19-vaccine-researchers">connected with the FSB</a>, Russia’s internal security service, had <a href="http://www.telegraph.co.uk/news/2016/12/16/russias-cyber-warriors-should-west-do/">gotten inside the Democratic National Committee</a> networks prior to the 2016 election.</p>
<p>This latest incident illustrates yet again how, beyond carrying all of our phone, text and internet communications, cyberspace is an active battleground, with cybercriminals, government agents and even military personnel probing weaknesses in corporate, national and even personal online defenses. Some of the most talented and dangerous cybercrooks and cyberwarriors come from Russia, which is a longtime meddler in other countries’ affairs.</p>
<p>Over decades, Russian operators have stolen terabytes of data, taken control of millions of computers and raked in billions of dollars. They’ve <a href="https://www.wired.com/story/russian-hackers-attack-ukraine/">shut down electricity in Ukraine</a> and <a href="http://www.nbcnews.com/news/us-news/intelligence-director-says-agencies-agree-russian-meddling-n785481">meddled in elections in the U.S.</a> and elsewhere. They’ve engaged in <a href="https://www.nytimes.com/2015/06/07/magazine/the-agency.html?hp&action=click&pgtype=Homepage&module=second-column-region&region=top-news&WT.nav=top-news&_r=1">disinformation</a> and disclosed pilfered information such as the <a href="https://en.wikipedia.org/wiki/Podesta_emails">emails stolen from Hillary Clinton’s campaign chairman, John Podesta,</a> following <a href="http://www.cnn.com/2017/06/27/politics/russia-dnc-hacking-csr/">successful spearphishing attacks</a>.</p>
<p>Who are these operators, why are they so skilled, and what are they up to?</p>
<h2>Back to the 1980s</h2>
<p>The Russian cyberthreat dates back to at least 1986 when Cliff Stoll, then a system administrator at Lawrence Berkeley National Laboratory, linked a 75-cent accounting error to intrusions into the lab’s computers. The hacker was after military secrets, downloading documents with important keywords such as “nuclear.” A lengthy investigation, described in Stoll’s book “<a href="http://www.penguinrandomhouse.com/books/173930/cuckoos-egg-by-clifford-stoll/">The Cuckoo’s Egg</a>,” led to a German hacker who was selling the stolen data to what was then the Soviet Union.</p>
<p>By the late 1990s, Russian cyberespionage had grown to include the multi-year “<a href="https://medium.com/@chris_doman/the-first-sophistiated-cyber-attacks-how-operation-moonlight-maze-made-history-2adb12cc43f7">Moonlight Maze</a>” intrusions into U.S. military and other government computers, foretelling the massive espionage from Russia today.</p>
<p>The 1990s also saw the arrest of <a href="http://www.nytimes.com/1995/08/19/business/citibank-fraud-case-raises-computer-security-questions.html">Vladimir Levin</a>, a computer operator in St. Petersburg. Levin tried to steal more than US$10 million by hacking Citibank accounts, foreshadowing Russia’s prominence in cybercrime. And Russian hackers defaced U.S. websites during the <a href="http://edition.cnn.com/TECH/computing/9904/06/serbnato.idg/index.html">Kosovo conflict</a>, portending Russia’s extensive use of disruptive and damaging cyberattacks.</p>
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<h2>Conducting advanced attacks</h2>
<p>In more recent years, Russia has been behind some of the most sophisticated cyberattacks on record. The <a href="https://www.wired.com/story/russian-hackers-attack-ukraine/">2015 cyberattack on three of Ukraine’s regional power distribution companies</a> knocked out power to almost a quarter-million people. Cybersecurity analysts from the Electricity Information Sharing and Analysis Center and the SANS Institute reported that the multi-staged attacks were conducted by a “<a href="https://ics.sans.org/media/E-ISAC_SANS_Ukraine_DUC_5.pdf">highly structured and resourced actor</a>.” Ukraine <a href="http://www.reuters.com/article/us-ukraine-crisis-cyber-idUSKBN15U2CN">blamed the attacks on Russia</a>.</p>
<p>The attackers used a <a href="https://ics.sans.org/media/E-ISAC_SANS_Ukraine_DUC_5.pdf">variety of techniques</a> and adapted to the targets they faced. They used <a href="https://theconversation.com/spearphishing-roiled-the-presidential-campaign-heres-how-to-protect-yourself-68274">spearphishing</a> email messages to gain initial access to systems. They installed “<a href="https://ics-cert.us-cert.gov/alerts/IR-ALERT-H-16-056-01">BlackEnergy</a>” malware to establish remote control over the infected devices. They harvested credentials to move through the networks. They developed custom malicious firmware to render system control devices inoperable. They hijacked the <a href="https://doi.org/10.1109/PROC.1987.13932">Supervisory Control and Data Acquisition</a> system to open circuit breakers in substations. They used “<a href="https://thehackernews.com/2016/01/Ukraine-power-system-hacked.html">KillDisk</a>” malware to erase the master boot record of affected systems. The attackers even went so far as to strike the control stations’ battery backups and tie up the energy company’s call center with <a href="https://www.wired.com/2016/03/inside-cunning-unprecedented-hack-ukraines-power-grid/">thousands of calls</a>.</p>
<p>The Russians <a href="https://www.wired.com/story/russian-hackers-attack-ukraine/">returned in 2016</a> with more advanced tools to take down a major artery of Ukraine’s power grid. Russia is believed to have also invaded energy companies in the U.S., including those operating <a href="https://www.washingtonpost.com/world/national-security/us-officials-say-russian-government-hackers-have-penetrated-energy-and-nuclear-company-business-networks/2017/07/08/bbfde9a2-638b-11e7-8adc-fea80e32bf47_story.html">nuclear power plants</a>.</p>
<h2>Top-notch cybereducation</h2>
<p>Russia has many skilled cyberoperators, and for good reason: Their <a href="https://krebsonsecurity.com/2017/06/why-so-many-top-hackers-hail-from-russia/">educational system emphasizes information technology</a> and computer science, more so than in the U.S. </p>
<p>Every year, Russian schools take a disproportionate number of the top spots in the <a href="https://icpc.baylor.edu/worldfinals/results">International Collegiate Programming Contest</a>. In the 2016 contest, St. Petersburg State University took the top spot for the fifth time in a row, and four other Russian schools also made the top 12. In 2017, St. Petersburg ITMO University won, with two other Russian schools also placing in the top 12. The top U.S. school ranked 13th.</p>
<p>As Russia prepared to form a cyberbranch within its military, Minister of Defense <a href="https://www.rbth.com/society/2013/07/16/russia_to_get_cyber_troops_28069.html">Sergei Shoigu</a> took note of Russian students’ performance in the contest. “We have to work with these guys somehow, because we need them badly,” he said in a public meeting with university administrators.</p>
<h2>Who are these Russian cyberwarriors?</h2>
<p>Russia employs cyberwarriors within its military and <a href="https://www.us-cert.gov/sites/default/files/publications/JAR_16-20296A_GRIZZLY%20STEPPE-2016-1229.pdf">intelligence services</a>. Indeed, the cyberespionage groups dubbed APT28 (aka Fancy Bear) and APT29 (aka Cozy Bear and The Dukes) are believed to <a href="http://www.telegraph.co.uk/news/2016/12/16/russias-cyber-warriors-should-west-do/">correspond to Russia’s military intelligence agency GRU and its state security organization FSB,</a> respectively. Both groups have been implicated in hundreds of cyberoperations over the past decade, including U.S. election hacking.</p>
<p>Russia <a href="https://www.nytimes.com/2016/12/29/world/europe/how-russia-recruited-elite-hackers-for-its-cyberwar.html">recruits cyberwarriors</a> from its colleges, but also from the cybersecurity and cybercrime sectors. It is said to turn a <a href="http://thehill.com/policy/cybersecurity/256573-kremlins-ties-russian-cyber-gangs-sow-us-concerns">blind eye</a> to its criminal hackers as long as they avoid Russian targets and use their skills to aid the government. According to <a href="http://thehill.com/policy/cybersecurity/256573-kremlins-ties-russian-cyber-gangs-sow-us-concerns">Dmitri Alperovitch</a>, co-founder of the security firm CrowdStrike, when Moscow identifies a talented cybercriminal, any pending criminal case against the person is dropped and the hacker disappears into the Russian intelligence services. <a href="http://www.news.com.au/technology/online/hacking/the-russian-hacker-with-a-4-million-bounty-on-his-head/news-story/e5c363e260e25c0a09641d39e1d37636">Evgeniy Mikhailovich Bogachev</a>, <a href="https://www.fbi.gov/wanted/cyber/evgeniy-mikhailovich-bogachev">wanted by the FBI</a> with a reward of $3 million for cybercrimes, is also on the <a href="https://www.treasury.gov/press-center/press-releases/Pages/jl0693.aspx">Obama administration’s list of people sanctioned</a> in response to interference in the U.S. election. Bogachev is said to work “<a href="https://www.nytimes.com/2017/03/12/world/europe/russia-hacker-evgeniy-bogachev.html">under the supervision of a special unit of the FSB</a>.” </p>
<h2>Allies outside official channels</h2>
<p>Besides its in-house capabilities, the Russian government has access to hackers and the Russian media. Analyst Sarah Geary at cybersecurity firm FireEye <a href="https://www.thecipherbrief.com/article/tech/cyber-proxies-central-tenet-russias-hybrid-warfare-1092">reported that the hackers</a> “disseminate propaganda on behalf of Moscow, develop cybertools for Russian intelligence agencies like the FSB and GRU, and hack into networks and databases in support of Russian security objectives.” </p>
<p>Many seemingly independent “<a href="http://faculty.nps.edu/dedennin/publications/CyberConflict-EmergentSocialPhenomenon-final.pdf">patriotic hackers</a>” operate on Russia’s behalf. Most notably, they attacked critical systems in <a href="https://ccdcoe.org/publications/books/legalconsiderations.pdf">Estonia in 2007</a> over the relocation of a Soviet-era memorial, <a href="https://ccdcoe.org/publications/books/legalconsiderations.pdf#page=66">Georgia in 2008</a> during the Russo-Georgian War and <a href="http://dx.doi.org/10.5038/2378-0789.1.1.1001">Ukraine in 2014</a> in connection with the conflict between the two countries. </p>
<p>At the very least, the Russian government condones, even encourages, these hackers. After some of the Estonian attacks were traced back to Russia, <a href="https://ccdcoe.org/publications/books/legalconsiderations.pdf">Moscow turned down</a> Estonia’s request for help – even as a commissar in Russia’s pro-Kremlin youth movement Nashi <a href="https://www.rferl.org/a/Russian_Groups_Claims_Reopen_Debate_On_Estonian_Cyberattacks_/1564694.html">admitted launching some of the attacks</a>. And when Slavic Union hackers successfully attacked Israeli websites in 2006, <a href="https://www.army.mil/article/19351/georgias-cyber-left-hook">Deputy Duma Director Nikolai Kuryanovich</a> gave the group a certificate of appreciation. He noted that “a small force of hackers is stronger than the multi-thousand force of the current armed forces.” </p>
<p>While some patriotic hackers may indeed operate independently of Moscow, others seem to have strong ties. <a href="http://www.ibtimes.com/meet-cyberberkut-pro-russian-hackers-waging-anonymous-style-cyberwarfare-against-2228902">Cyber Berkut</a>, one of the groups that conducted cyberattacks against Ukraine, including its central election site, is said to be a <a href="http://www.dia.mil/Portals/27/Documents/News/Military%20Power%20Publications/Russia%20Military%20Power%20Report%202017.pdf">front for Russian state-sponsored</a> cyberactivity. And Russia’s espionage group <a href="http://www.dia.mil/Portals/27/Documents/News/Military%20Power%20Publications/Russia%20Military%20Power%20Report%202017.pdf">APT28 is said to have operated under the guise of the ISIS-associated CyberCaliphate</a> while attacking the French station TV5 Monde and taking over the Twitter account of U.S. Central Command.</p>
<h2>One of many cyberthreats</h2>
<p>Although Russia poses a major cyberthreat, it is not the only country that threatens the U.S. in cyberspace. <a href="http://www.huffingtonpost.com/frank-j-cilluffo/recalibrate-us-cyber-effo_b_2975841.html">China, Iran and North Korea</a> are also countries with strong cyberattack capabilities, and more countries will join the pool as they develop their people’s skills. </p>
<p>The good news is that <a href="https://www.cisecurity.org/controls/">actions to protect an organization’s cybersecurity</a> (such as monitoring access to sensitive files) that work against Russia also work against other threat actors. The bad news is that many organizations do not take those steps. Further, hackers find new vulnerabilities in devices and exploit the weakest link of all – <a href="https://theconversation.com/cybersecuritys-weakest-link-humans-57455">humans</a>. Whether cyberdefenses will evolve to avert a major calamity, from Russia or anywhere else, remains to be seen.</p>
