Modernna says its COVID-19 vaccine works in infants, young children and preschoolers
Moderna’s COVID-19 vaccine works with infants, young children and preschoolers, the company announced Wednesday – and if regulators agree, there could be an opportunity to start vaccinating young children by the end of the summer.
Moderna said next week that it would ask regulators in the United States and Europe to approve two short-dose shots for young people under the age of six. The agency seeks to clear more large-dose shots for older children and adolescents in the United States.
The country’s 18 million children under the age of 5 are the only ones who are not yet eligible for vaccination. Competitive Pfizer currently offers child-sized doses for school-age children and full-strength shots for those 12 years of age or older.
But parents anxiously await protection for young children, frustrated by the pitfalls and confusion over when shots can work. Pfizer is testing even smaller doses for children under 5 years of age but if the two do not prove strong enough they had to add a third shot to the study. These results are expected in early April.
Bill Mারller, a researcher at Modernwestern Pediatric Studies at Northwestern University, said in an interview before the company released its results that “vaccinating the youngest has been a somewhat ongoing goal for the past few months.” “There is still, I think, a long-term urgency to try to get it done as soon as possible.”
The younger the baby, the lower the dose being tested. Moderna says that a quarter of the dose it uses for adults works well for young people under 6 years of age.
Moderna recorded about 6,900 tots in a study of 25-microgram doses. Preliminary data from the two shots showed that young people had stronger levels of the virus-resistant antibody just as much as young adults taking regular energy shots, the company said in a press release.
Modern said that small doses are safe, and the main side effects are associated with mild fever as with other commonly used pediatric vaccines.
Once Moderna submits data to the FDA, regulators will debate whether to allow emergency use of small doses for Tots. If so, the Centers for Disease Control and Prevention will decide whether to recommend them.
Although COVID-19 is generally not as dangerous for young people as it is for adults, some do get seriously ill. The CDC says about 400 children under the age of 5 have died in Kovid-19 since the outbreak began. The Omicron variant specifically hits children, with under-5s hospitalized at a higher rate than those previously at Delta Growth, the CDC found.
In general, COVID-19 vaccines do not prevent infection with Omicron mutants, nor do they stop previous forms – but they do provide strong protection against serious illness.
Moderna reported that the same trend in trials of children under 6 years of age, was conducted during omikron growth. Although there was no serious illness, the vaccine has been shown to be effective in preventing any infection in children up to 2 years of age and in about 38% of pre-schoolers.
Moderna added Wednesday that it would ask the Food and Drug Administration to clear large doses for older children.
While other countries have already allowed the use of Moderna shots in children under 6, the United States has limited its vaccine to adults. A Moderna request has been stuck for months to extend his shots between the ages of 12 and 17.
The agency said Wednesday that armed with additional evidence, it is updating its FDA application for teen shots and is also requesting green light for 6- to 11-year-olds.
Modern says its original adult dose – two 100-microgram shots – is safe and effective for 12- to 17-year-olds. For children of early age, it is using half the dose of adults.
But the FDA has never ruled on Moderna’s application for a teen shot because there are concerns about very rare side effects. After receiving the Pfizer or Modern vaccine, heartburn sometimes occurs in adolescents and young adults, mostly men. Moderna is doing extra checking because its shots are much more dose than Pfizer.
The risk seems to be linked to adolescence, and regulators in Canada, Europe and elsewhere have recently expanded the modern vaccine for children under 6.
“That concern was not seen in young children,” said Muller of the Northwest.
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