The Food and Drug Administration has agreed to let adolescents between the ages of 12 and 15 be vaccinated with the Pfizer and BioNTech Covid-19 vaccine, making it the first vaccine to be available for use in children under the age of 16.
The FDA announced Monday that it was altering the emergency use authorization for the vaccine. Its decision was based on a Phase 3 trial that showed the vaccine to be both safe and effective in the age group.
The companies announced late last month they had applied to the European Medicines Agency for a similar expansion of eligibility there. Last week Health Canada expanded its emergency use provision for the vaccine to allow it to be used in adolescents aged 12 to 15.
The move positions the Pfizer and BioNTech vaccine to make early inroads into the adolescent market, as parents look to have their children immunized against Covid-19 in advance of next fall’s return to school. The company is already testing the vaccine in children aged 2 to 11 and plans to test it in children aged 6 months to 2 years in coming weeks.
“Today’s expansion of our EUA represents a significant step forward in helping the U.S. government broaden its vaccination program and help protect adolescents ages 12 – 15 before the start of the next school year,” Pfizer CEO Albert Bourla said in a statement. “Together, we hope to help bring a sense of normalcy back to young people across the country and eventually around the world.”
An expert panel that advises the Centers for Disease Control and Prevention will meet Wednesday to review Pfizer’s data on use in 12- to 15-year olds. The Advisory Committee on Immunization Practices is expected to recommend that the vaccine be used in this age group.
Moderna is testing its vaccine in children, with one trial focused on adolescents aged 12 to 18 and a second looking at the safety and effectiveness of the vaccine in children 6 months to 12 years. Johnson and Johnson announced in early April that it has begun testing its one-dose vaccine in adolescents 12 to 17 years of age.
Pfizer’s Phase 3 trial in children aged 12 to 15 generated both immunogenicity data — evidence of the immune response triggered by the vaccine — and efficacy data showing it prevented disease among the vaccinated children.
The trial enrolled 2,260 children. There were 18 cases of Covid-19 infection in children in the placebo arm of the trial but none of the children who received vaccine became infected, resulting in a 100% efficacy estimate. Antibody levels in blood drawn from a subset of the children showed a robust response — stronger than the response seen in earlier trials of the vaccine involving people aged 16 to 25.
The companies said the vaccine was well tolerated in this age group, with a side effect profile similar to what was seen in the trials involving 16 to 25 year olds. Common side effects with this vaccine include pain at the injection site, fatigue, headache, muscle pain, chills, and fever.