No clinical trials. No advisory committee. Newly formulated boosters to be injected starting in 10-12 days !?!
FDA Plans to Approve Omicron-Targeting Booster Vaccines
Remember the movie, "The Gods Must Be Crazy." Well, the Biden administration and its FDA and CDC regulators must feel like Gods to do this, and they must be crazy. And so are you, if you go along with this plan. Three days ago, Pfizer asked for permission to inject these shots into people for the first time to perform a clinical trial. YES! Before two days ago, no human being had received even one dose of this vaccine. Now, Pfizer said its trial is expected to start this month.
And now, before 2 weeks goes by, our federal government will try to pull out all the stops and inject all of us with this experimental potion without a single clinical trial. The FDA's vaccine advisory committee will not be allowed to weigh in on how crazy this is. THEY WILL INJECT YOU--IF YOU LET THEM. THIS IS THE TIME TO SAY NO. This is not science, this is not medicine, this is reckless endangerment.
August 25, 2022
Pfizer-BioNTech and Moderna have developed new booster shots optimized for Omicron. They could be approved as soon as Labor Day.
The Food and Drug Administration (FDA) will likely authorize new Pfizer-BioNTech and Moderna vaccine boosters, updated to combat the emerging COVID-19 variants.
Both mRNA vaccine manufacturers submitted their bivalent booster vaccine candidates to the FDA for Emergency Use Authorization (EUA). The Moderna and Pfizer-BioNTech bivalent boosters are both designed to target the Omicron BA.4/BA.5 and original wild-type COVID-19 strains.
As COVID-19 mutates, it has become more resistant to the vaccines intended to combat its earliest iteration. Additionally, the COVID-19 vaccines naturally wane over time. The highly infectious BA.5 variant is now responsible for an estimated 90% of COVID-19 cases in the United States. This has motivated Pfizer-BioNTech and Moderna to rapidly produce “new and improved” boosters; the BA.5 variant only emerged in June 2022.
Moderna’s EUA seeks approval to administer the updated booster to adults 18 years and older. Pfizer-BioNTech filed their EUA for persons 12 years and older.
Notably, the FDA’s Vaccine and Related Biological Products Advisory Committee (VRBPAC) is not expected to convene and offer a recommendation on the EUAs. If the FDA authorizes these boosters, as the agency is expected to do, the decision will then go to the US Centers for Disease Control and Prevention (CDC).
The CDC’s Advisory Committee on Immunization Practices (ACIP) will convene on September 1 and 2, after which CDC Director Rochelle Walensky, MD, MPH, must sign off on the updated boosters.
Pfizer-BioNTech and Moderna have presented positive data of these new boosters in animal models, human studies have not been completed. [Have they even started yet?]
If Walensky does approve the new Omicron boosters after next week’s meeting, the shots could be rolled out within a couple days of Labor Day.