Pfizer-BioNTech requests FDA authorization for fourth COVID vaccine shot for 65 and older

Pfizer and its collaborator BioNTech requested federal permission Tuesday to provide an additional booster dose of their COVID-19 vaccine Comirnaty to people 65 and older.

The request is based on data from Israel during a recent omicron outbreak there. One study of more than 1 million Israelis over 60 showed that those who got a fourth dose were half as likely to become infected and four-times less likely to fall severely ill than those who had only three shots. 

In a second study of 700 Israeli health care workers, those who received a fourth dose, saw a 10-fold jump in protective antibodies two weeks after the shot.

COVID IS 'NOT OVER,' BUT CDC SAYS MOST OF AMERICA DOESN'T NEED TO WEAR A MASK: Should you listen?

STAY CONNECTED:  Subscribe to Coronavirus Watch, your free daily update on all things COVID-19 in the USA

The fourth dose was delivered three months after the third in both studies and neither raised new safety concerns. Neither study has been peer-reviewed.

Other studies show that effectiveness against both infection and severe disease begins to fade about three months after a third dose, so another dose may be needed, particularly in older people who are at highest risk for severe disease.

Right now, 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 Johnson & Johnson shot.  

It's not clear how long the Food and Drug Administration will take to review the request or whether it will convene its expert panel to review it. 

The country is enjoying a lull in COVID infections, with only 2% of the nation considered at high risk for 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 vaccine have been administered, according to the Centers for Disease Control and Prevention, which would also have to sign off on any new use of the vaccine. 

Just under 77% of Americans ages 5 and up have been vaccinated at least once and 44% of those 12 and up have received a booster dose.

Contact Weintraub at kweintraub@usatoday.com 

Health and patient safety coverage at USA TODAY is made possible in part by a grant from the Masimo Foundation for Ethics, Innovation and Competition in Healthcare. The Masimo Foundation does not provide editorial input.