Pfizer has reported that its COVID-19 vaccine works well for children ages 5 to 11 and that it will soon be requesting authorization for its use in the United States for this younger age group.
According to Pfizer, kids between ages 5 and 11, were tested using a third of the amount that is currently in each vaccinations for anyone age 12 and up, and that after the children that were tested received a second dose of the vaccine the children developed COVID-19 fighting antibody levels as strong as teenagers and young adults getting the regular-strength shots.
Pfizer says it will apply to the Food and Drug Administration by the end of the month for emergency use in this age group.
Studies have shown that kids are at lower risk of COVID-related severe illness or death than older people and that more than 5 million children in the U.S. have tested positive for COVID-19 since the start of the pandemic. At least 460 have died, according to the American Academy of Pediatrics.
Pfizer said in a press release that its study included using a lower dose in 2,268 kindergartners and elementary school-aged kids. The FDA required what is called an immune “bridging” study: evidence showing clearly that the younger children developed COVID-19 antibody levels already proven to be protective in teens and adults.
“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.”
“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.”
Pfizer’s soon-coming request for emergency use approval for children ages 5-11 is likely to be met with opposition by those still not trusting the vaccination or that may believe full FDA approval is more appropriate and safer, especially for kids age 5-11.