BOSTON – Results from a trial assessing the safety and efficacy of the Pfizer and BioNTech COVID-19 vaccine for children 5 to 11 years old showed “a favorable safety profile and robust neutralizing antibody response,” the drugmakers announced Monday.
The announcement that Pfizer will soon seek U.S. Food and Drug Administration approval for using its COVID-19 vaccine in people as young as 5 years old means the protection of a vaccine might become available to younger school children partway into their third academic year to be shaded by the pandemic.
“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. “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.”
Former FDA head Scott Gottlieb, a Pfizer board member who began advising Gov. Charlie Baker early in the pandemic, said this summer that he would expect a vaccine to become available to kids this winter.
“The FDA recently indicated that it’s unlikely to be available before midwinter because I believe that the FDA is likely to require at least six months of follow-up, four to six months of follow-up of the children in that clinical trial,” he said in July. “So that puts it more in the winter timeframe.”
The Pfizer vaccine in the trial was a 10-microgram vaccine, a smaller dose than the 30-microgram vaccine used for people who are 12 and older.