<p><em>Editor’s note: This is an updated version of <a href="https://theconversation.com/tracing-the-sources-of-todays-russian-cyberthreat-81593">an article</a> originally published Aug. 15, 2017.</em></p><img src="https://counter.theconversation.com/content/143047/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Dorothy Denning 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>The Russian cyberthreat, now targeting coronavirus vaccine research, goes back over three decades, extends into the country’s educational systems and criminal worlds, and shows no signs of letting up.Dorothy Denning, Emeritus Distinguished Professor of Defense Analysis, Naval Postgraduate SchoolLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1392662020-06-17T12:16:33Z2020-06-17T12:16:33ZI study coronavirus in a highly secured biosafety lab – here’s why I feel safer here than in the world outside<figure><img src="https://images.theconversation.com/files/341959/original/file-20200615-65912-tgot70.jpg?ixlib=rb-1.1.0&rect=6%2C12%2C4307%2C2910&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Troy Sutton works with potentially deadly pathogens but the right precautions greatly reduce the risks.</span> <span class="attribution"><span class="source">Penn State</span>, <a class="license" href="http://creativecommons.org/licenses/by-nd/4.0/">CC BY-ND</a></span></figcaption></figure><p>It’s quiet in the laboratory, almost peaceful. But I’m holding live SARS-CoV-2 in my hands and this virus is not to be taken lightly.</p>
<p>As I dilute the coronavirus to infect cultured cells, I hear the reassuring sound of purified air being blown by my respirator into my breathing space. There are three layers of nitrile and protective materials between me and the virus, and every part of my body is wrapped in protective equipment.</p>
<p>Thanks to these precautions and other features of our high containment lab, I’m not nervous about being up close and personal with this dangerous pathogen. </p>
<p><a href="https://scholar.google.com/citations?user=ZqoZn8QAAAAJ&hl=en&oi=ao">As an expert on respiratory virus transmission and vaccine development</a>, I’ve halted all other research in my lab so we can devote our expertise to studying SARS-CoV-2, the virus that causes COVID-19. The goal is to understand the virus and develop a vaccine, fast. </p>
<p>We do this research in what’s called a high-containment <a href="https://www.phe.gov/s3/BioriskManagement/biosafety/Pages/Biosafety-Levels.aspx">biosafety level 3</a>-enhanced lab, with <a href="https://www.cdc.gov/labs/BMBL.html">stringent precautions in place</a> to protect everyone from the potentially deadly pathogens we work with. In addition to SARS-CoV-2, researchers study the microbes that cause diseases including tuberculosis, anthrax and avian influenza in <a href="https://doi.org/10.1089/bsp.2013.0060">other facilities of this type across the U.S.</a></p>
<p>As a result of our precautions, many colleagues have told me they feel safer <a href="https://www.research.psu.edu/arp/animal-facilities/eva-j.-pell-laboratory-for-advanced-biological-research.html">inside the containment lab</a> than they do shopping for groceries during the pandemic. Here’s why.</p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/341976/original/file-20200615-65961-1md20md.png?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="" src="https://images.theconversation.com/files/341976/original/file-20200615-65961-1md20md.png?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/341976/original/file-20200615-65961-1md20md.png?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=329&fit=crop&dpr=1 600w, https://images.theconversation.com/files/341976/original/file-20200615-65961-1md20md.png?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=329&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/341976/original/file-20200615-65961-1md20md.png?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=329&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/341976/original/file-20200615-65961-1md20md.png?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=413&fit=crop&dpr=1 754w, https://images.theconversation.com/files/341976/original/file-20200615-65961-1md20md.png?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=413&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/341976/original/file-20200615-65961-1md20md.png?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=413&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">Biosafety levels are defined by how much risk is involved in working with particular pathogens.</span>
<span class="attribution"><span class="source">The Conversation</span>, <a class="license" href="http://creativecommons.org/licenses/by-nd/4.0/">CC BY-ND</a></span>
</figcaption>
</figure>
<h2>Suiting up like you’re on a space mission</h2>
<p>When performing a SARS-CoV-2 experiment, my days start by coordinating with a least one of my lab members – we always work in pairs inside containment. We outline the experiment step-by-step, check we have all of the required supplies, confirm and review any procedures and communicate with the facility staff.</p>
<p>First thing on site, we check multiple gauges and monitors to ensure the facility is functioning properly. Then we enter the changeroom, where we remove all of our street clothes, including jewelry and underwear. We don’t want to bring any potentially contaminated clothing or items out of containment at the end of the day. “You enter and leave containment as you were at birth” is our saying.</p>
<p>We don scrubs, close-toed laboratory shoes, a full-body disposable suit, shoe covers, multiple pairs of gloves and a surgical gown. Most importantly, we also put on our air-purifying respirators. This device includes a Batman-style utility belt that houses a motor attached to an air filter capable of filtering out any infectious agents in the air. Powered by a battery pack that will last at least six hours, the respirator blows purified air up a tube into a hood that covers my entire head and shoulders. The hood is under positive pressure so no air from the environment can enter my breathing space.</p>
<p>Through the clear plastic face shield I can see that we look like astronauts in space suits. Once fully equipped, we enter the containment facility and proceed to our designated virus culture and animal holding rooms. This whole process has taken between 30 and 45 minutes.</p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/342294/original/file-20200616-23221-wczqw2.JPG?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="" src="https://images.theconversation.com/files/342294/original/file-20200616-23221-wczqw2.JPG?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/342294/original/file-20200616-23221-wczqw2.JPG?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=399&fit=crop&dpr=1 600w, https://images.theconversation.com/files/342294/original/file-20200616-23221-wczqw2.JPG?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=399&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/342294/original/file-20200616-23221-wczqw2.JPG?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=399&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/342294/original/file-20200616-23221-wczqw2.JPG?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=501&fit=crop&dpr=1 754w, https://images.theconversation.com/files/342294/original/file-20200616-23221-wczqw2.JPG?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=501&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/342294/original/file-20200616-23221-wczqw2.JPG?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=501&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">Inside the lab, experiments are done under a vented hood that sucks air away to be filtered.</span>
<span class="attribution"><span class="source">Penn State</span>, <a class="license" href="http://creativecommons.org/licenses/by-nd/4.0/">CC BY-ND</a></span>
</figcaption>
</figure>
<h2>What’s inside?</h2>
<p>The facility itself is a giant vacuum. All of the air flows from outside into the lab. It exhausts through air filters that remove any stray infectious agents. The facility is designed to accommodate failures. If one filter fails, there’s a second one, and all work stops until both are working again.</p>
<p>Within this space our work is divided into rooms where we grow virus in cells in plastic dishes. There are separate spaces where we house animals that we use to evaluate how the virus is transmitted and if our vaccines are working.</p>
<p>When we’re done for the day, the materials we used are treated with bleach or stored safely. All waste is sealed in plastic bags and treated in a pressurized, high-heat oven called an autoclave to ensure any remaining virus is dead.</p>
<p>To leave the lab, as we move through various anterooms toward the exit, at every stage we remove a layer of gloves and protective equipment. We also regularly spray our suits and respirators with powerful disinfectants. At the last step, we remove our respirator and scrubs and “shower out” of the facility. Even the wastewater from the shower is boiled for an hour under high pressure to kill any microorganisms.</p>
<p>The only living thing that leaves the facility is the scientist.</p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/341975/original/file-20200615-65956-1weky85.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="" src="https://images.theconversation.com/files/341975/original/file-20200615-65956-1weky85.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/341975/original/file-20200615-65956-1weky85.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=317&fit=crop&dpr=1 600w, https://images.theconversation.com/files/341975/original/file-20200615-65956-1weky85.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=317&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/341975/original/file-20200615-65956-1weky85.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=317&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/341975/original/file-20200615-65956-1weky85.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=399&fit=crop&dpr=1 754w, https://images.theconversation.com/files/341975/original/file-20200615-65956-1weky85.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=399&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/341975/original/file-20200615-65956-1weky85.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=399&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">An exterior view of the Eva J. Pell BSL-3 containment laboratory at Penn State.</span>
<span class="attribution"><span class="source">Penn State</span>, <a class="license" href="http://creativecommons.org/licenses/by-nd/4.0/">CC BY-ND</a></span>
</figcaption>
</figure>
<h2>Training and oversight</h2>
<p>Many of the safety precautions around working in a high containment facility happen long before a researcher steps foot on the site. To gain access to this laboratory, I underwent an extensive FBI and police background check.</p>
<p>I was subject to a medical exam, and my lung capacity was tested. I was vaccinated against influenza. I’m sure when a COVID-19 vaccine becomes available, I’ll get that shot as well.</p>
<p>A rigorous training and testing process made sure I know how to handle agents like SARS-CoV-2 safely, as well as things like what to do during a fire, a bomb threat and even a tornado. Regardless of my over 10 years experience working with viruses, everyone entering the facility is trained from scratch. </p>
<p>Every high containment lab in the U.S. is subject to regular inspections by the U.S. Department of Agriculture, the Centers for Disease Control and Prevention or both. Once open, a facility is reinspected and certified every three years. During the interim, inspectors arrive unannounced to review all aspects of the facility, including maintenance records, inventories of agents and operating procedures. My university also provides oversight.</p>
<p>In addition, there is a myriad of other security features. One of my colleagues once joked that during a zombie apocalypse, the containment lab would be the best place to hide.</p>
<p>Ultimately, all these precautions are in place to help us understand how the SARS-CoV-2 virus is transmitted in animals and determine the optimal vaccine formulation that will prevent transmission. The facility at Penn State, like others throughout the U.S., was built for this type of research so scientists could quickly and safely respond during a pandemic. With a bit of luck, the work done by dedicated researchers in these facilities will help bring the COVID-19 pandemic to an end, sooner than later.</p>
<p><em>This article was updated to remove details that were not meant to be made public.</em></p>
