The COVID vaccine made by Pfizer and BioNTech appears to work in children as young as 12 years old. That news comes from results from a study the company conducted in volunteers aged 12 to 15, reports here suggest
The vaccine was 100% effective in protecting against symptomatic disease in a study of more than 2,200 children, the companies said. Researchers also didn’t find any safety concerns. The Pfizer-BioNTech vaccine was safe and effective in adolescents as young as 12, the drug companies announced in a joint news release last week.
New clinical trials showed that Pfizer’s COVID-19 vaccine elicits “100% efficacy and robust antibody responses” in adolescents from 12 to 15 years old, the drug company announced last week. The trial included 2,260 participants; the results are even better than earlier responses from participants ages 16 to 25.
Pfizer and its vaccine partner BioNTech said they will submit the results “as soon as possible” to the U.S. Food and Drug Administration and the European Medicines Agency, asking regulators to expand their authorizations for the vaccine’s use in young people.
Pfizer will submit the data “in the coming weeks,” Pfizer CEO and Chairman Albert Bourla said in a news release about the trial. Calling the results encouraging, he added that the company is acting “with the hope of starting to vaccinate this age group before the start of the next school year.”
The Covid-19 vaccine from Pfizer Inc. and BioNTech SE safely protects children between the ages of 12 and 15, the companies said, results likely to lead to inoculations within that age group before this summer.
Data from a trial of the vaccine in nearly 2,300 people between the ages of 12 and 15 will be submitted to the Food and Drug Administration in the coming weeks, with the hope that vaccinations could begin before the next school year.
“Across the globe, we are longing for a normal life. This is especially true for our children. The initial results we have seen in the adolescent studies suggest that children are particularly well protected by vaccination,” said Ugur Sahin, chief executive of BioNTech, the German company that developed the vaccine in partnership with U.S. pharmaceutical giant Pfizer.
The findings, though expected, were much anticipated by parents, health authorities and school officials. They have been waiting for signs on when vaccines that adults have been getting could also be made available to children.
Like other authorized vaccines, the Pfizer-BioNTech shot hasn’t yet been cleared for use in adolescents under 16 years of age. Health experts say children will need to be vaccinated for a population to move past pandemic restrictions, like masking and physical distancing.
The vaccine was 100% 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.
The data is the beginning of what many families, eager for normalcy to return, have been waiting to see. The Pfizer-BioNTech vaccine is currently authorized by the FDA for emergency use for people 16 and older. If regulators extend the authorization to younger age groups, Pfizer chief executive Albert Bourla said that vaccinations could begin before the school year.
Last week, Pfizer-BioNTech also started a trial in younger children, ages 6 months to 11 years. That trial will step down in age, establishing a safe dose first in children 5 to 11, then in 2- to 5-year-olds and then in children from 6 months to 2 years.
U.S. biotech firm Moderna is also conducting similar trials to test its coronavirus vaccine in teenagers and young children. Its vaccine is authorized by the FDA for emergency use for people over age 18.
Moderna, whose COVID-19 vaccine is authorized for people 18 and older in the U.S., is also testing its vaccine in adolescents; it announced a trial of around 3,000 participants from 12 to 18 years old in December. Moderna also said earlier this month it had administered the first doses of its vaccine to young children in a separate study that involves kids from 6 months to less than 12 years old.
Johnson & Johnson, whose vaccine got U.S. authorization one month ago, has also been moving to include children in clinical trials. The company will test the vaccine in only a small number of adolescents initially, with plans to expand the study if it is shown to be safe, according to a spokesperson at Janssen, the Johnson & Johnson subsidiary that developed the vaccine.