FDA oks Pfizer booster for kids

Jan. 3, 2022

The U.S. FDA has authorized the use of a third dose of the Pfizer-BioNTech COVID-19 vaccine, Comirnaty, for children ages 12-15 and narrowed the interval for booster shot eligibility from 6 months to five, as Omicron infections continue to surge around the country.

The vaccine is currently approved as a 2-dose series for individuals 16 years of age and older and was authorized under EUA to provide a 2-dose primary series to individuals 12 through 15 years of age. Now, the agency has reissued the December 16, 2021 letter of emergency authorization to Pfizer in its entirety with revisions amending the EUA.

In addition to the booster shot eligibility changes, the agency has authorized a third primary series dose for children aged 5 through 11 years who are immunocompromised.

The FDA said its decision was based on a review of prepublications, accepted publications, published publications and real-world evidence on the safety of booster doses provided by the Israeli Ministry of Health. This includes data from over 6,300 individuals 12 to 15 years of age who received a Pfizer-BioNTech COVID-19 vaccine booster dose at least 5 months following completion of the primary series.