<p>[<em>You need to understand the coronavirus pandemic, and we can help.</em> <a href="https://theconversation.com/us/newsletters?utm_source=TCUS&utm_medium=inline-link&utm_campaign=newsletter-text&utm_content=upper-coronavirus-help">Read The Conversation’s newsletter</a>.]</p><img src="https://counter.theconversation.com/content/139266/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Troy Sutton receives funding from Centers of Excellence for Influenza Research (CEIRS), the National Institute of Allergy and Infectious Diseases (NIAID), and The Huck Institutes of Life Sciences at Pennsylvania State University. </span></em></p>To find a SARS-CoV-2 vaccine, scientists need to work hands-on with the highly infectious coronavirus. It happens in a super secure lab designed to keep them safe and prevent any escapes.Troy Sutton, Assistant Professor of Veterinary and Biomedical Sciences, Penn StateLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1356142020-04-06T15:20:28Z2020-04-06T15:20:28ZCoronavirus weekly: as global cases pass one million, health-care workers take the strain<figure><img src="https://images.theconversation.com/files/325385/original/file-20200403-74235-zv58vm.jpg?ixlib=rb-1.1.0&rect=97%2C116%2C6383%2C4232&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">A hospital worker at a COVID-19 assessment centre for staff at Lions Gate Hospital, in North Vancouver, on March 19, 2020.</span> <span class="attribution"><span class="source">THE CANADIAN PRESS/Darryl Dyck</span></span></figcaption></figure><p>The world shut down in March. Schools, industries, amateur and professional sports, entertainment and cultural events, and businesses large and small all ceased operating in a manner so sudden and complete it would have been unimaginable a few months ago.</p>
<p>April began with the acceptance that these efforts to contain the spread of COVID-19 must continue. Millions of people were faced with the realities of having to pay bills, rent and mortgages despite layoffs and shuttered businesses. And on April 2, the pandemic itself passed a couple of grim milestones: <a href="https://coronavirus.jhu.edu/map.html">more than one million confirmed infections and 50,000 deaths worldwide</a>.</p>
<figure class="align-right ">
<img alt="" src="https://images.theconversation.com/files/325383/original/file-20200403-74220-hfwvru.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=237&fit=clip" srcset="https://images.theconversation.com/files/325383/original/file-20200403-74220-hfwvru.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=442&fit=crop&dpr=1 600w, https://images.theconversation.com/files/325383/original/file-20200403-74220-hfwvru.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=442&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/325383/original/file-20200403-74220-hfwvru.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=442&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/325383/original/file-20200403-74220-hfwvru.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=555&fit=crop&dpr=1 754w, https://images.theconversation.com/files/325383/original/file-20200403-74220-hfwvru.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=555&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/325383/original/file-20200403-74220-hfwvru.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=555&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">A man wearing a mask on his head walks past a graffiti mural in Toronto on March 25, 2020.</span>
<span class="attribution"><span class="source">THE CANADIAN PRESS/Nathan Denette</span></span>
</figcaption>
</figure>
<p>It is the health-care workers who are dealing head-on with the reality of those staggering global statistics. The rest of us can help control the numbers by staying at home and practising social distancing.</p>
<p>This fifth weekly column by our team of international health editors highlights more of the recently published articles from The Conversation’s global network.</p>
<h2>Vulnerable heroes</h2>
<p>In photos, front-line health-care workers are rendered anonymous by gowns, masks and gloves, like superheroes with secret identities but less glamorous costumes. Unlike their comic-book counterparts, they have no superpowers, not even the dependable tools of vaccines and evidence-based treatments. </p>
<p>And they are frighteningly mortal — as vulnerable as the rest of us to the illness they’re trying to treat. </p>
<p>● <strong>Shortage of masks</strong>. This makes <a href="https://theconversation.com/we-dont-talk-in-terms-of-supply-numbers-we-talk-in-terms-of-days-135012">the growing shortage of personal protective equipment</a> a dire emergency, writes W. Graham Carlos of Indiana University School of Medicine. </p>
<figure class="align-center ">
<img alt="" src="https://images.theconversation.com/files/325379/original/file-20200403-74198-ur7rs2.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/325379/original/file-20200403-74198-ur7rs2.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=408&fit=crop&dpr=1 600w, https://images.theconversation.com/files/325379/original/file-20200403-74198-ur7rs2.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=408&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/325379/original/file-20200403-74198-ur7rs2.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=408&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/325379/original/file-20200403-74198-ur7rs2.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=513&fit=crop&dpr=1 754w, https://images.theconversation.com/files/325379/original/file-20200403-74198-ur7rs2.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=513&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/325379/original/file-20200403-74198-ur7rs2.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=513&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">A seamstress sews sleeves as part of the production of medical gowns at the SP Apparel company in Granby, Que., which normally manufactures sports uniforms, on April 1, 2020.</span>
<span class="attribution"><span class="source">THE CANADIAN PRESS/Paul Chiasson</span></span>
</figcaption>
</figure>
<p>● <strong>Shortage of ventilators</strong>. It’s also very likely that health-care workers will face difficult decisions about which patients get ventilators and intensive care beds. Anthony Wrigley of Keele University, England, <a href="https://theconversation.com/coronavirus-and-triage-a-medical-ethicist-on-how-hospitals-make-difficult-decisions-134628">explains the ethical choices involved in allocating resources in a crisis situation</a>.</p>
<p>● <strong>Shortage of staff</strong>. With all hands on deck at hospitals, some facilities are encouraging people still in training or health-care workers from other jurisdictions to help out. However, <a href="https://theconversation.com/using-nursing-assistants-to-fill-coronavirus-gaps-brings-risks-if-theyre-not-up-to-the-job-134242">as Nicole Blay of Western Sydney University and Christine Duffield and Michael Roche of University of Technology Sydney point out</a>, we must be sure that those brought in to help cope with the pandemic are qualified to take on those tasks.</p>
<hr>
<figure class="align-right ">
<img alt="" src="https://images.theconversation.com/files/320716/original/file-20200316-18073-ruhw8b.png?ixlib=rb-1.1.0&q=45&auto=format&w=237&fit=clip" srcset="https://images.theconversation.com/files/320716/original/file-20200316-18073-ruhw8b.png?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=600&fit=crop&dpr=1 600w, https://images.theconversation.com/files/320716/original/file-20200316-18073-ruhw8b.png?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=600&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/320716/original/file-20200316-18073-ruhw8b.png?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=600&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/320716/original/file-20200316-18073-ruhw8b.png?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=754&fit=crop&dpr=1 754w, https://images.theconversation.com/files/320716/original/file-20200316-18073-ruhw8b.png?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=754&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/320716/original/file-20200316-18073-ruhw8b.png?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=754&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
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<span class="caption"></span>
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<p><strong><em>This is our weekly roundup of expert info about the <a href="https://theconversation.com/topics/covid-19-82431">Coronavirus</a>.</em></strong>
<br><em>The Conversation, a not-for-profit group, works with a wide range of academics across its global network. Together we produce evidence-based analysis and insights from across academia. The articles are free to read – there is no paywall – and to republish.</em></p>
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<h2>Their work will get harder in many places</h2>
<p>The coronavirus continues to spread exponentially around the world, which means that as more people become infected, the virus spreads faster. </p>
<p>● <strong>Speed of transmission</strong>. Christian Yates of the University of Bath, England, <a href="https://theconversation.com/coronavirus-is-growing-exponentially-heres-what-that-really-means-134591">explains the math</a> behind the virus’s exponential spread. </p>
<p>● <strong>Examining Indonesia’s high mortality rate</strong>. In many regions, the worst is yet to come. While cases in the northern hemisphere are spiking, the first case in Indonesia was only diagnosed on March 2. Since then, the fatality rate in Indonesia has become the highest in Southeast Asia. However, Henry Surenda, of the Eijkman-Oxford Clinical Research Unit, explains <a href="https://theconversation.com/3-overlooked-facts-behind-indonesias-high-covid-19-death-rate-135223">three reasons why that fatality rate does not reflect the reality on the ground</a>. </p>
<figure class="align-center ">
<img alt="" src="https://images.theconversation.com/files/325380/original/file-20200403-74202-1hcz209.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/325380/original/file-20200403-74202-1hcz209.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/325380/original/file-20200403-74202-1hcz209.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/325380/original/file-20200403-74202-1hcz209.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/325380/original/file-20200403-74202-1hcz209.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/325380/original/file-20200403-74202-1hcz209.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/325380/original/file-20200403-74202-1hcz209.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">Staff inspect medical equipment on March 23, 2020 at an emergency COVID-19 hospital set up in Jakarta, Indonesia.</span>
<span class="attribution"><span class="source">Hafidz Mubarak A/Pool Photo via AP</span></span>
</figcaption>
</figure>
<p>● <strong>Unique issues in Africa</strong>. SARS-CoV-2 has arrived in Africa later than it did in Asia and Europe, just as SARS did in 2003 and H1N1 did in 2009. Elena Gomez Diaz, from the López-Neyra Institute of Parasitology and Biomedicine, and Israel Cruz Mata, of Instituto de Salud Carlos III, explain <a href="https://theconversation.com/por-que-preocupa-tanto-la-pandemia-de-covid-19-en-africa-135079">why the COVID-19 pandemic in Africa is so worrying</a> (in Spanish).</p>
<p>● <strong>Testing decisions</strong>. Doyin Odubanjo, executive secretary of the Nigerian Academy of Science, explains why testing is central to the fight against COVID-19, and discusses some of the <a href="https://theconversation.com/covid-19-to-test-or-not-to-test-134934">many factors African countries must consider when making decisions about how to approach testing</a>.</p>
<p>● <strong>Who is at risk?</strong> Meanwhile, areas already hit hard by the virus are beginning to reckon with the losses. Jean-François Toussaint, from the Université de Paris, and Guillaume Saulière, of the Institut national du sport de l'expertise et de la performance, <a href="https://theconversation.com/covid-19-qui-sont-les-plus-vulnerables-134412">describe the toll of COVID-19 on vulnerable older populations</a> (in French).</p>
<h2>Treatment updates</h2>
<figure class="align-right ">
<img alt="" src="https://images.theconversation.com/files/325382/original/file-20200403-74212-1qt9ei8.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=237&fit=clip" srcset="https://images.theconversation.com/files/325382/original/file-20200403-74212-1qt9ei8.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=469&fit=crop&dpr=1 600w, https://images.theconversation.com/files/325382/original/file-20200403-74212-1qt9ei8.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=469&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/325382/original/file-20200403-74212-1qt9ei8.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=469&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/325382/original/file-20200403-74212-1qt9ei8.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=589&fit=crop&dpr=1 754w, https://images.theconversation.com/files/325382/original/file-20200403-74212-1qt9ei8.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=589&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/325382/original/file-20200403-74212-1qt9ei8.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=589&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">Electron microscope image of the virus that causes COVID-19, from the U.S. National Institutes.</span>
<span class="attribution"><span class="source">(NIAID-RML via AP)</span></span>
</figcaption>
</figure>
