Company officials have announced that Moderna’s COVID-19 vaccine generated a robust immune response and was generally well-tolerated in children aged six to 11 years.
The pharmaceutical giant plans to submit its findings later this week to federal regulators.
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.
“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,” Stéphane Bancel, Chief Executive Officer of Moderna, 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 FDA advisers expects to determine on Tuesday whether to authorize Pfizer and BioNTech’s Covid vaccine for children aged five to 11.
The Moderna vaccine has been authorized for adults over 18, and the company recently won approval for a third dose – or booster shot – in some Americans.
The U.S. Food and Drug Administration remains undecided on Moderna’s vaccine for those aged 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 kids were mild or moderate in severity, with fatigue, headache, fever, and injection site pain 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 noted.