tag:theconversation.com,2011:/id/topics/vaccine-approval-91785/articlesVaccine approval – The Conversation2021-07-01T15:14:33Ztag:theconversation.com,2011:article/1633722021-07-01T15:14:33Z2021-07-01T15:14:33ZSouth African government’s handling of COVID-19: study shows declining trust<figure><img src="https://images.theconversation.com/files/409298/original/file-20210701-5437-1fvhyh4.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Some of the first South African COVID-19 vaccine trial volunteers at the Baragwanath hospital in Soweto, in 2020.
</span> <span class="attribution"><span class="source">EPA-EFE/Siphiwe Sibeko (Pool)</span></span></figcaption></figure><p>The public has been overwhelmed by a surge in misleading and false information during the COVID-19 pandemic. The World Health Organisation has decried this <a href="https://www.who.int/health-topics/infodemic#tab=tab_1">“infodemic”</a>, which can lead to mistrust in health authorities and undermine the public health response. People often do not know which information to trust, making them vulnerable to disinformation. </p>
<p>New <a href="http://disinfoafrica.org/2021/06/14/working-paper-trust-in-institutions-covid-19-related-information-seeking-and-vaccination-messaging-in-south-africa/">research</a> suggests that South Africans are more likely to trust scientific sources, such as doctors and the World Health Organisation, than their own government. Most disapprove of the government’s handling of the pandemic. </p>
<p>These are the findings of an online survey we conducted to find out where people were getting their information about COVID-19 from and which sources they trusted most. We also conducted a small experiment to test people’s views on vaccinations. Both were done online, which means that the views represent only those South Africans with access to the web. </p>
<p>Our <a href="http://disinfoafrica.org/2021/06/14/working-paper-trust-in-institutions-covid-19-related-information-seeking-and-vaccination-messaging-in-south-africa/">study</a>, conducted with support from the World Health Organisation’s (WHO’s) Africa Infodemic Response Alliance, showed that when it came to getting information about the pandemic, South Africans appeared to rely mostly on “traditional” media sources. On average, 74% said they got information about COVID-19 via media such as television, radio and newspapers. </p>
<p>The results also showed that approval of the South African government’s response to the pandemic had declined from a year ago, when we conducted <a href="http://disinfoafrica.org/wp-content/uploads/2021/04/What-Motivates-The-Sharing-of-Misinformation-about-China-and-COVID-19.pdf">a similar study</a>. </p>
<p>The current survey showed a high level of disapproval: 61% of respondents said they “strongly” or “somewhat” disapproved of the way the government was handling the pandemic, while only 21.1% said they “strongly approved”. This has an impact on the effectiveness of messages promoting vaccination. If receivers of pro-vaccination messages disapprove of the sender of the message, they are less likely to trust the content of the message or share such messages with others. </p>
<p>The deteriorating level of trust in the government may be related to the stuttering vaccine rollout in the country, which was high on the news agenda at the time of the study. The rollout plan suffered several setbacks and the government was <a href="https://www.news24.com/news24/southafrica/news/concerns-grow-over-slow-pace-of-sas-vaccine-rollout-20210323">widely criticised</a> for not meeting its targets. The survey was also fielded at the time when the country’s health minister, Zweli Mkhize, was put on special leave while an investigation against allegations of corruption <a href="https://citizen.co.za/news/south-africa/breaking-news/2525292/zweli-mkhize-special-leave-corruption-probe-8-june/">was under way</a>. </p>
<h2>The research</h2>
<p>Our study consisted of two parts. </p>
<p>First, we conducted an online survey in which we asked 1,585 South African social media users what media they consumed, which sources of information they trusted most, and their attitudes towards COVID-19. We also asked them how they would evaluate the government’s response to the pandemic.</p>
<p>The second part of the study involved an online experiment with 1,180 social media users. We sought to determine how effective social media messaging strategies were in promoting vaccination, and what role the sender of the message played in how users responded to it.</p>
<iframe title="Trust in COVID-19 information sources in South Africa" aria-label="Bar Chart" id="datawrapper-chart-4xAtL" src="https://datawrapper.dwcdn.net/4xAtL/1/" scrolling="no" frameborder="0" style="border: none;" width="100%" height="420"></iframe>
<p>The online survey showed that, overall, medical doctors and the World Health Organisation were the most trusted sources of information, followed by radio and television. News websites, family and the South African government were less trusted. But they were still more trusted than social media, friends, community leaders, celebrities and faith leaders. </p>
<p>Respondents who intended voting for the governing African National Congress (ANC) or opposition Economic Freedom Fighters (EFF) tended to trust the government’s communication more than supporters of other parties, such as the official opposition party, the Democratic Alliance (DA).</p>
<p>Overall, most said they consulted established news media sources like television (85.6%), radio (79.2%) and newspapers (online 58.3%, print 73.4%) more than they did social media. The exception was Facebook, which had a high usage (85.1%), followed by WhatsApp (67.5%). </p>
<p>Google was also a popular platform to obtain information from (85.3%), but other social media platforms like TikTok (19.6%), Twitter (29.2%), Instagram (26.6%) and YouTube (45.6%) were much less popular sources of information. </p>
<iframe title="COVID-19 News consumption habits in South Africa" aria-label="Stacked Bars" id="datawrapper-chart-9D7oA" src="https://datawrapper.dwcdn.net/9D7oA/1/" scrolling="no" frameborder="0" style="border: none;" width="100%" height="383"></iframe>
<p>In the Facebook experiment, participants saw one of four versions of a Facebook post that included a video encouraging citizens to get vaccinated. Each of the four versions was made to look like it had been posted from a different account. Two of these accounts were from political parties in South Africa (the ANC and DA), and two were institutional accounts (WHO and the National Department of Health).</p>
