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

https://live.childrenshealthdefense.org/admin/fda-advisory-committee/fullscreen-chat

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

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.

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Anonymous
Anonymous
2 months ago

"All Ships At Sea"!

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

https://www.forbes.com/sites/johnlamattina/2018/06/28/the-biopharmaceutical-industry-provides-75-of-the-fdas-drug-review-budget-is-this-a-problem/?sh=49b38b6849ec

Anonymous
Anonymous
2 months ago

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:
https://youtu.be/x8rq247E80I?t=17871

"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.

Deb Hawthorn
Deb Hawthorn
2 months ago

Jeezum, Meryl, this meeting sounds like a circus. Thank you for sharing your transcript and your summary so the rest of us can see the extent to which the “authorities” are floundering. New boosters are locked into an impossible timeline, while past approval processes were glaringly flawed and the existing shots are causing ever more visible harm. The “vaccine” program is a complete disaster, but there’s no way for the “authorities” to admit that without losing face. As “Anonymous” has written, below, someone else will have to put a stop to it. Who can that be if the general public is unwilling to stand up and say “no more” on its own behalf?

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