adult dose, with two injections given three weeks apart.
“As a mother and a physician, I know that parents, caregivers, school staff and children have been waiting for today’s authorization. Vaccinating younger children against COVID-19 will bring us closer to returning to a sense of normalcy,” Acting FDA Commissioner Dr. Janet Woodcock says in an agency statement announcing the approval on Friday. “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.”
At the time, infectious disease experts welcomed the approval.
“It’s an incredibly important tool in the return to normalcy,” Dr. Larry Corey, a virologist at the Fred Hutchinson Cancer Research Center in Seattle and a leader of the COVID-19 Prevention Network, tells the New York Times. “To be able to know that your child is protected and not going to get severely ill by going to school is an incredible psychological relief.”
The panel’s tough decision
Earlier last week, the FDA’s vaccine advisory panel voted to recommend the approval. The vote was nearly unanimous at 17-0, with one abstention.
Despite the vote count, some panel members noted at the time that they struggled with the decision.
“This is a much tougher one, I think, than we had expected coming into it,” panel member Dr. Eric Rubin, editor-in-chief of the New England Journal of Medicine, said during the meeting. “The data shows that the vaccine works and it’s pretty safe … [yet] we’re worried about a side effect that we can’t measure yet,” he said, referring to a heart condition called myocarditis that has cropped up in rare cases in some younger recipients of COVID vaccines.
Another panel member questioned whether the vaccinations were needed at all for these youngest Americans.
“It just seems to me that in some ways, we’re vaccinating children to protect the adults, and it should be the other way around,” committee member Dr. James Hildreth, president and CEO of Meharry Medical College in Tennessee, tells NBC. “I do believe that children at highest risk do need to be vaccinated. But