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Pfizer Seeking Emergency Use Authorization for Second Booster

The pharmaceutical giant has moved to gain authorization of another dose of its COVID-19 vaccine for older patients

On Tuesday, Pfizer and its partner, BioNTech, filed for emergency authorization of a second booster shot of their COVID-19 vaccine for people aged 65 and over.

The move is an effort to bolster waning immunity that occurs within a few months after the first booster, the companies announced.

Pfizer’s statement said, “Emerging evidence, including data from Kaiser Permanente Southern California, suggests that effectiveness against both symptomatic COVID-19 and severe disease caused by Omicron wanes 3 to 6 months after receipt of an initial booster (third) dose.”

The Food and Drug Administration submission includes data collected in Israel, one of only a few countries to authorize a second booster for older people. A decision from the FDA could come reasonably quickly if officials conclude the data does not have to be reviewed by a panel of outside experts.

The FDA plans to hold a meeting with advisers in early April to assess whether there should be an effort in October or November, in conjunction with the annual influenza vaccine campaign, to encourage some or all adults to get additional boosters. The advisory panel may also debate whether the vaccines should be the same formula as current vaccines or modified for new variants.

The filing comes just days after Pfizer CEO, Albert Bourla, said a fourth dose of the COVID-19 vaccine would be needed.

Bourla offered his latest insights in an interview on CBS’s Face the Nation on Sunday.

“The protection that we are getting from the third [dose], it is good enough, actually quite good for hospitalizations and deaths, it’s not that good against infections, but doesn’t last very long,” Bourla said. “We are just submitting those data to the FDA, and then we will see what the experts also will say, outside of Pfizer.”

In December, Israel became the first country to approve the fourth dose of COVID-19 vaccines after Prime Minister Naftali Bennett announced that the additional dose would be available to people ages 60 or older and at-risk groups.

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