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‘Preposterous’: FDA, CDC Authorize New COVID Boosters for Kids as Young as 5 — With No Data, No Independent Review

By Suzanne Burdick, Ph.D.

The U.S. Food and Drug Administration (FDA) on Wednesday amended the Emergency Use Authorizations (EUAs) for the new Pfizer and Moderna COVID-19 Omicron booster shots for children as young as 5 years old — despite having no direct data on the safety or effectiveness of the shots in children.

Within hours, Dr. Rochelle Walensky, director of the Centers for Disease Control and Prevention (CDC), signed off on the boosters — without a meeting of the CDC’s independent panel of vaccine experts.

“FDA’s authorization of updated (bivalent) COVID-19 vaccines for this younger age group, and CDC’s recommendation for use, are critical next steps forward in our country’s vaccination program,” CDC officials said in a statement

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