Pfizer to seek COVID-19 vaccine booster authorization, draws rebuke from FDA, CDC

Pfizer Inc. will soon seek authorization for a booster dose of its COVID-19 vaccine, the company said yesterday, in an attempt to “stay ahead” of the coronavirus and its various mutations. The drug maker cited encouraging data from an ongoing booster trial for a third dose of the vaccine, in which patients’ immune response to SARS-CoV-2 was 5 to 10 times higher than with the primary two doses.
 
However, the Centers for Disease Control and Prevention and Food and Drug Administration immediately pushed back at the notion of boosters. In a July 8 joint statement following Pfizer’s announcement, the agencies stated, “Americans who have been fully vaccinated do not need a booster shot at this time,” and instead committed to a science-based, rigorous process to consider boosters’ necessity by taking into account laboratory, clinical trial and cohort data.