HealthDay News — Pfizer Inc. announced Wednesday that its COVID-19 vaccine is safe and remarkably effective in children as young as 12 years.
In a news release issued by Pfizer and its vaccine development partner, BioNTech, company executives said data from a trial of the vaccine in nearly 2,300 people between the ages of 12 and 15 years will be submitted to the U.S. Food and Drug Administration in the coming weeks. The Pfizer-BioNTech vaccine is now authorized by the FDA for emergency use for people aged 16 years and older.
“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 Chairman and CEO Albert Bourla, Ph.D., said in the news release. “We plan to submit these data to FDA as a proposed amendment to our Emergency Use Authorization in the coming weeks and to other regulators around the world, with the hope of starting to vaccinate this age group before the start of the next school year.”
In the phase 3 trial, the vaccine was 100 percent effective at preventing symptomatic illness within the trial, with 18 cases of COVID-19 in the group that received a placebo and none in the group that received the vaccine, the companies said. The vaccine triggered immune responses that were even more robust than those seen in young adults.
Last week, Pfizer-BioNTech also started a trial in younger children, aged 6 months to 11 years. That trial will first establish a safe dose in children 5 to 11 years, then in 2- to 5-year-olds, and then in children ages 6 months to 2 years, the companies said. Moderna is also conducting similar trials to test its COVID-19 vaccine in teenagers and young children. Its vaccine is authorized by the FDA for emergency use for people older than 18 years of age.