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Moderna Has Asked the FDA to Approve the Covid Vaccine for Children Under the 6

On Thursday, Moderna submitted a request to the FDA to expand the use of its Covid-19 vaccination to children aged six months to 5 years. The FDA will now evaluate the drugmaker’s request and is likely to make a final judgment in June.

The Vaccines and Related Biological Products Advisory Committee, the agency’s advisory committee, is anticipated to provide input.

The Covid vaccine is only available to children under five in the United States; the Pfizer-BioNTech vaccine is available to anybody as young as five, while Moderna’s and Johnson & Johnson’s doses are only available to adults.

Moderna’s vaccine is administered in two 25-microgram doses four weeks apart to children aged six months to 5 years. The dosage is a fraction of what adults are given.

According to clinical trial results revealed in March, the vaccination wasn’t particularly effective against infection in this age group, but it did prevent severe disease.

Dr. Paul Burton, Moderna’s chief medical officer, told NBC News that the vaccine’s decreased efficiency against infection was owing to the highly contagious omicron form, which has also harmed the effectiveness of current immunizations for other age groups.

Nonetheless, Burton claims that the two-dose vaccine for young children provides an “excellent level of protection” and “can protect these kids.”

The FDA’s approval of Moderna’s application may welcome news to parents eager to get their children vaccinated. According to research published in March by the Centers for Disease Control and Prevention, children under five were hospitalized at roughly five times the rate during the winter omicron surge.

The CDC estimates that three-quarters of all children and teenagers in the United States had contracted Covid at least once by February. However, officials say it’s unknown how long that protection from past infections will persist or whether it’ll be as effective as vaccine-based protection.

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Vaccination will be a crucial tool for this age group since it has been found “to provide higher protection than natural infection,” according to Dr. Sean O’Leary, vice head of the American Academy of Pediatrics’ Committee on Infectious Diseases.

A former FDA vaccine chief, Dr. Jesse Goodman of Georgetown University, agreed, stating that natural infection protection might “variate enormously” between people.

Pfizer is also preparing to submit data to the FDA on a possible three-dose immunization regimen for children under five.

In February, Pfizer postponed its application for the age group after discovering that two doses of its vaccine failed to work correctly in a clinical trial of children aged 2 to 4.

If Pfizer submits its application shortly, it’s unclear whether the FDA will approve the Moderna and Pfizer vaccines separately or wait and approve both.

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While Moderna applied for a two-dose regimen, Burton said the firm plans to seek approval for a booster dosage for this age group. He believes the vaccine will be available in the fall and will be a bivalent vaccination, targeting two coronavirus strains in one dose.

According to the business, most side effects from the two-dose regimen were “low to moderate,” and no incidences of myocarditis, a rare heart inflammation disorder, were reported.

In Moderna’s vaccination application for children aged 12 to 17, the FDA was particularly concerned about the potential of myocarditis. That application is still pending.

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Suppose the vaccination for children under the age of six is approved. In that case, federal officials will have to explain to parents the benefits of having the vaccine, such as reducing the risk of severe sickness and MIS-C, or multisystem inflammatory syndrome, according to Goodman.

Vaccination rates for older children in the United States remain low.

According to CDC data, just around a third of children aged 5 to 11 had received two doses of vaccination.

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