Moderna will seek FDA emergency use authorization for its vaccine in kids under 6
Moderna said it plans to seek emergency use authorization from the U.S. Food and Drug Administration for its COVID-19 vaccine in children under age 6 "in the coming weeks."
The company released clinical trial data Wednesday showing neutralizing antibody levels were similar to those seen in adults.
The vaccine in children is a two-dose, 25-microgram shot, about a quarter of the dose used for adults, given 28 days apart.
"So we're working around the clock right now to submit the data in to regulators over the coming weeks," Moderna's president, Dr. Stephen Hoge, told Good Morning America. "And so we would expect [in] April to be able to complete those submissions globally, but just in the United States with the FDA then it becomes a question of conducting those reviews."
The company says it has enrolled approximately 4,200 children ages 2 to under 6 years and about 2,500 children ages 6 months to under 2 years in its pediatric trial in the U.S. and Canada.
During the omicron surge, there were enough children infected in the clinical trial to estimate two doses of the vaccine were 44% effective against any COVID-19 infection, including asymptomatic and mild infections, for children aged 6 months to 2 years, Moderna said. The vaccine was also 38% effective among kids aged 2 to 6.
Because none of the participants in the study became severely sick, Moderna could not give an estimate of how effective the vaccine is at preventing severe illness.
None of the children in the study were hospitalized or died.
The vaccine was safe, Moderna said, with children experiencing similar side effects to adults, The side effects were mostly mild or moderate and were more commonly reported after the second dose.
Additionally, no cases of myocarditis or pericarditis were reported, which are believed to be more common side effects in younger vaccine recipients, particularly young men. Myocarditis occurs when there is inflammation of the heart muscle and pericarditis occurs when there is inflammation of the heart lining.
“We believe these latest results from the ... study are good news for parents of children under 6 years of age," Stéphane Bancel, CEO of Moderna, said in a statement. "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."
Currently, Pfizer has the only vaccine available for U.S. children -- but only for kids as young as 5.
If Moderna's vaccine receives the green light from the FDA, it would be the first COVID vaccine approved for toddlers and babies in the U.S.
Pfizer had started the process of asking the FDA for authorization of its vaccine for children between ages 6 months to under 5, but also said it would wait for efficacy of a third dose.
Pfizer had started its trial with two 10 microgram dose for children, which the company found wasn't effective enough for certain age groups and expects results from a third dose in the weeks ahead.
Similarly, Moderna is also evaluating a COVID-19 booster dose for children, including those age 6 months to under 6 years.
ABC News' Sony Salzman contributed to this report.
