Moderna said on Thursday that it had asked the Food and Drug Administration to authorize its coronavirus vaccine for children under 6, making it the first manufacturer to do so. A senior official said the company would complete providing data to regulators by May 9th.
The expected development could increase pressure on federal regulators to allow a vaccine for the country’s youngest children. The parents of approximately 18 million young Americans, the only population still not eligible for vaccination, are waiting months for pediatric doses
So far, Moderna vaccine has only been approved for adults. The FDA has generally approved vaccines against Covid by age group, estimating that the risks of serious illness and the benefits of vaccination are highest for older Americans and reduced for young recipients. Moderna has also asked for permission for its Covid vaccine for 6- to 11-year-olds and 12- to 17-year-olds, and a spokeswoman said she would provide data completing those requests in about two weeks.
At a Senate oversight hearing Tuesday, Dr. Peter Marx, who oversees the regulation of vaccines for the FDA, hinted that the agency could consider Moderna’s applications for anyone under 18 in general. Some requests are “complex because they are relatively large and cover larger parts of the pediatric population than others,” he said in response to a senator’s question about when the pediatric vaccine would be ready.
Moderna and Pfizer-BioNTech have been developing doses for the youngest children since last year. Moderna offers a two-dose regimen for children 6 months to 5 years of age, using a quarter of the adult dose. Pfizer and BioNTech work on a three-dose schedule for those aged 6 months to 4 years, at one-tenth the adult dose. Pfizer has not yet applied for permission from the FDA, but is expected to do so soon.
Most applications for coronavirus vaccines are submitted on an ongoing basis, with the FDA sometimes reviewing data even before receiving a formal request.
In an interview last week, Dr. Anthony C. Fauci, chief medical adviser to the White House, suggested that the FDA wanted to review data on Moderna and Pfizer at the same time to directly compare the merits of each vaccine to young children rather than “confuse.” people. “
Dr Paul Burton, Moderna’s chief medical officer, said earlier that he expected the FDA to review Moderna’s vaccine for all three age groups under 18 in one fell swoop. But in an interview Wednesday, he said “there is an unmet medical need” for the youngest children, adding that he hopes the FDA “will carefully and appropriately evaluate the data and not withhold it.”
Data from Moderna’s clinical trials show that the antibody response in the youngest children compares favorably with that in adults aged 18 to 25 years, meeting the main criterion for the success of the study. Although the trial was not large enough to measure the effectiveness of the vaccine, Moderna said Thursday that the vaccine appears to be 51 percent effective against symptomatic infection among those under 2 years of age and 37 percent effective among those 2 to 5 years old.
These results were slightly better than those that Moderna released earlier for children under 2 years old. The company said this was because the second time the company ruled out infections that had not been confirmed by a PCR test analyzed in a laboratory.
Dr Burton said the new results came from a more rigorous analysis, but did not differ significantly from earlier ones. He said that the Omicron variant, which proved to be skilled in bypassing the body’s first line of defense, accounted for about 80 percent of the infections in the study group. This, he said, explains the low rate of efficacy compared to earlier vaccine studies.
It seems unlikely that regulators will act on Moderna’s application before June. Federal officials said they would ask the agency’s external advisory panel to review the data before authorizing any vaccine for young children. The panel’s meetings, scheduled for May, have been moved to June.
Dr Sean O’Leary, an infectious disease specialist at Colorado Children’s Hospital, said: “There are many parents who are really desperate for a vaccine for many good reasons. And we’re almost there. “
“I think these kids need a vaccine,” he said. “On the other hand, I also acknowledge that this is a complex situation for the FDA.”
Dr. O’Leary is also vice chairman of the Infectious Diseases Committee of the American Academy of Pediatrics.
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