FDA Approves COVID-19 Boosters for All Adults

The FDA decision was followed by a CDC advisory panel meeting Friday, and as expected, CDC Director Rochelle Walensky, MD, MPH, who has spoken in favor of booster shots, signed off on the plan.

This story has been updated.

The FDA Friday approved COVID-19 booster shots for all US adults over the age of 18 if they are more than 6 months out from completing their primary vaccination series of mRNA vaccines.

A CDC advisory panel met Friday, and CDC Director Rochelle Walensky, MD, MPH, who has spoken in favor of booster shots, signed off on the plan in the evening, paving the way for boosters to become more widely available this weekend.

The move comes as cases are climbing again in some parts of the United States; on Friday, The New York Times reported, Michigan urged residents to begin wearing masks again indoors and asked businesses to consider mandatory mask wearing. Moreover, federal officials are concerned about the combination of colder weather and holiday travel in the weeks ahead.

About 130 million people in the United States would be eligible to receive the additional shots, according to Reuters. Around 32.5 million people have received a booster shot so far, according to CDC data.

Anyone who got the 1-dose Johnson & Johnson vaccine can already get a booster.

Adults can choose to receive either a Pfizer or Moderna booster, regardless of which vaccine they had first. Some states have already started allowing the practice.

Even without adding boosters, all 3 COVID-19 vaccines used in the United States offer strong protection against severe illness and death, but protection can fade with time.

Previously, only certain vulnerable populations, including older Americans, those with chronic health problems, and individuals whose jobs put them at greater risk of infection, were eligible to get boosters. Earlier this month, Pfizer asked the FDA to expand that decision to everyone, citing new data from a study of 10,000 people, which found that that a booster restored protection against symptomatic infections to about 95%, even while the extra-contagious delta variant was surging. The FDA decided there was enough evidence, from studies and real-world use of boosters, to back the expansion for both Pfizer and Moderna, although Moderna did not submit a formal application.

“The FDA has determined that the currently available data support expanding the eligibility of a single booster dose of the Moderna and Pfizer-BioNTech COVID-19 vaccines to individuals 18 years of age and older,” Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, said in a statement. “Streamlining the eligibility criteria and making booster doses available to all individuals 18 years of age and older will also help to eliminate confusion about who may receive a booster dose and ensure booster doses are available to all who may need one.”