Most injections should be given in pediatricians’ offices. There are approximately 19 million children under age 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 Moderna and Pfizer-BioNTech’s pediatric vaccines are safe and effective. The Centers for Disease Control and Prevention must also recommend the injections before they can be administered.
“I am not here to prejudge the outcome of this process. The administration is working hard to plan all sorts of scenarios depending on the outcome,” Jha told a press briefing. “If and when the FDA clears, we move from planning to execution.”
The FDA’s outside advisers are scheduled to meet June 14-15 to discuss pediatric vaccines, and the agency is expected to act quickly after the meeting. If the FDA grants clearance, Jha said, the government can start shipping doses.
CDC advisers are expected to meet soon after the FDA makes a decision, and Jha predicted vaccinations would begin after the long weekend. June 20 is a public holiday and some medical offices will not be open. He predicted that vaccinations could start on June 21 at the earliest.
On Wednesday, Pfizer and its German partner, BioNTech, finalized their request for emergency authorization of a three-shot vaccine for children 6 months to 4 years old. Moderna filed its application 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 adolescents, since shooting is currently permitted for those 18 and older.
Frustrated parents repeatedly questioned why the Moderna vaccine review was taking so long, but Jha said the FDA’s decision was based on the agency’s ability to review the data.
“They moved very quickly to consume and analyze a very large slice of data from Moderna,” Jha said. “At the end of the day, we all want to go fast, but we want to do it right.”
Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, previously told the Washington Post that the review of the Moderna vaccine was not delayed to allow simultaneous review of the two companies’ vaccines. He added that if analyzes of Moderna’s and Pfizer’s injections were completed within a week of each other, the FDA would schedule their review side by side.
The Moderna diet consists of two injections, four weeks apart. It was found to be 51% effective in preventing disease in children 6 months to 2 years old and 37% effective in children 2 to 5 years old.
The Pfizer diet is three strokes. The second injection is given three weeks after the first. The next blow comes two months later. The ultimate efficacy of this vaccine is not known, but early analysis – which is subject to change – suggested it was 80% effective against symptomatic disease.