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

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Fri, 2022-03-18 22:08 — mike kraft

Pfizer/BioNTech seek FDA authorization for fourth Covid-19 vaccine doses for people 65 and up Pfizer and BioNTech submitted an application to the US Food and Drug Administration for emergency use authorization of 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. Amanda Sealy, Carma Hassan and Jamie Gumbrecht, CNN CNN

(CNN) Pfizer and BioNTech submitted an application to the US Food and Drug Administration for emergency use authorization of 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.

The first data set cited in the release was an analysis of records for more than 1.1 million adults 60 and older by the Israeli Ministry of Health that showed a decreased rate of infection and severe illness after a second booster.

The participants had no known history of Covid-19 and were eligible for an additional booster. "These data showed rates of confirmed infections were 2 times lower and rates of severe illness were 4 times lower among individuals who received an additional booster dose of the Pfizer-BioNTech COVID-19 Vaccine administered at least four months after an initial booster (third) dose compared to those who received only one booster dose," the news release says.

That research has not been peer-reviewed or published in a professional journal.

The second data set is the result of an ongoing trial looking at health care workers 18 and older who had gotten three doses of Pfizer/BioNTech's Covid-19 vaccine. Those findings were published Wednesday in the New England Journal of Medicine. ...

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