FDA Panel Recommends Pfizer Vaccine for Children 5 to 11

The lower-dose vaccine was deemed safe and highly effective at preventing symptomatic Covid-19 infections in young children

A young girl pointing to a bandaid on her left arm and smiling with parents in background
The Food and Drug Administration And Centers for Disease Control and Prevention are likely to authorize the vaccine for young kids within the next few days. VioletaStoimenova via Getty Images

A panel of independent advisers to the Food and Drug Administration (FDA) recommended yesterday that regulators authorize a lower-dose version of the Pfizer-BioNTech Covid-19 vaccine for 5- to 11-year-olds. The announcement brings about 28 million children closer to being vaccinated against Covid-19, a move many parents and public health officials have been eagerly awaiting.

The FDA panel reviewed Pfizer's study of 1,518 children who received two doses of the 10-microgram vaccine and found the vaccine was around 91 percent effective in preventing symptomatic Covid-19 infections in young kids, according to Matthew Herper and Helen Branswell for STAT. The Pfizer vaccine for young children contains one-third the dose of an adult shot and would be given 21 days or more after their first shot. The company’s lower-dose vaccine prompts a strong immune response while minimizing side effects, according to Pfizer.

“We don’t want children to be dying from Covid, even if it is far fewer children than adults, and we don’t want them in the ICU,” said Amanda Cohn, a panel member and Centers for Disease Control and Prevention (CDC) vaccine official, during yesterday’s virtual committee hearing. She noted that Covid-19 is “the eighth-highest killer of kids in this age group over the past year.”

The panel’s vote was  nearly unanimous with a total of 17 in favor and one abstention. Experts anticipate the FDA and CDC will issue their final approval decision within the next few days. Though children are less likely to become infected and seriously ill from Covid-19, the spread of the Delta variant increased pediatric cases. Around 8,300 children between 5 and 11 have been hospitalized with Covid-19 and nearly 100 have died since the beginning of the pandemic. Others have had lingering symptoms dubbed “long Covid” months after infection. The rate of hospitalization is three times higher among children of color than among white children, reports Joe Neel for NPR.

Some panel members expressed concern about limited clinical trial data, along with the risk of a rare heart condition called myocarditis, which has been tied to the mRNA-based Pfizer and Moderna vaccines, particularly in younger men. Some young trial participants had mild side effects, like headaches, fatigue, or pain at the injection site. Researchers found no cases of myocarditis in Pfizer’s studies of young children, and the committee felt the protection provided by the Covid-19 vaccine outweighed the risk of complications.

“The question is, when do you know enough?” said Paul Offit, a voting panel member who heads the Vaccine Education Center at Children’s Hospital of Philadelphia. “We certainly know that there are many children between 5 and 11 years of age who are susceptible to this disease who could very well be sick and/or hospitalized, or die from it.”

As of May 2021, kids aged 12 to 15 have been eligible to receive Pfizer’s FDA-approved Covid-19 vaccine, and 46 percent of that population have been fully vaccinated, compared with about 69 percent of adults, report Sharon LaFraniere and Noah Weiland for the New York Times. Public health officials emphasize that the best way for adults and parents to protect children is to be fully vaccinated. Some 65 million Americans eligible for the vaccine have failed to get inoculated—more than twice the number of young children that would have access to the Pfizer jab under the recent recommendation.

"It just seems to me in some ways we're vaccinating children to protect the adults," said James E.K. Hildreth, the president and chief executive of Meharry Medical College. "It should be the other way around."