After a COVID-19 Vaccine: Collaboration Or Competition?

Entry Point

nations like the US move to lock up future supplies of experimental COVID-19 vaccines through individual deals with manufacturers even as other countries pool their resources to develop and equitably distribute vaccines through the World Health Organization (WHO)– sponsored COVID-19 Vaccine Global Ac- cess Facility (COVAX).1,2 Experts discussed these unprecedent- ed opportunities and challenges at a Health Affairs online symposium, “Pro- moting Innovation and Equity as COVID- 19 Vaccines and Treatment Emerge,” presented August 24, 2020. There was excitement among the speakers about the rapid, pandemic- driven advances in science, clinical trial, and regulatory processes and collabora- tions among governments, manufacturers, and nongovernmental organizations that could improve global health in the future. But there were deep concerns about whether the US, China, and other countries will be able to transcend na- tionalist rivalries to defeat their com- Vaccine: Volunteer Melissa Harting, from Harpersville, New York, receives a COVID-19 vaccine mon viral foe and whether profit incen- injection from nurse Kathe Olmstead. Harting is participating in the world’s largest study of a possible COVID-19 vaccine, developed by the National Institutes of Health and Moderna Inc. tives will get in the way. “We can choose to collaborate and bring the world back to health equitably, doi: 10.1377/hlthaff.2020.01732 or we can compete and exacerbate in- equities,” Orin Levine, director of Glob- al Delivery Programs at the Bill & After A COVID-19 Vaccine: Melinda Gates Foundation, said in his opening remarks. “A moment is coming soon when we have a breakthrough on a Collaboration Or lifesaving vaccine. Then humanity will Competition? be tested on the question of equity.” ‘Missed Opportunity’ As COVID-19 vaccines and therapies emerge, critical questions remain On September 1, 2020, a White House about access and affordability around the world. spokesperson said that the US would not BY HARRIS MEYER join COVAX to develop and equitably distribute a vaccine because the effort is “influenced by the corrupt World Health Organization and China.”3 ffective international col- livery. Alternatively, lack of cooperation Meanwhile, Germany, Japan, and the laboration not only could and coordination by governments, non- European Commission have announced end the coronavirus disease governmental organizations, and man- their participation, although the terms of 2019 (COVID-19) pandemic ufacturers could prolong the pandemic, their cooperation remain undisclosed. and restore the global econ- producing an outcome where more peo- A total of seventy-eight higher-income Eomy but also could lead to revolutionary ple die and economic devastation con- countries and ninety-two lower-income improvements in vaccine and therapeu- tinues indefinitely. countries have expressed interest in par- tic drug development, drug regulation, Those sharply different scenarios ticipating, according to Gavi, the Vac- clinical trial design, and health care de- both remain possible as some wealthy cine Alliance, which co-leads COVAX

Photograph by AP Photo/Hans Pennink November 2020 39:11 Health Affairs 1 Downloaded from HealthAffairs.org on September 28, 2020. Copyright Project HOPE—The People-to-People Health Foundation, Inc. For personal use only. All rights reserved. Reuse permissions at HealthAffairs.org. Entry Point with the WHO and the Coalition for Epi- trials, with a pledge to buy those that the symposium, said in an interview. demic Preparedness Innovations (CEPI) prove effective. The nine candidates In a new paper, Yamey and several (Gavi spokesperson, personal commu- include vaccines being developed by Duke colleagues urge that such deals nication, September 16, 2020). Coun- Moderna, AstraZeneca, Inovio, and include provisions to promote the shar- tries had until September 18 to make a Novavax. ing of data and technology with other binding legal commitment—a date that One of those potential vaccines, devel- manufacturers and countries, enabling was pushed back from the original Au- oped by AstraZeneca and the University others to rapidly produce and distribute gust 31 deadline. of Oxford, suffered a setback in early effective vaccines throughout the Resistance from wealthy nations re- September when Phase III trials in the world.11 portedly forced the COVAX sponsors US were put on hold because of a sus- “There are dramatic opportunities for to redesign the program and delay the pected serious adverse reaction to the all to win, and also dramatic opportuni- deadlines. Among the changes made is a product by a participant in the United ties for all to lose,” said David McAdams, more flexible payment model enabling Kingdom.7 Although the hold could be an economics professor at Duke who countries to opt out of vaccines they al- temporary, it may delay efficacy results coauthored the paper. ready have acquired through individual as trials of other candidates race ahead. purchase deals and to trade any excess An additional nine candidate vaccines ‘The Same Access Questions’ vaccines from their own deals through a are being evaluated for inclusion by Food and