Wednesday, April 6, 2022

What happened at the FDA's Advisory Committee meeting on the selection of future boosters?

Here is my live blog.  I was trying to converse with another watcher at the same time--something I had not done before while live-blogging--and the result is more errors and typos than usual.  Sorry.  Authorizing vaccine for the 6 months up to 5 year 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 awful vaccines on our youngest kids?  Or is there simply too much money at stake, too many promised school mandates of COVID vaccines, too many done deals behind closed doors?

Below this link are my takeaway messages from yesterday.

Important takeaways

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, when people predict (without any data) another big wave

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.

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 deliberate slow-roll as a means of getting out of the COVID vaccine disaster, or rather we were watching an agency and advisors who are highly risk-averse for themselves 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 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.  See this WSJ article published 3 days before this meeting, about the lack of transparency in FDA's 4th dose decision. 


Of course, what the FDA needs to say, 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, 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. 

Somehow, I never win a spot to testify in FDA's "lottery" for spaces.  This was the third time I was rejected to provide testimony.


Anonymous said...

"All Ships At Sea"!

'The Biopharmaceutical Industry Provides '75% Of The FDA's Drug Review Budget'. Is This A Problem?'

Anonymous said...

Thank you for your live comments. I watched the part with the BARDA guy:

1. I've never seen him before, and some people are naturally nervous, but his body language and the substance of his answers made it seem like his main goal was to say as little as possible about manufacturing.

2. He did say this at about the 4:58:00 point:

"If the decision is that we would like to have product available for a boost in September, and the strain selection decision is not going to be made until the beginning of May, and in order to get that license you have to get a clinical trial, if you're not on your way to that clinical trial by the beginning of May, I think it's going to be very difficult to have across manufacturers enough product to meet that demand."

So, I think they have to choose the strain within a few weeks from now in order to have it available by September. He emphasized a few times that it depended on the decision regarding a clinical trial.

The way he was dancing around and avoiding questions made me wonder what wasn't being said. Perhaps they are thinking of skipping the clinical trial?

It's so weird to me that they were obsessing about time between strain selection and when an updated vaccine would be available, yet they have no problem recommending the fourth & fifth shots made from a strain from two years ago.

PS My takeaway is that none of them know what to do, and maybe nothing can be done. I agree they should give up on these vaccines and focus on early treatment, but I don't see how they can do this and save face. Someone else will have to put a stop to it.

Anonymous said...

Here's a press release from Moderna about their experiments on ages 6 months to 6 years.

"The Company is evaluating booster doses of mRNA-1273 and its bivalent booster candidate (mRNA-1273.214), which includes Omicron variant booster and mRNA-1273."

It seemed like they were unaware that Moderna was already planning on testing a new strain. It was a strange meeting - you are right that it seemed directionless.

Anonymous said...

Covid...was created in a lab in Ukraine..Metabiota.. they were in partnership with the Wuhan lab.. where it was RELEASED.. to steal an election by getting mail in ballots

Hunter Biden and our Department of Defense were FUNDING the Metabiota lab in Ukraine

Therefore the BIDENS are implicated in COVID!!

The Bidens ..and let's be real.. several congressmen from BOTH sides of the isle have been stealing our tax dollars.. in the Ukraine..and various other "financial aid" we give to other country's