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FDA Hearing on COVID-19 Vaccines

Oct 23, 2020 2:40 pm

Yesterday the Food and Drug Administration's (FDA) "Vaccines and Related Biological Products Advisory Committee" convened a panel of experts to assess the development of vaccines for COVID-19 infection. Overall, the committee questioned many of its own rules and discussed the agency's standards for a coronavirus vaccine.

One of the prime concerns was whether there was a rush to approve a COVID-19 vaccine, only to later field concerns regarding safety or efficacy. Not only would this undermine public confidence in COVID-19 vaccines and treatment, it would fuel the concerns of many who are against preventative vaccines. 

A public survey on vaccines presented by the Reagan-Udall Foundation showed an overall distrust of government and industry when it comes to vaccines.

In late November, Pfizer said it plans to submit its vaccine for emergency approval. Yet the panel discussed the FDA's rule that manufacturers must wait two months after giving a final dose to patients before applying for approval; some panelists felt this time frame was too short.

One advisory panelist (Archana Chatterjee, dean of Chicago Medical School) said, "What we're being asked to do is to build this plane as we fly it."

Another player in vaccine development, Moderna, has announced they have finished enrolling participants and with more than two-thirds of trial participants having received their second dose, they would now begin to track subject outcomes two more months and then submit their data..

FDA is requiring manufacturers to do studies of at least 30,000 people to prove if a vaccine protects and how safe it is. Those studies must include people at highest risk from COVID-19, like older adults, minorities and people with underlying health issues.  Moreoever, the FDA has made clear that any vaccine must be at least 50 percent effective. 

The FDA has said it does not consider the emergency approval of a vaccine to be grounds for stopping blinded trials. While there are no plans for an emergency use authorization, if a vaccine were authorized under emergency use - it would still be considered experimental, and ongoing safety and efficacy data would be needed. 

The panel did not review data for COVID-19 vaccine approval, as clinical trials are still continuing. The FDA has said it expects to reconvene the panel multiple times in the future to examine the evolving evidence, especially if a vaccine manufacturer applies for emergency authorization or FDA approval.

The author has no conflicts of interest to disclose related to this subject

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