By Jefferey Jaxen
In what is becoming a common occurrence, the U.S. Food and Drug Administration (FDA) has omitted convening their Vaccines and Related Biological Products Advisory Committee (VRBPAC) to weight the data and vote on its recent approval of a Pfizer booster for children 12-15 years old.
The move was not lost on members of the scientific community. Surgical oncologist and chief of the Johns Hopkins Islet Transplant Center Marty Makary, MD, MPH wrote on Twitter:
Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research was quoted in the FDA’s recent press releases stating:
“Based on the FDA’s assessment of currently available data, a booster dose of the currently authorized vaccines may help provide better protection against both the delta and omicron variants. In particular, the omicron variant appears to be slightly more resistant to the antibody levels produced in response to the primary series doses from the current vaccines,”
However, on August 18, 2020 in an article written by Marks in HealthAffairs.org he, along with then acting FDA commissioner Stephan Hahn, claimed “[the] FDA has committed to use an advisory committee composed of independent experts to ensure deliberations about authorization or licensure are transparent for the public.“
They also wrote, “By convening VRBPAC, FDA will ensure public transparency around discussions of vaccine safety and effectiveness to provide a window into its decision-making process and help address potential concerns from vaccine-hesitant populations.“
In addition to not convening their VRBPAC committee, the FDA’s recent ‘science by press release’ statement made no mention of new trials. In fact, they appear to be basing their EUA extension in children based on “real-world data from Israel”.
Senator Rand Paul wrote:
Meanwhile, overall data analysis continues to show that the danger to children of SARS-COV-2 and its recent omicron variant, is low compared to older populations and especially those with comorbidities.
Even Dr. Tony Fauci himself was forced to admit what had been known for nearly a year during a recent interview.
He added some children who are currently listed as being in the hospital with COVID may actually be receiving treatment for “a broken leg or appendicitis,” rather than for a severe reactions to the virus.
Yet with each injection, children are asked to take on a risk profile that is still not fully understood. Emerging data continues to point to the increased risks of myocarditis after COVID vaccination in younger populations.
A new study looked at 12 to 39 years old patients insured by Kaiser Permanente Northwest who received at least one dose of an mRNA vaccine (Pfizer-BioNTech or Moderna) between December 2020 and October 2021. The researchers concluded “The true incidence of myopericarditis is markedly higher than the incidence reported to US advisory committees.” How much higher? 1 in 2700 Boys 12-17 1 in 1860 for Men 18-24
Cardiologist Ramin Farzaneh-Far MD commented on Twitter stating:
While Vinay Prasad, MD MPH wrote:
The FDA also suffered recent two black eyes it hopes the public didn’t see. Presumably because of the agency’s rush to authorize boosters against a backdrop of missing data and uncertain safety outcomes, its two senior vaccine regulators stepped down in unison.
Marion Gruber, director of the FDA’s Office of Vaccines Research & Review, and deputy director Phil Krause will exit the agency in October and November, respectively.
At the time in late August 2021 Politico reported:
“…the agency is facing a potential mutiny among its staff and outside vaccine advisers, several of whom feel cut out of key decisions and who view the plan to offer boosters to all adults as premature and unnecessary.”
The wrote further that “The tension within the administration plus open skepticism from outside experts has fueled finger-pointing and divisions among health agencies. Career scientists in particular have been confused and surprised by the process...“