Pfizer/BioNTech seek FDA authorization for fourth Covid-19 vaccine doses for people 65 and up

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(CNN) -- Pfizer and BioNTech submitted an application for emergency use authorization to the US Food and Drug Administration for an additional booster dose of their Covid-19 vaccine for adults 65 and older who have gotten a booster dose of any of the authorized or approved vaccine, the companies said Tuesday.

The submission is based on two data sets from Israel. "Both data sets showed evidence that an additional mRNA booster increases immunogenicity and lowers rates of confirmed infections and severe illness," the companies said in a news release.

Pfizer CEO Albert Bourla said Sunday that he expects that a fourth dose of Covid-19 vaccine will be needed.

"It is necessary -- a fourth boost for right now. The protection we are getting from the third, it is good enough -- actually quite good for hospitalizations and deaths -- is not that good against infections, but doesn't last very long," Bourla said Sunday on CBS' "Face the Nation." "But we are just submitting those data to the FDA, and then we'll see what the experts also would say outside Pfizer."

One of the Israeli data sets, released in a preprint study this year, showed that a fourth dose of Pfizer/BioNTech's Covid-19 vaccine restored antibodies to the level seen after the third dose, but efficacy against breakthrough infections from the Omicron variant was low.

Some countries are offering fourth vaccine doses, especially to people at higher risk of severe disease and death.

In the United States, certain immunocompromised adults can receive three doses of the coronavirus vaccine and a fourth shot as a booster dose.

Two doses of the Pfizer/BioNTech coronavirus vaccine are available for people 5 and older, and people 12 and older are eligible to receive a booster five months after their second shot.

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