Source: Zachary Stieber
The U.S.-based pharmaceutical company and its German partner BioNTech sent the request to the Food and Drug Administration (FDA) about a week after submitting data they said showed the vaccine triggered antibody responses in children in a Phase 2/3 clinical trial. Full results for the trial, which is run by the companies, have not yet been released.
“With new cases in children in the U.S. continuing to be at a high level, this submission is an important step in our ongoing effort against COVID-19,” Pfizer said in a statement.
Pfizer’s shot is already authorized for children aged 12 to 17 and approved for adults 18 and older, though the approved version isn’t yet available in the United States.
Some experts and parents are pushing for a shot for younger children, arguing they can pass on the virus that causes COVID-19 to others even if they are at little risk of severe disease themselves. But opponents note the low risk and the elevated chances kids have of suffering heart inflammation if they get a vaccine. Some European countries are now recommending just one dose of the vaccines like Pfizer that utilize messenger RNA technology because of side effects.
Pfizer’s trial gave children a two-dose regimen of 10 micrograms each while older populations were given doses of 30 micrograms each. The lower dosage “was carefully selected as the preferred dose for safety, tolerability and immunogenicity in children,” Pfizer and BioNTech said last month.
Dr. Janet Woodcock, the acting commissioner of the FDA, said recently that the vaccine “may need a different dosage or formulation from that used in an older pediatric population or adults.”
“We know from our vast experience with other pediatric vaccines that children are not small adults, and we will conduct a comprehensive evaluation of clinical trial data submitted in support of the safety and effectiveness of the vaccine used in a younger pediatric population,” she said.
The agency’s vaccine advisory panel will meet on Oct. 26 to go over the efficacy and safety data. A meeting of the Centers for Disease Control and Prevention’s (CDC) vaccine advisory committee on the matter has not yet been scheduled.
White House COVID-19 response coordinator Jeffrey Zients said on CNN the new request could be granted before Thanksgiving.
“We will be ready as soon as the CDC and the FDA give the go ahead,” he said. “We are ready. We have the supply. We’re working with states to set up convenient locations for parents and kids to get vaccinated including pediatricians’ offices and community sites.”
The submission comes after new studies show Pfizer’s vaccine sharply wanes in effectiveness against infection and severe disease over time. In addition, a trio of scientists from the company were recently recorded acknowledging that natural immunity, or the protection bestowed from getting COVID-19 and recovering, is similar to or better than the protection from the company’s vaccine.
COVID-19 is the disease caused by the CCP (Chinese Communist Party) virus.