<p>● <strong>Vaccine development</strong>. The best way to combat the virus is a vaccine. Kylie Quinn, from RMIT University, and Damian Purcell, of the Peter Doherty Institute for Infection and Immunity, Melbourne, offer <a href="https://theconversation.com/where-are-we-at-with-developing-a-vaccine-for-coronavirus-134784">an update on the efforts to develop a SARS-CoV-2 vaccine</a>.</p>
<p>● <strong>Chloroquine studies</strong>. In terms of treatments, there was hope that the malaria medication chloroquine might be a useful treatment for COVID-19. But as Arsène Zongo from the Université Laval, Canada, reports, <a href="https://theconversation.com/chloroquine-et-covid-19-les-etudes-publiees-ne-permettent-pas-de-prouver-son-efficacite-134838">published studies have not proven its effectiveness</a> (in French). </p>
<p>● <strong>Antiviral drugs</strong>. Vicente Soriano of Universidad Internacional de La Rioja writes about antiviral medications, <a href="https://theconversation.com/asi-funcionan-los-antivirales-mas-prometedores-frente-a-covid-19-135109">which can shorten the duration and severity of symptoms</a> (in Spanish).</p>
<h2>Stay informed, stay home, stay six feet away</h2>
<p>For the vast majority of us who are not researchers or health-care workers or providing essential services, the best way to help is to stay informed, stay home and stay two metres away from others.</p>
<p>● <strong>COVID-19 glossary</strong>. You can improve your understanding of what scientists, researchers and health-care workers are talking about with this <a href="https://theconversation.com/coronavirus-jargon-buster-how-to-sound-like-an-expert-134845">handy cheat-sheet on coronavirus jargon</a>, provided by Lindsay Broadbent of Queen’s University Belfast.</p>
<figure class="align-center ">
<img alt="" src="https://images.theconversation.com/files/325381/original/file-20200403-74202-132repx.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/325381/original/file-20200403-74202-132repx.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/325381/original/file-20200403-74202-132repx.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/325381/original/file-20200403-74202-132repx.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/325381/original/file-20200403-74202-132repx.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/325381/original/file-20200403-74202-132repx.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/325381/original/file-20200403-74202-132repx.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">The statue of Eros in Piccadilly Circus in London, normally a crowded spot, is deserted on March 24, 2020, as people stay at home to help prevent the spread of COVID-19.</span>
<span class="attribution"><span class="source">AP Photo/Matt Dunham</span></span>
</figcaption>
</figure>
<p>Many people are looking for practical information about the virus and how to prevent infection. The Conversation’s editors around the globe have recruited experts to answer many of those questions. </p>
<p>● <strong>Social distancing rules</strong>. The Conversation team in Australia got answers about <a href="https://theconversation.com/can-i-visit-my-boyfriend-or-my-parents-go-fishing-or-bushwalking-coronavirus-rules-in-the-northern-territory-and-tasmania-135549">where people can and can’t go during social distancing</a> from legal experts Brendan Gogarty at the University of Tasmania and Ros Vickers at Charles Darwin University.</p>
<figure class="align-right ">
<img alt="" src="https://images.theconversation.com/files/325390/original/file-20200403-74255-er9mqg.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=237&fit=clip" srcset="https://images.theconversation.com/files/325390/original/file-20200403-74255-er9mqg.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=374&fit=crop&dpr=1 600w, https://images.theconversation.com/files/325390/original/file-20200403-74255-er9mqg.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=374&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/325390/original/file-20200403-74255-er9mqg.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=374&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/325390/original/file-20200403-74255-er9mqg.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=470&fit=crop&dpr=1 754w, https://images.theconversation.com/files/325390/original/file-20200403-74255-er9mqg.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=470&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/325390/original/file-20200403-74255-er9mqg.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=470&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">Coronavirus-themed graffiti spray-painted on the ground in Munich, Germany, March 16, 2020.</span>
<span class="attribution"><span class="source">(Sven Hoppe/dpa via AP)</span></span>
</figcaption>
</figure>
<p>● <strong>Coronavirus FAQs</strong>. Craig Janes, from the University of Waterloo, Canada, patiently answered a long list of questions about <a href="https://theconversation.com/coronavirus-faqs-can-people-without-symptoms-spread-covid-19-how-long-does-it-live-on-surfaces-what-cleaning-products-kill-the-virus-134945">how to destroy the virus, how long it persists on surfaces and more</a>.</p>
<p>● <strong>Sex and social distancing</strong>. But there was still one more question, and we weren’t afraid to ask. <a href="https://theconversation.com/coronavirus-and-sex-dos-and-donts-during-social-distancing-134007">Here are the dos and don’ts of sex during social distancing</a>, courtesy of Gonzalo R. Quintana Zunino at Concordia University, Canada.</p>
<hr>
<figure class="align-center ">
<img alt="" src="https://images.theconversation.com/files/320718/original/file-20200316-18056-1umaqbp.png?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/320718/original/file-20200316-18056-1umaqbp.png?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=90&fit=crop&dpr=1 600w, https://images.theconversation.com/files/320718/original/file-20200316-18056-1umaqbp.png?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=90&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/320718/original/file-20200316-18056-1umaqbp.png?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=90&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/320718/original/file-20200316-18056-1umaqbp.png?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=113&fit=crop&dpr=1 754w, https://images.theconversation.com/files/320718/original/file-20200316-18056-1umaqbp.png?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=113&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/320718/original/file-20200316-18056-1umaqbp.png?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=113&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption"></span>
</figcaption>
</figure>
<p><em>Get the latest news and advice on <a href="https://theconversation.com/topics/covid-19-82431">COVID-19</a>, direct from the experts in your inbox. Join hundreds of thousands who trust experts by <a href="http://theconversation.com/newsletter"><strong>subscribing to our newsletter</strong></a>.</em></p><img src="https://counter.theconversation.com/content/135614/count.gif" alt="The Conversation" width="1" height="1" />
This fifth weekly column by our team of international health editors highlights more of the recently published articles from The Conversation’s global network.Patricia Nicholson, Health + Medicine Editor, The Conversation CanadaLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1347262020-03-30T16:25:00Z2020-03-30T16:25:00ZCoronavirus vaccine: here are the steps it will need to go through during development<figure><img src="https://images.theconversation.com/files/324019/original/file-20200330-146683-1cvrccs.jpg?ixlib=rb-1.1.0&rect=35%2C28%2C4756%2C3161&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">A vaccine must go through six crucial steps.</span> <span class="attribution"><a class="source" href="https://www.shutterstock.com/image-photo/doctor-nurse-scientist-hand-blue-nitrile-1489783262">PhotobyTawat/ Shutterstock</a></span></figcaption></figure><p>Since humans haven’t previously been exposed to the novel coronavirus (<a href="https://www.who.int/health-topics/coronavirus">SARS-CoV-2</a>), our bodies aren’t well equipped to deal with being infected by it. A vaccine would allow the body to safely develop an immune response to COVID-19 that could prevent or control infection.</p>
<p>But it takes time to develop safe and effective vaccines – usually five to ten years on average. Despite promising reports about <a href="https://www.theguardian.com/world/2020/mar/25/coronavirus-vaccine-when-will-it-be-ready-trials-cure-immunisation">potential coronavirus vaccines</a> being developed worldwide, it could still take an estimated <a href="https://www.businessinsider.fr/us/us-top-virus-expert-coronavirus-vaccine-12-18-months-away-2020-3">12-18 months</a> to develop one. </p>
<p>It’s becoming quicker to develop new vaccines than it was in the past as we can build on research from vaccines used for other diseases. During outbreaks, more resources and funding may also become available, which can speed up the process. Products might also be considered for use even before being formally granted licences to control the disease in severely affected areas during emergencies.</p>
<p>The development of a potential novel coronavirus vaccine is being partly led by experts who were already developing vaccines for other coronaviruses. This type of virus was identified as a possible <a href="https://www.who.int/activities/prioritizing-diseases-for-research-and-development-in-emergency-contexts">cause of the next big pandemic</a> as the other coronaviruses <a href="https://www.who.int/ith/diseases/sars/en/">SARS</a> and <a href="https://www.who.int/news-room/fact-sheets/detail/middle-east-respiratory-syndrome-coronavirus-(mers-cov)">MERS</a> have been responsible for two global outbreaks in the last 20 years. Research on vaccines for these coronaviruses was already <a href="https://www.nature.com/articles/d41587-020-00005-z">undergoing clinical trials</a>. </p>
<p>The first new vaccine to <a href="https://time.com/5790545/first-covid-19-vaccine/">enter human trials for COVID-19</a> was developed by the US firm Moderna Therapeutics. About <a href="https://www.who.int/blueprint/priority-diseases/key-action/novel-coronavirus/en/">35 other companies and academic institutions</a> are also working on COVID-19 vaccines. Most are currently in “pre-clinical testing”, including one being developed by a <a href="https://www.theguardian.com/society/2020/mar/19/uk-drive-develop-coronavirus-vaccine-science">team of researchers</a> at the University of Oxford. The vaccine candidate was identified in January and is nearing the clinical testing phase. </p>
<p>During development, a vaccine needs to go through the following steps:</p>
<h2>1. Basic understanding of the virus</h2>
<p>In the past, most studies of human viruses looked at how the virus altered or affected human or animal cells in the lab. Scientists first identify the proteins and sugars on the surface of the viruses or infected cells, then study whether these proteins can be used to produce an immune response.</p>
<figure class="align-center ">
<img alt="" src="https://images.theconversation.com/files/324022/original/file-20200330-146705-ttnxps.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/324022/original/file-20200330-146705-ttnxps.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/324022/original/file-20200330-146705-ttnxps.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/324022/original/file-20200330-146705-ttnxps.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/324022/original/file-20200330-146705-ttnxps.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/324022/original/file-20200330-146705-ttnxps.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/324022/original/file-20200330-146705-ttnxps.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">Knowing the virus’s genetic sequence has also helped develop coronavirus test kits.</span>
<span class="attribution"><a class="source" href="https://www.shutterstock.com/image-photo/analysis-dna-sequences-genetic-laboratory-112365716">science photo/ Shutterstock</a></span>
</figcaption>
</figure>
<p>In the present case, this stage was made easier for researchers after Chinese scientists found and published the <a href="https://www.who.int/csr/don/12-january-2020-novel-coronavirus-china/en/">genetic sequence of novel coronavirus</a> in January. Researchers worldwide have been able to identify the structure of proteins that make up the virus, create a genetic history of the family of viruses, and determine when the first human was infected. It also enabled diagnostic testing kits to be developed, and lets researchers identify potential treatment options.</p>
<h2>2. Vaccine candidates</h2>
<p>This may involve isolating the live virus before inactivating or weakening it and then determining whether this modified virus, which is known as a vaccine candidate, might produce immunity in people. </p>
<p>Sometimes the live virus is not part of the process. Instead, its genetic sequence is used to make the vaccine. The genetic sequence can also be used to make <a href="https://www.sciencedirect.com/topics/neuroscience/recombinant-proteins">recombinant proteins</a>, a vaccine production method that has been used before for vaccines like <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3854212/">hepatitis B</a>. </p>
