I read, with both enthusiasm and respect, a commentary published in JAMA and an interview of FDA Commissioner Stephen M Hahn, MD on the FDA’s process for reviewing and licensing potential COVID vaccines.
I believe there are several major “take home points” which are worth review:
- There are currently 174 applicants for COVID vaccines with the FDA
- 6 agents have entered Phase 3 clinical trials
- Once licensed, a COVID vaccine will have accumulated almost 10 times as many patient exposures (30,000 subjects) as compared to another vaccine (influenza)
- Due to the speed of the trials, the FDA will require any licensed product to continue to undergo monitoring. This is called Phase 4 trials (post-marketing safety)
- Despite the FDA’s advising of Operation Warp-Speed, the agency maintains its independence to review all products which receive funding/subsidies from this unique public-private partnership.
- According to Commissioner Hahn, the FDA has a more talented group of researchers/scientists/mathematicians/public health experts than it ever has, and these teams were re-organized in the Spring of 2019 (pre-COVID). Therefore, he feels the Agency is extremely well prepared to advise, re-direct, and review (for approval) these COVID-based trials.
- The “effectiveness” bar was set at a reasonable threshold, as a deference to safety. Said differently, the FDA has agreed to accept vaccines which reduce clinical symptoms by 50% (modest reduction, yet still relevant) in order to license extremely safe vaccines from the beginning.
I appreciate Dr. Hahn’s pragmatic approach that certain people won’t feel comfortable with these vaccines, and we need to respect their autonomy and also calculate those decisions into our modeling for effect of these efforts.
I believe with Commissioner Hahn at the helm of the FDA (and his highly skilled teams), “we” are in the best position to launch several safe and effective vaccines to help change the curve of this pandemic.
Overall, I’ve not seen such eloquent, yet simple and transparent communication regards vaccines and trials from the FDA in the last 25+ years.