FDA Authorizes Booster Shot for Children Aged 5-11
The U.S. Food and Drug Administration amended the emergency use authorization for the Pfizer-BioNTech COVID-19 vaccine on Tuesday for children as young as 5 to receive a booster.
Under the EUA, children aged 5-11 are now authorized for a single booster shot at least five months after completing the primary vaccine series with the Pfizer-BioNTech COVID-19 vaccine. The FDA previously authorized the use of a single booster on Jan. 3 for individuals aged 12-15.
To evaluate for effectiveness, the FDA analyzed immune response data from children aged 5-11 enrolled in a placebo-controlled trial, and gathered results from 67 study participants who received a booster dose seven to nine months after completing a two-dose primary series of the vaccine. Antibody levels against the SARS-CoV-2 virus one month after the booster dose were increased compared with before the booster dose.
To evaluate for safety, the FDA examined results from 400 children who received a booster at least five months after the two-dose primary series and found the most common side effects were swelling at the injection site, fatigue, headache, and muscle or joint pain.
The FDA advised that while it did not hold a meeting of the Vaccines and Related Biological Products Advisory Committee regarding the recent EUA, the FDA did previously convene the committee for extensive discussion regarding booster doses, which did not indicate any need for further discussion.
Alexa can be reached at [email protected]
