FDA: Vaccines Don't Have to Prevent Infection or Transmission
New COVID-19 vaccine guidance, dosage, revoked FDA approval & EUA extension
An FDA reply letter to the Coalition Advocating for Adequately Labeled Medicines (CAALM) dated April 18, 2023, states that, “A vaccine can meet the licensure standard if the vaccine’s benefits of protecting against disease outweigh the vaccine’s risks for the licensed use,” Dr. Peter Marks, a top official at the U.S. Food and Drug Administration (FDA). “There is no requirement that the vaccine also prevents infection with the pathogen that can cause the disease or transmission of that pathogen to others.”
“Emergency use authorization (EUA) can be granted “without any evidence that the vaccine prevents infection or transmission,” he also said.”
Fauci, June 23, 2021 (minute 1:43 start) states that “If your vaccinated, you’re safe.” If you’re not, you’re at risk.” So, at what point did the FDA COVID-19 vaccination criteria change considering their PR campaign stated that getting the vaccine was the best way to protect yourself and others from getting COVID-19?
EUAs were given to the Pfizer and Moderna COVID-19 vaccines in late 2020 due to a March 2020 declaration by then-Health Secretary Alex Azar under the Public Readiness and Emergency Preparedness (PREP Act) Act. The vaccines were reverted to emergency authorization by the FDA this month when it switched all existing COVID-19 vaccines to the updated, unproven bivalent formulations.
The Food and Drug Administration authorized a second omicron-targeted bivalent COVID-19 booster vaccine for people over 65 or who are immunocompromised, the agency announced Tuesday.
Pfizer-BioNTech COVID-19 Vaccine, Bivalent is now authorized for use for all individuals 6 months through 4 years of age.
The FDA also said any adult who has not yet been vaccinated will get one dose of an updated bivalent shot, rather than starting with the original vaccine and receiving the bivalent shot as a booster.
The FDA is withdrawing authorization for those older COVID-19 vaccines targeting the original strain of the virus.
This seems to be an overall move to simplify the COVID-19 vaccination process, shifting towards a flu shot-like model for COVID-19 vaccines, where people get a single shot every year that's updated annually to match the virus strain predicted to be in circulation.
The FDA also changed the dosage of the COVID-19 vaccines, check out this Tweet: “The @US_FDA revoked the authorization for all previously licensed Covid vaccines and then cut the dosage by 75% for all new vaccinations using the EUA bivalent vaccine.”
4.21.23: Peggy Hall, Esq., The Healthy American, stated in an Instagram video the notes from her call to the FDA, the key takeaways were:
The monovalent (single strain) cocktails for Moderna & Pfizer are no longer authorized under EUA (Emergency Use Authorization)
Comirnaty is no longer being used in the US
The Bivalent (two strain) cocktail will still be authorized under EUA
FDS ACIP will meet in June to discuss the future of these vaccines that are not “approved.”
No vaccine company has submitted an application for the biologics license application (BLA) to get approval for licensure.
There are so many questions left to ask regarding this new COVID-19 vaccine guidance, the extension of the EUA for thee vaccines given the “state of emergency” in the US “ends” next week.
Stay tuned friends…. #covidscience continues…..
#ipanj #njinsanity