FDA panel endorses vaccines for younger children

A key Food and Drug Administration (FDA) expert advisory panel on Tuesday recommended the agency authorize Pfizer’s COVID-19 vaccine for use in children between the ages of 5 and 11, bringing those children one step closer to getting a shot.

The Vaccines and Related Biological Products Advisory Committee (VRBPAC) found that the benefits of the vaccine outweighed its risks and voted nearly unanimously 17-0 — with one abstention — to recommend the agency authorize the shot.

The FDA is not bound to follow the panel’s recommendation, though it often does.

Significance: Extending vaccine eligibility to children younger than 12 has been a major goal of public health officials and has been 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.

Safety: There were some concerns about monitoring the safety profile of the vaccine, because of the potential for an extremely rare but serious condition called myocarditis, or heart inflammation. Cases of myocarditis are generally more common in teenagers between the ages of 16 and 19. It’s less common in adolescents, and even more rare in young children.

Patrick Moore, a professor at the University of Pittsburgh Cancer Institute, said the potential risks of myocarditis are important, but theoretical. The risks of COVID-19 to children are much more tangible.

Moore noted that 94 children in the 5- to 11-year-old age group have died of COVID.

“All of them had names. All of them had mothers,” he said.

Next up: ​​A decision by agency regulators is expected in the coming days, and a Centers for Disease Control and Prevention (CDC) panel is scheduled to meet Nov. 2-3 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.