Moderna Inc said on Monday its COVID-19 vaccine generated a strong immune response and was generally well-tolerated in children aged six to 11 years, and the company plans to submit the data to regulators soon.
Moderna said 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.
A panel of FDA advisers will vote on Tuesday whether to authorize rival Pfizer and BioNTech's COVID-19 vaccine for use in children aged five to 11 years.
The Moderna COVID-19 vaccine has been authorized for adults over the age of 18 years, and recently gained clearance for a third dose in some Americans.
However, the U.S. Food and Drug Administration is yet to authorize the vaccine for use in adolescents aged 12 through 17. