Pfizer asks FDA to approve fourth COVID-19 vaccine for older adults

Data from Israel show the fourth dose lowers the rate of severe illness, Pfizer stated.

Published: March 15, 2022 7:07pm

Updated: March 15, 2022 7:35pm

Pfizer and BioNTech submitted an application to the U.S. Food and Drug Administration (FDA) to issue an Emergency Use Authorization (EUA) for older adults to receive an additional COVID-19 vaccine booster dose, the companies announced Tuesday in a press release.

The submission included Israeli data from when the Omicron variant was "widely circulating," the press release stated. Israel began offering a fourth COVID vaccine dose on Jan. 2, 2022, for all healthcare workers and people over the age of 60, The Lancet reported.

The data from Israel's fourth dose show the additional Pfizer booster increases immune response and "lowers rates of confirmed infections and severe illness," the vaccine manufacturers stated. 

"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 companies stated.

Pfizer noted that "no new safety concerns" arose from those who received the fourth vaccine.

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