FDA Committee Endorses Pfizer COVID-19 Vaccine for Kids 5-11 | Health News

The Food and Drug Administration’s vaccine advisory committee on Tuesday overwhelmingly endorsed a smaller dose of the Pfizer COVID-19 vaccine for kids ages 5-11, a key step in getting shots to the 28 million children in the age group.

The committee decided that the benefits of the vaccine outweigh the risks for the age group. Many members said the shot would be important to continuing in-person learning for children. On the other hand, some cited the increased risk of myocarditis, a rare condition of heart inflammation that has been linked to the Pfizer and Moderna shots, as a concern. Others expressed worry that authorization of the vaccine in this age group could lead to vaccine mandates from schools.

The FDA doesn’t have to follow the committee’s recommendations, though it usually does. The Centers for Disease Control and Prevention’s vaccine advisory committee meets next week to consider the shot. If the CDC director accepts the recommendations, the shots can begin.

The Biden administration has already published its plan to distribute the shots should they gain authorization. It includes sending the shots to more than 25,000 pediatric offices and other primary care sites, over 100 children’s hospital systems and tens of thousands of pharmacies. Hundreds of schools and community-based clinics will also get the shots.

In documents filed with the FDA, Pfizer said that its vaccine is nearly 91% effective against symptomatic infection in the age group. Pfizer proposes the two-dose series to be administered three weeks apart.

Pfizer studied shots for children ages 5-11 that are approximately one-third the dosage given to adults. The smaller dosage was “carefully selected as the preferred dose for safety, tolerability and immunogenicity in children 5 to 11 years of age,” the company said in a press release. The company said side effects for children are “generally comparable to those observed in participants 16 to 25 years of age.”

While kids generally don’t get severe cases of COVID-19 as often as older populations, they can still get seriously ill and die from the disease. More than 600 children in the U.S. have died from the disease, according to CDC data. Coronavirus cases in children peaked in September as many parents sent their kids back to school. While infections are down, kids still make up over 25% of new cases, according to a recent report.