The Food and Drug Administration approved the Pfizer-BioNTech Covid-19 vaccine “for emergency use” in children aged 5 to 11.
The approval came after the FDA’s drug advisory panel recommended the approval on Tuesday. The Biden Administration says the doses of the shot will be at pediatricians’ offices, health centers, hospitals, pharmacies, and clinics, and that 15 million doses are ready for shipment.
“The authorization was based on the FDA’s thorough and transparent evaluation of the data that included input from independent advisory committee experts who overwhelmingly voted in favor of making the vaccine available to children in this age group,” the FDA said in a statement that was prepared on Thursday and released on Friday.
Key points, as described by the FDA:
- Effectiveness: Immune responses of children 5 through 11 years of age were comparable to those of individuals 16 through 25 years of age. In that study, the vaccine was 90.7% effective in preventing COVID-19 in children 5 through 11.
- Safety: The vaccine’s safety was studied in approximately 3,100 children age 5 through 11 who received the vaccine and no serious side effects have been detected in the ongoing study.
- The Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices will meet next week to discuss further clinical recommendations.
“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, M.D. “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.”
The Pfizer-BioNTech Covid-19 vaccine for children 5-11 years of age is a two-dose primary series, given 3 weeks apart, but is a lower dose (10 micrograms) than that used for individuals 12 years of age and older (30 micrograms).
In the U.S., Covid-19 cases in children 5 through 11 years of age make up 39% of cases in individuals younger than 18 years of age, the FDA says.
According to the CDC, approximately 8,300 Covid-19 cases in children 5-11 years of age resulted in hospitalization. As of Oct. 17, 691 deaths from COVID-19 have been reported in the U.S. in individuals less than 18 years of age, with 146 deaths in the 5-11 years age group. The agency did not report whether those children were already ill or had other complicating conditions.
“The 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, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research.
The FDA said that the Pfizer vaccine has met the criteria for emergency use authorization.
“Based on the totality of scientific evidence available, the known and potential benefits of the Pfizer-BioNTech COVID-19 vaccine in individuals down to 5 years of age outweigh the known and potential risks,” the FDA said in a statement.