According to data released by the company, the two-dose Covid vaccine was effective in preventing infections from omicron in children 6 months to under 2 years old and in children 2 to 5 years old.
The majority of breakthrough cases were mild, according to the company. Stephane Bancel, CEO of Moderna, said in a statement that the FDA will grant emergency use authorization for the vaccine for children under 6 years old.
FDA approved for adults ages 18 and older. Moderna asked the FDA to approve its vaccine for children between the ages of 6 and 11.
When the shots were first authorized for adults in December 2020, they had a vaccine effectiveness mark of around 94%, but the omicron variant has reduced it to around 85%. Moderna said the vaccine effectiveness for children under 6 years old against omicron was in line with the approved vaccine for adults 18 and older.
Children under the age of 6 years old received two 25 microgram doses of its vaccine administered 28 days apart, much smaller than the 100 microgram shots given to adults. Two 50 microgram doses are given to children.
Moderna said there were no new safety concerns for children under 6 years old. No deaths or cases of myocarditis, pericarditis or multisystem inflammatory syndrome were reported according to the company. According to the Centers for Disease Control and Prevention, the second dose of Moderna's and Pfizer's vaccines has been associated with elevated rates of heart inflammation in younger men.
Moderna said that the side effects in young children were less severe after the second dose. More than a quarter of kids under 2 years old developed a 100 degrees Fahrenheit or 38 degrees Celsius fever, while less than a fifth of kids 2 to 5 years old did. Only a few children in each age group were observed with a high temperature, according to the company.
The data on the youngest children comes from a larger clinical trial. There were 4,200 kids 2 to 5 years old in the trial. The study was done in partnership with the National Institutes of Health.
Only children under 5 years old are eligible for Covid vaccine. According to the CDC, hospitalizations of kids in this age group with Covid were five times higher during the omicron peak in January compared with last year.
The first two doses of Pfizer and BioNTech's vaccine for children under 5 years old were delayed because the data did not meet expectations. The data on a third dose in this age group is expected to be submitted by Pfizer and BioNTech in April.
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