Moderna Says Its Low-Dose COVID Vaccines Work for Children Under 6

Moderna’s COVID-19 vaccine works in infants, toddlers and preschoolers, the company announced on Wednesday, and if regulators agree, it could mean a chance to finally start vaccinating the smallest children by summer.

Moderna said it will ask regulators in the US and Europe in the coming weeks to allow two low-dose shots for children under 6 years of age. The company is also seeking to allow high-dose vaccines for older children and teens in the US.

18 million children under the age of 5 are the only age group not eligible for vaccination. Competitor Pfizer currently offers pediatric doses for school-age children and full doses for children 12 years of age and older.

But parents have been looking forward to protecting younger toddlers, frustrated by setbacks and confusion about which vaccines can help and when. Pfizer is testing even smaller doses for children under 5, but was forced to add a third dose to its study when two were not strong enough. These results are expected by early April.

Vaccinating the little ones “has been kind of a moving target for the past few months,” Northwestern University’s Dr. Bill Muller, Moderna’s pediatric researcher, said in an interview before the company published its findings. “I think there is still an urgent need to try and get it done as soon as possible.”

The younger the child, the lower the tested dose. Moderna has stated that a quarter of the dose it uses for adults works well for children under the age of 6.

Moderna enrolled about 6,900 babies in the 25 microgram study. Preliminary data showed that after two vaccinations, the young people had levels of antibodies to fight the virus that were as high as those of young people receiving routine vaccinations, the company said in a press release.

Moderna said low doses were safe and the main side effects were mild fevers, similar to those associated with other commonly used pediatric vaccines.

Once Moderna submits data to the FDA, regulators will debate whether to allow emergency use of low doses in toddlers. If so, the Centers for Disease Control and Prevention will decide whether to recommend them.

While COVID-19 is generally not as dangerous to children as it is to adults, some do get seriously ill. The CDC reports that about 400 children under the age of 5 have died from COVID-19 since the start of the pandemic. The CDC found that the omicron variant hit children particularly hard, with children under 5 years old being hospitalized more frequently than at the peak of the previous delta surge.

COVID-19 vaccines generally do not prevent omicron mutant infection in the same way that they did in earlier versions, but they still provide strong protection against severe disease.

Moderna reported the same trend in a study of children under 6 years of age conducted during a micron surge. Although there were no serious illnesses, the vaccine was less than 44% effective in preventing any infection in children under 2 years of age and nearly 38% effective in preschoolers.

Moderna also said it will ask the Food and Drug Administration on Wednesday to allow higher doses for older children.

While other countries have already allowed Moderna vaccines for children as young as 6, the US has restricted its vaccine to adults. Moderna’s request to expand its workforce for 12- to 17-year-olds has been delayed for months.

The company said on Wednesday that, armed with more evidence, it is updating its FDA application for teen vaccinations and asking for a green light for children aged 6 to 11 as well.

Moderna says its initial adult dose of two 100mcg injections is safe and effective for children ages 12 to 17. For young children, half the adult dose is used.

But the Food and Drug Administration (FDA) never ruled on Moderna’s application to vaccinate teenagers due to concerns about a very rare side effect. Inflammation of the heart sometimes occurs in adolescents and young adults, mostly men, after the administration of the Pfizer or Moderna vaccines. Moderna is under further scrutiny because its doses are much higher than those of Pfizer.

Risk also appears to be associated with puberty, and regulators in Canada, Europe, and elsewhere have recently extended Moderna vaccination to children as young as 6 years of age.

“This anxiety has not been seen in younger children,” Northwestern’s Mueller said.

Source link

Leave a Reply

Your email address will not be published.

Back to top button