Children ages 5 to 11 were cleared for the emergency use authorization of Pfizer’s Covid-19 vaccine by the US Food and Drug administration advisory committee on Tuesday. The FDA’s Vaccine and Related Biological Products Advisory Committee voted 17-0, with one abstention, and agreed to the benefits of vaccinating young children whose benefits appeared to outweigh risks.
The FDA will take the committee’s vote under consideration and is likely to extend the vaccine for younger children soon. Pfizer’s vaccination for children under 12 will be one-third of the adult dose which is said to protect children against symptomatic infection.
"It is reassuring to me that we are giving a lower dose," said Dr. Paul Offit, who directs the Vaccine Education Center at Children's Hospital of Philadelphia.
Like adults, the full vaccination series will come in a series consisting of two doses administered three weeks apart. Children's doses will come in vials with an orange cap and label. Doses for adults and children are packaged in vials with purple caps and labels. Currently, Pfizer’s vaccines are authorized for youth aged 12-17.
"We think that we have optimized immune response and minimized reactions," Pfizer Senior Vice President William Gruber said.
Authorities hope it will cause fewer side effects. An issue in discussion was the theoretical risk of myocarditis, an inflammatory heart condition seen in people who received Pfizer and Moderna vaccinations and is more common among men. At this point, it is unclear whether children are at risk for this cognition as not enough studies have been conducted.
"We've identified a lower dose which we expect is going to decrease the frequency of the rare side effect of myocarditis," said Dr. Arnold Monto, chairman of the committee and a professor of epidemiology at the University of Michigan.
"I am just worried that if we say yes, then the states are going to mandate administration of this vaccine for children to go to school and I do not agree with that," said Dr. Cody Meissner, a professor of pediatrics at Tufts University School of Medicine. "I think that would be an error at this time."
The risk is unlikely according to Dr. Peter Marks who is the head of the FDA’s vaccine research at The Center for Biologics Evaluation and Research. Pfizer reports clinical trials showed the vaccine was more than 90 percent effective in preventing symptomatic infection in children.
Advisors to the US Centers for Disease Control and Prevention will convene on Nov. 2-3 to discuss and decide whether to recommend that kids in the United States get the vaccine.
