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 10 times higher, when administered six months after the second dose. The companies plan to submit data “in the coming weeks.”

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 diseases expert, reiterated earlier Thursday that two shots of the Pfizer and Moderna vaccines are protective even against the delta variant.

However, Pfizer pointed to data from Israel.

“As seen in real world data released from the Israel Ministry of Health, vaccine efficacy in preventing both infection and symptomatic disease has declined six months post-vaccination, although efficacy in preventing serious illnesses remains high,” Pfizer said.

“Based on the totality of the data they have to date, Pfizer and BioNTech believe that a third dose may be beneficial within 6 to 12 months following the second dose to maintain highest levels of protection,” the companies said.

Pfizer also said that it is preparing to begin clinical trials in August of a modified vaccine specifically targeted at the delta variant, in case it is needed. The company said, though, that a third dose of the original vaccine could be a better course.
After Pfizer’s announcement, the FDA and the CDC released a joint statement on Thursday night downplaying the need for a booster shot. 
“Americans who have been fully vaccinated do not need a booster shot at this time,” the agencies said, while adding that they are engaged in a “science-based, rigorous process,” to determine if one will be needed. 
The agencies again stressed that the current vaccine regimens are effective. “People who are fully vaccinated are protected from severe disease and death, including from the variants currently circulating in the country such as Delta,” the agencies said. 
Updated 8:48 p.m.
Tags Anthony Fauci Centers for Disease Control and Prevention COVID-19 vaccines emergency use authorization Food and Drug Administration Moderna Pfizer
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