In its announcement, the agency found that the vaccine, given 5 to 11 year olds as two shots, each one-third the size of any adult shot, elicited an immune response comparable to that seen in young adults. The FDA added that the ongoing Pfizer and BioNTech clinical trial reported “no serious side effects” in younger children.
The FDA announced on Friday that approximately 8,300 children between the ages of 5 and 11 had been hospitalized with Covid-19 and 146 deaths from Covid-19 had been reported in that age group as of October 17.
The agency’s action comes days after its independent vaccine advisory committee voted 17-0, with one abstention, to recommend the use of the Pfizer BioNTech shot in younger children.
Panel members were influenced in part by data from the Centers for Disease Control and Prevention, which showed that children ages 5-11 are “at least as likely” as adults to contract the virus, and that the Hospitalization rates among black children are three times higher than among white children.
“This will be a peace of mind for parents and a return to normal for so many children and families,” said Leana Wen, emergency doctor and public health professor at George Washington University. “Many parents with young children live as if they were not vaccinated themselves.”
Parents have been careful about transmitting Covid-19 to their unvaccinated children, or letting unvaccinated children bring the virus home from school to family members at high risk. Inclusion will also make it easier for children to get back to normal life, including any after-school activities, overnight stays, or indoor birthday parties that parents may have avoided for safety reasons.
“That will give you a big sigh of relief,” said Wen.
Some members of the FDA panel had indicated that when millions of adults remain unvaccinated and the full range of side effects for children may not yet be known, they are careful about vaccination regulations for children. In the end, however, the committee decided that the benefits of vaccination outweighed the possible risks based on the data available.
“We want to make sure that the entire population at risk is vaccinated,” Woodcock told reporters on Friday.
Thomas Murray, a pediatric infectious disease specialist at Yale New Haven Children’s Hospital, said it was “absolutely right that children are more prone to illness than adults in the acute phase.”
But some children still develop severe cases of Covid-19, and even those who show only mild symptoms during initial infection are at risk of post-Covid multisystem inflammation syndrome, “which can make them extremely, extremely sick”, he said. And like adults, children can develop what is known as a long Covid, with systems that persist even after their infections have ended.
“We don’t understand the long-term effects of acute infection,” said Murray.
Pfizer and BioNTech continue to investigate their Covid-19 vaccine in children six months of age. Availability for this age group is “likely to have a few more months left,” said Peter Marks, the FDA’s chief vaccine regulator, during a press briefing on Friday.
“In younger children, the risk-benefit ratio is weighed even more carefully, as the youngest children are least directly affected when it comes to severe Covid-19,” said Marks.
He shied away from guessing when the agency could fully approve Pfizer BioNTech’s inclusion for ages 5-11, citing the need to collect more data.
The vaccine is fully approved for people aged 16 and over and approved for emergency use in people between the ages of 5 and 15. It is the only Covid-19 vaccination available to people under the age of 18 in the United States.
The CDC’s own external advisory group will meet Tuesday to discuss how the vaccine should be administered, including whether its use should be restricted to certain children within this age group.
The final step before the vaccine is launched will be formal approval by CDC Director Rochelle Walensky, who will decide whether to adopt the panel’s recommendations or give a green light to vaccinations in line with the general language of the FDA. Depending on when she acts, shots could be available for young children as early as Wednesday.
“I would be shocked if they didn’t make the vaccines available to at least some children,” said Wen of the CDC panel.
Murray believes the federal government will allow more expansive usage. “I wouldn’t be surprised if they endorsed it for all children at this point,” he said. “It’s a very safe and effective vaccine.”