(AP)
Moderna announced on Wednesday that the COVID-19 vaccine from COVID-19 works on infants, toddlers and preschoolers, 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.
Early results showed that babies produced high levels of anti-virus antibodies from injections containing a quarter of the dose given to adults – although they were less effective against the supercontagious mutant omicron than previous options.
“The vaccine provides the same level of protection against COVID in young children as in adults. We think this is good news, ”said Dr. Stephen Hoge, President of Moderna, to the Associated Press.
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 its study when two were not strong enough. Such results are expected by early April.
Vaccination of the youngest has been a moving goal for the past few months, ”said Dr. Bill Mueller of Northwestern University, a researcher at Moderna Pediatric Research, in an interview 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 enrolled about 6,900 children under the age of 6, including infants aged 6 months, in a 25-microgram dose study. They have developed levels of antibodies as strong as those of young adults who are gaining full strength, the company said.
Vaccines against COVID-19 generally do not prevent infection with omicron mutants and also repel previous options, although they still provide strong protection against serious diseases.
The Moderna study on infants was conducted during the omicron outbreak and found the same trend: although there were no severe diseases, the vaccine proved to be just under 44% effective in preventing lung infections in children under 2 years of age and almost on 38% – in preschool children. .
But Hoge said high antibody levels should still turn into protection against serious diseases in young children as well as adults, “which ultimately is probably the most compelling reason for someone to get vaccinated.”
Moderna said small doses were safe, and the main side effects were mild fevers, similar to those associated with other commonly used pediatric vaccines.
Booster doses have proven crucial to combat amicron for adults, and Moderna is currently testing booster doses for children, either a third injection of the original vaccine, or an additional dose that combines protection against the original virus and the omicron variant.
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 variant hit children particularly hard, and those under 5 were hospitalized more often than at the peak of the previous delta jump.
Parents may be confused by the fact that Moderna is trying to vaccinate the youngest children before they are allowed to vaccinate teenagers. While other countries have already allowed the use of Moderna vaccines to children under the age of 6, the U.S. has restricted its 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.
Hoge said he was optimistic that the company would be able to offer its vaccine “all age groups in the United States before the summer.”
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.
About 1.5 million teens have used Moderna vaccine in other countries, “and so far we have seen very encouraging safety from this experience,” Hoge said.
It seems that the risk to the heart is also related to puberty, and regulators in Canada, Europe and other countries have recently expanded the Moderna vaccine to children as young as 6 years old.
“Such concerns have not been observed in young children,” said Mueller of Northwestern.
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