Young children across the country are now able to receive a coronavirus vaccine.
The Food and Drug Administration on Friday authorized Pfizer and BioNTech’s shot for kids between 5 and 11 years old, affirming the recommendation of its advisory committee
The announcement paves the way for up to 28 million young Americans to receive Pfizer’s shot. It also makes a powerful tool available to help protect children from COVID-19 and keep schools open, a potential turning point in the pandemic.
"Vaccinating younger children against COVID-19 will bring us closer to returning to a sense of normalcy," said the FDA's acting commissioner, Janet Woodcock, in a statement. "Our comprehensive and rigorous evaluation of the data pertaining to the vaccine’s safety and effectiveness should help assure parents and guardians that this vaccine meets our high standards."
Still, it’s not yet clear whether all children aged 5 to 11 will be recommended for vaccination by the Centers for Disease Control and Prevention, whose own advisory group is set to meet and issue guidance next week. Broad use among children was a hotly debated topic at the FDA’s meeting on Tuesday. Despite a near-unanimous vote in favor of authorization, some panelists were unsure whether healthy young kids, many of whom appear strongly shielded from COVID-19’s worst outcomes, need to be vaccinated.
"Let’s be honest, the best way to protect the health of some kids would be to do nothing at all because they're going to be just fine," James Hildreth, the CEO of Meharry Medical College and a panelist who voted in support of the vaccine, said. "But there are lots and lots of children who, for this vaccine, would be the difference between health and even life."
Pfizer showed in clinical testing that two doses a third of the size of those given to teenagers and adults sparked a similarly strong immune response in 5- to 11-year-olds. The shot was also about 91% effective at preventing symptomatic disease, although the total number of cases was small, making the results less certain.
Crucially, the vaccine was also safe. Pfizer reported no serious side effects related to vaccination, including a form of heart inflammation known as myocarditis that has been a top concern of drug regulators and FDA advisers. The side effect, which is generally mild but can lead to hospitalization, has been seen in rare instances, primarily among teenage boys and young men. Myocarditis is also associated with COVID-19.
Pfizer’s results were supported by the FDA, which concluded in briefing documents before the meeting that the potential benefits of vaccination outweighed the risks of myocarditis in most scenarios. Those benefits included an impact not only on severe disease, but also the potential to limit milder infections that can have long-lasting symptoms, reduce the likelihood of outbreaks in schools and more.
Though kids are less vulnerable to COVID-19 than adults, the pandemic has taken a toll. Kids’ hospitalization rates from COVID-19 match those from pre-pandemic flu seasons, according to a CDC presentation. Hospital stays are longer for COVID-19 patients, and rates of intensive care unit admissions, breathing support and death match or even exceed that of flu, for which yearly shots are recommended for children. As of Oct. 17, 146 U.S. children between 5 and 11 years old had died from COVID-19, the FDA said Friday.
"When do you know enough? I think we certainly know that there are many children between 5 and 11 years of age who are susceptible to this disease [and] who could very well be sick and are hospitalized or die from it," said panelist Paul Offit, director of a vaccine center at the Children's Hospital of Philadelphia. "For me, I think I know enough to move forward."
Peter Marks, the agency’s top vaccine reviewer, also noted the impact the pandemic has had on the psychological and social development of children. "Protect your children so they can get back to a normal life," Marks said on a call with reporters on Friday.
Nonetheless, some questioned the perceived benefits of vaccination, citing the high rates of asymptomatic infections in young kids and uncertainty regarding the shot’s ability to slow transmission in the face of new variants like delta. Pfizer’s study was also too small to properly detect a rare side effect like myocarditis. And though the company has argued a smaller dose should carry less risk, the one committee member who abstained from voting, Michael Kurilla, an infectious disease expert at the National Institutes of Health, was concerned the kids’ regimen wouldn’t be as durable.
"I do not expect protection from infection to last more than a few months and this may negatively impact public perception of vaccines," Kurilla said in a statement following the meeting, adding that he would have preferred a "more nuanced approach" over a broad authorization.
That job will now fall to the CDC’s advisory committee, which will discuss the issue next week.
"The question of how broadly you use it, I think, is a substantial one," panelist Eric Rubin, an immunology professor at the Harvard T.H. Chan School of Public Health said during the FDA meeting. "I know it's not our question, and I know we're kind of punting that to the [CDC]. But I do think that it's a relatively close call."
CDC director Rochelle Walensky will need to affirm the committee’s recommendations after the meeting.
In the meantime, however, the Biden administration has laid the groundwork for what could be a difficult rollout. A Kaiser Family Foundation poll found that less than a third of parents intend to immediately get their 5- to 11-year-olds vaccinated upon FDA authorization. Parents’ most common concerns involve potential safety issues, according to Kaiser, reflecting the challenge ahead for public health officials. Woodcock, acknowledging potential hesitancy, said she hopes they’ll gain confidence as they see more "children getting vaccinated and being protected [and] able to participate in activities without concern."
"As a parent, if I had young children in this age group, I would get them vaccinated now," she said on Friday.
The administration, for its part, has emphasized the "critical role" community healthcare providers will play in the rollout.
Distribution and administration of the shots will be done through pediatricians' offices, children's hospitals, schools and community clinics. The U.S. government purchased 50 million more doses from Pfizer on Thursday to bolster the effort.
Pfizer’s vaccine may not be available to kids younger than 5, however, for a while. Marks said Friday that clinical data for that age group is "a few more months off."
Editor's note: This story has been updated with comments from FDA officials.