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White House Coronavirus Response Coordinator Ashish Ja said on Thursday that long-awaited vaccinations for children under 5 could begin as early as June 21, pending decisions from regulators and public health officials.
The United States may begin ordering vaccines on Friday, with 10 million doses initially available. States were asked to give priority to the spread of high-risk children, hard-to-reach areas and facilities such as children’s hospitals, which will be able to vaccinate large numbers of children quickly.
Most injections are expected to be given in pediatricians’ offices. There are about 19 million children under the age of 5 in the United States.
Ja said the date is a planning scenario, not a security one, and will 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 vaccines before they can be given.
“I am not here to decide the outcome of this process. The administration is working hard, planning all sorts of scenarios based on any outcome, “Ja said during a briefing. “If and when the FDA approves, we move from planning to implementation.”
FDA external advisers are scheduled to meet on June 14 and 15 to discuss pediatric vaccines, and the agency is expected to act soon after the meeting. If the FDA gives permission, Ja said, the government could start delivering doses.
CDC advisers are expected to meet soon after the FDA makes a decision, and Ja predicted that vaccinations would begin after the long weekend. June 20 is a holiday and some doctors’ offices will be closed. He predicts that vaccinations may begin as early as June 21.
On Wednesday, Pfizer and its German partner BioNTech finalized their application for an emergency permit for a three-injection vaccine for children aged 6 months to 4 years. Moderna applied in late April for a two-injection regimen for children 6 months to 6 years old. The agency is also reviewing data on older children and teenagers, as the shot is currently allowed for people aged 18 and over.
Disappointed parents have repeatedly wondered why the Moderna vaccine took so long to review, but Ja said the FDA’s decision was based on the agency’s ability to review the data.
“They moved very fast to consume and analyze a very large tranche of data from Moderna,” Ja said. “At the end of the day, we all want to move fast, but we want to do it right.
Peter Marx, director of the FDA’s Center for Biological Substance Evaluation and Research, told The Washington Post earlier that the review of the Moderna vaccine was not delayed to allow the two companies’ vaccines to be considered at the same time. He added that if the analysis of the Moderna and Pfizer photos is completed within a week of each other, then the FDA will schedule them to be reviewed side by side.
Moderna’s regimen is two injections four weeks apart. It has been shown to be 51 percent effective in preventing disease in children between 6 months and 2 years of age and 37 percent effective in children 2 to 5 years of age.
Pfizer mode is three shots. The second injection is given three weeks after the first. The next shot comes two months later. The ultimate efficacy of this vaccine is not known, but early analysis – which is likely to change – suggests that it is 80 percent effective against symptomatic disease.
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