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Pfizer to ask FDA to authorize booster dose of COVID vaccine as Delta variant spreads

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Pfizer Inc plans to ask U.S. regulators to authorize a booster dose of its COVID-19 vaccine within the next month, the drugmaker's top scientist said on Thursday, based on evidence of greater risk of reinfection six months after inoculation and due to the spread of the highly contagious Delta variant. Pfizer Chief Scientific Officer Mikael Dolsten said the recently reported dip in the vaccine's effectiveness in Israel was mostly due to infections in people who had been vaccinated in January or February. The country's health ministry said vaccine effectiveness in preventing both infection and symptomatic disease fell to 64% in June.

"The Pfizer vaccine is highly active against the Delta variant," Dolsten said in an interview. But after six months, he said, "there likely is the risk of reinfection as antibodies, as predicted, wane."

He stressed that data from Israel and Britain suggests that even with waning antibody levels, the vaccine remains around 95% effective against severe disease. Dolsten said that early data from the company's own studies shows that a third booster dose generates antibody levels that are five to 10-fold higher than after the second dose, suggesting that a third dose will offer promising protection.

Because boosters will drive increasing demand for vaccines as much of the world is still unvaccinated, Dolsten said Pfizer is looking at ways to boost production.

 

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