FDA Announces New COVID-19 Vaccine Guidance Requiring More Data Before Approval

Posted by Marianne C. LeBlanc

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Marianne is a trial attorney with over two decades of experience in representing clients and a member of BBO and served on the Regulators Subcommittee of the SJC Committee on Lawyer Well-Being. With record-setting verdicts in MA, Marianne’s advocacy skills draw on her commitment to making a difference both for clients and the community at large. Meet Marianne

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As the United States approached 7.5 million confirmed coronavirus infections, the U.S. Food and Drug Administration unveiled new guidance last week that may push back authorization of a COVID-19 vaccine. In its announcement, the FDA stated that they hoped the new COVID-19 vaccine guidance would “help the public understand our science-based decision-making process that assures vaccine quality, safety and efficacy for any vaccine that is authorized or approved.” 

The FDA has long had the authority to grant Emergency Use Authorizations (“EUA”), allowing them to protect public health against threats by facilitating the availability and use of unapproved medical products needed during public health emergencies such as the coronavirus disease. Although they are granted during emergencies, EUAs still require a determination by the FDA that the product’s known and potential benefits outweigh its known and potential risks. Historically, the majority of EUAs that have been issued by the FDA have been in response to H1N1 in 2009. Now, the manufacturers of a coronavirus vaccine will need to apply for an EUA with the FDA in order to supply and distribute the drug to the United States population. 

There has been much talk that a coronavirus vaccine could be available to Americans at any time now. However, on October 6, 2020, the FDA put a halt on that push by stating that they will be requiring much more data than originally thought before approving the vaccine for an EUA. Specifically, the FDA announced that EUA applications should contain at least two months of follow-up data collected after patients have been fully vaccinated. With most vaccine trials only starting over late summer, this inevitably means that EUA applicants will be delayed while they collect, organize, and submit the required data to the FDA. The FDA will then need additional time to review all of the data and grant the applications. 

In response to the guidance, the White House objected to the stricter provisions which has since prompted the FDA to establish an outside advisory committee of experts that will meet publicly prior to any vaccine authorization. The FDA expects that the committee will enforce the guidelines regardless of the White House’s blockade.