FDA authorizes updated bivalent COVID-19 booster for children aged 5 and older

The booster was first rolled out for kids aged 12 and older in September.

October 12, 2022, 1:40 PM

The U.S. Food and Drug Administration authorized the updated bivalent COVID-19 booster for younger children Wednesday.

The Pfizer booster has been authorized for children aged 5 and older and the Moderna booster for children aged 6 and older.

When the new boosters were initially authorized in September, the Pfizer booster was only available for those aged 12 and older and the Moderna booster for those aged 18 and older.

Following the FDA's announcement, the Centers for Disease Control and Prevention also authorized the expanded use and Director Dr. Rochelle Walensky signed off on the decision memo. Her signature was the final step before boosters can start to be given to the younger age group.

The FDA says children can receive the booster at least two months after completing their primary series or receiving a separate booster dose.

"Since children have gone back to school in person and people are resuming pre-pandemic behaviors and activities, there is the potential for increased risk of exposure to the virus that causes COVID-19," Dr. Peter Marks, director of the Center for Biologics Evaluation and Research at the FDA, said in a statement. "Vaccination remains the most effective measure to prevent the severe consequences of COVID-19, including hospitalization and death.

"While it has largely been the case that COVID-19 tends to be less severe in children than adults, as the various waves of COVID-19 have occurred, more children have gotten sick with the disease and have been hospitalized. Children may also experience long-term effects, even following initially mild disease."

PHOTO: Pfizer manufacturing COVID-19 bivalent vaccine for ages 5-11, in Oct. 2022.
Pfizer manufacturing COVID-19 bivalent vaccine for ages 5-11, in Oct. 2022. The U.S. authorized updated COVID-19 boosters for children as young as 5, seeking to expand protection ahead of an expected winter wave.
Pfizer via AP

The updated booster specifically protects against the omicron subvariants BA.4 and BA.5, which account for the majority of COVID-19 infections in the U.S.

With the updated authorization from the FDA, this means more than 216 million Americans are now eligible to receive the bivalent booster.

In its announcement, the FDA said it relied on data showing the original bivalent boosters -- which targeted the original variant from Wuhan and the original omicron variant BA.1 -- were safe and effective in adults.

"The FDA considers such data as relevant and supportive of vaccines containing a component of the omicron variant BA.4 and BA.5 lineages," the health agency wrote.

Data from the CDC shows 11.5 million Americans have received an updated booster since they were rolled out.