Pfizer seeks FDA clearance for second booster for ages 65 and older
Pfizer and collaborator BioNTech on Tuesday sought federal approval to provide an additional booster dose of their COVID-19 Comirnaty vaccine to people 65 and older.
The request is based on data from Israel during a recent omicron outbreak there. A study of more than a million Israelis over the age of 60 showed that those who received a fourth dose were half as likely to become infected and four times less likely to become seriously ill than those who did not. only received three injections.
In a second study of 700 Israeli health workers, those who received a fourth dose saw a 10-fold increase in protective antibodies two weeks after injection.
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The fourth dose was given three months after the third in both studies and neither study raised any new safety concerns. Neither study has been peer reviewed.
Other studies show that effectiveness against serious infections and illnesses starts to fade about three months after a third dose, so another dose may be needed, especially in older people who are most at risk of serious illness.
Currently, people can get a single booster shot of the Pfizer-BioNTech vaccine after two doses of the same vaccine, one from Moderna or a single shot from Johnson & Johnson.
It’s unclear how long the Food and Drug Administration will take to review the request or if it will convene its panel of experts to review it.
The country is experiencing a lull in COVID infections, with only 2% of the nation considered to be at high risk of infection.
As of Monday, just under 80 million Americans have caught COVID-19 since the pandemic began two years ago, and 557 million doses of the vaccine have been administered, according to the Centers for Disease Control and Prevention, which should also sign off on any new use of the vaccine.
Just under 77% of Americans ages 5 and older have been vaccinated at least once, and 44% of those ages 12 and older have received a booster dose.
Contact Weintraub at [email protected]
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