<p>Researchers now know how to manufacture and test the relevant vaccine and check it has been made properly. They even know about likely doses, including how many doses will be needed to build immunity. This background knowledge speeds up the development of each new vaccine made using the same technology.</p>
<h2>3. Pre-clinical testing</h2>
<p>Initial safety testing is usually carried out in <a href="https://academic.oup.com/ilarjournal/article/56/1/53/661264">animals</a> to give an idea of responses in humans. These are also used to see how effective the vaccine is at preventing the disease, and allows researchers to adapt the vaccine. </p>
<p>During an outbreak, different research groups often work together to speed up this process. </p>
<h2>4. Clinical trials – testing in humans</h2>
<p>This step is where many promising potential vaccines fail. There are three phases of a clinical trial:</p>
<ol>
<li>Testing on a few dozen healthy volunteers, looking at how safe the vaccine is, and if it has any adverse effects;</li>
<li>Testing on several hundred people for efficacy (a “target population” who are ideally those most at risk of the disease);</li>
<li>Testing on several thousand people for efficacy and safety.</li>
</ol>
<p>Through these phases the vaccine needs to show it’s safe, leads to a strong immune response, and provides effective protection against the virus. During an outbreak, experimental vaccines may be used in severely affected populations if they’re at high risk of disease, before progressing to regulatory approval.</p>
<h2>5. Regulatory approvals</h2>
<p>If regulators have approved similar products before, approval can be accelerated – although this is not likely for COVID-19. Use of a vaccine before full licensure can be considered in a public health emergency. </p>
<h2>6.Production</h2>
<p>Once a vaccine has been produced at a small scale and passed safety tests, it can be used in clinical trials. However, significant manufacturing capacity, such as infrastructure, personnel and equipment, will be needed to produce large quantities of a vaccine for use. Quality control is also needed. All of these processes are very carefully monitored. Once licensed, policy must be developed to decide how to prioritise those who should be vaccinated, such as those in the most high-risk groups and locations.</p>
<p>Along the way, if any of these vaccine “candidates” are shown to be unsafe or ineffective, researchers must return to the laboratory to develop a new candidate. This is why vaccine development can be a long and uncertain process.</p><img src="https://counter.theconversation.com/content/134726/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Samantha Vanderslott receives funding from the National Institute for Health Research (NIHR) and the New Venture Fund. She is also a steering committee member for the Vaccination Acceptance Research Network (VARN).</span></em></p><p class="fine-print"><em><span>Andrew Pollard chairs the Department of Health and Social Care's Joint Committee on Vaccination and Immunisation and is a member of the World Health Organisation's SAGE.</span></em></p><p class="fine-print"><em><span>Tonia Thomas 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>Researchers around the world are working hard on developing a vaccine – but the process may still take 12-18 months. Here’s why.Samantha Vanderslott, Postdoctoral Researcher in Social Sciences, University of OxfordAndrew Pollard, Professor of Paediatric Infection and Immunity, University of OxfordTonia Thomas, Vaccine Knowledge Project Manager, University of OxfordLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1342822020-03-23T18:27:14Z2020-03-23T18:27:14ZCoronavirus vaccine must be affordable and accessible<figure><img src="https://images.theconversation.com/files/322021/original/file-20200320-22614-1613lp5.jpg?ixlib=rb-1.1.0&rect=17%2C296%2C5973%2C3691&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Globally, billions of dollars in public funds have been committed for COVID-19 vaccine development. It's crucial that the resulting vaccine be accessible to all.</span> <span class="attribution"><a class="source" href="https://www.shutterstock.com/image-photo/virus-vaccine-development-vaccines-against-coronavirus-1630332622">(Shutterstock)</a></span></figcaption></figure><p>The race is on to develop a vaccine to protect against COVID-19. <a href="https://donortracker.org/German-funding-CEPI-vaccine-development-efforts-COVID-19">Germany</a>, the <a href="https://www.congress.gov/bill/116th-congress/house-bill/6074/text">United States</a>, the <a href="https://ec.europa.eu/commission/presscorner/detail/en/IP_20_474">European Union</a> and <a href="https://www.kff.org/global-health-policy/issue-brief/donor-funding-for-the-global-novel-coronavirus-response/">others</a> have collectively committed more than a billion dollars. </p>
<p>On March 11, Canada announced it would provide <a href="https://pm.gc.ca/en/news/news-releases/2020/03/11/prime-minister-outlines-canadas-covid-19-response">$275 million</a> toward the research and development of some of the world’s most promising candidate vaccines, diagnostics and therapeutics, among other public health and clinical research.</p>
<p><a href="https://www.cbc.ca/news/health/drugs-government-funded-science-1.4547640">Public funds are the backbone of the underlying science</a> that’s needed to develop the medical tools that we need and use. But today there is little indication — and no requirement — that the billions of public dollars being spent will result in a vaccine or treatment for COVID-19 that is affordable. </p>
<figure class="align-right ">
<img alt="" src="https://images.theconversation.com/files/322023/original/file-20200320-22622-1squugx.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=237&fit=clip" srcset="https://images.theconversation.com/files/322023/original/file-20200320-22622-1squugx.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=462&fit=crop&dpr=1 600w, https://images.theconversation.com/files/322023/original/file-20200320-22622-1squugx.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=462&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/322023/original/file-20200320-22622-1squugx.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=462&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/322023/original/file-20200320-22622-1squugx.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=580&fit=crop&dpr=1 754w, https://images.theconversation.com/files/322023/original/file-20200320-22622-1squugx.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=580&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/322023/original/file-20200320-22622-1squugx.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=580&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 holds a news conference on March 13, 2020 announcing federal funding to address the health and economic impact of COVID-19.</span>
<span class="attribution"><span class="source">THE CANADIAN PRESS/Fred Chartrand</span></span>
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</figure>
<p>Instead, governments appear poised to let the private market sort out the details of <a href="https://www.statnews.com/2020/02/27/azar-coronavirus-affordable-trump/">who gets access and at what price</a>. Their logic is that public funding should be used to support early stage discovery, but that the research should ultimately transferred to private companies in order to be fully developed and priced based on what the market can bear. This logic, whether for COVID-19 or for any other disease, is flawed.</p>
<p>For its $275 million investment, Canada has yet to announce what safeguards it will enact to ensure that the vaccines, diagnostics and therapeutics it develops are affordable and accessible to the people and health systems that need them. Given the massive public contributions being made, governments must ensure that the return on these investments comes in the form of lifesaving health services that are free for patients and affordable for health systems — not in the form of high profits for private companies. This is not only the ethical thing to do, it’s also what makes sense as a matter of global public health policy.</p>
<h2>Lessons from the Ebola vaccine</h2>
<p>Canada has recent experience in developing a vaccine that the world needed. The rVSV-ZEBOV vaccine for Ebola was <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5662448/">developped by researchers</a> working at the National Microbiology Laboratory in Winnipeg in the early 2000s. Yet the vaccine was only approved for use by the <a href="https://www.ema.europa.eu/en/news/first-vaccine-protect-against-ebola">European Medicines Agency</a> and the <a href="https://www.fda.gov/news-events/press-announcements/first-fda-approved-vaccine-prevention-ebola-virus-disease-marking-critical-milestone-public-health">U.S. Food and Drug Administration</a> in the fall of 2019, nearly 20 years after it was first developed and many years after the completion of <a href="https://doi.org/10.1016/S0140-6736(16)32621-6">the clinical trial showing it was effective</a>.</p>
<figure class="align-center ">
<img alt="" src="https://images.theconversation.com/files/322022/original/file-20200320-22590-1arekoe.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/322022/original/file-20200320-22590-1arekoe.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/322022/original/file-20200320-22590-1arekoe.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/322022/original/file-20200320-22590-1arekoe.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/322022/original/file-20200320-22590-1arekoe.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/322022/original/file-20200320-22590-1arekoe.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/322022/original/file-20200320-22590-1arekoe.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">
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<span class="caption">The National Microbiology Laboratory in Winnipeg, where Canadian scientists developed the rVSV-ZEBOV vaccine for Ebola, is shown in 2009 file photo.</span>
<span class="attribution"><span class="source">THE CANADIAN PRESS/John Woods</span></span>
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<p>Why the delay? For a long time, there was simply no financial interest from the private sector in moving it forward — Ebola outbreaks occur in countries that can’t afford the prices that make vaccine development lucrative for pharmaceutical companies. </p>
<p>As the Canadian government shopped around for a private sector partner to develop and commercialize the vaccine, <a href="https://doi.org/10.1503/cmaj.170704">there was little interest</a>. One company with no previous experience bringing a vaccine to market acquired the rights in 2010 for $205,000 and has since sub-licensed the vaccine to Merck for US$50 million after having apparently done <a href="https://www.statnews.com/2020/01/16/public-science-behind-merck-ebola-vaccine/">little to advance the development of the vaccine</a> despite being contractually obligated to do so.</p>
<p>As a colleague put it recently in <a href="https://openparliament.ca/committees/health/42-1/115/dr-aled-edwards-5/only/">testimony to Parliament’s Standing Committee on Health</a>, there is no law of physics that says that the private pharmaceutical industry has to do research and development of lifesaving drugs and vaccines. In fact, the private sector has shown itself to be remarkably out-of-step with many global public health priorities, walking away from research and development of things we all need — <a href="https://www.nytimes.com/2019/12/25/health/antibiotics-new-resistance.html">like new antibiotics</a>. They have, however, become adept at demanding high prices under the threat of <a href="https://lifesciencesontario.ca/news/new-federal-drug-pricing-rules-are-already-delaying-medicine-launches-and-costing-jobs-in-canada-survey-reveals/">delaying the launch of new medicines</a> if these pricing demands aren’t met.</p>
<h2>Public funds don’t guarantee accessible drugs</h2>
<p>It is essential that we learn the lessons from the Ebola vaccine and many other discoveries that have been supported by public funds and get it right, not only with COVID-19 but with our whole approach to publicly funded health innovation. Governments around the world play an integral role in supporting the science that leads to discovering lifesaving technologies. </p>
<p>In Canada alone, researchers in publicly funded labs have discovered an Ebola vaccine, <a href="https://www.theglobeandmail.com/news/national/canada-150/insulin-the-canadian-discovery-that-has-saved-millions-of-lives/article35537847/">insulin</a>, the <a href="https://www.bcmj.org/articles/john-hopps-and-pacemaker-history-and-detailed-overview-devices-indications-and">cardiac pacemaker</a>, a <a href="https://www.canada.ca/en/national-research-council/news/2017/12/vaccine_to_preventdeadlyinfectionsincanadasnorthreachesmanufactu.html">vaccine for haemophilus influenzae</a> and many others.</p>