<p>All four posts included the same video, which was designed to look like a <a href="https://twitter.com/viralfacts">#ViralFact message</a> such as the ones distributed by the WHO’s Africa Infodemic Response Alliance. The video combined two common health communication messaging strategies, “humour” and “fear”.</p>
<p>We were interested in comparing how users would react to the same information coming from different messengers. Specifically, we looked at whether different messengers would result in people being more or less likely to get vaccinated. We also looked at whether users would be more or less likely to share the social media posts depending on where they came from. </p>
<p>We found that media users’ intentions to get vaccinated weren’t particularly swayed by which political party did the posting. In all cases, after seeing the Facebook ad, their intention to get the COVID-19 shot remained very high, confirming <a href="https://protect-za.mimecast.com/s/OapFCzm4GXCXP0NRSJ1Vej">findings by other researchers</a>.</p>
<p>But when it came to sharing social media posts, users were less likely to say they would share the Facebook post when they thought it came from an ANC account. Users who were told the post came from the WHO, the National Department of Health or the DA were significantly more likely to share the post.</p>
<p>The study supports <a href="https://cramsurvey.org/wp-content/uploads/2021/05/3.-Burger-R_Policy-Brief.pdf">others</a> showing a relatively high rate of vaccine acceptance among South Africans. It also suggests that the content of pro-vaccination messages is important for promoting vaccine acceptance. So is the sender.</p>
<h2>Implications</h2>
<p>The strong disapproval of the government’s handling of the pandemic, as well as the overall low levels of trust in the ANC, should be a warning to government communicators that crafting persuasive pro-vaccine messages is not enough. The trust deficit in the messenger also has a negative impact on people’s trust in the message itself, and people’s likelihood to share those messages.</p><img src="https://counter.theconversation.com/content/163372/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>
This work is based on the research supported by the National Institute for the Humanities and Social Sciences.</span></em></p><p class="fine-print"><em><span>Dani Madrid-Morales 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>The strong disapproval of the South African government’s handling of the pandemic is a warning that crafting persuasive pro-vaccine messages is not enough.Herman Wasserman, Professor of Media Studies in the Centre for Film and Media Studies, University of Cape TownDani Madrid-Morales, Assistant Professor in Journalism at the Jack J. Valenti School of Communication, University of HoustonLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1460912020-09-22T18:59:19Z2020-09-22T18:59:19ZHow and when will we know that a COVID-19 vaccine is safe and effective?<figure><img src="https://images.theconversation.com/files/358194/original/file-20200915-20-141c8is.jpg?ixlib=rb-1.1.0&rect=26%2C66%2C4415%2C3856&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">How much longer must society wait for a vaccine?</span> <span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/illustration/hourglass-inside-syringe-artwork-royalty-free-illustration/488635523?adppopup=true">ANDRZEJ WOJCICKI/Getty Images</a></span></figcaption></figure><p>With COVID-19 vaccines currently in the final phase of study, you’ve probably been wondering how the FDA will decide if a vaccine is safe and effective.</p>
<p>Based on the status of the <a href="https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine-tracker.html">Phase 3 trials</a> currently underway, it is unlikely that the results of these trials will be available before November. But it is likely that not just one but several of the competing COVID-19 vaccines will be shown to be safe and effective by the end of 2020. </p>
<p><a href="https://scholar.google.com/citations?hl=en&user=6yMIM1MAAAAJ&view_op=list_works&sortby=pubdate">I am a scientist and infectious diseases specialist</a> at the University of Virginia, where I care for patients with COVID-19 and conduct research on the pandemic. I am also a member of the World Health Organization Expert Group on COVID-19 Vaccine Prioritization. </p>
<h2>What is the status of COVID-19 vaccines in human clinical trials?</h2>
<p><a href="https://partners.mediasite.com/mediasite/Play/968f633a874c4f1a80c368496f49d4661d">Phase 3 studies are underway</a> for the Moderna and BioNTech/Pfizer vaccines, the Oxford/AstraZeneca viral vector vaccine and now the <a href="https://www.washingtonpost.com/health/2020/09/23/coronavirus-vaccine-jj-single-shot/">Johnson & Johnson viral vector vaccine</a>. </p>
<p>Each of these vaccines uses the SARS-CoV-2 spike glycoprotein, which the virus uses to infect cells, to trigger the immune system to generate protective antibodies and a cellular immune response to the virus. Protective antibodies act by preventing the spike glycoprotein from attaching the virus to human cells, thereby neutralizing the SARS-CoV-2 virus that causes COVID-19.</p>
<p>In the case of <a href="https://theconversation.com/coronavirus-a-new-type-of-vaccine-using-rna-could-help-defeat-covid-19-133217">Moderna’s nucleic acid vaccine</a>, the messenger RNA encoding the spike glycoprotein is encased in a fat droplet – called a liposome – to protect the mRNA from degradation and enable it to enter cells. Once these instructions are inside the cells, the mRNA is read by the human cell machinery and made into many spike proteins so that the immune system can respond and begin producing antibodies against this coronavirus. </p>
<p>The Oxford/AstraZeneca and <a href="https://www.jnj.com/johnson-johnson-initiates-pivotal-global-phase-3-clinical-trial-of-janssens-covid-19-vaccine-candidate">Johnson & Johnson</a> vaccines use a different strategy to activate an immune response. Here an adenovirus found in chimpanzees shuttles the instructions for manufacturing the spike glycoprotein into cells.</p>
<p><a href="http://doi.org/10.1126/science.abc5312">Phase 1 and 2 studies by pharmaceutical companies Janssen and Merck</a> also use viral vectors similar to the Oxford/AstraZeneca and J&J vaccines, while vaccines by Novavax and GSK-Sanofi use the actual spike protein itself. </p>
<h2>Animal tests show the vaccines provide protection from coronavirus infection</h2>
