The agency said in a statement that the vaccine – given to 5-11 year olds in two injections, one-third the size of each adult vaccine – elicited an immune response comparable to that of young adults. The FDA added that no serious side effects were observed in the ongoing clinical trial of Pfizer and BioNTech in young children.
The FDA announced on Friday that approximately 8,300 children aged 5 to 11 were hospitalized for Covid-19, and as of October 17, 146 deaths due to Covid-19 had been reported in that age group.
The agency took action a few days after its independent vaccine advisory committee voted 17 to 0, with one abstention, to recommend the use of Pfizer-BioNTech in young children.
The members of the commission were partly influenced by data from the Centers for Disease Control and Prevention, which show that children aged 5 to 11 are “at least as likely” as adults to get the virus, and that the hospitalization rate is three times higher in colored children than among white children.
“It will mean peace for parents and a return to normalcy for so many children and families,” said Leana Wen, an emergency physician and professor of public health at George Washington University. “A lot of parents with young children live as if they themselves are unvaccinated.”
Parents were wary of spreading Covid-19 to their unvaccinated children, she said, or that unvaccinated children would bring the virus home from school to high-risk family members. The footage will also make it easier for children to return to normal life, including extracurricular activities, overnight stays or birthday parties indoors, which parents may have avoided for safety reasons.
“This will give them a big sigh of relief,” Wen said.
Some FDA committee members have stated that they are wary of vaccination mandates for children when millions of adults remain unvaccinated and the full extent of side effects for children may not yet be known. But in the end, the committee decided, based on the available data, that the benefits of vaccination outweighed the potential risks.
“We want to ensure that the entire vulnerable population is vaccinated,” Woodcock told reporters on Friday.
Thomas Murray, a pediatric infectious disease specialist at Yale New Haven Children’s Hospital, said “it’s absolutely true that children in the acute phase have milder illnesses than adults.”
But some children still develop severe cases of Covid-19, and even those who show only mild symptoms during the initial infection are at risk for Covid multisystem inflammatory syndrome, “which can make them extremely, extremely sick,” he said. Children, just like adults, can develop so-called long-term Covid with systems that persist even after the end of their infection.
“We don’t understand the long-term effects of an acute infection,” Murray said.
Pfizer and BioNTech continue to study their Covid-19 vaccine in six-month-old children. Availability for this age group is “probably a few more months of rest,” Peter Marks, the FDA’s chief regulator of vaccines, said during Friday’s press call.
“When it comes to younger children, the benefit-risk balance needs to be considered even more carefully, as the youngest children are the least directly affected in terms of severe Covid-19,” Marks said.
He avoided speculating when the agency could fully approve the Pfizer-BioNTech footage for the 5-11 age group, citing the need to collect more data.
The vaccine is fully approved for people aged 16 years and over and approved for emergency use in those aged 5 to 15 years. This is the only Covid-19 shot available to people under the age of 18 in the United States.
The CDC’s external advisory group will meet on Tuesday to discuss how the vaccine should be given, including whether its use should be restricted to certain children in that age group.
The final step before the introduction of the vaccine will be the formal approval of CDC Director Rochella Walensky, who will decide whether to accept the committee’s recommendations or the green light vaccination in line with the FDA’s broad language. Depending on when she plays, the footage could become available to young children as early as Wednesday.
“I would be shocked if vaccines were not made available to at least some children,” Wen of the CDC said.
Murray believes the federal government will allow wider use. “I wouldn’t be surprised if we supported him at this point for all the kids,” he said. “It’s a very safe and effective vaccine.”