FDA Extends Pfizer Vaccine EUA to Children 12-15 Years Old

May 11, 2021

On Monday, the FDA granted Pfizer emergency use authorization of their vaccine in children ages 12-15 years old. This is the first vaccine authorized for persons 12+ years old. 

In a Phase 3 clinical trial, 2,260 participants ages 12-15 were given a placebo or two doses of the vaccine, 21-days apart. Eighteen cases of symptomatic COVID-19 were recorded in the placebo group, but none were recorded amongst children who received the vaccine. The trial showed a “vaccine efficacy of 100% in participants with or without prior SARS-CoV-2 infection and robust antibody responses.” The vaccine was also “well-tolerated,” and side effects were comparable to those seen in clinical trials amongst young adults, ranging from 16-25 years of age.

Pfizer is continuing to collect data on asymptomatic cases from clinical trial participants, and participants will be monitored “for long-term protection and safety for an additional two years after their second dose.” 
While the risk of children catching COVID-19 is low, the risk of developing multi-inflammatory syndrome (MIS-C) is higher than the potential risk of experiencing symptoms from the vaccine. Additionally, being vaccinated against COVID-19 mitigates the development and spread of variants. 

The CDC’s Advisory Committee on Immunization Practices will be convening shortly to review the clinical data and make recommendations on the vaccine’s use in adolescents. After their endorsement, immunizations can begin. The data from Pfizer’s trial has also been submitted to the European Medicines Agency and other regulators to extend the EUA.