FDA Recommends COVID Vaccine for Children; AAPS Urges Caution

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A committee of experts advising the Food and Drug Administration met on Oct 26 and voted 17 to 0, with one abstention, to recommend authorizing the Pfizer-BioNTech coronavirus vaccine for children 5 to 11 years old.

In response, Association of American Physicians and Surgeons (AAPS) issued a statement that anyone who administers the shot must first obtain fully informed, completely voluntary consent, without threats or inducements.

AAPS notes that testing in children was limited. Only 1,518 children received the shots, and 750 received a placebo. Follow-up was for only two months in one group and 2.5 weeks in another.

The shots are claimed to be 91% effective against symptomatic COVID in children, based on 16 cases of COVID in the placebo group and three cases in the vaccinated group. AAPS observes that this is an absolute risk reduction of only about 2%.

The Food and Drug Administration (FDA) recognizes a risk of myocarditis (inflammation of the heart) and is requiring after-marketing studies lasting five years in adults in its letter approving the BioNTech Comirnaty vaccine, which is similar to the Pfizer product but not yet available in the U.S. All other products are available only under an Emergency Use Authorization (EUA).

AAPS states: “We do not and cannot know the long-term effects on cancer, fertility, or autoimmune diseases.” However, committee member Dr. Eric Rubin states: “We’re never going to learn about how safe this vaccine is unless we start giving it. That’s just the way it goes.”

AAPS concludes that “to give truly informed consent, parents need complete information about possible side effects, even if ‘extremely rare.’”            

The Association of American Physicians and Surgeons (AAPS) is a national organization representing physicians in all specialties since 1943. Its motto is omnia pro aegroto (everything for the patient).