Drug Administration (FDA) COVAX exchange platform.4 COVAX. Governments, vaccine manu- Commissioner Stephen Hahn recently Many public health experts lamented facturers, other organizations, and indi- said that he will consider granting emer- the Trump administration’s decision viduals have committed $1.4 billion to- gency authorization for a COVID-19 vac- not to join COVAX, which some criti- ward vaccine research and development cine even before clinical trials have been cized as vaccine nationalism. “If COVID so far, but an additional $1 billion is completed if the benefits outweigh the has taught us anything, it’s that we’re all needed to move the research and devel- risks. “This is going to be a science, med- interdependent,” Nicole Lurie, a CEPI opment portfolio forward, according to icine, data decision,” Hahn recently told strategic adviser and former Depart- the WHO. the Financial Times, even though he pre- ment of Health and Human Services as- At the same time, wealthy nations viously acknowledged he is under pres- sistant secretary who spoke at the sym- have struck their own deals with manu- sure to deploy a vaccine as fast as possi- posium, said in an emailed comment. facturers to develop and purchase ble. “This is not going to be a political “This is a huge missed opportunity to COVID-19 vaccine candidates should decision.”12 change the way the world works togeth- they be approved, potentially locking Robert Redfield, director of the Cen- er to respond to pandemics.” up billions of doses. The Trump admin- ters for Disease Control and Prevention The COVAX initiative grew out of the istration’s Operation Warp Speed initia- (CDC), recently urged states to get their world’s experience in dealing with the tive has reached deals for at least seven vaccine distribution sites ready by No- H1N1 influenza pandemic in 2009, candidates in various stages of develop- vember 1.13 State and local officials say when the US delayed for months in shar- ment, including products being devel- that will be a daunting challenge, given ing with less wealthy nations the vaccine oped by Moderna and Pfizer that are vaccine cold storage requirements, lack it had developed to combat that virus.5 in Phase III clinical trials in the US.8 of vaccine administration tracking The initiative’s approach is for wealth- The European Commission, negotiat- tools, public health departments’ limit- ier countries to provide up-front funding on behalf of all twenty-seven Euro- ed staffing and resources, and other lo- ing and purchasing guarantees to a pean Union states, has agreed to buy at gistical issues.14 range of COVID-19 vaccine developers least 300 million doses of AstraZeneca’s Vaccines are hardly the only tough is- with the stated goal of guaranteeing potential vaccine, with an option to buy sue. Symposium speakers stressed the all countries enough doses of proven an additional 100 million doses. That importance of rapidly testing and pro- vaccines to inoculate at least 20 percent product has just started Phase III trials ducing therapeutic products for COVID- of their populations.2 Advocates claim in the US.9 19 and making them affordable for peo- that everyone wins: Wealthier countries In total, the US, the European Union, ple all over the world. There are 184 get the promise of guaranteed access to a Japan, and the United Kingdom have treatments for COVID-19 in clinical tri- broader pool of potentially effective vac- agreed to buy more than three billion als, as well as forty-three antiviral prod- cines, and the entire world’s population doses of various vaccine candidates, ucts in trials, according to the Biotech- gets vaccinated, enabling the global whereas China and India, which are nology Innovation Organization, a economy to reopen. working on their own vaccines, likely pharmaceutical industry trade group. “With infectious disease, no one is will keep much of their production for Many of the COVID-19 therapeutics safe until everyone is safe,” Seth their own populations.10 in development are monoclonal anti- Berkley, Gavi’s chief executive officer, “If these giant bilateral deals result in bodies—biologically derived treatments wrote in July 2020.6 hundreds of millions of doses being that can cost more than $100,000 a year. COVAX currently is providing re- hoarded by rich countries, that’s a threat Previously approved monoclonal anti- search, development, and manufactur- to achieving global herd immunity,” body treatments for other diseases, such ing funding for nine candidate vaccines, Gavin Mark Yamey, a professor of global as for rheumatoid arthritis, are largely seven of which are now are in clinical health at Duke University who spoke at unavailable in poorer countries and

