FDA Grants Approval to Pfizer-BioNTech COVID-19 Vaccine for Children 12 to 15 Years Old

The FDA has granted full approved to Pfizer-BioNTech’s COVID-19 vaccine for children aged 12 to 15 years old, making it the only FDA-approved vaccine for that age group.

The agency said the approval was supported by a phase 3 study data involving 2,260 participants with the two-dose primary vaccine series. The vaccine showed 100 percent efficacy in preventing symptomatic COVID-19 infections.

The vaccine received Emergency Use Authorization for this specific pediatric population in May 2021 based on initial data from a phase 3 clinical trial. It has also secured a conditional marketing authorization in the EU for this age group.