Pfizer Seeks Authorization For Vaccine Booster But FDA, CDC Downplay The Need For One

Pfizer plans to ask the Food and Drug Administration for authorization for a third booster dose of its coronavirus vaccine but health agencies say one is unnecessary, at least for now, The Hill reports.

Pfizer said Thursday that their ongoing trial of a booster shot has produced “encouraging data” and provides levels of antibodies five to 10 times higher when given six months after the second dose.

The company said it plans to release the data in the “coming weeks.”

"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.”

Though there has been an increase in infections among the vaccinated amid the rise of the delta variant first discovered in India, there has not been a marked increase in serious illness, hospitalization, or death among the fully vaccinated.

FDA, CDC say it’s unnecessary:

Shortly after Pfizer’s announcement, the FDA and the Centers for Disease Control and Prevention released a statement downplaying the need for a booster.

The agencies said that data shows that the fully vaccinated are protected from severe disease, including from the Delta variant and “virtually all COVID-19 hospitalizations and deaths are among those who are unvaccinated.”

“Americans who have been fully vaccinated do not need a booster shot at this time,” the agencies said. “FDA, CDC, and NIH are engaged in a science-based, rigorous process to consider whether or when a booster might be necessary. This process takes into account laboratory data, clinical trial data, and cohort data – which can include data from specific pharmaceutical companies, but does not rely on those data exclusively. We continue to review any new data as it becomes available and will keep the public informed. We are prepared for booster doses if and when the science demonstrates that they are needed.”

Doctors say boosters may never be necessary:

“There’s really no indication for a third booster or a third dose of an mRNA vaccine, given the variants that we have circulating at this time,” Dr. Céline Gounder, an infectious disease specialist at Bellevue Hospital Center, told The New York Times. “In fact, many of us question whether you will ever need boosters.”

“Pfizer looks opportunistic by hanging an announcement on the back of very early and undigested data from Israel,” added John Moore, a virologist at Weill Cornell Medicine. “When the time is right for using boosters here, the decision isn’t theirs to make.”


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