2 Health Affairs November 2020 39:11 Downloaded from HealthAffairs.org on September 28, 2020. Copyright Project HOPE—The People-to-People Health Foundation, Inc. For personal use only. All rights reserved. Reuse permissions at HealthAffairs.org. even to Americans lacking good health make the case for its product. insurance. At the symposium, Mark If and when safe and Phyllis Arthur, the Biotechnology In- Feinberg, CEO of IAVI, a not-for-profit effective vaccines are novation Organization’s vice president research organization focused on global developed and approved, for infectious diseases and diagnostics health, urged stronger efforts to broad- policy, who spoke at the symposium, en access to these products, which may therewillbemajor said in an interview that manufacturers hold promise for COVID-19 prevention challenges in do accept the need for comparable data and treatment. distribution, allocation, on each COVID-19 vaccine candidate to “We need to map out what is necessary streamline regulatory review, although to make sure people can benefit from and prioritization of who her organization has not taken a posi- these products, and deal with the same gets them. tion on master protocols for COVID-19 access questions as for vaccines,” products. She added that manufacturers Feinberg said. might not find master protocols appro- One approach to making COVID-19 She advocated the master protocol priate for commercial products outside therapies more affordable is repurpos- model, in which a single infrastructure the COVID-19 space. ing off-patent or generic drugs. Rena and trial design is used to simultaneous- She also rejected the idea that manu- Conti, an associate professor of mar- ly evaluate multiple products in multiple facturers, as part of the COVAX frame- kets, public policy, and law at Boston substudies. For example, the WHO used work, should be required to share University, and colleagues found that a master protocol in its international technology with other countries and of about 300 drugs in development Solidarity trials to rapidly evaluate the manufacturers to accelerate develop- for COVID-19 treatment, one-third were potential COVID-19 treatment hydroxy- ment and production of vaccines around products that had lost patent pro- chloroquine, finding it ineffective. The the world. “Companies already are solv- tection.15 Adaptive COVID-19 Treatment Trial ing this issue through their own partner- But manufacturers have shown little master protocols, established through ships with manufacturers in other coun- interest in exploring these drugs for the National Institutes of Health, stud- tries to make sure there is global access,” COVID-19 treatment because “there’sno ied remdesivir. The British master pro- she said. “There’s no need for any re- money in it,” Conti said at the sympo- tocol study, RECOVERY, provided de- quired technology transfer.” sium. She called for the US government finitive evidence that dexamethasone to take a more prominent role in testing decreased mortality for severely ill pa- ‘Science By Press Release’ and manufacturing existing drugs for tients with COVID-19. If and when one or more safe and effec- treating coronavirus disease. Other research and regulatory innova- tive vaccines are developed and ap- The government also needs to design tions, such as greater use of telemedi- proved, there will be major challenges policy to make expensive orphan drugs cine and real-world evidence, also would in distribution, allocation, and prioriti- that show potential in for treating coro- help strengthen clinical trials, Krofah zation of who gets them. And it’s not navirus, such as nivolumab and ruxoli- added. clear whether enough Americans and tinib, far more affordable, Conti and In a recent op-ed, University of Penn- people in other countries will trust the Kao-Ping Chua wrote in a recent Health sylvania physician and bioethicist safety and efficacy of the vaccines and Affairs Blog post.15 Among the possible Ezekiel Emanuel and two colleagues get vaccinated. It’s estimated that as policy options are revoking the 340B contrasted the major COVID-19 research much of 70 percent of the population exemption for orphan drugs, encourag- results produced in Great Britain will have to get vaccinated to achieve ing generic and biosimilar competition, through large, simple, randomized tri- herd immunity.17 A vaccine must only and advance market deals between the als with the dearth of pathbreaking re- be 50 percent effective to win FDA ap- government and manufacturers for research in the US, where researchers lean proval.18 duced prices in exchange for volume toward smaller, complex trials.16 Multiple symposium speakers ex- purchasing and other benefits to com- “Imagine a world post-COVID where pressed fears that there may be far-reach- panies. these kinds of master protocol trials ing consequences if political considera- “We need an all-in strategy to develop could be helpful for rare diseases as well tions intrude into government approvals and repurpose existing therapeutics for as conditions like Alzheimer’s,” Krofah of COVID-19 therapies and vaccines. the pandemic now and to address other said. “Once the public health declara- They cited recent Trump administration pandemics in the future,” Conti said. tion [for COVID-19] has ended, will announcements and decisions on po- these innovations also end, or can we tential COVID-19 treatments—notably, ‘Imagine’ work them into our normal practice?” hydroxychloroquine and convalescent Standardized trial protocols and stream- The pharmaceutical industry, how- plasma therapy—that later were with- lining of regulatory processes also ever, isn’t necessarily enthusiastic about drawn or widely criticized because of a would speed development of vaccines master protocols, Lurie said. If a com- lack of scientific evidence.19 The appear- and treatments and reduce their costs pany’s vaccine candidate doesn’t per- ance of political interference and haste for the current and future pandemics, form as well as others in an apples-to- could limit the public’s willingness to said Esther Krofah, executive director apples comparison, it may become a lot get vaccinated at a time when there al- of FasterCures at the Milken Institute. more difficult for a manufacturer to ready is significant popular resistance to

