COVID-19 Vaccine Update: A Briefing from the FDA

On Wednesday December 9, the Alliance for a Stronger FDA was pleased to sponsor a briefing on COVID-19 vaccines with FDA Commissioner Dr. Stephen Hahn and CBER Director Dr. Peter Marks. While the pending COVID-19 vaccine advisory committee reviews on December 10 and 17 made his remarks timely, Commissioner Hahn’s focused on more general themes that will apply to all of the vaccine candidates. He touched upon:

• Clinical Trial Diversity -- FDA made efforts to ensure that COVID-19 vaccine clinical trials included diverse populations with people from different ages, ethnicities, and races.
• Data -- FDA is reviewing effectiveness, manufacturing, and safety data when considering whether to authorize the use of COVID-19 vaccines under an Emergency Use Authorization (EUA).
• Regulatory Considerations -- COVID-19 vaccines will be approved initially under EUAs, which require compelling evidence from Phase III clinical trials. FDA released a preliminary assessment of the Pfizer vaccine on their website.
• Situational Update -- Dr. Hahn indicated that FDA will not compromise when evaluating the safety and efficacy of COVID-19 vaccines and that working toward approval of a COVID-19 vaccine has required an “all hands on deck” approach to be sure the application is thoroughly reviewed.
• Vaccines and Related Biological Products Advisory Committee -- FDA is always the decision-maker on product approvals. Decisions will be made based on all the available evidence plus guidance from the advisory committee.

Dr. Marks continued with some additional details:

• Post-Market Surveillance -- COVID-19 vaccine clinical trials will continue for another 1-2 years and FDA is working with CDC to implement a text-based opt-in vaccine adverse event reporting system. FDA will also utilize the Vaccine Adverse Event Reporting System.
• Regulatory Considerations -- The October 6th guidance set the standard for COVID-19 vaccine authorization closer to the ceiling of a Biologics License Application rather than the floor of an EUA.
• Supply Chain -- FDA is working with CDC, HHS, and Operation Warp Speed to provide regulatory advice surrounding COVID-19 vaccine supply chains.

Based on questions posed by Alliance members and journalists, Alliance President Wayne Pines asked Drs. Hahn and Marks:

• How will FDA ensure that individuals receive second doses of COVID-19 vaccines? FDA will work to provide clear instructions and provide transparency surrounding side effects. CDC will issue a card to remind individuals they need a second dose.
• What has been done in response to allergic reactions to COVID-19 vaccines occurring in Great Britain? FDA is working with British health authorities to better understand the adverse reactions.
• What is FDA doing to support vaccine refrigeration? FDA is working with CDC to establish cold storage guidelines.
• When will other COVID-19 vaccines become available? Six vaccines have been sponsored by the US government and FDA has supplied them with regulatory advice. However, it is unclear when those vaccines will become available.

Editorial Note: The Analysis and Commentary section is written by Steven Grossman, Deputy Executive Director of the Alliance for a Stronger FDA. Special thanks to Reed Diskey for sharing his meeting notes.