Pfizer on Monday said its COVID-19 vaccine is safe and generated a “robust” antibody response in children aged 5 to 11, a positive sign as parents clamor to protect their children against the virus.
The company said its data were from a study of 2,200 children who received two doses, three weeks apart. Each dose contained about 10 micrograms, or about one-third of the dosage for teens and adults.
Pfizer said it will submit its data to the Food and Drug Administration as soon as possible. It must complete the trials and submit efficacy results later this year.
“Over the past nine months, hundreds of millions of people ages 12 and older from around the world have received our COVID-19 vaccine,” Pfizer CEO Albert Bourla said. “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’s vaccine is available to people aged 12 and older. Versions from Moderna and Johnson & Johnson are available to adults.
“We are pleased to be able to submit data to regulatory authorities for this group of school-aged children before the start of the winter season,” said Dr. Ugur Sahin, CEO and co-founder of BioNTech, the German company working with Pfizer. “The safety profile and immunogenicity data in children aged 5 to 11 years vaccinated at a lower dose are consistent with those we have observed with our vaccine in other older populations at a higher dose.”
Many parents are eager to get their children vaccinated because schools and fall activities have resumed. Hospitalizations in kids have surged under the delta variant of the virus. Yet severe illness and death remain relatively rare overall, so some parents might be leery.
Roughly half of eligible adolescents and teens ages 12 to 17 have been vaccinated in the U.S.
Former FDA Commissioner Scott Gottlieb said the data on the younger group is “encouraging.”
“It’s going to be submitted to the FDA very quickly. Subject to the FDA’s careful review of vaccine for children ages 5 to 11, it could be available as soon as the end of October,” he told MSNBC’s “Morning Joe.”
Dr. Gottlieb, who sits on Pfizer’s board, said the company found a dosage that produced the type of antibody response seen in adults while causing fewer side effects such as arm pain or fever.
“The company wanted to find a dose that would be very tolerable in young kids while still providing adequate efficacy, efficacy on par with what we were seeing in the older populations,” he said.
Pfizer did not report any instances of myocarditis, a rare heart condition that’s been linked to the vaccine in young people at times, although it is a rare event and the trial had a limited about of people.
Pfizer said it is studying its vaccine in two other cohorts — ages 2 to 5 years old and 6 months to 2 years old— and hopes to report results later this year.