A new study shows Moderna’s Covid-19 vaccine reliably generated substantial immune responses in children aged 6 months to 5 years, however, the shot had limited efficacy against the Omicron strain.

According to Moderna, the vaccine’s effectiveness against symptomatic illnesses was 43.7 percent in children aged 6 months to 2 years and 37.5 percent in children aged 2 to 5.

The efficacy rates were lower than those shown in adult testing prior to the appearance of Omicron, but comparable to the real-world effectiveness of two doses of Moderna’s vaccine observed among adults during the Omicron wave.

The Cambridge, Massachusetts-based business said it will seek regulatory approval for its vaccine for young children in the United States, Europe, and other countries in the coming weeks.

If regulators agree, one of the last age groups in the United States not eligible for Covid-19 vaccination—children under the age of five—might finally get the vaccine.

“We believe these results are really good news for the parents of children who are under 6 years of age, and for the children themselves,” said Jacqueline Miller, senior vice president of infectious diseases at Moderna. “We are hopeful to be able to bring this vaccine forward to address that unmet medical need.”

Moderna requested for FDA approval for this age group last year after a research revealed that the vaccine triggered immunological responses in the group. However, the FDA postponed a decision because it wanted to investigate the potential risk of heart-inflammation disorders such as myocarditis. Dr. Miller stated that Moderna is supplying the FDA with longer-term safety data.

Attempts to expand the Covid-19 vaccine campaign to include children under the age of five have met with hurdles, disappointing some parents who want their children immunized. Some parents, on the other hand, refuse to get their children vaccinated. According to a Kaiser Family Foundation poll conducted in January, 26 percent of parents with children under the age of five stated they would not get their children vaccinated.

The FDA postponed a decision on the use of the Pfizer-BioNTech vaccine in children under the age of five last month after the firms received conflicting findings in clinical testing.

Two doses of the Pfizer-BioNTech vaccine did not elicit a robust immunological response in 2- to 4-year-olds, but did in children under the age of two. The companies are waiting for more data to see if giving a third dose boosts the immune response.

Children have a lesser risk of severe Covid-19 than older adults, although there is still some danger. According to the Centers for Disease Control and Prevention, Covid-related hospitalization rates for children in the United States increased dramatically during the winter surge of Covid-19 cases caused by the Omicron variant.

Tina Tan, professor of pediatrics at Northwestern University Feinberg School of Medicine and infectious-disease expert at Ann & Robert H. Lurie Children’s Hospital of Chicago, said the Moderna pediatric study results are encouraging. Dr. Tan stated that a vaccine is required for younger children, and that it would be preferable for children to receive two doses for primary vaccination rather than the potential for three doses for the Pfizer vaccine.

Last year, Moderna, in conjunction with federal organizations including the National Institutes of Health, began a study of its vaccine in children aged 6 months to 11 years, enrolling approximately 11,700 in the United States and Canada.

The trial included around 4,200 children aged 2 to 6 years, as well as approximately 2,500 children aged 6 months to less than 2 years. Some participants received two doses of the vaccine, while others received placebos four weeks apart.

The dose of the vaccination given to children was one-fourth that given to adults.

According to Moderna, the vaccination elicited comparable levels of neutralizing antibodies against the coronavirus in young infants as were detected in adults aged 18 to 25 in a separate research completed in 2020.

The vaccine’s efficacy against symptomatic illness, however, was lower in children than in adults. In the adult research, Moderna’s full-dose vaccine was 94.1 percent effective against symptomatic Covid-19.

Moderna noted that the Omicron strain of the coronavirus predominated in the United States throughout the research of children under the age of six, and the business attributed the disparities to Omicron, which began spreading late last year.

According to Moderna, real-world data reveal that the vaccine’s efficacy for adults was lowered during the Omicron spike.

The majority of confirmed Covid-19 instances in the pediatric trial, according to Moderna, were minor, with no severe cases, hospitalization, or death.

The lower dose utilized for children, according to Dr. Miller, achieved a balance between eliciting an adequate immunological response and retaining an acceptable safety profile.

According to Moderna, the majority of side effects, such as injection site pain and fever, were mild to severe. Moderna reported no new safety issues, and no deaths, myocarditis, or occurrences of an inflammatory syndrome in children were documented in the research.

Moderna also intends to investigate the feasibility of administering a booster dose to all child groups.

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