I watched the FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting today. A few quick thoughts:

Watching the VRBPAC meeting was like sitting at my desk for hours with a knife stuck in my chest. It injures one’s soul to watch so many ideologically-driven people ignore science and data to serve their class interests by poisoning kids.

Some interesting wrinkles from the meeting.

We submitted 140,000 public comments to the FDA and the vast majority (99.999% according to Steve Kirsch) were opposed to the EUA. That is now part of the public record. If these bureaucrats are not frightened by that they should be because we all have a long memory.

During the debate, one of the VRBPAC members revealed that he received "thousands of emails over the last several days." That's us, that's what we did.

The majority of the committee said that they did not want mandates. There was broad consensus that the voting members wanted to amend the question to approve a narrow(er) use of this mRNA product. But then the Acting Chair (Monto), CBER Director (Marks), and CDC Captain (Cohn) bullied them into voting on the original question by stating that no children would have access to this shot if the original question was not approved (which is obviously a lie).
In spite of a majority of committee members expressing a wide range of misgivings they approved Pfizer’s EUA by a vote of 17 - 1. A reliable Pharma vote with a blatant conflict of interest, Eric Rubin at the New England Journal of Medicine, apparently did not vote (did he recuse himself?). Another member who usually votes yes, Michael Kurilla, abstained because, as he acknowledge, the data just wasn’t there.

The meeting and outcomes were heartbreaking. But the facts are on our side and our movement grows larger and stronger every day, so we push on. The fight now moves to the CDC’s Advisory Committee on Immunization Practices (ACIP) that will receive the FDA’s recommendation and decide whether to approve it for children ages 5 to 11 at their meeting on Nov. 2. I started drafting a new call to action tonight and will send it out tomorrow.

Blessings to all of the warriors. They call us warriors for a reason — we never give up. Prayer, meditation, self-care, and spending time with loved ones are in order. Then we gear up again and take this battle to the CDC, the courts, the streets, and the ballot box. A revolution is coming. When we take power we will dismantle the FDA and CDC brick by brick and put the entire leadership on trial for crimes against humanity. Onward. ✊

Updated (October 27, 2021) to add:

1. Lots of people have highlighted this comment from Eric Rubin yesterday during the discussion. I saw it live and it was jarring:

“We’re never going to learn about how safe the vaccine is unless we start giving it, and that’s just the way it goes. That’s how we found out about rare complications of other vaccines.” — Dr. Eric Rubin, October 26, 2021, VRBPAC meeting

Something strange was going on with Dr. Rubin yesterday. Previously he has been criticized for conflicts of interest (“Eric Rubin, editor in chief of the New England Journal of Medicine, has published all the Pfizer clinical trials, and the NEJM will have earned a considerable sum for reprints and advertising from Pfizer.”) Dr. Rubin was all over the debate trying to influence the vote. But he did not vote himself. Did he recuse himself because of his conflicts of interest? IF SO he should have recused himself from the discussion as well.

2. The VRBPAC meeting yesterday revealed that the woeful FDA risk-benefit analysis was written by Hong Yang and Richard Forshee. Other federal agencies (CDC, Congressional Research Service) routinely disclose who writes their research reports. But the FDA keeps that hidden from the public until it is too late to properly vet their qualifications and conflicts of interest. I have serious questions about Dr. Yang’s role. Dr. Yang’s accent is so heavy that many voting members (and the public) could not understand her responses to their questions (this problem was made worse by the FDA’s low quality video platform). While I have enormous sympathy for the challenges faced by English-as-a-second-language learners (I used to teach ESL), given the stakes, Dr. Yang was *not* the proper person to present this information. The FDA’s risk-benefit analysis is a matter of national security. If the VRBPAC gets the answer wrong (and they did) then many children will be hurt and killed by their misinformed actions. Sadly I don’t think this was a “mistake”. I think the FDA intentionally chose a sympathetic figure who is very difficult to understand as a way to obscure the flaws in the underlying data.

uTobian

Some thoughts on today's VRBPAC meeting...