March 31, 2021
Pfizer plans to ask the U.S. Food and Drug Administration to allow its COVID-19 vaccine to be given to adolescents after a clinical trial found it to be safe and effective among children ages 12-15.
The two-dose vaccine was 100% effective in a Phase 3 study involving 2,260 adolescents, the company said Wednesday. It produced a "robust" antibody response that nearly doubled the levels observed in a separate trial involving people ages 16-25. There were no serious side effects.
Pfizer and BioNTech, which helped develop the vaccine, said they plan to submit their data to the FDA as soon as possible. The hope is to begin vaccinating adolescents before the next school year starts in the fall.
"We share the urgency to expand the authorization of our vaccine to use in younger populations and are encouraged by the clinical trial data from adolescents between the ages of 12 and 15," Pfizer CEO Albert Bourla said.
The study recorded 18 COVID-19 cases, but all of them were among participants who received a placebo. Vaccinated participants experienced minor side effects, including pain at the injection site, fatigue and fever.
The findings from the study have not yet been published in a scientific journal or peer reviewed.
The news comes as more schools are bringing students back into the classroom — including the School District of Philadelphia. Pennsylvania has released updated school guidelines that reduce physical distancing requirements to three feet in most classroom settings.
Health experts say the United States cannot achieve herd immunity against the coronavirus without vaccinating children, who make up 23% of the population. So far, 29% of adults have received one dose of the vaccine and 16% have been fully inoculated, according to data from the Centers for Disease Control and Prevention.
Last week, Pfizer launched a clinical trial to study its vaccine among children 6 months to 11 years old.
The trial will examine the safety and efficacy of the vaccine in three age groups — 6 months to age 2, ages 2-5, and ages 5-11. The children in the oldest group received their first doses last week. The middle group is set to get their first shots next week.
Moderna also is testing its COVID-19 vaccine on children in two clinical trials — one for adolescents ages 12-17 and the other for children 6 months to 11 years old. The Children's Hospital of Philadelphia is participating in the latter trial.
Dr. Anthony Fauci, the leading infectious disease expert in the U.S., estimates that younger children may have to wait until 2022 to get their shots. Other health officials say it could reach high-risk children by this summer and the rest of children by December, CNN reported.
Pennsylvania will make everyone 16 and older eligible for a COVID-19 vaccine on April 19. Philadelphia, which has eligibility requirements separate from the state, plans to make that change by May 1.