Pfizer and its partner, BioNTech, will request federal authorization to administer fourth doses of its COVID-19 vaccine to adults 65 and older.
The companies could jointly submit clinical data backing up the need for a second booster dose as soon as Tuesday, the Washington Post reported. The submission will include data collected in Israel, where government regulators have authorized another round of boosters in the senior population, which is at a higher risk of severe illness than younger people.
The Food and Drug Administration generally convenes its panel of independent vaccine experts to consider expanding a vaccine’s emergency use authorization, an accelerated pathway that gets the shots in people’s arms faster than waiting for full approval. However, the availability of data showing how the senior population fared when given a fourth dose could justify expanded authorization without the panel’s input.
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Studies of the benefits of a second booster dose are so far relatively limited. Still, one study published last month in pre-print form found that Israeli adults 60 and older who received a fourth shot in January had lower rates of infection due to the omicron variant than those who did not. People who received a fourth dose were also less likely to become seriously ill.
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Pfizer CEO Albert Bourla, meanwhile, has said that he anticipates the general population will need a second booster dose at some point, noting that immunity wanes over time. The first booster, he said, is “actually quite good for hospitalizations and deaths. It’s not that good against infections.”
