3 Reasons the FDA Shouldn't Rush the Coronavirus Vaccine - COVID-19 Clinical Trial
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3 Reasons the FDA Shouldn’t Rush the Coronavirus Vaccine

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    Politicians, economists, scientists, and health experts alike all view the development of a coronavirus vaccine as the best solution to the COVID-19 pandemic. As a result, vaccine testing is occurring on an accelerated schedule, faster than ever seen before.  

    Some experts, such as Steven Joffe, a professor of pediatrics at the University of Pennsylvania Perelman School of Medicine, warn that rushing the coronavirus vaccine undermines the rigorous testing required to ensure safety and efficacy.  

    What is Trump Administration’s Operation Warp Speed? 

    On Friday, May 15, 2020, the Trump Administration announced the creation of Operation Warp Speed (OWS), a national program designed to “accelerate the development, manufacturing, and distribution of COVID-19 vaccines, therapeutics, and diagnostics.” 

    Using a public-private partnership framework, Operation Warp Speed involves the collaboration of the CDC, FDA, NIH, Biomedical Advanced Research and Development Authority (BARDA), Department of Defense, Department of Agriculture, other select federal agencies, and private firms.  

    The official White House press release explained that Operation Warp Speed “will coordinate existing HHS-wide efforts, including the NIH’s ACTIV partnership for vaccine and therapeutic development, NIH’s RADx initiative for diagnostic development, and work by BARDA.” 

    It’s true that the government and pharmaceutical companies face incredible pressure to develop vaccines quickly, but Joffe and his colleague, assistant professor of medical ethics Holly Fernandez Lynch, worry that “at some point the Food and Drug Administration will be asked to authorize a vaccine candidate for widespread use. Although the FDA could allow use of a coronavirus vaccine based on weak evidence, it must not make that mistake.” 

    Emergency Authorization of a New Vaccine Is Unprecedented 

    The FDA was granted special authority to issue temporary authorizations of medical treatments and products in 2004. These emergency use authorizations (EUA) are permitted when a public health emergency “has a significant potential to affect national security or the health and security of United States citizens.”  

    The available evidence for a medical product or treatment must suggest it “may be effective” for prevention, diagnosis, or treatment, and that there exists “no adequate, approved, and available alternative.” 

    In a massive health crisis such as the COVID-19 pandemic, EUAs have the potential to save lives. Critically ill patients accept treatment with these investigational drugs and understand the risks involved. The emergency authorization of a vaccine, however, is unprecedented.  

    The only time the FDA provided an EUA for a vaccine was in 2005 in response to anthrax bioweapon attacks, but that vaccine was developed decades ago for a different purpose. If the FDA chooses to provide emergency authorization for a coronavirus vaccine, it will mark the first EUA allowed for a new, investigational vaccine.  

    A New Vaccine Will Reach Millions of Healthy People 

    It’s also important to note that a new coronavirus vaccine won’t treat patients already suffering from severe COVID-19 illness. Instead, a vaccine will be distributed to millions of healthy adults not yet infected with the coronavirus. This means their potential to benefit may be far less than the benefit of seriously ill patients given experimental drugs. It’s vital to ensure that any vaccine candidates prove their safety through rigorous testing before widespread use is authorized.  

    Public Trust in Vaccines Is a Critical Consideration 

    Of course, public trust in vaccinations is a consideration that can’t be ignored. The anti-vaccine movement has gained traction in recent years. Any negative consequences of a vaccine approved too early could propel and exacerbate anti-vaccine sentiments.  

    The bottom line, Joffe and Lynch emphasize, is that the FDA “must wait until data from a well-controlled trial demonstrates that a vaccine is able to prevent COVID-19 and that it is safe enough to give to millions of people.” 


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