Pfizer Trial Shows Vaccine Is Safe & Effective for Children Ages 5 to 11

Pfizer has announced the first results from a key trial of its COVID-19 vaccine in children under the age of 12.

In a statement shared Monday, Pfizer and BioNTech said the results from a Phase 2/3 trial showed a “favorable safety profile” and “robust neutralizing antibody responses” in children between the ages of 5 and 11. The dosage administered in the trial was smaller than the standard used in a previous study focused on people between the ages of 16 and 25, yet still showed comparable antibody responses in participants.

Moving forward, Pfizer CEO Albert Bourla said, the goal is to extend the vaccine protection seen in people 12 and older, particularly in light of a rise in pediatric cases of COVID-19 in recent months.

“Since July, pediatric cases of COVID-19 have risen by about 240 percent in the U.S.—underscoring the public health need for vaccination,” Bourla said. “These trial results provide a strong foundation for seeking authorization of our vaccine for children 5 to 11 years old, and we plan to submit them to the FDA and other regulators with urgency.”

This data will soon be shared with the FDA, EMA, and other regulatory groups. As for younger age ranges, Pfizer said Monday that results for those under 5 years of age are expected to be made available as soon as later this year.