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.
In the U.S., no COVID-19 vaccines have been approved for children under the age of 12, leaving many children and the adults who are in close proximity to them vulnerable during the most recent surge brought on by the delta variant.
National Institutes of Health Director Francis Collins on Sunday said he believed parents and teachers should be placed in the same category as health care workers in terms of COVID-19 risk, due to their close contact with children who are ineligible to be vaccinated.
In August, the number of pediatric hospitalizations in the U.S. due to COVID-19 reached a record high of nearly 2,000. While children are generally believed to be less likely to develop severe cases of the coronavirus, new variants continue to pose the potential threat of causing more severe symptoms.
This announcement comes shortly after an advisory panel for the FDA voted last week in favor of recommending a third dose of the Pfizer-BioNTech vaccine for people over 65 and in certain high-risk groups. The panel voted against administering a third dose to all vaccine-eligible people.
According to the Centers for Disease Control and Prevention, nearly 75 percent of the eligible population — ages 12 and up — has received at least one dose of a COVID-19 vaccine. Around 64 percent of those over the age of 12 are fully vaccinated.
--Updated at 7:46 a.m.