Pfizer on Monday announced that testing showed that its COVID-19 vaccine was “safe” and “well tolerated” by children ages 5 to 11, and “robust neutralizing antibody responses” were observed.
The pharmaceutical company said that a “favorable safety profile” had been observed in its trial of the vaccine among children under the age of 12. For its trial, the company used doses a third of what is administered to people ages 12 and up.
“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.
“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 [Food and Drug Administration (FDA)] and other regulators with urgency,” he added.
Pfizer’s trial included 2,268 participants between the ages of 5 and 11. According to the company, the doses resulted in side effects comparable to what was observed among the trial for patients ages 16 to 25. It also said that it expects to include its results in an upcoming submission to the FDA for emergency use authorization.