Almost exactly 18 months after the first adult coronavirus vaccine was approved, and after months of scientific hiccups, the youngest Americans can finally get their injections.
During talks scheduled for Friday and Saturday, scientific advisors from the Centers for Disease Control and Prevention will debate the use of Moderna’s vaccine for children under 6 years of age and Pfizer-BioNTech’s vaccine for children under 5 years of age. Neither vaccine is intended for infants under 6 years of age. months old.
No surprises are expected. On Wednesday, advisors to the Food and Drug Administration unanimously approved both vaccines, despite flimsy evidence of their efficacy, particularly against the coronavirus variants now spreading across the country.
Still, overall, the data indicates that both vaccines will at the very least protect children from serious illness, said Dr. Ofer Levy, director of the precision vaccination program at Boston Children’s Hospital and an FDA advisor.
“These vaccines are largely safe and effective,” he said. “This was a remarkable achievement.”
Assuming the advisors support the vaccines, CDC director Dr. Rochelle Walensky, will sign. The White House has said states have already obtained millions of doses and will be ready to offer children injections as early as Tuesday.
But while some parents have pushed for the vaccines, many others seem hesitant — because their children may already have received some protection from an infection, or because they still have doubts about the vaccines’ safety and effectiveness.
Pfizer’s vaccine has been available for children ages 5 to 11 since November, but less than 30 percent of children in that age group have received two injections.
Acceptance of the vaccines will depend in part on how clear-cut the CDC’s recommendations are. The FDA authorization allows the use of vaccines, but doctors look to the CDC’s advisory board for details on their use.
This time, that advice will likely be complicated, as the two vaccines differ in almost every aspect.
For young children who received the Moderna vaccine, the FDA approved two doses of 25 micrograms each, one-fourth the amount used for adults, four weeks apart.
But according to data presented to the agency on Wednesday, two doses of the Pfizer vaccine — just three micrograms each or one-tenth the adult dose — failed to produce strong immunity to the virus in young children.
To be effective, the Pfizer vaccine must be given in three doses: the first two three weeks apart and a third at least two months after that.
The differences will make it difficult for parents and caregivers to choose between the two, said Dr. levy. But “the riddle is that they haven’t been directly compared.”
Scientists from both companies will present evidence Friday in support of their vaccines for young children. The advisers will have the opportunity on Saturday to ask questions and raise concerns before making their recommendations.
FDA advisors also approved the use of Moderna’s vaccine for children ages 6 and older on Tuesday, but the CDC committee has postponed that discussion for now.