Pfizer/BioNTech says its COVID-19 vaccine is good to go for children ages 5 to 11 after its own study, with plans to seek approval from the Food and Drug Administration and other agencies soon.
On Monday, the company issued its first test results from this age group, reporting that there was a "favorable safety profile and robust neutralizing antibody responses" in the kids, using a smaller dose in the two shots than older people would receive (10 µg instead of 30 µg). They said the results showed the "vaccine was safe, well-tolerated" among children.
Pfizer earned FDA approval for its vaccine among people ages 16 and up last month. The vaccine is still under emergency use approval for kids aged 12 to 15 as the FDA continues to fully vet the shot.
"Over the past nine months, hundreds of millions of people ages 12 and older from around the world have received our COVID-19 vaccine. 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," Albert Bourla, chairman and CEO of Pfizer, said in a statement.
"Since July, pediatric cases of COVID-19 have risen by about 240 percent in the U.S. — underscoring the public health need for vaccination," Bourla continued. "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."
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Today with @BioNTech_Group, we are proud to announce positive topline results from the pivotal trial of our #COVID19 vaccine in children 5-11 years of age. https://t.co/a1mSEgxNHQ pic.twitter.com/9xGfYEzFuy
— Pfizer Inc. (@pfizer) September 20, 2021
Results from the other two age groups from the trial (children 2 to 5 years and children 6 months to 2 years) are expected later this year.
"We are pleased to be able to submit data to regulatory authorities for this group of school-aged children before the start of the winter season," said Dr. Ugur Sahin, CEO and co-founder of BioNTech, in a statement. "The safety profile and immunogenicity data in children aged 5 to 11 years vaccinated at a lower dose are consistent with those we have observed with our vaccine in other older populations at a higher dose."
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