FDA expected to approve Pfizer, Moderna boosters without relying on human trials

[Stone]

FDA expected to approve Pfizer, Moderna boosters without relying on human trials
The agency will instead rely on data from trials on mice and data from previous jabs.

Tue Aug 30, 2022
SILVER SPRING, Maryland (LifeSiteNews [adapted]) – The Food and Drug Administration (FDA) is expected to approve requests for approval from Pfizer and Moderna for their new COVID boosters after the companies asked the agency for approval last week despite not being tested on humans, The Wall Street Journal reported.

The Journal noted that the FDA would usually look at a study showing that the vaccine in question would be both safe and effective, something that studies have shown the mRNA vaccines are not, and that the agency would instead be relying on data from trials conducted on mice, as well as data from current jabs and previous boosters.

In a Twitter thread released by FDA chair Dr. Robert Califf, he stated that “Real world evidence from the current mRNA COVID-19 vaccines, which have been administered to millions of individuals, show us that the vaccines are safe.”

Bivalent and multivalent vaccines are very common and modifying a vaccine to include different virus strains often does not require a change in other ingredients. FDA has extensive experience with reviewing strain changes in vaccines, as is done with the annual flu vaccine.

— Dr. Robert M. Califf (@DrCaliff_FDA) August 25, 2022

“As we know from prior experience, strain changes can be made without affecting safety,” he said. Califf added that modifying pre-existing jabs to include protection against other strains of the same disease did not require a change in ingredients and is normal practice while producing annual flu vaccines.

Califf also noted that the FDA would not call a meeting to discuss the new boosters as the “agency feels confident in the extensive discussion that was held in June.” He also noted that the Vaccines and Related Biological Products Advisory Committee (VTBPAC) “voted overwhelmingly to include an Omicron component in COVID-19 boosters,” and that the FDA “has no new questions to warrant committee input.”

Reacting to the potential approval, Dr. Paul Offit, an adviser to the FDA and director of the Vaccine Education Center at Children’s Hospital of Philadelphia, voiced his concern. Speaking to the Journal, Offit stated that “I’m uncomfortable that we would move forward — that we would give millions or tens of millions of doses to people — based on mouse data.”

In June, Offit and Dr. John P. Moore, a virologist and microbiology and immunology professor at Weill Cornell Medicine, released an op-ed 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. If approved, the new boosters would be available within the next three weeks.

The FDA has approved of COVID boosters without any clinical information in the past. 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 the jab includes severe anaphylactic reactions to include fatal thrombotic events, the inflammatory heart condition myocarditis, and neurologically disabling disease like Guillain Barré Syndrome.

In 2021, the FDA added a warning to patient and provider fact sheets for both Pfizer and Moderna COVID vaccines suggesting an increased risk of myocarditis and pericarditis — particularly following the second dose and with onset of symptoms within a few days after vaccination. The FDA’s update followed a June 23 meeting that concluded the benefits of receiving a COVID vaccine still outweigh any risks.