Critics are aghast after the Biden Federal Drug Administration passed a recommendation for boosters in children despite pushback from its own advisers.
Context: The FDA recommended boosters in children as young as 12 while bypassing its standard process.
The typical process involved would be for the authorization to be voted on by the Vaccine and Related Biological Products Advisory Committee and then follow the recommendation.
Famously the committee voted against giving booster shots to most people in September limiting it to those 65 and older and those with severe illnesses.
However, despite the committee’s vote, the FDA approved boosters for everyone 18 and older by November.
Why this is important: Medical professionals are criticizing the agency and demanding they put this authorization before a vote, a vote that will likely fail.
The last rogue authorization from the agency resulted in the resignation of top officials, the FDA’s Office of Vaccines Research & Review, Marion Gruber, and its deputy director Phil Krause.
They blasted the agency in the medical journal “The Lancet,” warning, “current evidence does not appear to show a need for boosting in the general population, in which efficacy against severe disease remains high.”
Dr. Marty Makary, chief of the Johns Hopkins Islet Transplant Center and Fox News contributor stated: “Dear President Biden, FDA is bypassing it’s scientific advisors to authorize boosters for all kids 12-15 next week. This is unconscionable – undermines the integrity of the FDA’s standard process! Please require FDA to put this authoriz [sic] before the VRBPAC advisory comm for a vote!”
Makary continued: “It is a slap in the face to science for @US_FDA to circumvent the standard convening of the expert advisory board… FDA is quietly doing this because their experts previously voted it down, voicing concerns about medical harms.”
Fox NEw Contributor Dr. Marc Seigel wants the issue taken up to squash anti-vaxxer criticism who he says are clogging hospitals.