FDA clears updated COVID-19 vaccines ahead of fall booster campaign

The Food and Drug Administration (FDA) on Wednesday authorized updated COVID-19 booster shots specifically targeting a subvariant of omicron. 

The move comes ahead of a fall campaign to give Americans booster shots, which is expected to launch in the coming days. 

The move marks the first time the vaccines have been updated since the first shots were cleared at the end of 2020, and the updated shots are designed to catch up to evolutions in the virus.

The shots from Pfizer and Moderna target the omicron subvariants BA.4 and BA.5, as well as the original virus. 

The shots can begin going into arms once the final step in the process, a Centers for Disease Control and Prevention committee, clears them, which is expected to occur on Thursday.  

A major question, though, is how many people will actually want the new shots, given that uptake for the existing booster shots has lagged.  

Only about half of people who got the first two shots received the initial booster dose.  

“The COVID-19 vaccines, including boosters, continue to save countless lives and prevent the most serious outcomes (hospitalization and death) of COVID-19,” said FDA Commissioner Robert Califf. “As we head into fall and begin to spend more time indoors, we strongly encourage anyone who is eligible to consider receiving a booster dose with a bivalent COVID-19 vaccine to provide better protection against currently circulating variants.”  

Seeking to keep up with the ever-evolving virus, the FDA did not wait for the time-consuming process of going through full clinical trials on this tweaked vaccine. But it noted that it is highly confident that the vaccines are safe and effective. The agency pointed to the millions of doses of the original vaccines that have been given, as well as data from another version of the updated vaccine, along with preliminary data on this one.  

Peter Marks, a top FDA vaccine official, compared the process to the annual updates to the flu vaccine that seek to adapt to the changes in that virus.  

“The public can be assured that a great deal of care has been taken by the FDA to ensure that these bivalent COVID-19 vaccines meet our rigorous safety, effectiveness and manufacturing quality standards for emergency use authorization,” Marks said.  

The updated Moderna vaccine is cleared for people 18 and older, and the Pfizer vaccine for people 12 and older.  

For both, people are eligible for the booster shot of the updated vaccine if it has been at least two months since their last shot.  

— Updated at 10:20 a.m.