Pfizer to seek FDA authorization for booster of COVID-19 vaccine
Pfizer and BioNTech announced Thursday that they plan to seek authorization from the Food and Drug Administration (FDA) for a third dose of their COVID-19 vaccine, saying it would provide even stronger protection.
In a statement released Thursday afternoon, the companies said they have seen “encouraging data” from an ongoing trial of the booster shot, adding that it provides levels of neutralizing antibodies five to ten times higher when administered six months after the second dose. The companies plan to submit data “in the coming weeks.”
But: It will be up to U.S. regulators — the FDA and the Centers for Disease Control and Prevention — whether to recommend a third dose.
Some experts have cautioned that vaccine makers have a financial incentive to develop booster shots and for the government to invest in more doses.
U.S. health officials have thus far said it is not clear whether a booster shot is needed.
Anthony Fauci, the government’s top infectious disease expert, reiterated earlier Thursday that two shots of the Pfizer and Moderna vaccines are protective even against the delta variant.