November 2020 39:11 Health Affairs 3 Downloaded from HealthAffairs.org on September 28, 2020. Copyright Project HOPE—The People-to-People Health Foundation, Inc. For personal use only. All rights reserved. Reuse permissions at HealthAffairs.org. Entry Point vaccines in general. ‘The Other Side’ Seventy-eight percent of Americans Multiple symposium Even as the fate of the international vac- worry that the COVID-19 vaccine ap- speakers expressed cine effort remains uncertain, many ex- proval process is being driven more by fears that there may perts hold out hope that the world’s ef- politics than science, according to a re- be far-reaching forts to combat the COVID-19 pandemic cent survey by the Harris Poll and will lead to major advances in global STAT.20 Another recent Harris Poll sur- consequences if political health. At the very least, the crisis has vey found that about 30 percent of Amer- considerations intrude exposed weaknesses in public health icans said they were unlikely to seek a into government systems, clinical research and regulato- COVID-19 vaccine.21 ry processes, national social safety nets, “We’re unfortunately seeing science approvals of COVID-19 and international collaborative struc- by press release,” Margaret Hamburg, therapies and vaccines. tures, potentially spurring reforms. foreign secretary of the National Acade- The Gates Foundation’s Levine point- my of Medicine and former FDA com- ed to how the pandemic has sped up missioner, said at the symposium. “I “Why are these communities hesitant, efforts to expand the availability of med- worry this is adding a new form of vac- especially with that hyperbole?” said ical oxygen to children in lower-income cine hesitancy, even for the most sophis- Garth Graham, vice president and chief countries suffering from pneumonia. ticated vaccinologists.” community health officer at CVS Health. Historically, such children have died Vaccine hesitancy remains particular- “Because this may be moving at a speed by the millions as a result of a lack of ly problematic in poor and minority that’s not beneficial to them.” access to this life-saving therapy. Given communities in the US, where decades The Department of Health and Hu- the urgent need for treatment of pa- of racism, discriminatory medical treat- man Services recently announced that tients with COVID-19 with medical oxy- ment, and infamous medical abuses like it will launch a major public awareness gen, countries and organizations such the Tuskegee syphilis experiment have campaign in the media focusing on vac- as the United Nations Children’s Fund seeded a deep skepticism of medical au- cine safety and efficacy.21 But Graham are working to improve supply chains, thority. said that public health officials and pro- financing, and training of health care Vaccine trials in the US so far have viders need to embed themselves deeply workers for this therapy, with the bene- failed to recruit enough people of color in communities to correct misinforma- fits spilling over to kids with pneumonia. to match their percentage of the population and build vaccine trust. “It’s hard right now, when everyone is tion.22 This shortcoming persists de- “If you want to reach the community, in emergency mode with their lizard spite the high rate of COVID-19 cases you need to be in the community and use brain firing, to look at the horizon,” among Blacks, Hispanics, and Native trusted people,” Graham said. “Years of Levine said in an interview. “There is Americans, which is more than 2.5 times systemic racism have shaped these com- an opportunity to come out the other the rate among Whites; hospitalization munities. We have to understand their side better than where we went in.” ▪ rates for those groups are four to five experiences.” times higher those of Whites, and death CVS, for example, has made COVID-19 The Health Affairs symposium described in this rates among Blacks are twice as high as testing available at nearly 1,000 store article was supported by Anthem Inc., Amgen Inc., 23 Avalere, Kaiser Permanente, Pharmaceutical for Whites, according to the CDC. locations and partnered with free clin- Research and Manufacturers of America (PhRMA), It probably didn’t help that the Trump ics, community colleges, and federally Gilead, McKesson, Quest Diagnostics, Dynavax, administration dubbed its vaccine devel- qualified health centers to provide tests Alexion, and Danaher. Harris Meyer opment effort “Operation Warp Speed,” in underserved communities at no cost, ([email protected]) is a freelance writer based in Chicago, Illinois. [Published online stressing haste over safety. Graham said. September 28, 2020.]