<p>Studies in animal models of COVID-19 provide convincing evidence that vaccination with the spike glycoprotein will protect from COVID-19. Experiments have show that when the immune system is shown the spike protein – which alone cannot trigger disease – the immune system will generate an antibody response that protects from infection with SARS-CoV-2.</p>
<p><a href="https://doi.org/10.1038/s41591-020-1070-6">In studies in hamsters</a> an adenovirus viral vector – the approach used by Oxford/AstraZeneca, for example – was used to immunize with the Spike glycoprotein. When the hamsters were infected with SARS-CoV-2 they were protected from pneumonia, weight loss and death.</p>
<p><a href="http://doi.org/10.1126/science.abc6284">In nonhuman primates</a>, DNA vaccines – which deliver the gene for the spike glycoprotein – reduced the amount of virus in the lungs. Animals that produced antibody that prevented virus attachment to human cells were most likely to be protected.</p>
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<figcaption><span class="caption">History of vaccines: Smallpox to SARS-CoV-2.</span></figcaption>
</figure>
<h2>What have the early Phase 1 and 2 studies in humans shown?</h2>
<p>Overall, <a href="https://www.nejm.org/doi/full/10.1056/NEJMoa2026920?query=featured_coronavirus">vaccination has triggered a more potent neutralizing antibody response</a> than even that seen in patients recovering from COVID-19. </p>
<p>This has also been the case for <a href="http://doi.org/10.1056/NEJMoa2022483">Moderna’s vaccine currently in Phase 3 trials</a> and for vaccines from <a href="https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)31611-1/fulltext">CanSino Biologics and Oxford/ AstraZeneca.</a> </p>
<h2>What side effects have been observed?</h2>
<p><a href="https://doi.org/10.1016/S0140-6736(20)31605-6">Physicians have recorded</a> <a href="https://doi.org/10.1016/S0140-6736(20)31604-4">mild to moderate reactions</a> <a href="http://doi.org/10.1056/NEJMoa2022483">when the subjects were observed</a> up to 28 days after vaccination. These side effects included mild pain, warmth and tenderness at the site of injection, and fever, fatigue, joint and muscle pain. </p>
<p>But Phase 1 and 2 studies are by small by design, with just hundreds of participants. So these trials will not be large enough to detect uncommon or rare side effects. </p>
<p>The emphasis on safety as the primary goal was recently demonstrated in the Phase 3 Oxford/AstraZeneca vaccine trial <a href="https://www.nature.com/articles/d41586-020-02594-w">where one vaccinated individual developed inflammation of the spinal cord</a>. It isn’t clear whether the vaccine caused this reaction – it might be a new case of multiple sclerosis unrelated to the vaccine – but the Phase 3 trial was halted in the U.S. until more is known.</p>
<h2>How is the FDA ensuring that a vaccine will be safe yet quickly produced?</h2>
<p>The <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/development-and-licensure-vaccines-prevent-covid-19">FDA has issued guidance for industry</a> on the steps required for developing and ultimately licensing vaccines to prevent COVID-19 – these are the same rigorous safety standards required for all vaccines.</p>
<p>There are, however, ways to speed the process of approval that are centered on “platform technology.” What this means is that if a vaccine is using an approach such as an adenovirus that has previously been shown to be safe, it may be possible for a company to use previously collected data on toxicity and pharmacokinetics to fast-track clinical trial approval. </p>
<p>While speed and safety may appear conflicting goals, it is also encouraging to note that the <a href="https://www.wsj.com/articles/covid-19-vaccine-developers-prepare-joint-pledge-on-safety-standards-11599257729">rival vaccine manufacturers have jointly pledged</a> not to bow to any political pressures to rush vaccine approval, but to maintain the most rigorous safety standards. </p>
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<figcaption><span class="caption">How to develop a vaccine, quickly.</span></figcaption>
</figure>
<h2>How protective does a vaccine need be to receive FDA approval?</h2>
<p>The FDA has set the bar for the primary endpoint of a Phase 3 trial of 50% protection for approval of a COVID-19 vaccine. </p>
<p>Protection is defined as protection from symptomatic COVID-19 infection, defined as laboratory-confirmed SARS-CoV-2 infection plus symptoms such as fever or chills, cough, shortness of breath, fatigue, muscle aches, loss of taste or smell, congestion or runny nose, diarrhea, nausea or vomiting. </p>
<p>This means that an effective vaccine is considered one that will reduce the number of infections in vaccine recipients by half. This is the <a href="https://doi.org/10.1016/S0140-6736(20)31821-3">minimal protection that is anticipated to be clinically useful</a>. That is, in part, because lower levels of efficacy could paradoxically increase COVID-19 infections if it leads vaccinated people to decrease mask wearing or social distancing because they think they are completely protected.</p>
<p>Since a vaccine might be more effective at preventing severe COVID-19, the FDA instructs that <a href="https://www.fda.gov/media/139638/download">protection from severe COVID-19</a> should be a secondary endpoint.</p>
<h2>How many people have to be vaccinated to know if a vaccine works in Phase 3?</h2>
<p>The current Phase 3 trials are enrolling 30,000-40,000 subjects. Most of these participants will receive the vaccine and some a placebo.</p>
<p>When, exactly, the results of Phase 3 studies will be released depends in large part on the rate of infection in the placebo recipients. The way that these vaccine studies work is that they test if naturally acquired new coronavirus infections are lower in the group that received the vaccine compared with the group receiving the placebo. </p>
<p>So while it is good news that COVID-19 infections have dropped recently in the U.S. from <a href="https://www.nytimes.com/interactive/2020/us/coronavirus-us-cases.html?auth=login-email&login=email">70,000 to 40,000 cases per day</a>, this drop in new infections may slow the vaccine studies.</p>
<h2>Will Emergency Use Authorization fast-track vaccine?</h2>
<p>In an emergency such as we are faced with the COVID-19 pandemic, with approximately 700 new deaths and 40,000 new cases per day right now, the FDA is authorized to allow the use of unapproved products for the diagnosis, treatment and prevention of disease. That includes a vaccine.</p>