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<img alt="" src="https://images.theconversation.com/files/322025/original/file-20200320-22622-g2v1sr.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=237&fit=clip" srcset="https://images.theconversation.com/files/322025/original/file-20200320-22622-g2v1sr.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=735&fit=crop&dpr=1 600w, https://images.theconversation.com/files/322025/original/file-20200320-22622-g2v1sr.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=735&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/322025/original/file-20200320-22622-g2v1sr.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=735&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/322025/original/file-20200320-22622-g2v1sr.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=923&fit=crop&dpr=1 754w, https://images.theconversation.com/files/322025/original/file-20200320-22622-g2v1sr.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=923&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/322025/original/file-20200320-22622-g2v1sr.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=923&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
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<span class="caption">An electron microscope image of SARS-CoV-2, the coronavirus that causes COVID-19.</span>
<span class="attribution"><span class="source">NIAID-RML file photo via AP</span></span>
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</figure>
<p>While Canada and other governments have supported this important work by directing funding towards universities and research institutes, these funding models generally fail to capture the process from discovery through to use, and instead rely on universities or the researchers themselves to figure out how to get their game-changing discoveries to patients. </p>
<p>Historically, they’ve done this by <a href="https://cihr-irsc.gc.ca/e/50439.html">commercializing their discoveries via the private sector</a>, giving one company exclusive rights to do the subsequent development of the technologies and then to control the sale and price of them when they become a product — with no safeguards or assurances to ensure that patients would have affordable access once the drug or vaccine hits the market.</p>
<p>This no-strings-attached approach to science is foolhardy in an era of patients dying because health systems can’t afford drugs that now routinely cost <a href="https://www.theglobeandmail.com/canada/british-columbia/article-rare-diseases-expensive-drugs-health-canada-showdown-coming/">hundreds of thousands of dollars for some conditions</a>, and where companies are already gearing up to massively profit off of COVID-19 vaccines and therapeutics. </p>
<p>As these new medical tools are developed, licensed and become commercially available, there is a real risk that, given the way the biomedical innovation system works today, they may be rendered inaccessible to those who need them. This should be unacceptable to Canadians, considering the significant public investment that’s been made.</p>
<h2>Making access a priority</h2>
<p>Canada can get this right. We have world-class scientists who by all accounts have promising <a href="https://www.canada.ca/en/institutes-health-research/news/2020/03/government-of-canada-funds-49-additional-covid-19-research-projects-details-of-the-funded-projects.html">candidate vaccines and therapeutics</a> for COVID-19 in the works. We should support their work with public funds through Canada’s research granting councils and other mechanisms. </p>
<p>But we should not blindly accept that the only way these productive, world-class scientists can get their vaccines and therapeutics to patients is by selling them to pharmaceutical companies without negotiating access for patients and health systems upfront. We need safeguards that ensure that if the public paid for it, Canadians and everyone else around the world who needs it will be able to access it quickly and affordably, at a fair price. Public funds should deliver medicines and vaccines that are affordable for the public.</p>
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<a href="https://theconversation.com/coronavirus-weekly-expert-analysis-from-the-conversation-global-network-133646">Coronavirus weekly: expert analysis from The Conversation global network</a>
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<p>Canada may not even have to depend on commercial partners to bring medical innovation from the lab bench to the patient’s bedside. The experience of the Ebola vaccine’s development shows that public sector researchers did much of the heavy lifting in the development and even manufacturing of early batches of the vaccine. We have experts in clinical trials in our hospitals, universities and vaccine research groups who are more than capable of doing the necessary clinical trials to develop and deliver new health technologies quickly and affordably.</p>
<p>We can do health research and development differently, in a way that prioritizes access and affordability for patients and ends the profiteering off sick people in times of crisis. Let’s get to work.</p><img src="https://counter.theconversation.com/content/134282/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Jason Nickerson has received funding in the past from the Canadian Institutes of Health Research (CIHR), the Bill and Melinda Gates Foundation, and the Canadian Foundation for Healthcare Improvement (CFHI), the University of Ottawa, and the Canadian Society of Respiratory Therapists (CSRT). He is employed by Doctors Without Borders/Médecins Sans Frontières (MSF). </span></em></p>Canada is investing millions to develop COVID-19 treatments, but there are no safeguards to ensure that those vaccines and medications will be affordable and accessible to the people who need them.Jason Nickerson, Humanitarian Affairs Advisor, L’Université d’Ottawa/University of OttawaLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/741592017-03-07T05:15:01Z2017-03-07T05:15:01ZIs there a test your child can take before getting vaccinated, as Pauline Hanson said?<p><em>During an exchange with journalist Barrie Cassidy on the ABC television program <a href="http://www.abc.net.au/insiders/content/2016/s4630647.htm">Insiders</a>, One Nation leader Pauline Hanson suggested there are tests available to see if children will have an adverse reaction to vaccinations.</em></p>
<blockquote>
<p>HANSON: Barrie, some of these - parents are saying - vaccinations have an effect on some children. Go and have your tests first. You can have a test on your child first…</p>
<p>CASSIDY: Take advice from the doctor.</p>
<p>HANSON: Have a test and see if you don’t have a reaction to it first. Then you can have the vaccination.</p>
</blockquote>
<p><em>It’s not clear what kind of test Hanson was referring to. (The Conversation contacted her office to ask, but didn’t hear back before deadline.) The Conversation asked three experts for more information.</em></p>
<hr>
<p>Immunisation programs <a href="https://www.science.org.au/learning/general-audience/science-booklets/science-immunisation">prevent millions of deaths</a> worldwide each year. Vaccine safety monitoring – what experts call vaccine <a href="http://vaccinepvtoolkit.org/">pharmacovigilance</a> – as well as many other <a href="http://www.immunise.health.gov.au/internet/immunise/publishing.nsf/Content/F466A36DFA42DD93CA257F0F000216D7/$File/How-are-vaccines-shown-to-be-safe.pdf">checks and balances</a> before and after <a href="http://www.ncirs.edu.au/vaccine-safety/">vaccines registration</a>, ensure that vaccines have a minimal risk of causing harm. </p>
<p>Almost all vaccine side effects are mild and short lived. Common reactions such as low grade fever or pain at the injection occur in about one in every 10 children and go away within a day or two. Such reactions are evidence of our immune response to vaccines and a small trade-off for protection against serious diseases. </p>
<p>In most cases, we can’t predict which person will be the one in a million to have a potentially more serious reaction after a vaccine. </p>
<p>There is no blood test to see if vaccines shouldn’t be given. In fact, the best “test” for a deciding if a vaccine is appropriate is taking a good old medical history. </p>
<h2>Pre-vaccination screening</h2>
<p>Pre-vaccination screening involves the nurse or doctor asking the patient a series of questions. It is done to ensure any conditions for which vaccines should or shouldn’t be given are noted. </p>
<p>For example, <a href="https://theconversation.com/vaccines-to-expect-when-youre-expecting-and-why-50587">pregnant women</a> should not receive <a href="http://vaccine-safety-training.org/live-attenuated-vaccines.html">live attenuated</a> vaccines (meaning vaccines derived from disease-causing pathogens that have been weakened in the lab) such as measles-mumps-rubella vaccine. That’s because there is a potential risk of rubella virus infection in the fetus.</p>
<p>However, they <em>should</em> have the inactivated pertussis (whooping cough) and influenza (‘flu) vaccines to protect both themselves and their newborns against these diseases. </p>
<p>People who have a compromised immune system, due to a medical condition or treatment, should not be given live vaccines. This includes elderly people who need their medical history checked carefully prior to administration of the live attenuated Zoster or “<a href="https://theconversation.com/explainer-how-do-you-get-shingles-and-who-should-be-vaccinated-against-it-64436">shingles</a>” vaccine. </p>
<p>Vaccines should be used in the correct way: nurses and doctors who administer them have to have proper training. There is also extensive guidance for healthcare workers, who must update their knowledge each year. </p>
<p>Our centre – the National Centre for Immunisation Research and Surveillance <a href="http://www.ncirs.edu.au">(NCIRS)</a> – works with the <a href="http://www.immunise.health.gov.au/internet/immunise/publishing.nsf/Content/atagi">Australian Technical Advisory Group on Immunisation</a> and others who support the <a href="http://www.immunise.health.gov.au/internet/immunise/publishing.nsf/Content/Home">National Immunisation Program</a> to update the <a href="http://www.immunise.health.gov.au/internet/immunise/publishing.nsf/Content/Handbook10-home">Australian Immunisation Handbook</a> regularly to support this. </p>
<h2>Managing risk</h2>
<p>Parents take risks all the time because of the benefits of their action. We put babies in car seats, we let them play in playgrounds, and we vaccinate them. Vaccines are hugely beneficial but they are like any medicine: there are some rare but well-documented risks. </p>
<p>One is anaphylaxis, a life-threatening allergic reaction that occurs within minutes in about one in 1 million people. This risk is why patients are observed for 15 minutes after immunisation – if an anaphylactic reaction does occur, adrenaline is available to fully treat it. </p>
<p>If a patient has experienced anaphylaxis soon after a vaccine, expert opinion from a <a href="http://www.immunise.health.gov.au/internet/immunise/publishing.nsf/Content/Handbook10-home%7Ehandbook10part3%7Ehandbook10-3-3#3-3-1">specialist immunisation service</a> should be sought. There are also <a href="http://www.ncirs.edu.au/vaccine-safety/clinical/">clinics</a> in most major cities. </p>
<p>Specific clinical assessment can help to differentiate if the cause was a vaccine ingredient or something coincidental – such as the peanut butter sandwich or aspirin taken shortly after the vaccine.</p>
<h2>Causation versus correlation</h2>
<p>Some problems previously blamed on vaccines have been found to be caused by other things.</p>
<p>For example, research into the human genome has helped disprove a link between vaccines and at least one serious condition. <a href="https://theconversation.com/explainer-what-is-dravet-syndrome-and-how-can-it-be-managed-50077">Dravet syndrome</a> is a severe incurable form of epilepsy due to a genetic change that affects nerve cells. </p>
<p>The condition was previously associated with vaccines because the seizures appear in the first months of life in previously healthy babies and are often triggered (but not caused) by fever. </p>
<p>If a vaccine caused the fever, it <em>appeared</em> that vaccination caused the syndrome. It didn’t.</p>
<p>Unfortunately, other conditions that become apparent in children in the first 12-24 months of life, such as autism spectrum disorder, have also wrongly been blamed on vaccines. In the case of <a href="https://theconversation.com/au/topics/autism-533">autism</a>, dozens of high quality studies and reviews over more than 15 years have shown <a href="https://theconversation.com/mondays-medical-myth-the-mmr-vaccine-causes-autism-3739">absolutely no link to vaccines</a>. </p>
<p><a href="http://www.wehi.edu.au/research/research-fields/personalised-medicine">Personalised medicine is beginning to help understand disease</a> at the individual patient level, such as by customising treatment based on the genetic make-up of a person’s cancer. Gazing into the future, we may eventually learn more about what can predict both reactions as well as good responses to vaccines.</p>
