On the eve of Halloween, the U.S. Food and Drug Administration (FDA) authorized emergency use of the Pfizer-BioNTech COVID-19 vaccine in children ages 5 to 11 years old on Friday after recent studies showed it is more than 90 percent effective and safe for that age group.
The authorization, the FDA said in a comunicado, was based on a thorough and transparent evaluation of the data that included input from experts on the independent advisory committee who voted overwhelmingly in favor of making the vaccine available to children in this age group.
Immune responses in children aged 5 to 11 years were comparable to those in people aged 16 to 25 years, and it was found to be 90.7 percent effective in preventing COVID-19 in that age group.
The safety of the vaccine was studied in approximately 3,100 children aged 5 to 11 years and no serious side effects have been detected.
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 the youngest children against COVID-19 will bring us closer to returning to normal,” said Acting FDA Commissioner Janet Woodcock.
“Our thorough and rigorous evaluation of the data relating to the vaccine’s safety and efficacy should help reassure parents and guardians that this vaccine meets our high standards,” she added.
The Pfizer-BioNTech COVID-19 vaccine for children ages 5 to 11 is administered as a two-dose primary series, 3 weeks apart, but is a lower dose ‒ 10 micrograms ‒ than the one used for people 12 years of age and older ‒ 30 micrograms ‒.
In the U.S., COVID-19 cases in children ages 5 to 11 account for 39 percent of cases in people under age 18. According to the CDC, approximately 8,300 COVID-19 cases in children ages 5 to 11 have resulted in hospitalization, and as of Oct. 17, 691 COVID-19 deaths have been reported in the U.S. in people under age 18, of which 146 deaths were in the 5 to 11 age group.
“As part of our commitment to transparency around our decision-making, which included our public advisory committee meeting earlier this week, we are releasing documents supporting our decision today, and additional information detailing our evaluation of the data will be released soon. We hope this information will help build confidence in parents who are deciding whether to vaccinate their children,” said Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research.
The FDA has determined that this Pfizer vaccine meets the criteria for emergency use authorization. Based on the totality of the available scientific evidence, the known and potential benefits of the Pfizer-BioNTech COVID-19 vaccine in people younger than 5 years of age outweigh the known and potential risks.
Commonly reported side effects in the clinical trial included pain at the injection site, arm pain, redness and swelling, fatigue, headache, muscle and/or joint pain, chills, fever, swollen lymph nodes, nausea, and decreased appetite.
More children reported side effects after the second dose than after the first. Side effects were generally mild to moderate in severity and occurred within two days of vaccination, with most going away within one to two days.
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