<p><a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/development-and-licensure-vaccines-prevent-covid-19">The standard approval process for vaccines</a> can require more than one year of observation after vaccination. If the short-term safety is good and the vaccine works to prevent COVID-19, then the vaccine should be approved for use under an Emergency Use Authorization while it is still being studied.</p>
<p>Under Emergency Use Authorization, the FDA will <a href="https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization">continue to collect information</a> from the companies producing the vaccines for benefit and harm, including surveillance for vaccine-associated enhanced respiratory disease or other potentially rare complications that might be observed in only one in a million.</p>
<h2>What should we expect in terms of approvals?</h2>
<p>I expect that the FDA will approve several vaccines by the end of 2020 under its Emergency Use Authorization authority so that vaccination can begin immediately, starting with high-risk groups including first responders, health care personnel, and the elderly and those with preexisting medical conditions. </p>
<p>This will be followed rapidly with <a href="https://theconversation.com/video-who-should-get-a-covid-19-vaccine-first-146285">roll-out of vaccination</a> to the population at large, while all of the time the FDA and vaccine manufacturers will continue to monitor for side effects and work to improve upon these first vaccines. This process is <a href="https://www.usatoday.com/story/news/health/2020/09/02/covid-19-vaccine-rollout-plan-united-states-worries-experts/5694037002/">expected to take months</a>.</p>
<p>It may not be life back to normal next year, but all signs point to a healthier 2021.</p>
<p><em>This article was updated on September 25 with information on the Johnson & Johnson vaccine trial.</em></p><img src="https://counter.theconversation.com/content/146091/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>William Petri receives funding from the NIH and the Bill & Melinda Gates Foundation.</span></em></p>Several vaccines are in Phase 3 trials. So when will we know whether any of these will protect against COVID-19?William Petri, Professor of Medicine, University of VirginiaLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1450822020-08-27T12:25:14Z2020-08-27T12:25:14ZFDA is departing from long-standing procedures to deal with public health crises, and this may foreshadow problems for COVID-19 vaccines<figure><img src="https://images.theconversation.com/files/354956/original/file-20200826-7028-6mlsaf.jpg?ixlib=rb-1.1.0&rect=6%2C27%2C4650%2C3051&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">FDA Commissioner Stephen Hahn, right, and President Trump at a Coronavirus Task Force meeting March 19, 2020.</span> <span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/news-photo/president-donald-trump-listens-to-fda-commissioner-stephen-news-photo/1213540766?adppopup=true">Chip Somodevilla/Getty Images</a></span></figcaption></figure><p>On the eve of the <a href="https://apps.npr.org/liveblogs/20200824-rnc/">Republican National Convention</a>, Food and Drug Administration Commissioner Dr. Stephen Hahn announced that the FDA had <a href="https://www.fda.gov/news-events/press-announcements/fda-issues-emergency-use-authorization-convalescent-plasma-potential-promising-covid-19-treatment">issued emergency use authorization</a> for investigational convalescent plasma as a treatment for COVID-19. </p>
<p>Plasma is the liquid part of blood. Sometimes, for treatment purposes, it is taken from people who have been infected with but recovered from a disease, because it contains antibodies that fought the disease. <a href="https://theconversation.com/im-a-lung-doctor-testing-the-blood-plasma-from-covid-19-survivors-as-a-treatment-for-the-sick-a-century-old-idea-that-could-be-a-fast-track-to-treatment-144105">Doctors then inject this so-called convalescent plasma into patients</a> who currently have a disease in hopes that the antibodies in the plasma can help current patients.</p>
<p>Hahn and several <a href="https://www.commonwealthfund.org/blog/2020/why-we-cant-rely-health-insurance-alone-guarantee-universal-immunization-against-covid-19">members of the administration hailed</a> the authorization as an extraordinary public health achievement. The announcement, however, has drawn <a href="https://www.nytimes.com/2020/08/24/health/fda-blood-plasma.html">extensive criticism</a>. Many scientists have said that both the FDA and the administration greatly overstated and even mischaracterized data on the efficacy of convalescent plasma. </p>
<p>Two days later, <a href="https://apnews.com/a7f0e8aac34a860ad502912564681b7c">Hahn publicly apologized</a> for misrepresenting the benefits of convalescent plasma in connection with COVID-19, but he maintained that the decision to authorize the treatment for emergency use was based upon sound science and data. </p>
<p><div data-react-class="Tweet" data-react-props="{"tweetId":"1298071620414824452"}"></div></p>
<p>Commentators and other <a href="https://www.washingtonpost.com/opinions/the-fda-should-not-have-caved-to-trumps-latest-covid-19-demand/2020/08/24/afc5c97c-e626-11ea-970a-64c73a1c2392_story.html">researchers have questioned</a> whether the decision also reflected extreme political pressure to rush approvals of treatments for COVID-19. </p>
<p>We are law professors and have examined the regulatory posture of the FDA since the beginning of the outbreak. <a href="https://academic.oup.com/jlb/advance-article/doi/10.1093/jlb/lsaa060/5882039">We have studied</a> how the FDA’s decisions have varied with the external pressures that it has faced, comparing it to past emergency decision making by the agency. </p>
<p>We believe that this episode is symptomatic of a larger problem, and we worry that FDA’s repeated departure from evidence-based standards and long-tested and proved procedures will soon translate into a <a href="https://www.bbc.com/news/world-us-canada-53899908">poorly considered</a> authorization of COVID-19 vaccines.</p>
<figure class="align-center ">
