Congressmen Ask Good Questions of FDA Prior to Meeting on Authorizing COVID Vaccine for Children under Five

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On June 14-15, the Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee will meet to consider granting Emergency Use Authorization (EUA) for COVID-19 vaccinations for children under age 5. Prior to the meeting, at least 18 congressmen, led by Rep. Bill Posey (R-FL), Rep. Louie Gohmert (R-TX), Sen. Ted Cruz (R-TX), and Sen. Ron Johnson (R-WI), sent a letter calling for answers to a number of questions.

The Association of American Physicians and Surgeons (AAPS) sent copies of the letter to its members, suggesting that they might want to ask their congressional delegation to sign on.

Questions include the following:

  • “Why has the FDA been so slow to release the hundreds of thousands of pages of data from pre-approval manufacturer studies, post-approval adverse events data, other post-approval manufacturer data submitted to the FDA as required by law?”
  • “What is the cardiac risk factor in administering these EUA COVID vaccines to children?”
  • “Why has the FDA recently lowered the efficacy bar for COVID vaccines for youngest children?”

“The vaccines have evidently been procured and paid for already, and availability is being advertised on television and by medical associations, on the presumption that authorization will be granted,” states AAPS executive director Jane Orient, M.D.

“An EUA is not the same as FDA approval,” she notes. “Informed consent is still required. In case of a serious adverse reaction, limited compensation might be available under the PREP Act, which also protects from liability entities that manufacture, distribute, or administer the vaccine.”

“Parents might have the same questions as congressmen ask in this letter,” she adds.

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).