Pfizer has submitted a request to federal regulators for emergency authorization of its coronavirus vaccine for children ages 5 to 11.
It’s estimated that more than 28 million children would become eligible if the request is approved.
Food and Drug Administration officials are expected to begin considering the application for the vaccine, which was developed alongside German company BioNTech, and have scheduled a meeting for later this month.
With school reopenings contributing to an uptick in COVID-19 diagnoses, many have expressed a desire for vaccines for children.
“Over the past nine months, hundreds of millions of people ages 12 and older from around the world have received our COVID-19 vaccine,” Albert Bourla, Pfizer chairman and CEO, said last month after a clinical trial reportedly found that the vaccine was safe and generated a “robust antibody response” in children ages 5 to 11.
The September study counted as the first such results released for that age group for a 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,” Bourla said. “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.”