Pfizer and BioNTech have asked the U.S. Food and Drug Administration to approve their COVID-19 vaccine for use in children ages 5 to 11, Pfizer announced this morning. If the FDA approves an emergency use authorization, it would be the first time a COVID-19 vaccine was available for children younger than 12.
“With new cases in the U.S. continuing to be at a high level, this submission is an important step in our ongoing effort against #COVID19,” Pfizer said in an announcement on Twitter this morning. “We’re committed to working with the FDA with the ultimate goal of helping protect children against this serious public health threat.”
Since the delta variant’s rise in Mississippi in mid-summer, cases have surged among children, and the child death toll has tripled. Of the nine children in the state confirmed to have died from a novel coronavirus infection, six of those deaths happened on or after July 25, 2021, including the death of an infant less than a year old last month. All children who have died of COVID-19 in Mississippi this year were either unvaccinated or ineligible for vaccination.
Among Mississippians under 18 who are eligible for vaccination, 30% of children between the ages of 12 to 15 are now vaccinated along with 34% of those between the ages of 16 and 17.
Pfizer and BioNTech, its German partner, submitted data to the FDA last month showing that “a favorable safety profile and robust neutralizing antibody response in children 5 to 11 years of age” with doses of the Pfizer vaccine spread 21 days apart.
“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,” Dr. Ugur Sahin, CEO and co-founder of BioNTech, said in a Sept. 20 press release.
The FDA is expected to meet and consider authorizing emergency use for the vaccine in the 5 to 11 age group later this month. Pfizer says it expects to release data on trials in children younger than five in the fourth quarter.
