FDA Revises Covid Vax Approval, Myocarditis Mentioned Multiple Times

The US Food and Drug Administration (FDA) issued a revised Covid-19 vaccine approval on Dec. 16. As a reminder, the only FDA-approved vaccine is Comirnaty, which is not available to the general US public. Yet Comirnaty has proven to be so problematic where it has been used—one Hong Kong study cited by mRNA vaccine inventor Dr. Malone found that 1 in every 2700 boys vaxxed with Comirnaty would develop myocarditis, for example—that the FDA adjusted its approval to be for a new formulation of Comirnaty. Apparently the FDA itself realized it messed up its first authorization. And myocarditis was mentioned multiple times in the new FDA letter.

Here are two very key passages (emphasis added):

“On December 16, 2021, FDA approved a supplement to the COMIRNATY (COVID-19 Vaccine, mRNA) BLA to include a new 30 microgram dose formulation of COMIRNATY (COVID-19 Vaccine, mRNA) that uses Tris buffer in addition to the PBS buffer used in the originally approved vaccine. . .

[footnote 18] Although COMIRNATY (COVID-19 Vaccine, mRNA) is approved to prevent COVID-19 in individuals 16 years of age and older, there is not sufficient approved vaccine available for distribution to this population in its entirety at the time of reissuance of this E[mergency]U[se]A[uthorization]. Additionally, there are no COVID-19 vaccines that are approved to provide: COVID-19 vaccination in individuals 5 through 15 years of age; a third primary series dose to certain immunocompromised populations described in this EUA; a homologous booster dose to the authorized population described in this EUA; or a heterologous booster dose following completion of primary vaccination with another authorized COVID-19 vaccine.”

To use fewer words, Comirnaty, the only FDA-approved Covid vaccine, is not available to the general American public (remember that when your employer tells you that you have to be vaccinated). It hasn’t been and it still isn’t. The available vaccines are the ones still under EUA or Emergency Use Authorization.

Furthermore, according to this chart, 5 to 11-year-olds are ONLY allowed to receive the Tris formulation, which is the newly approved formulation. Footnote 12 also states: “The formulation that uses Tris buffer is the only formulation that is authorized for use in individuals 5 through 11 years of age.” Except before what was approved/authorized and theoretically available was the PBS formulation, so I’m assuming that’s what was given to 5 to 11-year-olds in places where the vaccine was available? And notice that the PBS formulation is still supposed to be diluted for recipients 12+.

The letter does in fact mention “risk of myocarditis” just before it discusses “a revision to the Pfizer-BioNTech COVID-19 Vaccine EUA.” Did the FDA just admit that the number of vaccine-induced myocarditis cases are the reason that the EUA had to be revised? It’s possible.

“The Pfizer-BioNTech COVID-19 Vaccine that uses PBS buffer and COMIRNATY (COVID-19 Vaccine, mRNA) that uses PBS buffer have the same formulation. Additionally, the PfizerBioNTech COVID-19 Vaccine that uses Tris buffer and COMIRNATY (COVID-19 Vaccine, mRNA) that uses Tris buffer have the same formulation. The products are legally distinct with certain differences that do not impact safety or effectiveness.”

Right. There’s so little difference between them that one is approved. . .and the other isn’t. If they’re the same thing, why does one only have an EUA?

“Pfizer Inc. will conduct post-authorization observational studies to evaluate the association between Pfizer-BioNTech COVID-19 Vaccine and a pre-specified list of adverse events of special interest, including myocarditis and pericarditis, along with deaths and hospitalizations, and severe COVID-19.”

So the FDA just admitted that the Covid vaccines can cause adverse events including death—and may not prevent severe Covid. I know for a fact YouTube’s Covid “misinformation” policy forbids saying the vaccine even could cause serious adverse events including death. So if I posted a video of myself reading the FDA letter, would I get penalized by YouTube?

The FDA certainly doesn’t sound terribly confident in the vaccines. The Pfizer vaccine EUA is justified with the words (emphasis added) “that it is reasonable to believe that Pfizer-BioNTech COVID‑19 Vaccine may be effective in preventing COVID-19.”

Sounds like an excellent reason to risk myocarditis and death to me—after all, Covid-19 only has a 99% survival rate, and the vaccine may prevent Covid, if only you “believe.” Just trust the FDA. They clearly know what they are doing.

Daniel Salgado contributed to this report.