SILVER SPRING, Maryland (LifeSiteNews) – The U.S. Food and Drug Administration (FDA) approved a request from Pfizer and Moderna for Emergency Use Authorization (EUA) for their new COVID-19 Omicron subvariant booster shots Wednesday.
FDA will likely authorize the Omicron vaccine later today/tomorrow based on data from 8 mice and no human clinical data avail to the public. Americans deserve to see the data. Why is the White House/Dr. Jha pushing it so hard & universally w/o public data? https://t.co/mfgyJnHOiv
— Marty Makary MD, MPH (@MartyMakary) August 31, 2022
In a statement released by the FDA, the agency stated that the boosters would be bivalent, or able to fight two strains of a disease, in this case both the original COVID strain and the BA.4 and BA.5 substrains of the Omicron variant, and are approved for single booster doses at least two months after receiving an initial jab or a booster. The agency also stated that Moderna’s booster would be available for adults ages 18 and older, and Pfizer’s booster would be available for anyone 12 and older.
FDA is recommending the new boosters just *TWO MONTHS* after taking your last booster.https://t.co/xfLuQexDj8
— Jordan Schachtel @ dossier.substack.com (@JordanSchachtel) August 31, 2022
“The COVID-19 vaccines, including boosters, continue to save countless lives and prevent the most serious outcomes (hospitalization and death) of COVID-19,” FDA Commissioner Robert M. Califf, M.D. claimed in a statement. Nowhere in its press release did the FDA claim that the Omicron boosters will even prevent transmission of the disease. The CDC reports COVID-19 has an infection survival rate of greater than 99.95% for those under age 50.
“As we head into fall and begin to spend more time indoors, we strongly encourage anyone who is eligible to consider receiving a booster dose,” said FDA Commissioner Dr. Robert Califf. H claimed it will “provide better protection against currently circulating variants.”
FDA has granted ’emergency authorization’ for a booster that has only been tested on MICE.
“It’s not that we don’t have clinical data…we don’t even have human immunologic data.”
-Paul Offit MD, FDA & former CDC vaccine advisorhttps://t.co/jzhU6SGSzz
— Remnant | MD (@RemnantMd) August 31, 2022
A vaccine advisory panel for the Centers for Disease Control and Prevention (CDC) is scheduled to meet Thursday and Friday to discuss the EUA and could approve the jabs as early as Thursday afternoon, Forbes reported. CDC director Dr. Rochelle Walensky is expected to approve the panel’s decision. If approved, the jabs would likely available as early as this weekend.
The EUAs were granted despite concern that the data used to assess the jabs comes from trials conducted on mice and on previous jab data, including data on previous Pfizer and Moderna boosters designed to fight Omicron. Speaking to the New York Times last week, Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, stated that the agency had “extremely good” data that he claims shows that the shots are safe and effective, despite overwhelming evidence to the contrary.
“I take great issue with those who say, ‘Oh, you’re just approving this with mouse data,’” Marks said in response to criticism for relying on data from mouse rather than human trials. “We’re authorizing this with the totality of the evidence that we have.”
The sequence inside mRNA vax has everything to do with myocarditis
Make a new seq (bivalent) & shove it in a vax
You might lower myocarditis
You might raise it
If you only give it to mice, and/or 65+, you have no idea about young men
You are flying blind
— Vinay Prasad, MD MPH 🎙️📷 (@VPrasadMDMPH) August 31, 2022
At least one member of the FDA’s vaccine advisory committee – a prominent advocate for not just COVID vaccination but also the gambit of American childhood shots – is concerned about the lack of data used to approve the EUA requests. Dr. Paul Offit, an adviser to the FDA, director of the Vaccine Education Center at Children’s Hospital of Philadelphia, and inventor of the rotavirus vaccine, voiced his concern to a local NBC affiliate, saying. “Right now they’re saying we should trust mouse data,” he said, “and I don’t think that should ever be true.”
When Paul Offit says your data is not good enough for EUA; you can rest assured you are overstepping pic.twitter.com/I9EBkXcwrT
— Vinay Prasad, MD MPH 🎙️📷 (@VPrasadMDMPH) August 31, 2022
Offit and Dr. John P. Moore, a virologist and microbiology and immunology professor at Weill Cornell Medicine, released an op-ed in June that urged the FDA not to approve vaccines without proper research. “A decision of this magnitude should be based on as much expertise and analysis as is reasonably practical,” they wrote.
Moderna has already begun human trials for its new booster, and Pfizer is expected to at some point this month. However, human trials are not expected to be completed until sometime in the spring.
In January, the FDA previously approved COVID boosters without any clinical data, allowing for Pfizer’s jab authorization to be extended to children as young as age 12. The agency authorized boosters for all adults in November.
In June, the FDA authorized use of Pfizer and Moderna’s jabs for children as young as six months old. Days before the agency granted the authorization, an analysis of reports submitted to the U.S. government’s Vaccine Adverse Event Reporting System (VAERS) stated that at least 58 infants under age three have suffered life-threatening adverse events after receiving the mRNA coronavirus injections.
The list of FDA-recognized adverse events to COVID injections includes severe anaphylactic reactions, fatal thrombotic events, the inflammatory heart condition myocarditis, and neurologically disabling diseases like Guillain Barré Syndrome.
FDA officials said in May that COVID shots may need to become like annual flu shots.
Moderna is suing Pfizer for patent infringement. Neither company can be sued by the general public if they are harmed by their (often-mandated) products.
LifeSiteNews has produced an extensive COVID-19 vaccines resources page. View it here.