Moderna said Wednesday its Covid-19 vaccine generated a strong immune response and was generally well-tolerated in kids ages 6 months up to 6 years.
The drugmaker said two 25-microgram doses of the vaccine, a quarter of the dose given to those 18 and older, produced an antibody response similar to what was seen in a clinical trial of adults.
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For the approximately 6,900 children in the trials, the majority of side effects were “mild or moderate,” and no cases of a rare heart condition called myocarditis were reported, the company said.
Protection against infection from the omicron variant of the coronavirus was low. For children ages 6 months to 2 years, efficacy was 43.7 percent, and in children ages 2 to 6, it was only 37.5 percent. Moderna said the majority of the infections were mild. There were no cases of severe illness, hospitalization or death.
The findings may come as welcome news to some parents. A recent report from the Centers for Disease Control and Prevention found that during the surge of the omicron variant, which began in late December, the hospitalization rate for infants and children up to age 4 was about five times the rate during the peak of the delta variant last summer and fall.
Moderna said it plans to submit the data to the Food and Drug Administration and other regulators in the coming weeks.
“Given the need for a vaccine against Covid-19 in infants and young children we are working with the U.S. FDA and regulators globally to submit these data as soon as possible,” Moderna CEO Stéphane Bancel said in a statement.
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Most children in the age group are ineligible to receive a Covid vaccine; the Pfizer-BioNTech vaccine has been authorized for use in the U.S. only for people as young as 5.
Moderna’s vaccine has been authorized only for adults.
Pfizer said last month that it was postponing its rolling application to the FDA to expand the use of its vaccine for kids under 5 after it found that two doses of its shot didn’t generate a strong enough immune response in kids ages 2 to 4.
The Pfizer vaccine dose for young kids is 3 micrograms, lower than the 25 micrograms Moderna tested for the age group.
Pfizer said at the time that it would wait for its data on a three-dose series of the vaccine, because it believes three doses “may provide a higher level of protection.”
While Moderna is asking the FDA to authorize two doses of its vaccine for kids under 6, the company said Wednesday it is preparing to evaluate the potential of a booster dose for all children.
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