<img alt="A young woman lies in a hospital bed donating plasma." src="https://images.theconversation.com/files/354957/original/file-20200826-7216-1fudayh.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/354957/original/file-20200826-7216-1fudayh.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=421&fit=crop&dpr=1 600w, https://images.theconversation.com/files/354957/original/file-20200826-7216-1fudayh.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=421&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/354957/original/file-20200826-7216-1fudayh.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=421&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/354957/original/file-20200826-7216-1fudayh.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=529&fit=crop&dpr=1 754w, https://images.theconversation.com/files/354957/original/file-20200826-7216-1fudayh.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=529&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/354957/original/file-20200826-7216-1fudayh.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=529&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">Former COVID-19 patient Melissa Cruz donates plasma at a hospital in Seattle as part of a study to determine if antibodies in formerly infected patients’ plasma could treat others with the disease.</span>
<span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/news-photo/melissa-cruz-donates-covid-19-convalescent-plasma-at-news-photo/1210313205?adppopup=true">Karen Ducey/Getty Images</a></span>
</figcaption>
</figure>
<h2>The convalescent plasma decision in context</h2>
<p>Traditional FDA approval takes <a href="https://www.fda.gov/media/82381/download">several years</a> and relies on extensive data. During public health crises, however, the <a href="https://www.fda.gov/regulatory-information/laws-enforced-fda/federal-food-drug-and-cosmetic-act-fdc-act">law</a> gives FDA the ability to authorize the use of unapproved products on an emergency basis. The agency does so by issuing an emergency authorization, or EUA. </p>
<p>The <a href="https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization">EUA pathway</a> gives FDA the flexibility to act faster and green-light worthy products that have otherwise not been sufficiently vetted. An EUA is based on <a href="https://www.law.cornell.edu/uscode/text/21/360bbb-3">much less data</a> than an approval. </p>
<p>A properly issued EUA is balanced by legal and scientific checks. The law directs the FDA to assess whether a specific product considered for an EUA “<a href="https://www.law.cornell.edu/uscode/text/21/360bbb-3">may be effective</a>” in light of the “<a href="https://www.law.cornell.edu/uscode/text/21/360bbb-3">totality of scientific evidence available</a>.” The agency must also determine whether the product’s potential benefits “outweigh the known and potential risks” and that “there is no adequate, approved, and available alternative.”</p>
<p>In the case of convalescent COVID-19 plasma, the FDA justified the EUA by stating that the treatment <a href="https://www.nytimes.com/2020/08/24/health/fda-blood-plasma.html">would save 35 out of every 100 patients</a>. </p>
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<p>President Trump <a href="https://www.latimes.com/politics/story/2020-08-23/former-fda-chief-rejects-trump-claim-of-coronavirus-therapy-foot-dragging">called the EUA</a> “a very historic breakthrough.” </p>
<p>However, experts like former FDA Commissioner Robert Califf, were quick to note that the statement of 35 lives saved was not supported by available data. </p>
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<p>Moreover, the EUA for convalescent plasma was based on data generated over the course of just <a href="https://www.nytimes.com/2020/08/04/health/trump-plasma.html">a few tests</a> since April. Scientists – including one involved in the <a href="https://www.nytimes.com/2020/08/24/health/fda-blood-plasma.html">Mayo Clinic study</a> used by the FDA to support the EUA – noted that the FDA had <a href="https://www.washingtonpost.com/health/2020/08/24/some-administration-claims-effectiveness-convalescent-plasma-are-wrong-or-dubious-scientists-say/">improperly framed the data</a> to make unsupported efficacy claims. In his apology, Hahn said the criticism was “<a href="https://abcnews.go.com/Health/wireStory/fda-commissioner-overstated-effects-virus-therapy-72595122">entirely justified</a>.”</p>
<h2>Science yields to political pressure</h2>
<p>This is not the first time in the COVID-19 pandemic that the FDA made a controversial decision involving an EUA. In March, <a href="https://www.nytimes.com/2020/06/16/us/politics/trump-hydroxychloroquine-coronavirus.html">under pressure</a> from the Trump Administration, the agency issued an EUA for hydroxychloroquine and chloroquine. Randomized trials, however, <a href="https://www.wired.com/story/the-fda-revokes-its-emergency-use-authorization-for-hydroxychloroquine/">failed to show</a> any benefit associated with these drugs. Three months later, in the face of continued lack of evidence to meet even the lower threshold of an EUA, the FDA <a href="https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-revokes-emergency-use-authorization-chloroquine-and">revoked</a> the EUA. </p>
<p>Yet the Trump administration attempted to control the framing of the revocation. It portrayed it as the removal of a barrier to the use of these drugs, when in fact the revocation did exactly <a href="https://www.factcheck.org/2020/06/azar-trump-mislead-on-fdas-hydroxychloroquine-decision/">the opposite</a>.</p>
<p>Recent events like these provide unsettling clues of a deterioration of standards at the FDA. The flexibility that is required to deal with emergency responses creates opportunities for nimbleness. However, it also poses the danger that standards will be displaced. For an agency already overtly yielding to political pressure and short-termism, we are concerned that things are unlikely to improve as the COVID-19 vaccine race accelerates.</p>
<p>[<em>You need to understand the coronavirus pandemic, and we can help.</em> <a href="https://theconversation.com/us/newsletters/the-daily-3?utm_source=TCUS&utm_medium=inline-link&utm_campaign=newsletter-text&utm_content=coronavirus-help">Read The Conversation’s newsletter</a>.]</p>
<h2>Concerns with emerging COVID-19 vaccines</h2>
<p>There should be absolutely no link between the coming election and the vaccine regulatory process. Yet, there are growing concerns – voiced by experts like <a href="https://thehill.com/changing-america/well-being/prevention-cures/513516-fauci-warns-rushing-a-covid-19-vaccine-to-market">Dr. Anthony Fauci</a> – that there might be a push for a rushed authorization of a COVID-19 vaccine in the U.S. President Trump needs a boost in the polls, and the nation is desperate for a vaccine. The EUA of convalescent plasma, and in particular the misrepresentation of data at FDA level, have fueled these concerns.</p>
