FDA Advisory Panel Endorses Pfizer Vaccine for Children 5 to 11

A Food and Drug Administration (FDA) advisory panel on Tuesday voted to recommend authorizing the Pfizer COVID-19 vaccine for children ages 5 to 11.

If the FDA agrees to authorize the shot—and it gets an official recommendation from Centers for Disease Control and Prevention (CDC)—around 28 million children would become eligible, closing a major gap in the efforts to vaccinate the U.S. population. Pediatric shots could be distributed as early as the beginning of November.

More than 1.9 million children between 5 and 11 have been infected with COVID-19, according to FDA data presented at the panel. More than 8,300 have been hospitalized, a third of them required intensive care, and nearly 100 died.

The Pfizer vaccine is nearly 91% effective at preventing severe disease and death in this age group, according to data from both Pfizer and the FDA. The common side effects align with those experienced by adolescents.

Although the FDA voted 17-to-0 with one abstention, the panel had a lengthy debate on the risk of myocarditis—a rare inflammatory heart disease that has been linked to both COVID-19 and the vaccines. Some panelists expressed concern about authorizing the vaccine for all children in this age group, saying only those at high risk of COVID-19 should be eligible.

Ultimately, however, they determined that the benefit of allowing some children to get the shot was greater than the potential risk.

Why Pediatric Shots Are Needed

While the risk of serious outcomes like long COVID and death is lower for children than for adults, infections can lead to troubling complications like multisystem inflammatory syndrome (MIS-C). And sick children can spread the disease to those more vulnerable to infection.

“Even in asymptomatic individuals who have experienced this disease, there are outcomes one would not necessarily want for their children,” said Hayley Gans, MD, an FDA panelist and pediatrics professor at Stanford University Medical Center.

Compared to June and July, August and September saw a 419% increase in pediatric COVID-19 cases. In the first half of 2021, COVID-19 was a top 10 leading cause of death for children aged 5 to 14, according to data presented by Pfizer.

Given the prevalence of asymptomatic cases in children, antibody tests indicate that children are at least as likely as adults to be infected, though cases are often publicly underreported, according to Fiona Havers, MD, MHS, medical officer for the CDC COVID-19 epidemiology task force.  

Weighing Risks Against Benefits

Pfizer requested authorization for a dose that's one-third of what's given to adults and teenagers. If authorized, eligible children can receive two shots, administered three weeks apart.

Some FDA panelists noted that certain long-term effects of the vaccines hadn’t yet been tested. The company hasn't tested how long the immune response will last based on memory cells, nor how vaccines will affect viral transmission, said William Gruber, MD, senior vice president for vaccine clinical research and development at Pfizer.

In a discussion ahead of the vote, panelists worried about making a yes or no decision with little flexibility to add nuance to the recommendation.

“It's always nerve-racking when you're asked to make a decision for millions of children based on studies of only a few thousand children,” said Paul Offit, MD, a panelist and professor of pediatrics at the Children’s Hospital of Philadelphia.

“You never know everything—the question is when you know enough,” Offit added. “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 be hospitalized or die from it.”

The panel focused heavily on the risk of myocarditis from the vaccine. The rare side effect has been linked to the COVID-19 vaccines and is most commonly reported in younger men.

When viral transmission is very low, the risk of vaccine-related myocarditis may be slightly higher than the risk of contracting COVID-19, an FDA team found. However, research indicates that vaccine-related myocarditis typically resolves after a few days in adolescents. Meanwhile, COVID-19 infections can lead to death or long-term complications.

None of the participants in Pfizer's clinical trial experienced myocarditis, severe allergic reaction, or death. No myocarditis cases linked to the vaccines and reported to the CDC have resulted in death.

In general, the study participants reported side effects at similar or lower levels than teens and adults. The most common side effects after the second dose of the vaccine included fatigue, headache, muscle aches. Chills and fever were reported less frequently compared to other age groups.

Several members of the public commented at the panel, many sharing stories of children and adolescents who experienced adverse effects from the vaccine. The FDA also received nearly 140,000 comments prior to the vote. By comparison, only 96 people submitted comments for the previous meeting on Pfizer's booster dose.

The government runs several safety monitoring systems, including the Vaccine Adverse Event Reporting System. Peter Marks, MD, PhD, director for the Center of Biologics Evaluation and Research says regulators are committed to closely watching these monitors and change the authorizations if needed.

“It really is going to be a question of what the surveillance issues are,” said Eric Rubin, MD, PhD, a panelist and adjunct professor at the Harvard TH Chan School of Public Health. “We're never going to learn about how safe the vaccine is unless you start giving it.”

Concerns About Vaccine Rollout for Kids 5-11

FDA officials aren’t required to follow the panel’s vote, though they often do. A CDC panel will meet next week to discuss whether to recommend vaccinating this age group.

Though the CDC cannot broaden the eligibility requirements set by the FDA, it can make them stricter.

“There are high-risk individuals and I think they do need to be attended to—we do need to provide a vaccine for them,” Steven Pergam, MD, MP, MPH, medical director at the Seattle Cancer Care Alliance, said. He added that others should have the option to get one or no dose and “they may not need anything more."

In an FDA survey conducted through August, 37% of children aged 5 to 11 who were hospitalized for COVID-19 were Black non-Hispanic, 31% were Hispanic, and 22% were White.

Given these stark disparities, James Hildreth, PhD, MD, panelist and president of Meharry Medical College in Nashville, said he voted yes to ensure the vaccine is available to “kids who really need the vaccine—primarily the Black and Brown children in our country.”

H. Cody Meissner, MD, a panelist and chief of the Division of Pediatric Infectious Diseases at Tufts Children’s Hospital, said that while he voted yes, he was concerned that authorization would lead to some state governments imposing vaccine mandates for school-aged children.

“I think that would be an error at this time, until we get more information about the safety,” Meissner said.

With the ongoing pandemic, schools are stuck making difficult decisions about how to keep students safe while promoting in-person learning. Oveta Fuller, PhD, a panelist and associate professor of microbiology and immunology at the University of Michigan, emphasized the importance of pediatric vaccination to minimize the effects of school closures and other pandemic-related disruptions on children’s mental health and well-being.

“I certainly believe that in hindsight, when we look back on this decision, giving parents the option to make that decision for themselves will be something that in history, we will be glad that we were able to do,” Fuller said.