Yes, the FDA Approved the New mRNA Boosters on Data from 8 Mice
On August 31, 2022, the FDA amended the emergency use authorizations for the new boosters [so no one could sue them]. The boosters include mRNA’s from both the original Wuhan variant and the current circulating variants BA.4 & BA.5, Dr. Panda wrote on substack.
“For BA.4/BA.5 boosters Pfizer and Moderna have only submitted animal data.”
Pfizer presented only preliminary findings in eight mice. These eight mice were given a BA.4/BA.5 vaccine as their third dose, which boosted the antibodies in the blood. There was an increase to all Omicron variants tested: BA.1, BA.2, BA.2.12.1, BA.4, and BA.5. This information is only found on a slide from the CDC ACIP committee meeting on September 1, 2022.
The booster was authorized for everyone over 18 years on eight mice, Dr. Panda writes on his substack. That was despite having no data.
At the Sentinel, we read this on Igor Chudov’s substack. By the way, the mice didn’t make it. Some died, and the others lingered in misery until they were euthanized.
The data on vaccinated pregnant women was based on eight pregnant French mice. Seriously. The number eight seems important to them. We’re not sure if nationality matters!
Dr. Panda said that human trials begin next month, and the FDA has already approved the boosters.
IT WON’T STOP TRANSMISSION
According to Dr. Panda, they must have human trials to get full authorization. Otherwise, they wouldn’t even bother.
Dr. Panda says, BUT just like Comirnaty (the fully FDA-approved vaccine), it will, assumably, never be produced. Why? It has no liability shield, and by the time it’s fully approved, Omicron will be long gone, like the original Wuhan variant. These vaccines will be useless, if they are even useful, to begin with.
The FDA didn’t even bother to convene its VRBPAC Expert Committee, but that didn’t stop committee member Paul Offit. He was one of two members of the FDA’s committee who voted against asking companies to make Omicron-specific boosters. “Current COVID-19 vaccines still prevent the most severe outcomes,” Offit says, “and if the goal is to stop infections, even updated vaccines will have little impact.”
“Even if 100% of the population were vaccinated and the virus hadn’t evolved at all, vaccines would do very little to stop transmission.”
There is NO HUMAN DATA or any data for these vaccines. Pfizer commented on not needing data since they’ve already tested and held trials for the vaccine.
Dr. Panda adds, Over in the UK, they approved a different version of a BA.1 booster for a variant that isn’t even circulating anymore and had dismal trial results.
Here is a local news report on a health system in Pennsylvania. Something you will never hear on the national news (brought to you by Pfizer®). They recommend waiting until human trials on the newest Moderna and Pfizer vaccines are concluded.