While the committee got nowhere on the choice of next boosters, there were a few very important reveals
By Meryl Nass, MD | April 10, 2022
Authorizing vaccine for the 6 months to 5 year old group was never mentioned. Can it be that FDA is finally grappling with the awful data, the longterm risks of vaccination, and will turn away from unleashing these vaccines on our youngest kids? Or is there simply too much money at stake, too many promised school mandates, too many done deals behind closed doors?
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.
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.
The link below is to my live blog of the all day meeting.
Of course, what the FDA needs to say, no doubt in some slowly unrolling, self-serving fashion, is that:
- The mRNA platform was the best we could do under the circumstances, but it didn’t actually work out that well.
- Coronaviruses are mutating or lab-tating too quickly to be able to vaccinate effectively against them.
- While we still have contracts for 5 or 10 doses per person, we are going to cancel them and try early treatments.
What they won’t way is that these vaccines sickened many thousands, or millions, and the US will now establish clinics to evaluate and treat the injured Americans who did what their government asked of them, cover their medical expenses and pay them disability.
PS. When the Japanese found that the HPV vaccines caused similar severe injuries, about 8 or 10 years ago, clinics were established to take care of the injured.