The federal agency published its analysis of the drug on its website ahead of a Wednesday meeting, when its Vaccine and Related Biological Products Advisory Committee is to consider amending emergency authorizations for Pfizer-BioNTech and Moderna vaccines to allow young children to be inoculated against the coronavirus.
Last week, the regulators posted documents stating the Moderna vaccine appears safe for children under the age of 6.
“Available data support the effectiveness of the Pfizer-BioNTech COVID-19 Vaccine three-dose primary series … in preventing COVID-19 in the age group of 6 months through 4 years,” it said.
The report underscored the benefit of a vaccine for those in this demographic, stating rates of hospitalization and death due to COVID-19 are higher among young children than adolescents 5 through 17 years of age and comparable to those 18-25.
“Given the uncertainty of the COVID-19 pandemic and likelihood of continued SARS-CoV-2 transmission during the ensuing months, deployment of the vaccine for use among children 6 months through 4 years of age will likely have a beneficial effect on COVID-19-associated morbidity and mortality in this age group,” it said.
SARS-CoV-2, which means severe acute respiratory syndrome coronavirus 2, is the official name of the virus that causes COVID-19.
The vaccine regimen proposed consists of the first two doses being administered three weeks apart followed by a third dose at least eight weeks after the second dose.
According to the document, Pfizer-BioNTech submitted data of a trial of 1,415 children who received the three-dose regimen and shows the drug has a vaccine efficiency of 80.4%, producing 10 COVID-19 cases, seven of which were from the placebo group.
If the advisory panel recommends amending the emergency authorization, approval from the U.S. Centers for Disease Control and Prevention is expected to soon follow.
Dr. Ashish Jha, the Biden administration’s COVID-19 response coordinator, has said that they have “plenty of supply” of both vaccines and are working on a plan to get kids inoculated.
On Thursday, he said the inoculation drive in earnest could begin June 21 and ramp up in the days and weeks that follow.
If both the FDA and CDC sign off on the vaccines, it would mark an “important moment” in the United States’ fight against the pandemic, he said.
“We have waited a long time for this moment,” he said. “It would mean that for the first time, essentially every American, from our oldest to our youngest, would be eligible for the protection that vaccines provide.”
