Pfizer and BioNTech say COVID-19 vaccine protects adolescents, plan to submit data to FDA
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Pfizer and BioNTech said Wednesday that their COVID-19 vaccine was highly protective among children aged 12 to 15 years in a phase 3 trial.
The companies said they plan to submit the data to the FDA “in the coming weeks” for a request to expand the vaccine’s emergency use authorization for use in the lower age group. Right now, the vaccine is authorized for use in people aged 16 years or older. It is the only COVID-19 vaccine authorized in the U.S. for any pediatric population.
“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, DVM, PhD, said in a statement.
Bourla said the goal of the FDA submission — and regulatory submissions elsewhere in the world, including Europe — is to be able to vaccinate children in this age group “before the start of the next school year.”
The trial enrolled 2,260 children aged between 12 and 15 years in the United States. According to a news release, there were 18 cases of COVID-19 in the placebo group (1,129 children) compared with none among 1,131 children in the vaccinated group.
The companies said the vaccine, BNT162b2, elicited SARS-CoV-2 neutralizing antibody geometric mean titers (GMTs) of 1,239.5 in study participants, “demonstrating strong immunogenicity in a subset of adolescents 1 month after the second dose.” That exceeded the response recorded in a trial of participants aged 16 to 25 years, in which GMTs were 705.1.
The companies also provided an update on a trial testing the vaccine among children aged 6 months to 11 years, reporting that the first healthy children started receiving doses last week.
“Across the globe, we are longing for a normal life,” BioNTech CEO and cofounder Ugur Sahin, MD, said in a statement. “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, which is very encouraging given the trends we have seen in recent weeks regarding the spread of the B.1.1.7 variant. It is very important to enable them to get back to everyday school life and to meet friends and family while protecting them and their loved ones.
Perspective
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The data are extremely exciting. They represent the first step toward ensuring that teenagers, particularly those at high risk for COVID-19 or its complications, could be vaccinated in the near future. It gives us even more confidence that as we go into summer and prepare for a fall school year, we may be able to vaccinate a substantial number of teenagers.
It’s remarkably reassuring that the safety profile and antibody responses mirror what we see in adults.
Perspective
Back to TopMonica Gandhi, MD, MPH
Although the Pfizer-BioNTech mRNA vaccine has been authorized by the FDA for use in children aged 16 years or older, it was not previously studied in those younger than 16 years. Today, the companies released preliminary findings from the study of the vaccine conducted among 2,260 participants aged 12 to 15 years in the U.S. Per the preliminary press release, the phase 3 trial enrolled 1,131 participants who got the vaccine and 1,129 participants who got a placebo shot. Participants were enrolled with or without prior evidence of SARS-CoV-2 infection, and the study found that 1) the Pfizer-BioNTech COVID-19 vaccine demonstrated 100% efficacy against symptomatic COVID-19 (eg, there were 18 COVID-19 cases, all among placebo recipients and none in those who got vaccine); and 2) the vaccine induced robust antibody responses, exceeding those recorded earlier in vaccinated participants aged 16 to 25 years, although CD4/CD8 responses were not mentioned in the press release. This high efficacy and immune responses from a younger population were expected and are good news in terms of being able to offer this vaccine to children aged 12 years or older before the fall school year.
Perspective
Back to TopPeter Hotez, MD, PhD, FASTMH, FAAP
I think it’s an important step for not only protecting adolescents from COVID-19 but also ensuring the safety of middle schools and high schools by the fall. If the stars align, meaning if the vaccine supply is adequate and we have the approvals and emergency use authorization, we can vaccinate potentially most adolescents over the summer. This can also help ensure we interrupt virus transmission by aiding in the full vaccination of the American people.
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