US health regulators are expected to authorize a booster shot of Pfizer and BioNTech's COVID-19 vaccine for children aged 5 to 11 as soon as Tuesday, Reuters reported on Monday, citing the New York Times.
People familiar with the matter said a meeting of outside vaccine experts on an advisory committee to the Centers for Disease Control and Prevention has been scheduled for Thursday.
The FDA declined to comment, while Pfizer and BioNTech did not respond to requests for comment.
Pfizer and BioNTech late last month submitted an application to the Food and Drug Administration (FDA) requesting authorization to administer a booster dose of their COVID-19 vaccine to children aged 5-11.
The companies cited data from a Phase 2/3 trial, which they said indicated a “strong immune response” in the younger age group after a booster dose was administered six months after primary immunization with its COVID-19 vaccine.
In September, the FDA authorized a booster dose of the Pfizer and BioNTech vaccine for older adults and some Americans at high-risk of illness.
Reuters noted that it is unclear how much demand there is for the third dose in the 5 to 11 age group. Just 28.8% of children aged 5 to 11 are fully vaccinated, according to data from the US Centers for Disease Control and Prevention.