FDA to Authorize Pfizer Booster Shots for All Adults This Week

Carolyn Crist

November 17, 2021

Editor's note: Find the latest COVID-19 news and guidance in Medscape's Coronavirus Resource Center.

The FDA intends to authorize booster shots of the Pfizer-BioNTech COVID-19 vaccine for all adults this week — potentially as early as Thursday.

The CDC's independent vaccine advisory committee also meets on Friday to discuss booster dose data. If both the FDA and CDC approve the extra shots this week, tens of millions of Americans could soon become eligible for additional shots, according to The New York Times.

Last week, Pfizer asked the FDA to authorize booster doses for ages 18 and older who received a second vaccine dose at least 6 months ago. Several top health officials in the Biden administration have recommended the plan to fight against another increase in coronavirus cases, especially before people gather for holiday celebrations, the newspaper reported.

But some states and cities have approved booster doses ahead of a federal decision. On Monday, New York City health officials encouraged all adults to get a booster shot. During the past week, Arkansas, California, Colorado, and New Mexico have made moves to open eligibility for adults.

And in other states, adults have found ways to get an extra dose, even if they didn't qualify yet, according to the Times. Even still, up to 40% of vaccinated adults are still excluded from eligibility.

In September, the FDA approved boosters for those age 65 years and older, adults with underlying health conditions, or those with high risks for contracting COVID-19 due to their jobs or living situations. In October, booster doses were also authorized for those who received the one-shot Johnson & Johnson vaccine and vulnerable groups who received the Moderna vaccine.

More than 30 million people have gotten booster shots, according to the latest CDC data. That includes 17 million adults who are age 65 and older.

The CDC committee is scheduled to meet on Friday for a shorter amount of time than other recent meetings about COVID-19 vaccines, the newspaper reported. The discussion is expected to be straightforward and focus on how the current booster campaign is already running, a federal official said.

Public health officials have been split on the idea this fall but may be coming to a consensus on boosters, according to the Times. Some said the Biden administration was rushing a widespread booster campaign in September and that a two-dose regimen was enough to prevent hospitalization and death.

But in recent weeks, some federal regulators and researchers have said the evidence shows that vaccine immunity is waning, especially for older adults and those with medical conditions.

During an event on Tuesday, Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, said the coronavirus could become endemic in the US next spring with more initial vaccine doses and booster shots for all adults, according to Reuters.

"To me, if you want to get to endemic, you have got to get the level of infection so low that it does not have an impact on society, on your life, on your economy," Fauci said.

For that to happen, COVID-19 cases need to fall "well below 10,000" per day for the nation to "get back to a degree of normality," he said. (For context, the US has reported an average of more than 83,000 new cases each day during the past week alone.)

"People will still get infected," he said. "People might still get hospitalized, but the level would be so low that we don't think about it all the time and it doesn't influence what we do."

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