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Pfizer and BioNTech announced on Monday that their COVID-19 vaccine is safe in children ages 5-11 years and produces a significant immune response.
Investigators tested the vaccine in 2,268 children using 10 microgram (μg) doses administered 21 days apart. The dose is one-third of the amount given to people ages 12 years and older.
Pfizer reported phase 2 and 3 trials showed SARS-CoV-2 neutralizing antibody geometric mean titer was about 1,198 compared to 1,147 in people ages 16 to 25 years. Pfizer said the doses were “well tolerated, with side effects generally comparable to those observed in participants 16 to 25 years of age.”
“We are eager to extend the protection afforded by the vaccine to this younger population, subject to regulatory authorization, especially as we track the spread of the Delta variant and the substantial threat it poses to children,” Pfizer Chairman and CEO Albert Bourla, D.V.M., Ph.D., said in a press release Monday.
The data have not been peer-reviewed or published in a medical journal. They come as nearly 226,000 children were diagnosed with COVID-19 during the week ending Sept. 16, the third highest weekly count since the start of the pandemic, according to data from the AAP and Children’s Hospital Association. Children made up about 26% of all COVID-19 cases last week.
“We are encouraged by Pfizer-BioNTech’s announcement and look forward to reviewing the data from the clinical trial,” said AAP President Lee Savio Beers, M.D., FAAP.
Dr. Beers has repeatedly stressed that in addition to impacting the physical health of the more than 5.5 million children who have been diagnosed, the pandemic also has caused emotional suffering and disruptions to children’s education.
Pfizer said it plans to submit its pediatric data to the Food and Drug Administration (FDA) for emergency use authorization (EUA) soon.
The Pfizer-BioNTech COVID-19 vaccine is FDA-approved for those ages 16 years and older. It also can be used for adolescents ages 12-15 years under EUA.
About 54% of adolescents ages 12-17 years have received at least one dose of COVID-19 vaccine and 43% are fully vaccinated, according to an AAP analysis of CDC data.
Federal health officials recently approved emergency use of a third dose of the Pfizer-BioNTech or Moderna vaccines for people who are immunocompromised. Last week, an FDA committee also recommended Pfizer-BioNTech boosters for individuals 65 years and older and those at increased risk of severe COVID-19. The acting FDA commissioner is expected to weigh in on that recommendation this week. A Centers for Disease Control and Prevention (CDC) vaccine panel will discuss booster doses when it meets on Wednesday and Thursday.
Pfizer said it could release vaccine trial results for children under 5 years later this year.