Moderna officials announced Monday that the drugmaker’s COVID-19 vaccine generated a robust immune response and was generally well-tolerated in children ages 6 to 11.
Moderna reported that its two-dose vaccine generated virus-neutralizing antibodies in children, and safety was comparable to what was previously seen in clinical trials of adolescents and adults. The pharmaceutical giant plans to submit its findings later this week to federal regulators.
“We are encouraged by the immunogenicity and safety profile of mRNA-1273 in children aged 6 to under 12 years and are pleased that the study met its primary immunogenicity endpoints,” Moderna CEO Stéphane Bancel said in a statement. “We look forward to filing with regulators globally and remain committed to doing our part to help end the COVID-19 pandemic with a vaccine for adults and children of all ages.”
A panel of Food and Drug Administration advisers expects to decide Tuesday whether to recommend authorization of the Pfizer-BioNTech vaccine for children ages 5 to 11.
The Moderna vaccine has been authorized for those 18 and older, and the company recently received approval for a third dose — or booster shot — in some Americans.
The FDA remains undecided on Moderna’s vaccine for those ages 12 through 17, with the doses reportedly resulting in cases of heart inflammation in young adults in Sweden.
Moderna officials claimed that most of the side effects in the trial for children were mild or moderate in severity, with fatigue, headache, fever and injection site pain being the most common.
Approximately 4,753 individuals participated in the trial, and the company provided each with 50 microgram doses, or half the strength used in the primary vaccine series for adults. The 50-microgram dose also received authorization for use as a booster shot.
“These results demonstrate strong immune response in this cohort of children one month after the second dose and met the co-primary immunogenicity endpoints for 6 to less than 12 years olds,” Moderna officials said.