FDA panel could pave way for coronavirus vaccines for kids

A key Food and Drug Administration (FDA) expert advisory panel on Tuesday could pave the way for children as young as 5 to get vaccinated against the coronavirus.

The panel is poised to weigh the evidence and provide the FDA with a recommendation to inform its decision on whether to authorize the vaccine from Pfizer and its German partner BioNTech for children. An estimated 28 million children would be eligible to receive the vaccine. 

Extending vaccine eligibility to children younger than 12 has been a major goal of public health officials and eagerly awaited by many pediatricians and families. The FDA has been under pressure for months to move quickly to authorize vaccines for younger children, one of the final barriers to overcome in the country’s historic vaccination campaign.  

Pfizer’s vaccine is already authorized for adolescents over 12 years old, and approved for anyone over 18, but many parents have been waiting anxiously for the ability to protect younger children, especially as the delta variant has proved far more contagious and dangerous for them.

Pfizer submitted data to the FDA in late September, and formally asked for emergency use authorization earlier this month. An agency review of the data published late Friday found that the benefits of the vaccine “clearly outweigh the risks,” indicating that FDA scientists have a favorable view of the evidence.

A decision by agency regulators is expected in the days following the meeting; a Centers for Disease Control and Prevention (CDC) panel is scheduled to meet Nov. 2 and 3 to recommend how the vaccines should be used. 

If the panel gives favorable recommendations and CDC Director Rochelle Walensky accepts them, the vaccination campaign would begin.

“It would be good to start getting that vaccine in the children’s arms as quickly as possible, because kids remain the last big unvaccinated reservoir of infection in the country, apart from adults who choose for various reasons not to take the vaccine,” said Philip Landrigan, a pediatrician and professor at Boston College. 

Although the mortality rate and risk of severe COVID-19 is substantially lower in children than in adults, experts said parents shouldn’t hesitate to vaccinate their children as soon as possible. More than 600 kids have died since the start of the pandemic

In addition, schools across the country reopened just as the highly contagious delta variant became the dominant strain, which has changed the calculus. 

“We’ve seen a huge surge in the number of kids being hospitalized with COVID, ending up in the ICU with COVID, developing long COVID symptoms,” said Kawsar Talaat, a vaccine researcher at the Johns Hopkins Bloomberg School of Public Health and a principal investigator of Pfizer’s pediatric trial.

Talaat said parents who might be hesitant about the safety of the shot should be reassured by how well it has performed in adults.

“I think the message you have for parents is that very few of our pediatric vaccines have gone into hundreds of millions, if not close to a billion adults at this point, worldwide … with a very large and established safety record,” Talaat said. “And so that should be reassuring that this is a vaccine that has been tested and put under a microscope that no other vaccine ever has.” 

A study from Pfizer released as part of its panel briefing document last week showed that smaller doses of its COVID-19 vaccine for children ages 5 to 11 appear safe, and are nearly 91 percent effective at preventing symptomatic disease.

Pfizer said vaccinating children in that age group “could prevent harms” including interruption of education, hospitalization, severe illness, long-term consequences, and death. 

“In addition, vaccinating this population will likely reduce community transmission, including transmission to older and more medically vulnerable individuals,” the company said.

Despite the broad public health benefits described by the company, and the pressure on FDA from parents, advocacy groups and lawmakers, the advisory panel’s discussion may not be straightforward.

Leana Wen, an emergency physician and public health professor at George Washington University, said some panel members may be uncomfortable with the relatively small size of the clinical trial, which enrolled only about 2,300 children ages 5 to 11.

“There will probably be some advisors who will argue in favor of collecting more data,” Wen said. “But the need for more data needs to be balanced with the urgency of getting vaccines available for children, and I hope at the end of the day that this urgency will drive matters, as everything is weighing the risks versus the benefits.”

The advisers are likely to discuss cases of myocarditis or heart inflammation, a rare side effect associated with the vaccine. The clinical trial did not find any cases of the condition, but the condition is rare enough that it might not be found unless a larger group was tested.

Talaat said the trial would have to be enormous to track such a rare condition. 

“You won’t find a rare signal in a study like this, because you need hundreds of thousands, if not millions of children to participate,” she said.  

Cases of myocarditis are generally more common in teenage males between the ages of 16 and 19. It’s less common in adolescents, and Pfizer said the rates will likely be even lower in young kids 5 to 11 years old.

The FDA’s analysis noted that even in the rare cases where a person was hospitalized with vaccine-caused myocarditis, the condition was easily treated and resolved in a few days with no long-term consequences. 

Unvaccinated people carry a higher risk of hospitalization and death if they contract COVID-19.