<p>Hahn published an op-ed on Aug. 5 <a href="https://www.washingtonpost.com/opinions/fda-commissioner-no-matter-what-only-a-safe-effective-vaccine-will-get-our-approval/2020/08/05/e897d920-d74e-11ea-aff6-220dd3a14741_story.html">saying</a> that he and his agency will not approve a vaccine that is not safe and effective, though previously he had <a href="https://www.forbes.com/sites/brucejapsen/2020/07/30/fda-chief-well-consider-emergency-authorization-for-covid-19-vaccine/#4711b19a574f">stated</a> that the FDA would consider issuing an EUA for a COVID-19 vaccine.</p>
<p>President Trump has <a href="https://www.reuters.com/article/us-health-cornavirus-vaccine-approval-ex/explainer-could-u-s-regulators-authorize-a-covid-19-vaccine-before-the-election-idUSKBN25L2OK">hinted at the possibility</a> of a COVID-19 vaccine being available before the election. Several <a href="https://www.ft.com/content/b053f55b-2a8b-436c-8154-0e93dcdb3c1a">reports</a> suggest that the administration is currently considering fast-tracking a COVID-19 vaccine being developed in the U.K., potentially through an EUA issued by the FDA. </p>
<p>Yet vaccine EUAs can be especially problematic. Because the threshold for an EUA is lower than for full regulatory approval, the FDA must make a risk-benefit assessment based on limited data whenever it uses the EUA pathway. Because of the nature of vaccines, many experts have <a href="https://pharmaintelligence.informa.com/resources/product-content/covid-19-vaccines-ex-fda-leaders-urge-high-bar-for-emergency-use-authorization">argued</a> that this pathway is too risky for vaccines. </p>
<p>One reason that vaccine EUAs would be especially risky is that, unlike treatments for diseases, vaccines are normally administered to healthy people. This makes it much harder to demonstrate their efficacy. When a person is sick and takes a drug, investigators can tell within a fairly short time if the drug works. That is not the case with a preventative like a vaccine. Therefore, to make an informed decision about whether a vaccine is safe and effective, FDA regulators are likely to need significantly more data than an EUA would give them. </p>
<p>Moreover, one of the leading COVID-19 vaccine candidates in the U.S. is an <a href="https://www.modernatx.com/modernas-work-potential-vaccine-against-covid-19">mRNA vaccine</a>, a type of vaccine never before approved anywhere in the world. Using the EUA pathway on such previously untested and unproved technology would be risky. This is even more concerning in light of the FDA’s recent track record of issuing EUAs with little or no data and recasting test results as wholesome without proper support. </p>
<h2>Adhering to its standards</h2>
<p>FDA’s departure from frameworks, scientific parameters and expertise care is contrary to the public interest and breeds distrust that could last for years. Regulatory history shows that the FDA can be flexible in times of crisis without compromising its credibility and its mission to protect the public health. We believe its departures from its standards under political pressure justifiably raises red flags. To be true to its mission, the FDA must stick to its regulatory guns. Right now, that means resisting pressure to further depart from its standards in the approval of COVID-19 vaccines.</p><img src="https://counter.theconversation.com/content/145082/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Ana Santos Rutschman has advised the Biden campaign on issues related to intellectual property and health technologies.</span></em></p><p class="fine-print"><em><span>Liza Vertinsky and Yaniv Heled do not work for, consult, own shares in or receive funding from any company or organization that would benefit from this article, and have disclosed no relevant affiliations beyond their academic appointment.</span></em></p>The rushed emergency approval for a treatment that might help COVID-19 patients has raised questions: Is the FDA abandoning its own guidelines?Ana Santos Rutschman, Assistant Professor of Law, Saint Louis UniversityLiza Vertinsky, Professor of Law, Emory UniversityYaniv Heled, Associate Professor of Law, Georgia State UniversityLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1441792020-08-24T19:17:12Z2020-08-24T19:17:12ZApproval of a coronavirus vaccine would be just the beginning – huge production challenges could cause long delays<figure><img src="https://images.theconversation.com/files/353923/original/file-20200820-18-k6mlcs.jpg?ixlib=rb-1.1.0&rect=88%2C132%2C7260%2C4418&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Billions of people are going to need a coronavirus vaccine and that demand is going to be hard to meet.</span> <span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/photo/syringes-and-injectable-medications-royalty-free-image/1161382041?adppopup=true"> Francesco Carta fotografo/Moment via Getty Images</a></span></figcaption></figure><p>The <a href="https://www.ajpmonline.org/article/S0749-3797(20)30284-1/fulltext">race for a SARS-CoV-2 vaccine is well underway</a>. It’s tempting to assume that once the first vaccine is approved for human use, all the problems of this pandemic will be immediately solved. Unfortunately, that is not exactly the case.</p>
<p>Developing a new vaccine is only the first part of the complex journey that’s <a href="https://theconversation.com/how-effective-does-a-covid-19-coronavirus-vaccine-need-to-be-to-stop-the-pandemic-a-new-study-has-answers-142468">supposed to end with a return to some sort of normal life</a>. Producing hundreds of millions of vaccines for the U.S. – and billions for the world as a whole – will be no small feat. There are many technical and economic challenges that will need to be overcome somehow to produce millions of vaccines as fast as possible.</p>
<p>I am a <a href="https://scholar.google.com/citations?hl=en&user=RCEISowAAAAJ">professor of health policy and management</a> at the <a href="https://sph.cuny.edu/">City University of New York (CUNY) School of Public Health</a> and have been working in and studying the worlds of <a href="https://www.forbes.com/sites/coronavirusfrontlines/2020/05/08/a-computational-scientist-explains-how-more-coronavirus-infections-could-cost-healthcare-systems-over-500-billion/#7d3df08f2ed2">vaccine development, production and distribution</a> for over two decades. The issues the world is facing today regarding the coronavirus vaccine are not new, but the stakes are perhaps higher than ever before.</p>
<p>There are four main challenges that must be addressed as soon as possible if a vaccine is to be produced quickly and at a large scale.</p>
<h2>Existing manufacturing capacity is limited</h2>
<p>The shrinking and outsourcing of U.S. manufacturing capacity has reached into all sectors. Vaccines are no exception.</p>
