Company will submit data to FDA for approval
One factor holding economic recovery back is parents concerned for the wellbeing of their unvaccinated younger children. While more than 75% of American adults have received at least one dose of a COVID-19 vaccine, there hasn’t yet been one approved for kids younger than 12. That could soon change, though, as Pfizer says it has enough data to show that vaccinating kids aged 5-11 is safe and effective. Pfizer will seek authorization to get doses out.
“We intend to submit the data by the end of the month and then, of course, it will be up to the FDA to review that data and determine whether the vaccine can be released for broad use,” Dr. Bill Gruber, Pfizer’s senior vice president of vaccine clinical research and development, as well as a pediatrician, told NBC’s “TODAY” show. “We hope that will go expeditiously.”
Pfizer and vaccine developer BioNTech said their trials showed their mRNA vaccine is “safe, well tolerated, and showed robust neutralizing antibody responses” in the 5-11 population in a trial of 2,000 children. More than 12 million kids — about 54% — aged 12-17 in the U.S. have had at least one dose, the American Academy of Pediatrics reported Sept. 15.
“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,” Pfizer CEO Albert Bourla said in a press release. “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.”
Approval could come by the end of October, just in time for winter cold and flu season, and push the U.S. closer to halting the pandemic.