FDA Rejects Request to Revoke Emergency Authorization of Pfizer’s Vaccine for Some Children

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U.S. drug regulators have rejected a request to revoke emergency authorization for Pfizer’s COVID-19 vaccine for 12- to 15-year-olds.

“Petitioner has provided no basis to demonstrate that the EUA should be revoked,” Dr. Peter Marks, a top Food and Drug Administration (FDA) official, wrote in a June 17 letter, which was made public on July 21.

He was responding to the Informed Consent Action Network, which in May urged the FDA in a citizen petition to revoke the emergency use authorization (EUA) for the shot, asserting that data has emerged since the EUA was issued in May 2021 shows the benefits of the vaccine do not outweigh the risks.

That data includes research estimating Pfizer’s shot provides just 51 percent protection against the Omicron variant of SARS-CoV-2, which causes COVID-19, after six weeks; a study backed by the Centers for Disease Control and Prevention that found the vaccine less effective against severe disease; and another study that effectiveness against Omicron-associated emergency department and urgent care visits was just 45- to 51-percent.

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