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Pfizer to ask FDA to authorize booster dose of its COVID-19 vaccine

By Brian Buntz | July 8, 2021

Pfizer-BioNTechPfizer (NYSE:PFE) has said that the efficacy of its vaccine wanes after six months in the presence of contagious variants such as Delta. The company and its German partner plan on using that justification to ask FDA to extend their EUA for their COVID-19 vaccine to cover a booster dose of their mRNA vaccine.

Reuters quoted Pfizer Chief Scientific Officer Mikael Dolsten as saying that a recent uptick in COVID-19 cases in Israel is evidence that the vaccine offers less protection against the Delta variant — especially in those vaccinated six months ago or earlier.

After six months, “there likely is the risk of reinfection as antibodies, as predicted, wane,” Dolsten said.

Israel’s Health Ministry shared data on July 5 that indicated that the Pfizer-BioNTech vaccine remained effective at preventing serious COVID-19 infections, but that it was less effective overall against the Delta variant.

Early Pfizer experiments show that a third dose of BNT162b2 vaccine generates antibody titers that are between five and 10 times higher than after the second dose.

The U.K. is currently planning on using COVID-19 boosters later this year, focusing on potentially administering them to the elderly and other high-risk groups.

CDC and FDA recently released a statement asserting that “Americans who have been fully vaccinated do not need a booster shot at this time.” The two agencies are collaborating with NIH to determine “whether or when a booster might be necessary.” “We are prepared for booster doses if and when the science demonstrates that they are needed,” the agencies concluded.

While Pfizer is developing a next-generation COVID-19 vaccine candidate, it is also continuing to bolster production of its current vaccine to meet global demand, which would rise even further if regulators sign off on booster doses of the vaccine.

The company is aiming to produce four billion doses of the vaccine in 2022.


Filed Under: Infectious Disease
Tagged With: BioNTech, coronavirus, covid-19, COVID-19 vaccine, COVID-19 vaccine trial, COVID-19 vaccines, FDA, Pfizer
 

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