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1 Callaway E. The unequal scramble rial on the Internet]. 2020 Sep 8 2020 Sep 10]. Available from: FDA must stand up for itself and for coronavirus vaccines—by the [cited 2020 Sep 10]. Available https://www.ft.com/content/ for science, not politics. numbers. Nature. 2020; from: https://www.statnews f8ecf7b5-f8d2-4726-ba3f- Washington Post [serial on the 584(7822):506–7. .com/2020/09/08/astrazeneca- 233b8497b91a Internet]. 2020 Aug 25 [cited 2 World Health Organization [In- covid-19-vaccine-study-put-on- 13 Wilner M. “Urgent” request sent 2020 Sep 16]. Available from: ternet]. Geneva: WHO; 2020. hold-due-to-suspected-adverse- to states in push for coronavirus https://www.washingtonpost Press release, 172 countries and reaction-in-participant-in-the- vaccine delivery by Nov. 1. Centre .com/opinions/the-fda-must- multiple candidate vaccines en- u-k/ Daily Times [serial on the Inter- stand-up-for-itself-and-for- gaged in COVID-19 vaccine Global 8 Hancock J. They pledged to do- net]. 2020 Sep 2 [cited 2020 Sep science-not-politics/2020/08/25/ Access Facility; 2020 Aug 24 nate rights to their COVID vac- 10]. Available from: https://www 7c253742-e70c-11ea-bc79- [cited 2020 Sep 10]. Available cine, then sold them to pharma. .centredaily.com/news/corona 834454439a44_story.html from: https://www.who.int/news- Kaiser Health News [serial on the virus/article245406245.html 20 Silverman E. Poll: most Americans room/detail/24-08-2020-172- Internet]. 2020 Aug 25 [cited 14 Szabo L. Health officials worry believe the Covid-19 vaccine ap- countries-and-multiple-candidate- 2020 Sep 16]. Available from: nation’s not ready for COVID-19 proval process is driven by politics vaccines-engaged-in-covid-19- https://khn.org/news/rather- vaccine. Kaiser Health News [se- not science. STAT [serial on the vaccine-global-access-facility than-give-away-its-covid-vaccine- rial on the Internet]. 2020 Sep 2 Internet]. 2020 Aug 31 [cited 3 Rauhala E, Abutaleb Y. U.S. says it oxford-makes-a-deal-with- [cited 2020 Sep 10]. Available 2020 Sep 10]. Available from: won’t join WHO-linked effort to drugmaker/ from: https://khn.org/news/ https://www.statnews.com/ develop, distribute coronavirus 9 Guarascio F. EU agrees first health-officials-worry-nations- pharmalot/2020/08/31/most- vaccine. Washington Post [serial COVID-19 vaccine deal with not-ready-for-covid-19-vaccine/ americans-believe-the-covid-19- on the Internet]. 2020 Sep 1 [cited AstraZeneca in WHO blow. U.S. 15 Chua K-P, Conti RM. How orphan vaccine-approval-process-is- 2020 Sep 10]. Available from: News & World Report [serial on drug policy could impede access to driven-by-politics-not-science/ https://www.washingtonpost the Internet]. 2020 Aug 14 [cited COVID-19 treatments. Health Af- 21 Hopkins JS. A Covid-19 vaccine .com/world/coronavirus-vaccine- 2020 Sep 10]. Available from: fairs Blog [blog on the Internet]. problem: people who are afraid to trump/2020/09/01/b44b42be- https://www.usnews.com/news/ 2020 Jun 25 [cited 2020 Sep 10]. get one.Wall Street Journal [serial e965-11ea-bf44-0d31c85838a5_ top-news/articles/2020-08-14/eu- Available from: https://www on the Internet]. 