Scott Hensley -NPR
"We believe additional information regarding the ongoing evaluation of a third dose should be considered as part of our decision-making for potential authorization," FDA officials said in a statement.
CDC Director Rochelle Walensky gave the green light to boosters just hours after a panel of vaccine advisors voted unanimously to recommend boosters for anyone 18 and older.
The companies studied a 10 microgram vaccine dose in children 5 to 11, a third of the dose used for adults, to minimize side effects and because it still prompts a strong immune response.
A panel advising the Centers for Disease Control and Prevention also endorsed a mix-and-match approach to boosters that would be flexible for patients and health care providers.
The Food and Drug Administration also gave an OK to boosters that differ from the vaccine originally used to immunize people against COVID-19. A mix-and-match approach could ease the booster rollout.
The Food and Drug Administration released briefing documents Tuesday on booster shots for the Moderna and Johnson & Johnson COVID vaccines ahead of a two-day advisory meeting that starts Thursday.
A third shot of the vaccine can be given at least six months after the two-dose regimen, according to the authorization. A booster rollout could begin this week.
The Food and Drug Administration has formally approved Pfizer's COVID-19 vaccine. The widely anticipated decision replaces the emergency use authorization granted by the agency last December.