CHICAGO – After a study that took 2,268 child participants ages 6 months to 11 years of age, Pfizer says the COVID-19 vaccine is now safe for children ages 5-11.
Pfizer-BioNTech made the announcement in a press release this morning.
“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,” said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. “Since July, pediatric cases of COVID-19 have risen by about 240 percent in the U.S. – underscoring the public health need for vaccination. 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.”
The company reports participates ages 5 to 11 years old the vaccine was safe, well tolerated and showed robust neutralizing antibody response. Data for children under the age of 5 are expected as soon as 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. “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.”
To date, no COVID vaccines have been authorized or approved for children under 12.