WASHINGTON (AP) – The Moderna vaccine against COVID-19 works on infants, toddlers and preschoolers, the company announced on Wednesday – and if regulators agree, it could mean a chance to finally start vaccinating the youngest children by summer.
Moderna said in the coming weeks it will ask regulators in the US and Europe to authorize two small doses of injections for children under 6. The company is also committed to achieving higher doses for older children and adolescents in the United States.
18 million children under the age of 5 are the only age group not yet eligible for vaccination. Currently, competitor Pfizer offers pediatric doses for school-age children and full-fledged injections for children 12 years and older.
But parents were looking forward to protection for the younger toddlers, frustrated by the setbacks and confusion about what tricks might work and when. Pfizer is testing even lower doses for children under 5, but had to add a third injection to the study if two were not strong enough. Such results are expected by early April.
Vaccination of the youngest has been a somewhat moving goal over the past few months, ”said Dr. Bill Mueller of Northwestern University, a Moderna pediatric research researcher, before the company released its results. “I think there’s still a need to try to do it as soon as possible.”
The younger the child, the lower the dose tested. Moderna said a quarter of the dose she uses for adults has worked well for children under 6 years old.
Moderna enrolled about 6,900 children in the 25-microgram dose study. Early data showed that after two injections, young people developed levels of antibodies that fight the virus, as strong as young adults who received regular injections, according to a company press release.
Moderna said small doses were safe, and the main side effects were mild fevers, similar to those associated with other commonly used pediatric vaccines.
Once Moderna submits the data to the FDA, regulators will discuss whether to allow emergency use of small doses for toddlers. If so, the Centers for Disease Control and Prevention will decide whether to recommend them.
While COVID-19 is usually not as dangerous to teens as it is to adults, some are really seriously ill. The CDC says about 400 children under the age of 5 have died from COVID-19 since the pandemic began. The omicron option has hit children particularly hard: those under the age of 5 are hospitalized with higher rates than at the peak of the previous delta burst, the CDC found.
COVID-19 vaccines generally do not prevent omicron mutant infection and also repel earlier variants, but they still provide strong protection against serious diseases.
Moderna reported a similar trend in a study of children under 6 years of age conducted during the omicron burst. Although there were no serious diseases, the vaccine proved to be just under 44% effective in preventing any infection in children under 2 years of age and almost 38% effective in preschool children.
Moderna also said Wednesday that it would ask the Food and Drug Administration to clean up larger doses for older children.
While other countries have already allowed Moderna vaccinations to be used in children under the age of 6, the U.S. has restricted the vaccine to adults. Moderna’s request to expand her filming to teenagers aged 12 to 17 stopped for several months.
The company said Wednesday that, armed with additional evidence, it is updating its FDA application for teen photography and is asking for the green light for children ages 6 to 11.
Moderna says its initial dose for adults – two injections of 100 micrograms – is safe and effective for teens 12 to 17 years old. Half the adult dose is used for young children.
But the FDA has never ruled on Moderna’s application for shooting teenagers because of concerns about very rare side effects. Inflammation of the heart sometimes occurs in adolescents and young adults, mostly men, after taking Pfizer or Moderna vaccines. Moderna is getting more attentive because her shots are much bigger than Pfizer’s.
The risk also seems to be related to puberty, and regulators in Canada, Europe and other countries have recently expanded Moderna vaccinations for children as young as 6 years old.
“Such concerns have not been observed in young children,” said Mueller of Northwestern.
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