FDA authorizes bivalent COVID boosters for younger children

The Food and Drug Administration (FDA) on Wednesday announced it has amended its emergency authorization of the bivalent COVID-19 boosters to include children between the ages of 5 and 11.

The FDA’s decision grants Moderna’s request for authorization to administer its bivalent booster to children as young as 6 and grants Pfizer’s request to administer its own booster to children as young as 5.

“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,” said Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research.

“Vaccination remains the most effective measure to prevent the severe consequences of COVID-19, including hospitalization and death,” Marks added.

With the authorization of the bivalent booster for young children, the FDA also announced that Pfizer’s original booster shot is no longer authorized for children aged between 5 and 11.

Prior to this, Pfizer’s updated omicron-specific vaccine was the only bivalent shot authorized for use in children, those as young as 12, while Moderna’s booster was only permitted for use in people 18 and over.

This decision from the FDA falls in line with what the Centers for Disease Control and Prevention said in September, stating in documents that it was anticipating a recommendation of boosters for young children in early to mid-October.

The Biden administration has urged Americans to get the updated booster, hoping to avoid a surge in cases during the fall and winter. The White House has ordered more than 170 million doses of the bivalent COVID-19 boosters to “ensure a robust and complete national booster vaccination campaign.”