FDA Grants EUA for Pfizer-BioNTech COVID-19 Vaccine Use in Children

The Pfizer-BioNTech COVID-19 vaccine is the first to receive FDA Emergency Use Authorization for use in children ages five to 11.

FDA announced that it has granted an Emergency Use Authorization (EUA) to the Pfizer-BioNTech COVID-19 vaccine for use in children ages five to 11 in an October 29, 2021, press release. According to the release, the decision was based on a detailed evaluation of all available data, including a recent recommendation from the FDA Vaccines and Related Biological Products Advisory Committee given three days prior to this announcement.

In the data cited by FDA, immune responses of children ages five through 11 were found to be comparable to those of individuals 16 to 25 years of age. In a preliminary analysis of the results conducted seven days after the second dose, three cases of COVID-19 occurred in 1305 recipients of the vaccine, whereas 16 occurred in the 663 placebo cases. Following these results, the vaccine was determined to be 90.6% effective in stopping COVID-19.

Children receiving the Pfizer-BioNTech vaccine will be given the same two-dose primary series, three weeks apart. However, the dosage will be 10 μg, one-third of the 30 μg dosage given to individuals 12 years of age or older.

“As a mother and a physician, I know that parents, caregivers, school staff, and children have been waiting for today’s authorization. Vaccinating younger children against COVID-19 will bring us closer to returning to a sense of normalcy,” said Acting FDA Commissioner Janet Woodcock in the press release. “Our comprehensive and rigorous evaluation of the data pertaining to the vaccine’s safety and effectiveness should help assure parents and guardians that this vaccine meets our high standards.”

“[FDA] is committed to making decisions that are guided by science that the public and healthcare community can trust. We are confident in the safety, effectiveness, and manufacturing data behind this authorization. As part of our commitment to transparency around our decision-making, which included our public advisory committee meeting earlier this week, we have posted documents today supporting our decision and additional information detailing our evaluation of the data will be posted soon. We hope this information helps build confidence of parents who are deciding whether to have their children vaccinated,” said Peter Marks, director of FDA’s Center for Biologics Evaluation and Research, in the press release.

Source: FDA