Most shots are expected to be administered in pediatricians’ offices. There are about 19 million children under 5 in the United States.
Jha said the date was a planning scenario, not a certainty, and would depend on whether the Food and Drug Administration determines that pediatric vaccines from Moderna and Pfizer-BioNTech are safe and effective. The Centers for Disease Control and Prevention must also recommend the shots before they can be administered.
“I’m not here to prejudge the outcome of this process. The administration is hard at work planning all sorts of scenarios based on whatever the outcome is,” Jha said during a news briefing. “If and when FDA authorizes, we move from planning to execution.”
The FDA’s outside advisers are scheduled to meet June 14 and 15 to discuss pediatric vaccines, and the agency is expected to act quickly after the meeting. If the FDA grants authorization, Jha said, the government can begin to ship doses.
The CDC’s advisers are expected to meet shortly after the FDA makes a decision, and Jha predicted that vaccinations would begin after the long weekend. June 20 is a holiday and some doctor offices will not be open. He predicted vaccinations could begin June 21 at the earliest.
On Wednesday, Pfizer and its German partner, BioNTech, completed their request for emergency authorization of a three-shot vaccine for children 6 months to 4 years old. Moderna submitted its request in late April for a two-shot regimen for children 6 months to 6 years old. The agency is also reviewing data on older children and teenagers, since the shot is currently authorized for people 18 and older.
Frustrated parents have repeatedly wondered why the review of the Moderna vaccine is taking so long, but Jha said that the FDA’s decision is based on the agency’s ability to review the data.
“They have moved very quickly to consume and analyze a very large tranche of data from Moderna,” Jha said. “At the end of the day, we all want to move fast, but we want to get it right.”
Peter Marks, director of the Center for Biologics Evaluation and Research at the FDA, previously told The Washington Post that the review of the Moderna vaccine was not being delayed to allow for concurrent consideration of the two companies’ vaccines. He added that if the analyses of the Moderna and Pfizer shots were complete within a week of each other, then the FDA would schedule them to be reviewed side by side.
The Moderna regimen is two shots, given four weeks apart. It was shown to be 51 percent effective in preventing illness in children between 6 months and 2 years old, and 37 percent effective in children 2 to 5.
The Pfizer regimen is three shots. The second shot is given three weeks after the first. The next shot comes two months later. The final efficacy of that vaccine is not known, but an early analysis — which is likely to change — suggested it was 80 percent effective against symptomatic illness.