Pfizer/BioNTech were required by FDA as a condition of licensure to conduct studies of subclinical myocarditis in young people. Those data were hidden from the ACIP members today. WHY?

ACIP should not play along with a crooked CDC, and only approve the rollout of products when ACIP has been provided with comprehensive and satisfactory data.

Part of my testimony to the Maine legislature on COVID vaccines (provided on January 11, 2022, the same day my license was suspended) dealt with the issue of myocarditis and how the FDA handled it. This is important for ACIP to know about. Dr. Malone and I talked about this back in 2021 when FDA approved the Pfizer vaccine.

Here is the full letter FDA sent to BioNTech on August 23, 2021 with additional study requirements for its COVID vaccine:

https://www.fda.gov/media/151710/download

Below, FDA’s letter said it could publicly post some of the results.

As described in 21 CFR 601.70(e), we may publicly disclose information regarding these postmarketing studies on our website at http://www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/Post-marketingPhaseIVCommitments/default.htm

Which takes you to a search page, where I filled in the blanks. This then took me to another page, which simply listed the status of the Comirnaty studies and provided no additional information, although some of the studies had been completed and “fulfilled.”

https://www.accessdata.fda.gov/scripts/cder/pmc/index.cfm

Why aren’t these studies available to the public, since FDA is allowed to post them and postmarketing commitments are not supposed to be secret? ?

Here is my testimony which excerpted from the above letter:

https://legislature.maine.gov/testimony/resources/HHS20220111NASS132862941356715133.pdf

While most of these studies were due for completion using ridiculously long timelines, a few will have been completed and were concealed by today’s briefers. Which studies are those? #s 5, 8 and 9. 8 and 9 sought info on subclinical myocarditis in recipients aged 5 through 30. Where are those data?

There are also interim reports that will have been provided. ACIP members must demand them.

Based on past experience, usually pharma companies provide honest reports to Congress and government agencies—not always—but they are subject to severe penalties when they don’t and are caught.