Pfizer, BioNTech say vaccine generates 'robust' response in kids aged 5-11
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Pfizer and BioNTech said Monday that their COVID-19 vaccine was safe and generated “robust” neutralizing antibody titers in a phase 2/3 study of children aged 5 to 11 years old.
The responses were comparable to those generated in a previous study involving people aged 16 to 25 years, the companies said.
The companies said they plan to share data from the study with the FDA and European regulators “as soon as possible,” including in a submission to the FDA for emergency use authorization (EUA) of the vaccine in the younger age group.
The vaccine, branded as Comirnaty, was fully approved by the FDA last month for people aged 16 years or older. It has been available under an EUA for children aged 12 to 15 years since May.
Pfizer chairman and CEO Albert Bourla said in a statement that the recent rise in pediatric cases demonstrates the need for a vaccine for children. Representatives from Pfizer have said that the vaccine could be authorized for the younger age group by Halloween.
“These trial results provide a strong foundation for seeking authorization of our vaccine for children 5 to 11 years old, and we plan to submit them to the FDA and other regulators with urgency,” Bourla said.
The proposed regimen for children aged 5 to 11 years is two shots given 21 days apart — same as in older age groups. However, this population would receive smaller doses, according to the study, which included 2,268 children aged 5 to 11 years who received two 10 µg doses.
In the study, SARS-CoV-2–neutralizing antibody geometric mean titer (GMT) was 1,197.6 (95% CI, 1106.1-1,296.6) — a response the companies said was noninferior that seen among people aged 16 to 25 years who received two 30 µg doses in a previous study.
Bill Gruber, MD, Pfizer’s senior vice president of vaccine clinical research, said in an interview on The Today Show that athough no full efficacy data was included in the release, the company intended to submit the data to the FDA by the end of September.
“We're hopeful and expectant that the FDA will approve the vaccine based on the data that we have now,” Gruber said. “It makes sense because the level of antibody the vaccine is generating in children five to 11 matches the level of antibody that we know provides protection for individuals 16 years of age and older. The FDA set the guidance along those lines, that's their expectation, and we believe we've met that expectation.”
References:
Gruber, B. The Today Show. September 20, 2021.
Pfizer and BioNTech Announce Positive Topline Results From Pivotal Trial of COVID-19 Vaccine in Children 5 to 11 Years. https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-announce-positive-topline-results. Published Sept. 20, 2021. Accessed Sept. 20, 2021.
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