FDA Endorses Pfizer Booster Vaccine for Children 12-15 Years Old: Expanded Recommendations

The FDA endorses the Pfizer booster vaccine for children aged 12-15 years old and authorizes an additional dose for immunocompromised children aged 5-11 years old, alongside shortened intervals for booster doses, aiming to enhance vaccine coverage and protection against COVID-19 in pediatric populations.

January 2022
FDA Endorses Pfizer Booster Vaccine for Children 12-15 Years Old: Expanded Recommendations

On January 3, the US Food and Drug Administration (FDA) authorized the use of a third dose of the Pfizer/BioNTech COVID-19 vaccine for children between 12 and 15 years old.

At the same time, it reduced the time of all booster immunizations to 5 months from 6 months after the end of the initial vaccination program and authorized a third dose in children aged 5 to 11 years who are immunocompromised.

The FDA made the decision after reviewing published data and real-world evidence on the safety of booster doses provided by the Israeli Ministry of Health, including data from more than 6,300 people ages 12 to 15 who received a Pfizer vaccine.

Laboratory tests showed that two doses of the Pfizer-BioNTech and Moderna vaccines generate a low immune response against Omicron, while booster doses appear to be protective against the new variant.