2020 Aug 28 story.html reaches-deal-with-astrazeneca- .healthaffairs.org/do/10.1377/ [cited 2020 Sep 10]. Available 4 Mancini DP, Peel M. “Vaccine for-at-least-300-million-doses-of- hblog20200623.498157/full/ from: https://www.wsj.com/ nationalism” delays WHO’s potential-covid-19-vaccine 16 Emanuel EJ, Zhang C, Diana A. articles/covid-19-vaccine- struggling Covax scheme. Finan- 10 Shah S. In race to secure Covid-19 Where is America’s groundbreak- hesitancy-is-a-growing-concern- cial Times [serial on the Internet]. vaccines, world’s poorest coun- ing Covid-19 research? New York for-researchers-health-officials- 2020 Sep 2 [cited 2020 Sep 10]. tries lag behind. Wall Street Jour- Times [serial on the Internet]. 11598607002 Available from: https://www.ft nal [serial on the Internet]. 2020 2020 Sep 1 [cited 2020 Sep 10]. 22 Johnson CY. Large U.S. covid-19 .com/content/502df709-25ac- Sep 1 [cited 2020 Sep 10]. Avail- Available from: https://www vaccine trials are halfway en- 48f6-aee1-aec7ac03c759 able from: https://www.wsj.com/ .nytimes.com/2020/09/01/ rolled, but lag on participant di- 5 World Health Organization. Main articles/in-race-to-secure-covid- opinion/coronavirus-clinical- versity. Washington Post [serial operational lessons learnt from 19-vaccines-worlds-poorest- research.html on the Internet]. 2020 Aug 27 the WHO pandemic influenza A countries-lag-behind- 17 O’Keefe SM. One in three Ameri- [cited 2020 Sep 16]. Available (H1N1) vaccine deployment ini- 11598998776 cans would not get COVID-19 from: https://www.washington tiative [Internet]. Geneva: WHO; 11 McAdams D, McDade KK, vaccine. Gallup [serial on the In- post.com/health/2020/08/27/ 2012 [cited 2020 Sep 10]. Avail- Ogbuoji O, Johnson M, Dixit S, ternet]. 2020 Aug 7 [cited 2020 large-us-covid-19-vaccine-trials- able from: https://apps.who.int/ Yamey G. Incentivizing wealthy Sep 10]. Available from: https:// are-halfway-enrolled-lag- iris/handle/10665/44711 nations to participate in the news.gallup.com/poll/317018/ participant-diversity/ 6 Berkley S. In the COVID-19 vac- COVID-19 Vaccine Global Access one-three-americans-not-covid- 23 Centers for Disease Control and cine race, nobody wins unless Facility (COVAX): a game theory vaccine.aspx Prevention. COVID-19 hospitali- everyone wins. Fortune [serial on perspective [Internet]. Durham 18 Food and Drug Administration. zation and death by race/ethnicity the Internet]. 2020 Jul 8 [cited (NC): Center for Policy Impact in Development and licensure of [Internet]. Atlanta (GA): CDC; 2020 Sep 10]. Available from: Global Health; 2020 Aug [cited vaccines to prevent Covid-19 [In- [last updated 2020 Aug 18; cited https://fortune.com/2020/07/ 2020 Sep 10]. Available from: ternet]. Silver Spring (MD): FDA; 2020 Sep 10]. Available from: 08/covid-19-vaccine-alliance- http://centerforpolicyimpact.org/ 2020 Jun [cited 2020 Sep 10]. https://www.cdc.gov/corona update-cooperation-coronavirus- wp-content/uploads/sites/18/ p. 14. Available from: https:// virus/2019-ncov/covid-data/ vaccines/ 2020/08/COVAX-Facility_Game- www.fda.gov/regulatory- investigations-discovery/ 7 Robbins R, Feuerstein A, Theory-Analysis_FINAL.pdf information/search-fda-guidance- hospitalization-death-by-race- Branswell H. AstraZeneca Covid- 12 Stacey K. FDA head says he is documents/development-and- ethnicity.html 19 vaccine study put on hold due willing to fast-track Covid-19 vac- licensure-vaccines-prevent- to suspected adverse reaction in cine. Financial Times [serial on covid-19 participant in the U.K. STAT [se- the Internet]. 2020 Aug 30 [cited 19 Hamburg MA, Sharfstein JM. The

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