<p>However, right now, the benefits of immunisation for children, adults and communities in eliminating or controlling some of the worst infectious diseases worldwide are clear.</p><img src="https://counter.theconversation.com/content/74159/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Kristine Macartney receives funding from the National Centre for Immunisation Research and Surveillance (NCIRS) and grant funding from the National Health and Medical Research Council (NHMRC).</span></em></p><p class="fine-print"><em><span>Julie Leask receives funding from the Australian Government Department of Health, National Centre for Immunisation Research and Surveillance and the National Health and Medical Research Council. </span></em></p><p class="fine-print"><em><span>Nicholas Wood has received funding from the NHMRC to investigate vaccine related research questions. He has also an investigator on a NHMRC partnership grant. He has previously received pharmaceutical industry support for investigator initiated clinical trials.</span></em></p>Speaking on the ABC program Insiders, One Nation leader Pauline Hanson suggested there are tests available to see if children will have an adverse reaction to vaccinations. We asked three experts.Kristine Macartney, Associate Professor, Discipline of Paediatrics and Child Health, University of SydneyJulie Leask, Associate Professor, University of SydneyNicholas Wood, Associate Professor, Senior Lecturer Paediatrics & Child Health, University of SydneyLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/692782016-12-11T19:07:32Z2016-12-11T19:07:32ZHow HIV’s evasion tactics could help fight the flu<figure><img src="https://images.theconversation.com/files/149003/original/image-20161207-25721-3burj8.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">HIV plays hide and seek with the body's immune system to evade detection. But we can learn from its tactics to make a range of vaccines against infectious diseases.</span> <span class="attribution"><a class="source" href="https://www.shutterstock.com/download/confirm/175902236?src=Bafv5GAoP-GQP_1jSjMBtg-1-61&id=175902236&size=medium_jpg">from www.shutterstock.com</a></span></figcaption></figure><p>One vaccine. Lifetime immunity. This is the goal for thousands of researchers tackling one of the world’s most evasive pathogens – human immunodeficiency virus (<a href="https://theconversation.com/au/topics/hiv-677">HIV</a>).</p>
<p>HIV has foiled both the immune system and vaccines. However, the success of HIV at evading the immune system is leading to vaccine research that may help tackle other illnesses, like influenza, hepatitis C, and mosquito-borne malaria, dengue and West Nile virus.</p>
<p>So how can the way HIV shields itself from the immune system lead us to make new vaccines for other infectious pathogens?</p>
<h2>HIV hides from the immune system</h2>
<p>HIV has a number of different tricks to evade the immune system. During an immune response to infection, antibodies normally lock onto a target on the surface of the virus to disable the infectious threat. To avoid this, HIV changes its shape so a known target for antibodies is hidden within the virus. Antibodies scan the surface, but can’t lock onto their target.</p>
<p>HIV can also adapt to mimic other proteins in our bodies. It is critical the immune system identifies and attacks foreign pathogens, but not target and damage normal cells. So when HIV changes its structure to imitate a normal part of our body, the immune system is tricked into leaving it alone.</p>
<p>By using these methods HIV escapes elimination. So, HIV is still responsible for a significant global burden of disease, with <a href="http://www.who.int/hiv/en/">1.8 million</a> children living with HIV and <a href="http://www.who.int/hiv/en/">1.1 million people</a> who died of HIV-related causes in 2015.</p>
<h2>New generation vaccines to outsmart HIV</h2>
<p>“Elite controllers” are HIV patients whose immune systems are unusually good at controlling the virus. When researchers looked at their immune systems, they found <a href="http://science.sciencemag.org/content/341/6151/1168">rare antibodies</a> that bind many different versions of the virus. These antibodies are also stickier and more potent than normal antibodies, latching onto many different parts of the virus to get a good firm grip. So, these patients’ immune system can better prevent the virus multiplying rapidly and overwhelming the body. </p>
<p>The focus is now on developing a new generation of vaccines against HIV that teach the immune system how to make these rare antibodies.</p>
<p>Standard vaccines involve injecting someone with an inactive whole or part of the pathogen to form immunity. For HIV, researchers first need to identify the antibody best able to disarm multiple variations of the virus. Then, researchers will <a href="https://www.ncbi.nlm.nih.gov/pubmed/27617678">design</a> a vaccination strategy to prompt the immune response to make that unique antibody. This may involve multiple injections with slightly different versions of the vaccine to <a href="https://www.ncbi.nlm.nih.gov/pubmed/27610569">guide</a> the immune response.</p>
<p>Although this strategy will likely be tricky to implement globally, the benefit of being able to defeat viral evasion techniques will be a giant step in tackling this disease.</p>
<h2>The good news for tackling other crafty pathogens</h2>
<p>Vaccines that prompt the body to make these special antibodies may have broader implications for other difficult-to-fight infections.</p>
<p>The influenza virus can reemerge in a different structure to evade immunity formed during a previous infection; the malarial parasite produces hundreds of targets during an infection, which confuses the immune system, making it difficult to focus antibody production on the best target to clear infection; and dengue virus can <a href="https://theconversation.com/explainer-how-viruses-can-fool-the-immune-system-43707">manipulate the immune system</a> to produce antibodies for the wrong target, with potentially lethal consequences.</p>
<p>There is now an intense effort to find unique antibodies that can overcome the evasion techniques of influenza, malaria, dengue and hepatitis C. To do this, researchers screen thousands of individual immune cells to find the most potent antibody that simultaneously disables multiple variations of each pathogen. There has been some progress; researchers have recently identified an antibody that can protect against all <a href="https://www.ncbi.nlm.nih.gov/pubmed/25581790">four versions of the dengue virus</a>.</p>
<h2>What are the barriers?</h2>
<p>There are two main options for using these antibodies – giving them directly to <a href="https://theconversation.com/antibody-injections-could-be-stepping-stone-to-hiv-vaccine-58858">patients already infected with a pathogen</a> or using vaccines to prevent infection in the first place and perhaps one day eradicating the disease. </p>
<p>A number of hurdles remain for vaccine development. During HIV infection, the best antibodies can take as long as a year after infection to develop their power. Acquired immunity to malaria takes multiple infections and many years to develop, leaving young children in particular at risk of dying. It is not yet known whether we can design vaccines to speed up the process.</p>
<p>Immunity also works because immune memory cells are faster and better at fighting an infection before it can damage the body. </p>
<p>Unfortunately, HIV, malaria and hepatitis C can all exhaust immune memory cells; they fight for so long they effectively retire. It’s unclear whether a vaccine for HIV will make effective immune memory cells, or whether exhausted memory cells may stop vaccines working effectively. </p>
<p>Despite these barriers, the knowledge gained in the past decade has made the once impossible task of generating vaccines for evasive pathogens appear to be in reach.</p><img src="https://counter.theconversation.com/content/69278/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Kim Jacobson receives funding from the National Health and Medical Research Council and is the current treasurer of the Australasian Society for Immunology.</span></em></p>Researchers are learning how HIV hides from the immune system to develop a new generation of vaccines for seemingly unrelated diseases, like the flu.Kim Jacobson, Senior Research Fellow, Biomedicine Discovery Institute and Department of Biochemistry and Molecular Biology, Monash UniversityLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/593742016-05-29T20:58:33Z2016-05-29T20:58:33Z‘No Vax, No Visit’? If mum was vaccinated baby is already protected against whooping cough<figure><img src="https://images.theconversation.com/files/123728/original/image-20160524-20557-1uuxu9f.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">There's no evidence to show your baby is at risk if visitors don't get a whooping cough vaccine. </span> <span class="attribution"><a class="source" href="https://www.flickr.com/photos/howardignatius/10952969694/">Lily/Flickr</a>, <a class="license" href="http://creativecommons.org/licenses/by-sa/4.0/">CC BY-SA</a></span></figcaption></figure><blockquote>
<p>NO VAX, NO VISIT! Our baby girl is due in four weeks. We can’t wait to meet her! If you would like to meet her, we ask that you ask your doctor for a whooping cough booster this week. Our daughter can’t receive her first vaccination until she’s six weeks old, so relies on us to keep her safe from germs. #NoVaxNoVisit</p>
</blockquote>
<p>Have you seen these requests in your social media feeds recently? </p>
<p>No Vax, No Visit is a movement being propagated through social media and social pressure. Expectant parents are demanding that all visitors who wish to visit their newborn are recently vaccinated against whooping cough. If visitors can’t prove they’re vaccinated, they’re refused permission to visit the baby in hospital or at home until after the newborn’s <a href="http://www.immunise.health.gov.au/internet/immunise/publishing.nsf/Content/national-immunisation-program-schedule">two-month vaccination</a> (which can be given at six weeks).</p>
<p>It is understandable that prospective parents, aware of how devastating whooping cough can be, want to leave no stone unturned to protect their baby. But is it supported by the best evidence?</p>
<p>No Vax, No Visit is an unofficial extension of the “cocooning” strategy, recommended by the <a href="http://www.immunise.health.gov.au/internet/immunise/publishing.nsf/Content/Handbook10-home%7Ehandbook10part4%7Ehandbook10-4-12">Australian Immunisation Handbook</a> since 2003. </p>
<p>The official cocooning recommendation is to vaccinate regular household contacts if they haven’t had a whooping cough booster within the last ten years. This strategy targets parents, siblings, grandparents and anyone who is in regular contact with babies, as they are <a href="http://www.ncbi.nlm.nih.gov/pubmed/23200883">the most common sources of infection</a> in newborns.</p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/123731/original/image-20160524-11032-a6isu1.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="" src="https://images.theconversation.com/files/123731/original/image-20160524-11032-a6isu1.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/123731/original/image-20160524-11032-a6isu1.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/123731/original/image-20160524-11032-a6isu1.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/123731/original/image-20160524-11032-a6isu1.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/123731/original/image-20160524-11032-a6isu1.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/123731/original/image-20160524-11032-a6isu1.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/123731/original/image-20160524-11032-a6isu1.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">‘Cocooning’ doesn’t mean a baby can’t come into contact with anyone who hasn’t been vaccinated.</span>
<span class="attribution"><a class="source" href="https://www.flickr.com/photos/vstrash/5609832806/">Tom Leuntjens/Flickr</a>, <a class="license" href="http://creativecommons.org/licenses/by/4.0/">CC BY</a></span>
</figcaption>
</figure>
<p>The cocooning recommendation doesn’t mean that anyone who comes through the front door to visit and say a quick hello must be vaccinated. It doesn’t mean regular household contacts need to be vaccinated for every child born within those ten years. </p>
<p>Although the idea of creating a “cocoon” of protection around babies is attractive, this approach has <a href="http://www.ncbi.nlm.nih.gov/pubmed/26320420">limitations</a>. And eliminating all possible sources of whooping cough this way just isn’t possible.</p>
<h2>So, what should parents do?</h2>
<p><a href="http://www.sciencedirect.com/science/article/pii/S0140673614606863">Evidence</a> became available in 2014 that showed if mums are vaccinated during pregnancy, the vaccine is 91% effective in preventing severe whooping cough in very young infants. </p>
<p>When a mum is vaccinated during pregnancy, the protective antibodies travel across the placenta and into the baby. It’s essentially a [baby’s first vaccine](http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(1460977-6/fulltext), so the baby is born with an army of antibodies ready for defence. </p>
