July 2021 - Page 3

BMJ: Why we petitioned the FDA to refrain from fully approving any covid-19 vaccine this year

Signal

A group of clinicians, including the senior editor of the British Medical Journal, Peter Doshi, has written to the US Food and Drug Administrator (FDA). They are asking the agency to delay any consideration of a “full approval” of a covid-19 vaccine until at least 2022. In the USA, COVID vaccines only have Emergency Use Authorisation (EUA)

We are part of a group of clinicians, scientists, and patient advocates who have lodged a formal “Citizen Petition” with the United States Food and Drug Administration (FDA), asking the agency to delay any consideration of a “full approval” of a covid-19 vaccine. The message of our petition is “slow down and get the science right—there is no legitimate reason to hurry to grant a license to a coronavirus vaccine.” We believe the existing evidence base—both pre- and post-authorization—is simply not mature enough at this point to adequately judge whether clinical benefits outweigh the risks in all populations.

The covid-19 vaccines in widespread use have emergency authorizations (EUA), not actual approvals, a crucial regulatory distinction that reflects major differences in the level of regulatory scrutiny and certainty about the risk-benefit balance.

We believe the existing evidence base….is simply not mature enough at this point to adequately judge whether clinical benefits outweigh the risks in all populations.

Linda Wastila, Peter Doshi et al

Our petition doesn’t argue that risks outweigh benefits—or that benefits outweigh risks. Rather, we focus on methods and processes, outlining the many remaining unknowns about safety and effectiveness—and suggest the kinds of studies needed to address the open questions.

If the FDA listens to us, they won’t give serious consideration to approving a covid-19 vaccine until 2022. Our first request is that the FDA require manufacturers to submit data from completed Phase III trials—not interim results. Trials by vaccine manufacturers were designed to follow participants for two years, and should be completed before they are evaluated for full approval, even if they are now unblinded and lack placebo groups. These Phase III trials are not simply efficacy studies; they also are necessary and important safety studies (as the study titles say), and all collected data remain invaluable….

Read the full letter – Why we petitioned the FDA to refrain from fully approving any covid-19 vaccine this year