New COVID booster approved from study of 8 mice, not humans
with lots of questions from the public
Lots of people have been asking:
Did the FDA approve the new mRNA boosters based on data from 8 mice?
Yes. Yes they did. Let’s look at some of the facts.
On August 31, 2022 the FDA amended the emergency use authorizations (EUAs, you know the ones that say you can’t sue Pfizer or Moderna for if you have severe vaccine side effects) of the Moderna and Pfizer-BioNTech COVID-19 vaccinations to authorize bivalent formulations. These updated vaccines include mRNA’s from both the original Wuhan variant and the current circulating variants BA.4 & BA.5.
For BA.4/BA.5 boosters Pfizer and Moderna have only submitted animal data. This information hasn’t been released publicly.
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 an a slide from the CDC ACIP committee meeting on September 1, 2022.
On the basis of this study, in eight mice, the FDA have authorized this vaccine for Emergency Use Authorization for the entire population over 18 years old.
Not to worry! According to the FDA clinical trials (human trials) will begin next month. So just to clarify, the FDA has already approved EUA for these injections, distributed them and people have already started receiving them BEFORE human trials have begun.
The human trials are required for full authorization, which is why they are even bothering with them 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, and these vaccines will be useless. If they are even useful to begin with.
The FDA didn’t even bother to convene it’s VRBPAC Expert Committee but that didn’t stop committee member Paul Offit. He was one of two members of 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.”
So there you have it folks. There is no data that supports these vaccinations will protect against severe illness or death. There are no human trials of the updated vaccines. The government has ordered 170 million doses. Over in the UK they approved a different version a BA.1 booster, for a variant that isn’t even circulating anymore and had dismal trial results.
Here is a local news report of 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. They seem to be more on top of things than the FDA or CDC.
This article is not medical advice. Please contact your doctor if you have any questions.
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Holy hell, this is terrifying. Actually went through the slides in-depth to ensure it wasn't hyperbole. Actually looks like the mRNA-1273.222 group was 10 mice total just to be pedantic (Counting the dots representing data points). I have no clue how they can approve this for public use without even preliminary results from a clinical trial. Great post!
Thank you for bringing this information to us - very helpful.