<p>Contrary to the American vaccine insert, many studies, such as this <a href="http://www.bmj.com/content/349/bmj.g4219">one</a>, have actually tested the vaccine on tens of thousands of pregnant women. The studies demonstrate how effective and safe this is for pregnant mums and their unborn child. Subsequently, in March 2015, the <a href="http://www.immunise.health.gov.au/internet/immunise/publishing.nsf/Content/Handbook10-home%7Ehandbook10-updates%7Ehandbook10-updates-27-03-2015">Australian Immunisation Handbook</a> began recommending that women who are between 28 and 32 weeks pregnant receive a whooping cough booster for each pregnancy.</p>
<p>If mums follow this pregnancy recommendation, the vaccination of all visitors (in addition to regular household contacts) could theoretically offer a small amount of additional protection for the baby. However, there’s no evidence to say this is the case. The person more likely to benefit is the one receiving the vaccination, particularly if they are <a href="http://www.ncbi.nlm.nih.gov/pubmed/22806592">elderly</a>.</p>
<h2>Social consequences</h2>
<p>Important things to consider with No Vax, No Visit are the unintended social consequences. </p>
<p>While some parents will find their family and friends are happy to be vaccinated, we are also hearing stories of isolation of new parents, division in social groups, and guilt of friends feeling irresponsible. Some new parents are even too scared to take their baby to the “disease-riddled” shopping centre, school or playground. </p>
<p>What seems to be forgotten is the high level of protection the baby already has if mum was vaccinated while pregnant. </p>
<p>While there’s no evidence that No Vax, No Visit will offer any additional protection for the newborn, there is <a href="http://www.ncbi.nlm.nih.gov/pubmed/7597543">evidence</a> that social isolation can lead to postnatal depression. This is particularly important when we consider <a href="https://www.beyondblue.org.au/who-does-it-affect/pregnancy-and-early-parenthood/mental-health-conditions/depression">one in seven new mothers</a> in Australia experiences postnatal depression. </p>
<p>Support for new parents is most needed during the newborn’s first few weeks of life. If new parents don’t have any visitors and are too scared to go out into the world with their newborn, what effect will this have on the family’s wellbeing?</p>
<p>So, what else can parents do to protect their newborn before the six-week vaccination if mum was vaccinated during pregnancy, and dad, siblings and grandparents are all up to date with their vaccines? Ask visitors to postpone their visit if they are sick, and hand-washing before cuddles is essential. </p>
<p>With all this in place, there’s little or no extra benefit from No Vax, No Visit.</p><img src="https://counter.theconversation.com/content/59374/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Kerrie Wiley receives funding from the Marie Bashir Institute. </span></em></p><p class="fine-print"><em><span>National Centre for Immunisation Research & Surveillance (NCIRS) is funded by Australian Department of Health and NSW Ministry of Health. NCIRS Provides technical secretariat for the Australian Technical Advisory Group on Immunisation. Peter McIntyre previously chaired the ATAGI Pertussis Working Party and also sits on the WHO IVIR Advisory Committee. NHMRC Grant 2010-2014 for neonatal pertussis trial. GSK in kind and Financial support for follow-on studies.</span></em></p><p class="fine-print"><em><span>Samantha Carlson 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>Prospective parents, aware of how devastating whooping cough can be, want to leave no stone unturned to protect their baby. But is No Vax, No Visit supported by the best evidence?Samantha Carlson, Social Science Research Officer for the National Centre for Immunisation Research and Surveillance, University of SydneyKerrie Wiley, Research Fellow, National Centre for Immunisation Research & Surveillance, and School of Public Health, University of SydneyPeter Bruce McIntyre, Professor and Director for the National Centre for Immunisation Research and Surveillance of Vaccine, University of SydneyLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/415362015-05-13T05:17:47Z2015-05-13T05:17:47ZPlan for bringing new vaccines to the developing world is finally starting to pay off<p>Most children in sub-Saharan Africa are today entitled to vaccines against <a href="http://www.who.int/immunization/policy/Immunization_routine_table1.pdf?ua=1">10 different diseases</a>. While this is notably fewer than in high-income countries – British children are vaccinated against 13 diseases, for example – substantial progress has been made in the past few decades in protecting children in the developing world. The World Health Organisation estimates that immunisation prevents between <a href="http://www.who.int/features/factfiles/immunization/en/">2m and 3m deaths</a> every year.</p>
<p>However, millions of people remain at risk of some of the world’s most threatening diseases, including malaria, tuberculosis and HIV/AIDS. Effective vaccines against these conditions would be in extraordinary demand in the developing world. But most vaccines offered today were originally developed by global pharmaceutical companies for markets in the West, which still control the direction of most vaccine development.</p>
<p>An <a href="http://rstb.royalsocietypublishing.org/content/370/1671/20140150">article published</a> by the Royal Society this week argues that the vaccine industry lacks incentives to invest in developing vaccines for diseases with no market in the Western world. The authors, Michèle Barocchi and Rino Rappuoli, who both work for the pharmaceutical firm Novartis, call for a more significant global effort to change this situation:</p>
<blockquote>
<p>These efforts include a clear policy, global co-ordination of funds dedicated to the development of neglected disease and an agreement on regulatory strategies and incentives for the private sector.</p>
</blockquote>
<p>Unfortunately, their arguments are not clearly articulated and the article puts forward no new ideas while ignoring existing strategies that show signs of success.</p>
<h2>Market solutions</h2>
<p>The global vaccine market is largely divided between numerous Indian manufacturers and global pharmaceutical companies headquartered in the West, such as GSK, Sanofi Pasteur, Novartis, Merck and Pfizer. As shown in a recent report by <a href="http://www.msf.org.br/sites/default/files/msf_the_right_shot_report_2nded_2015.pdf">Medecins Sans Frontieres</a>, vaccines from Indian manufacturers are generally substantially cheaper than those sold by the global companies.</p>
<p>Until the <a href="http://www.gavi.org/">creation of Gavi</a>, an alliance of public and private sector organisations, in the year 2000, vaccines developed by global pharmaceutical firms were generally only distributed in <a href="http://content.healthaffairs.org/content/30/6/1122.long">high-income countries</a>. Older vaccines, such as those for measles and polio, were bought for less than a dollar per child, primarily from Indian manufacturers.</p>
<p>Gavi has since raised more than US$9 billion (£5.8 billion) from donors and philanthropists and spends most of its funds on introducing vaccines into the poorest countries in the world. With the new vaccines, including <em>Haemophilus influenzae</em> type b, rotavirus and pneumococcal vaccines, the price of fully vaccinating a child has increased to around US$30 (£19). </p>
<figure class="align-center ">
<img alt="" src="https://images.theconversation.com/files/81422/original/image-20150512-25067-1ijp11o.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/81422/original/image-20150512-25067-1ijp11o.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/81422/original/image-20150512-25067-1ijp11o.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/81422/original/image-20150512-25067-1ijp11o.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/81422/original/image-20150512-25067-1ijp11o.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/81422/original/image-20150512-25067-1ijp11o.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/81422/original/image-20150512-25067-1ijp11o.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">Vaccine development is under the microscope.</span>
<span class="attribution"><span class="source">from www.shutterstock.com</span></span>
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</figure>
<p>In their article, Barocchi and Rappuoli put forward Gavi’s Advanced Market Commitment and the Health Impact Fund as novel, promising solutions to addressing the lack of incentives for developing vaccines for low-income countries. These are two similar concepts but neither of them are particularly new nor have they yet been proven to work.</p>
<p>The concept of the advanced market commitment uses the idea that a group of governments would give a binding commitment to purchase a specified vaccine product at a pre-set price. This would then create an incentive for vaccine manufacturers to develop it.</p>
<p>However, this commitment has so far only been used with the <a href="http://www.gavi.org/results/evaluations/pneumococcal-amc-process---design-evaluation/">pneumococcal conjugate vaccine</a>, which was already in late stages of development by two global pharmaceutical companies when the initiative was launched. To my knowledge, no other advanced market commitment has since been implemented.</p>
<p>The Health Impact Fund, <a href="http://www.thelancet.com/journals/lancet/article/PIIS0140-6736%2809%2961296-4/abstract">first suggested </a>in 2010, is a proposed global agency where pharmaceutical companies can register new medicines before they are developed. A firm would agree to provide the future drug at cost anywhere it is needed and, instead of profits, would receive additional funds depending on the actual global health impact of the drug. The greater the health impact, the greater the reward.</p>
<p>However, accurately estimating the health impact in terms of disease and death reduction is <a href="http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4340604/?report=reader">extremely challenging</a> in countries with weak disease monitoring infrastructure. And the cost of development and production of pharmaceuticals are normally confidential. These are probably some of the reasons why the concept has remained on the drawing board.</p>
<h2>Creating incentives</h2>
<p>It is puzzling that Barocchi and Rappuoli do not seek to highlight recent success stories in vaccine development based on other forms of public-private partnership and build on these for future recommendations.</p>
<p>For example, a <a href="http://www.tandfonline.com/doi/abs/10.4161/hv.19619">major leap forward </a> was seen in 2010 when a new meningitis vaccine solely developed for African strains came to market. The vaccine was developed by the Indian Serum Institute, which promised not to charge more than US$0.50 (£0.32) per dose after the Bill and Melinda Gates Foundation agreed to fund the development work. The vaccine has since been bought by Gavi and reached more than <a href="http://www.gavi.org/support/nvs/meningitis-a/">217m people</a>.</p>
<p>This success is proof that public/charitable development funding can work, although there are some caveats. The meningitis triumph is closely related to the fact that comparable vaccines had already been developed, which considerably eased the clinical process. And while substantial funding has been granted for development of vaccines against HIV/AIDS and TB, the technical challenges are enormous and no vaccine candidates against these diseases are yet in late-stage development. </p>
<p>However, there is no doubt that continuous vaccine procurement by Gavi over the past 15 years has increased the confidence of manufacturers to invest in development. For example, since Gavi started purchasing the combination vaccine containing <em>Haemophilus influenzae</em> type b in 2000, the number of manufacturers of the vaccine has increased from one to four and the price per dose has decreased by 40%.</p>
<p>The existence of Gavi has brought important understandings about the incentives needed for vaccine manufacturers to invest. During the Ebola epidemic, three global pharmaceutical companies rapidly began development of a vaccine, which is <a href="http://www.sciencedirect.com/science/article/pii/S0140673615606456">unprecedented</a> for a neglected, tropical disease. By showing that they are willing to finance vaccines for the poorest countries over the long term, development partners have helped to increase the trust of vaccine manufacturers in a viable market for these products.</p><img src="https://counter.theconversation.com/content/41536/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Ulla Kou Griffiths is a member of Gavi's independent review committee.</span></em></p>Big pharma is finally starting to pay attention to the developing world. Here’s why.Ulla Kou Griffiths, Senior lecturer in health economics, London School of Hygiene & Tropical MedicineLicensed as Creative Commons – attribution, no derivatives.