1. Many members and presenters agreed that antibody levels (aka titers) are not a valid measure of immunity (= not a correlate of protection)
2. Therefore the only way to determine vaccine effectiveness is a clinical trial
3. But there is not really time to do a clinical trial to pick a strain or strains by June to make vaccine available for the fall
4. Dr. Peter Marks, the director of the FDA’s vaccine division, CBER, admitted that the 4th booster dose approved 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.
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.
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 if this was a slow-roll or an agency and advisors who are highly risk-averse.
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 dog at Moderna 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.