Pfizer to ask FDA to authorize booster dose of COVID-19 vaccine within the next month as Delta variant spreads

• Pfizer and BioNTech will ask US regulators to authorize a COVID-19 booster shot within the next month.
• The companies are developing a booster shot that will target the highly transmissible Delta variant.
• Clinical trials could begin as early as August, according to CNBC.

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 and BioNTech said Thursday they are developing a booster shot that will specifically target the highly transmissible variant.

While the companies said they believe a third shot of the two-dose vaccine already in existence could possibly provide the "highest levels" of protection against all currently known variants, they are developing an updated version in order to "remain vigilant," CNBC reported.

Clinical studies could begin as early as August, depending on regulatory approval, according to the outlet.

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 with Reuters. But after six months, he said, "there likely is the risk of reinfection as antibodies, as predicted, wane."

Pfizer did not release the full set of Israeli data on Thursday, but said it would be published soon.

He stressed that data from Israel and Britain suggests that even with waning antibody levels, the vaccine remains around 95% effective against severe disease.

The vaccine, developed with German partner BioNTech SE, showed 95% efficacy in preventing symptomatic COVID-19 in a clinical trial the companies ran last year.

Dolsten said that early data from the company's own studies show 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.

He said that multiple countries in Europe and elsewhere have already approached Pfizer to discuss booster doses, and that some may begin administering them before a potential U.S. authorization.

Dolsten said he believes that booster shots are particularly important in older age groups.

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.

Pfizer is already targeting production of 3 billion doses this year and 4 billion doses next year. Dolsten declined to give a forecast of exactly how many more doses the company could add, but said: "We can step up billion after billion in '22."

Pfizer CEO Albert Bourla has said people will likely need a booster dose of the company's vaccine every 12 months - similar to an annual flu shot. But some scientists question when, or whether, such shots will be needed.