<p>The number of U.S. biotech and pharmaceutical companies involved in vaccines development and production has fallen from <a href="https://doi.org/10.1377/hlthaff.24.3.622">26 in 1967 to just five in 2004</a>. There are <a href="https://doi.org/10.1377/hlthaff.24.3.622">many causes</a> – relatively low profit margins, smaller markets compared to those of other medications, corporate mergers, liability risks and the anti-vaccination movement – but the result is that in some years, companies have struggled to meet need even for existing vaccines. Just take a look at the <a href="https://doi.org/10.1377/hlthaff.24.3.822">flu vaccine shortages of 2003-2005</a> and the <a href="https://doi.org/10.1377/hlthaff.24.3.635">childhood vaccine shortages of the early 2000s</a>. </p>
<p>When a coronavirus vaccine is approved, production of other vaccines will need to continue as well. With the flu season each year and children being born every day, you can’t simply reallocate all existing vaccine manufacturing capacity to COVID-19 vaccine production. New additional capacity will be needed. </p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/353927/original/file-20200820-22-1nb1au3.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="A drawing of a strand of RNA." src="https://images.theconversation.com/files/353927/original/file-20200820-22-1nb1au3.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/353927/original/file-20200820-22-1nb1au3.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=509&fit=crop&dpr=1 600w, https://images.theconversation.com/files/353927/original/file-20200820-22-1nb1au3.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=509&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/353927/original/file-20200820-22-1nb1au3.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=509&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/353927/original/file-20200820-22-1nb1au3.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=640&fit=crop&dpr=1 754w, https://images.theconversation.com/files/353927/original/file-20200820-22-1nb1au3.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=640&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/353927/original/file-20200820-22-1nb1au3.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=640&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">Many of the most promising vaccine candidates are using new technology, like RNA vaccines, that would require entirely new manufacturing processes.</span>
<span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/news-photo/genetics-rna-messenger-rna-news-photo/179795113?adppopup=true">BSIP/Contributor via Getty Images</a></span>
</figcaption>
</figure>
<h2>The type of vaccine is still unknown</h2>
<p><a href="https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine-tracker.html">While there are a few frontrunners at the moment</a>, it is still unknown <a href="https://www.who.int/publications/m/item/draft-landscape-of-covid-19-candidate-vaccines">which of the more than 160 vaccines in development</a> will get approval first, and therefore, what kind of manufacturing needs to be put in place. Producing a COVID-19 vaccine will not be the same as adding a new strain to an existing flu vaccines or simply tweaking how other existing vaccine are made. </p>
<p>Most existing vaccines, like those for flu and measles, use either <a href="https://theconversation.com/labs-are-experimenting-with-new-but-unproven-methods-to-create-a-coronavirus-vaccine-fast-134319">inactivated or weakened forms of those specific viruses</a> to generate immunity, but researchers can’t simply swap the flu virus for SARS-CoV-2. Additionally, a SARS-CoV-2 vaccine may not even use inactivated or weakened virus, but instead could incorporate a protein or genetic material from the coronavirus. Manufacturing such pieces of the virus in large amounts may require new processes that have never been tried before, since <a href="https://theconversation.com/labs-are-experimenting-with-new-but-unproven-methods-to-create-a-coronavirus-vaccine-fast-134319">the Food and Drug Administration hasn’t ever approved any DNA vaccines for human use</a>.</p>
<p>Some companies are developing <a href="https://theconversation.com/labs-are-experimenting-with-new-but-unproven-methods-to-create-a-coronavirus-vaccine-fast-134319">mRNA or DNA vaccines</a>. Others are working with inactivated SARS-CoV-2 or even other types of viruses like <a href="https://doi.org/10.1016/S0140-6736(20)31604-4">the chimp adenovirus</a>. Then there are those targeting <a href="https://www.bloomberg.com/features/2020-covid-vaccine-research/">different protein subunits of the virus</a>. Each vaccine may have very different manufacturing requirements and it is impossible to know which of these candidates will reach the market and when. </p>
<p>Governments and other funders face a difficult choice. If they gamble and provide funding to scale up manufacturing for a particular vaccine now, they could save time and thus lives. Picking wrong, though, could end up costing much more in money, suffering and lives. Ultimately, manufacturers will seek financial assurances – like upfront payments or commitments to buy the vaccine when it is available – from governments and funders to make sure that the time, effort and resources dedicated to vaccine development and manufacturing will not be wasted. For example, <a href="https://www.npr.org/sections/coronavirus-live-updates/2020/07/31/897701128/u-s-reaches-2-1-billion-deal-with-sanofi-and-glaxosmithkline-for-coronavirus-vac">the U.S. government’s $2.1 billion deal with Sanofi and GSK</a> will include scaling up of manufacturing capacity and the purchase of 100 million doses of the vaccine. </p>
<h2>The size of the problem is unprecedented</h2>
<p>As the saying goes, knowing is not the same as doing. Producing a completely new vaccine at such a large scale so quickly is unprecedented. </p>
<p><a href="https://www.reuters.com/article/us-flu-vaccine-usa/swine-flu-vaccines-delayed-cdc-says-idUSTRE59F4VV20091017">Numerous delays occurred</a> in the production of the H1N1 flu vaccine in 2009. Consider what may happen with a novel vaccine that could require new reagents, production processes, equipment and containers, among other things. Rollouts of the smallpox and polio vaccines occurred decades ago with less urgency and when populations were significantly smaller. Today, assuming that the <a href="https://doi.org/10.1016/j.jinf.2020.03.027">herd immunity threshold is at least 70%</a>, manufacturers would need to produce at least 230 million doses to cover the U.S. population and over 5.25 billion doses to cover world’s population. And that’s if only one dose is required. Requiring two doses per person would double the doses needed.</p>
