This article was originally published on dailyclout.io
- On August 31, 2022, the FDA authorized, under Emergency Use Authorization (EUA), Pfizer's latest COVID booster based on testing in eight mice, while also bypassing the protocol of earlier COVID shot reviews.
- The next Pfizer booster vaccine that people get this fall may have some surprises.
Pfizer seems to have anticipated the FDA's recommendation, as they have already begun developing bivalent booster vaccines.
- One vaccine will deliver a total dose of 30 micrograms (the same total dose as the original vaccines and boosters) of the original vaccine and 15 microgram of the Omicron variant vaccine
- Will they be safe?
- Pfizer chose the 30-microgram dose because the immune response and toxicity profile at the selected, relatively low dose indicate a favorable balance of reactogenicity [side effects] and immunogenicity (viral protection)
- Another vaccine is being developed which will deliver 60 microgram (twice the total dose) of vaccine and omicron variants
- What we don’t know is how many serious side effects will result from a dose higher than that of the first two vaccines
Why would the FDA recommend that bivalent booster vaccines continue to target the original virus strain, which is already extinct?
- Omicron strains circulating in the United States have a history of changing quickly, within a matter of a few months
- In making their recommendations, the FDA is proposing to adopt the same approach it uses for updating seasonal influenza vaccines
- This involves choosing which strains of influenza will dominate the next flu season and modifying existing influenza vaccines to target those strains
Will the approach to seasonal influenza vaccines be safe and effective if it is applied to developing bivalent booster vaccines for COVID-19?
- Pfizer's own clinical trials with two versions of its vaccine, with different mRNA sequences, is any indication.
- One mRNA version caused too many side effects, noting that "the nucleotide composition of RNA has been reported to affect its immune stimulatory activity."
Are they safe and effective?
- The FDA just approved the new Ba.5 bivalent booster, based on a trial of exactly 8 mice.
- What happened to the 8 mice in the trial? Did they die?
- Steve Kirsch, in a reply to my previous post, asked if the trial was a sham.
https://behindthefdacurtain.substack.com/p/pfizers-new-two-in-one-covid-19-booster
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