Blog Entry

FDA’s VRPAC Meets to Discuss Development, Authorization and Licensure of COVID Vaccines

The Vaccines and Related Biological Products Advisory Committee (VRBPAC) met today,  short of receiving an application for approval of any one vaccine, to hear presentations from experts on COVID disease and vaccine development. Likely, applications are weeks, if not months, away, but the committee still had plenty to discuss. Agenda items were:

  1. FDA's approach to COVID-19 vaccine safety and effectiveness data. FDA’s VRBPAC committee
  2. What happens once one vaccine is authorized — do all the others that are still in Phase 3 clinical trials continue and if so, how should that work?
  3. What studies should be done after vaccines are licensed or authorized under an Emergency Use Authorization?

The development of safe and effective vaccines to prevent SARS-CoV-2 infection and/or COVID-19 is essential to help bring the pandemic under control. As part of the committee briefs, the National Institutes of health updates on vaccine development as well as plans for vaccine distribution and monitoring of safety and effectiveness.

While it is expected that the committee will meet to review and approve submissions for vaccines, this is the start of “laying the groundwork” ahead of time. Review of current guidance to COVID-19 vaccine manufacturers and what kind of data they would wish to see as phase 3 trials come to a conclusion, and historical authorization rules and best practices.

The FDA did add approximately 90 minutes onto the published agenda to listen to input from the public. This event was made available on the FDA broadcast channel and published widely to allow for maximum transparency and allay public concerns over the efficacy and safety of any vaccines.

While the FDA is not mandated to implement the VRBPAC committee’s recommendation, it is expected that the group will be asked to review any application submitted for approval.

More about the meeting here: https://www.fda.gov/media/142723/download




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