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FDA Authorizes Pfizer-BioNTech COVID-19 Vaccine for Children Ages 5 to 11
Pfizer and BioNTech have also announced that they will be providing the US government with an additional 50 million of the 10 μg doses, with an expected delivery by April 30, 2022.
Officials with the FDA have authorized the COVID-19 vaccine from Pfizer and BioNTech for use in children 5 through 11 years of age, based on submitted data and an advisory committee recommendation.1
According to a press release, the immune response among children 5 through 11 years of age was comparable to individuals 16 through 25 years of age. In a clinical trial, the vaccine was 90.7% effective in preventing COVID-19 in the younger age group.1
Furthermore, the vaccine’s safety was evaluated in approximately 3100 children who received the vaccine. No serious adverse effects were detected in the ongoing study, according to the press release.1
“As a mother and a physician, I know that parents, caregivers, school staff, and children have been waiting for today’s authorization,” said Acting FDA Commissioner Janet Woodcock, MD, in the press release. “Vaccinating younger children against COVID-19 will bring us closer to returning to a sense of normalcy. 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.”1
The vaccine is administered in a 2-dose primary series, 3 weeks apart. Unlike the authorized vaccine for adolescents and adults, however, the authorized dose for children 5 to 11 years of age is a lower 10μg dose.1
The press release noted that COVID-19 cases in children 5 through 11 years of age in the United States comprise 39% of cases in individuals younger than 18 years of age. According to CDC data, approximately 8300 cases in children 5 through 11 years of age resulted in hospitalization, and as of October 17, 2021, 146 deaths from COVID-19 have been reported in the United States in this age group.1
“The FDA is committed to making decisions that are guided by science that the public and health care community can trust,” said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, in a press release. “We are confident in the safety, effectiveness, and manufacturing data behind this authorization.”1
Based on all of the submitted data, the FDA has determined this vaccine meets the criteria for emergency use authorization. According to the press release, the known and potential benefits of the vaccine outweigh the known and potential risks in children 5 to 11 years of age.1
Pfizer and BioNTech have also announced that they will be providing the US government with an additional 50 million of the 10μg doses, with an expected delivery by April 30, 2022. According to a press release from Pfizer, the extra doses are an effort to support preparedness for pediatric vaccinations.2
“From the very beginning, it has been our goal to provide access to a highly effective vaccine to as many people as possible,” said Ugur Sahin, MD, CEO and co-founder of BioNTech, in the press release. “This supply agreement will help to offer a vaccine to all children younger than 12 years of age in the United States.”2
REFERENCES
1. FDA Authorizes Pfizer-BioNTech COVID-19 Vaccine for Emergency Use in Children 5 Through 11 Years of Age. News release. FDA; October 29, 2021. Accessed October 29, 2021. https://www.fda.gov/news-events/press-announcements/fda-authorizes-pfizer-biontech-covid-19-vaccine-emergency-use-children-5-through-11-years-age
2. Pfizer and BioNTech to provide US government an additional 50 million pediatric doses of COVID-19 vaccine to support further preparedness for future needs. News release. Pfizer; October 28, 2021. Accessed October 29, 2021. https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-provide-us-government-additional-50
