The FDA on Monday expanded the emergency-use authorization (EUA) for Pfizer and BioNTech’s vaccine BNT162b2 to include preventing COVID-19 in adolescents 12 through 15 years of age, according to a FirstWord report. The two-dose mRNA-based vaccine was initially granted an EUA in December for use in people ages 16 years and older, with acting FDA Commissioner Janet Woodcock calling the expanded label a “significant step” in the fight against the pandemic.
“Today’s action allows for a younger population to be protected from COVID-19, bringing us closer to returning to a sense of normalcy,” she said, adding that “parents and guardians can rest assured that the agency undertook a rigorous and thorough review of all available data, as we have with all of our COVID-19 vaccine EUAs.” The move follows Health Canada’s decision last week to extend its authorisation for BNT162b2 to the younger adolescent group.
Pfizer and BioNTech’s filing was supported by topline data from a phase 3 study of adolescents aged 12 to 15, showing that BNT162b2 was safe and 100% effective at protecting against the disease. The analysis was calculated based on 18 cases of COVID-19, all of which were among placebo recipients. Side effects were also generally consistent with those observed in participants 16-to-25 years of age.
Distribution could start this week
The US Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) has scheduled a meeting on May 12 to review the expanded EUA. If approved by the CDC as expected, it could be distributed to this younger group of adolescents as soon as this week.
An application seeking to have the vaccine authorised among 12-to-15 year olds was also recently submitted to EU regulators and is being reviewed there under an accelerated assessment. Meanwhile, Pfizer and BioNTech are running another paediatric study of BNT162b2 in children under 12, with an initial readout expected in the second half of the year.