Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, announced the agency’s approval of COVID boosters for 6-month-olds, citing a trial with just 24 patients.
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The U.S. Food & Drug Administration (FDA) is approving booster doses of Pfizer’s COVID-19 shot for children as young as six months based on a trial of just 24 patients.
The FDA announced March 14 that it is amending its emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine, Bivalent, to allow a single booster dose for children between six months and four years, at least two months after being initially vaccinated.
“Currently available data show that vaccination remains the best defense against severe disease, hospitalization and death caused by COVID-19 across all age groups, and we encourage all eligible individuals to make sure that their vaccinations are up to date with a bivalent COVID-19 vaccine,” claimed Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research.
Buried in the press release, however, was the revelation that “among individuals 6 months of age and older, safety was assessed in participants in two clinical studies,” and that for the 6-23 months age group there were only 24 participants. The 2-4 year age group had 36.
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For the first group, “most common side effects included irritability, drowsiness, injection site redness, pain and swelling, decreased appetite, fatigue, and fever,” according to the agency. For the second group, effects included “fatigue, injection site pain, redness and swelling, diarrhea, vomiting, headache, joint pain, and chills.”
Medical freedom attorney and COVID vaccine critic Aaron Siri called it a “new low” for the FDA to make its decision based on such limited data.
A committee called the Select Subcommittee has been charged by Congress with thoroughly investigating the COVID-19 pandemic, including the development of vaccines and the subsequent policies and mandates.
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