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White House coronavirus response coordinator Ashish Jha said on Thursday that long-awaited vaccines for children under 5 could begin on June 21, pending decisions by regulators and health officials. public.
States may begin ordering vaccines on Friday, with 10 million doses initially available. States have been asked to prioritize distribution to high-risk children, hard-to-reach areas, and places such as children’s hospitals that will be able to vaccinate large numbers of children quickly.
Most vaccinations are expected to be administered at pediatrician consultations. There are about 19 million children under the age of 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 Moderna and Pfizer-BioNTech pediatric vaccines are safe and effective. Centers for Disease Control and Prevention should also recommend injections before they can be given.
“I am not here to judge the outcome of this process. The administration is working hard to plan all kinds of scenarios based on the outcome, “Jha told a news conference.” If and when the FDA authorizes it, we will move from planning to execution. “
FDA external advisors 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 the authorization, Jha said, the government can start sending doses.
CDC 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 medical offices will not open. He predicted that vaccinations could begin on June 21 at the earliest.
On Wednesday, Pfizer and its German partner, BioNTech, completed their emergency authorization application for a three-injection vaccine for children aged 6 months to 4 years. Moderna submitted its application at the end of April for a two-injection regimen for children aged 6 months to 6 years. The agency is also reviewing data on older children and teens, as shooting is currently allowed for people 18 and older.
Frustrated parents have repeatedly wondered why the Modern Vaccine review is taking so long, but Jha said 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 chunk of Moderna data,” Jha said. “At the end of the day, we all want to move fast, but we want to do well.”
Peter Marks, director of the FDA’s Center for Biological Assessment and Research, told The Washington Post earlier that the review of the Modern Vaccine was not being delayed to allow simultaneous consideration of the two companies’ vaccines. He added that if the analysis of the Moderna and Pfizer features were completed a week apart, the FDA would schedule them to be reviewed side by side.
Moderna’s regime is twofold, four weeks apart. It was shown to be 51% effective in preventing disease in children aged 6 months to 2 years, and 37% effective in children aged 2 to 5 years.
The Pfizer regime is three-shot. The second shot is taken three weeks after the first. The next shot comes two months later. The final efficacy of this vaccine is unknown, but early analysis, which is likely to change, suggested that it was 80 percent effective against symptomatic disease.