<p>Never before has humanity tried to produce something for every person on Earth as quickly as possible. There are going to be problems. </p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/353928/original/file-20200820-22-tcmxn1.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="A man walks out of the Moderna headquarters." src="https://images.theconversation.com/files/353928/original/file-20200820-22-tcmxn1.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/353928/original/file-20200820-22-tcmxn1.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/353928/original/file-20200820-22-tcmxn1.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/353928/original/file-20200820-22-tcmxn1.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/353928/original/file-20200820-22-tcmxn1.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/353928/original/file-20200820-22-tcmxn1.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/353928/original/file-20200820-22-tcmxn1.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">Pharmaceutical companies in the vaccine race, like Moderna, might face a choice between what is best for shareholders and what is best for public health.</span>
<span class="attribution"><a class="source" href="http://www.apimages.com/metadata/Index/Virus-Outbreak-Vaccine-Race/0b0b2742c69049ffa3f2c6f4f6a0b5e3/25/0">AP Photo/Bill Sikes</a></span>
</figcaption>
</figure>
<h2>Economic poker game</h2>
<p>Ultimately, most potential vaccine manufacturers are businesses, seeking to minimize costs and maximize revenue where possible. They will want incentives to forego other more lucrative opportunities, such as continuing to develop or produce medications that have <a href="https://doi.org/10.1377/hlthaff.24.3.622">higher profit margins</a>. </p>
<p>For example, companies may not readily reveal current and potential manufacturing capacity. After all, these can be major bargaining chips in negotiating contracts with governments and other possible funders. Revealing that you have too little capacity right now may jeopardize confidence in your ability to make the vaccine. Revealing that you already have enough capacity can hinder your bargaining for more funding and resources.</p>
<p>During the 2009 H1N1 flu pandemic <a href="https://www.forbes.com/sites/brucelee/2017/02/19/bill-gates-warns-of-epidemic-that-will-kill-over-30-million-people/#1e4b648d282f">while I was working within the U.S. Department of Health and Human Services</a>, we had to continuously deal with changing vaccine production schedules as manufacturers continued to renegotiate the terms with the government. </p>
<p>Moreover, the extent of the pandemic brings this poker game to the world stage. Different <a href="https://theconversation.com/how-vaccine-nationalism-could-block-vulnerable-populations-access-to-covid-19-vaccines-140689">countries may be negotiating with or even against each other</a> and manufacturers. For example, high-income countries may be angling to get ahead of other countries seeking to receive vaccines.</p>
<h2>A plan and a systems approach</h2>
<p>Ultimately, vaccine production is only one <a href="https://dx.doi.org/10.1016%2Fj.vaccine.2016.11.033">part of a complex, interconnected system</a> whose ultimate goal is to prevent people from getting a disease. </p>
<p>[<em>Deep knowledge, daily.</em> <a href="https://theconversation.com/us/newsletters/the-daily-3?utm_source=TCUS&utm_medium=inline-link&utm_campaign=newsletter-text&utm_content=deepknowledge">Sign up for The Conversation’s newsletter</a>.]</p>
<p>The type of vaccine developed, size and location of the initial target populations, the way the vaccine is administered, the number of doses and the storage requirements for the vaccine are all interconnected and just some of the factors that affect the production requirements. For example, work done by my team at the City University of New York has shown that that the number of vaccine doses that you put in a single vial can have a variety of <a href="https://doi.org/10.1016/j.vaccine.2018.12.010">cascading effects on vaccination and disease control programs</a>.</p>
<p>People’s lives, and life as we know it, are on the line. All of the complexities of producing a vaccine need to be addressed through open worldwide discussions and extensive mapping and modeling of these scenarios. Without proper planning and preparation, society may be left in a situation where production cannot meet demand or vaccines are shoddily produced. </p>
<p>And even when enough vaccines are manufactured, there’s still the challenge of actually <a href="https://www.forbes.com/sites/brucelee/2016/08/31/billions-of-dollars-of-vaccines-have-gone-to-waste/#5d560def55b7">getting them into hundreds of millions of people in the U.S. and billions around the world</a>. There are worries that there won’t be enough <a href="https://www.washingtonpost.com/business/2020/07/13/coronavirus-vaccine-corning-glass/">glass vials to store the vaccines</a> or <a href="https://www.theguardian.com/world/2020/aug/21/syringe-shortage-covid-19-vaccine-experts">syringes to administer them</a>, as well as concerns about the <a href="https://www.wsj.com/articles/drugmakers-race-to-build-covid-19-vaccine-supply-chains-11596101586">temperature controlled supply chain</a>. </p>
<p>These challenges of production and distribution, though large, are not insurmountable. The more planning governments and businesses do now, the better they will be able to deliver the vaccines the world so desperately needs.</p><img src="https://counter.theconversation.com/content/144179/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Bruce Y. Lee receives funding from the National Institutes of Health (NIH), the Agency for Healthcare Research and Quality (AHRQ), and the U.S. Agency for International Development (USAID). He has also received funding from the Bill and Melinda Gates Foundation, the Centers for Disease Control and Prevention (CDC), the United Nations Children's Fund (UNICEF), and various vaccine manufacturers to use computational modeling to find ways to improve vaccine development, production, delivery, implementation, and administration. </span></em></p>Once a coronavirus vaccine is approved, billions of doses need to be manufactured. Current vaccine production is nowhere near ready, for a variety of reasons, but planning now could help.Bruce Y. Lee, Professor of Health Policy and Management, City University of New YorkLicensed as Creative Commons – attribution, no derivatives.