1. Many members and presenters agreed that antibody levels (aka titers) are not a valid measure of immunity (they are not a correlate of protection, and there is currently NOTHING measurable in the blood that is considered a valid reflection of immunity). This admission is HUGE, as it reveals that neutralizing antibody titers can no longer be used to authorize or approve COVID vaccines.
2. Therefore the only way to determine vaccine effectiveness is a clinical trial
3. No one at the meeting (nearly 30 people) ventured a guess as to what strain might cause the next COVID wave. All seemed to agree there would be another wave, but this was just a guess. However, without a variant you can’t make a vaccine and you can’t conduct a clinical trial to see if the vaccine works. And you can’t possibly do this by June, to make vaccine available for the fall, when FDA and the VRBPAC expect it will be needed.
4. Dr. Peter Marks, the director of the FDA’s vaccine division, CBER, admitted that the 4th booster dose authorized last week was a “stopgap measure”–in other words, he claims it was to kick the waning vaccine efficacy can down the road
5. Claims were repeatedly made that vaccine still protects against severe outcomes and death, but FDA’s lead scientist for this presentation, Doran Fink, admitted that efficacy is also waning for severe outcomes. I’ll say it is.
6. NO data was presented at all regarding strain choice/prediction of what to use as the antigen(s) for a newer vaccine. It was as if everyone just got the idea to begin thinking about this yesterday.
7. It appeared that neither CDC, FDA nor the VRBPAC advisors wanted to take any initiative or responsibility in figuring out what kind of a vaccine comes next (with the exception of Dr. Kim, who did show initiative about prescribing a way forward). I am not sure any of them wanted to find a way forward. It is CDC, not FDA, that yearly chooses the flu strains that go into the flu vaccines. Did CDC shirk this responsibility for the COVID vaccines and dump it on FDA, which then dumped it on its advisory committee instead of its scientists, who would be the appropriate people to decide?
8. Was everyone dancing around the strain/variant choice because in fact no one really wants a newer vaccine, or because no one wanted to be responsible for picking a loser? I could not tell whether this was a deliberate slow-roll as a means of squeezing out of the COVID vaccine disaster, or whether we were watching an agency and advisors who are highly risk-averse but have no problems with the vaccines.
9. The Public Comments from about 1:30 pm to 2:30 pm (about 5 hours into the meeting) were evidence of outstanding work by independent scientists and heart-rending testimonies by the vaccine injured. There were only 2 people who favored vaccines in the group, one a top Moderna scientist (Dr. Rita Das) who did not actually belong there…had FDA begged Moderna to find someone to speak in favor of boosters?
10. The word transparency was used a lot. Which was peculiar since FDA’s COVID vaccine data, deliberations and decisions have been anything but transparent. Even the reason for today’s meeting is murky.
by Meryl Nass