The Centers for Disease Control and Prevention’s independent vaccine advisers unanimously recommended the Pfizer-BioNTech Covid-19 vaccine for kids ages 5 to 11.
The panel’s 14-0 vote on Tuesday marked the last major regulatory hurdle to immunizing school-aged children against the coronavirus. CDC Director Rochelle Walensky is expected to quickly endorse the shots’ administration, and federal officials have said that 15 million doses were being shipped to distribution centers ahead of the vote.
“Vaccines are really the only consistent and reliable way that we can provide that protection, other than cocooning [children] at home to minimize their risk,” said Grace Lee, advisory committee chair and professor of pediatrics at the Stanford University School of Medicine, noting inconsistent mask usage nationwide. “But then that is depriving them of many other sort of important aspects of their childhood.”
The CDC meeting came days after FDA authorized Pfizer-BioNtech’s Covid-19 vaccine for children in the younger age group following its own advisers’ recommendation to do so. Still, some members of FDA’s vaccine advisory committee last week suggested they would have been more comfortable supporting emergency use authorization if the shot were recommended only for kids of color or those with certain underlying health conditions, given the higher risk for disease for those groups and the still-thin safety data.
But the CDC advisers did not share those concerns, concluding that the existing data is augmented by the experience of safely vaccinating millions of Americans, including young teens; the known risks to children from contracting the virus, like multisystem inflammatory syndrome, known as MIS-C; and the number of deaths Covid has caused in kids compared to other diseases, like chicken pox and rubella, before vaccines were made available for them.
“We need to acknowledge the unknowns, but I think we’ve done that today,” said Matthew Daley, senior investigator at the Institute for Health Research at Kaiser Permanente Colorado and a member of the CDC panel.
Committee members also acknowledged racial disparities in health outcomes for kids who contract Covid, particularly with respect to hospitalizations and cases of MIS-C.
During Tuesday’s meeting, Walensky urged the panel to consider the rates of pediatric hospitalizations for other vaccine-preventable illnesses, many of which are much lower than those seen during Covid’s worst waves. Walensky said 745 children under 18 have died from Covid, 94 of them in the 5- to 11-year-old range, and more than 5,200 kids have been diagnosed with multisystem inflammatory syndrome after Covid infection.
Veronica McNally, a committee member and president and CEO of the Franny Strong Foundation, said her vote supporting the recommendation was intended “to prevent No. 95, the 95th death.”
“To say that this disease is not impacting kids is not an accurate statement,” she added.
The panel reviewed data on myocarditis, an inflammatory heart condition that’s been linked to the messenger RNA vaccines made by Pfizer and Moderna, especially among males under 30. It is also a known side effect of Covid-19, and in adults occurs more frequently among those who are infected than as a side effect of vaccination.
“Getting Covid is much riskier to the heart than getting the vaccine,” said Matthew Oster, a member of CDC’s vaccine task force.
While no children in Pfizer’s clinical trial developed myocarditis, the number of participants was too low to detect such a rare side effect, and the pediatric dose is one-third that for teens and adults. Still, parents have cited the rare side effect as a concern when considering whether to vaccinate their children when shots are made available to them.
Committee members noted that the baseline number of myocarditis cases among 5- to 11-year-olds that aren’t tied to the vaccine is much lower than that seen in adolescents, and they concluded that plus the lower dosage means incidence of the condition will likely be smaller in the younger age group.
The White House Covid-19 Task Force said Monday 15 million pediatric Pfizer doses, which are one-third the amount of an adult dose, are being sent to distribution centers in preparation for the CDC’s recommendation. Covid Coordinator Jeff Zients said the federal government has enough Pfizer vaccine to inoculate every child in the age group, indicating that Moderna’s announcement that it’s delayed seeking authorization for use of its pediatric vaccine in children under age 12 won’t impact supply.
David Lim contributed to this report.