The authorization makes all children in that age group who received their second shot at least five months ago eligible to receive a third shot of the Pfizer-BioNTech vaccine.
The companies requested the authorization based on a small study that the companies and FDA said demonstrated a third shot is safe and can significantly boost antibody levels, countering waning immunity and providing added protection against the virus, including the more contagious omicron variant.
Until now, only children ages 12 and older and adults were eligible for a booster.
It remains unclear how much of a demand there will be for the boosters. Less than a third of children ages 5 to 11 are fully vaccinated, and only about a quarter of adolescents have received a booster.
Many doctors and parents have been hoping for the authorization, saying it’s important to provide children with as much protection as possible, especially as the number of people catching the virus is rising again and so few people are now wearing masks.
The FDA didn’t ask its outside advisers for input on the decision because the agency said the committee had previously discussed the issues and no new questions were raised.
The Centers for Disease Control and Prevention‘s advisers on vaccine practices will meet Thursday and are expected to discuss implementation of a booster dose for this age group.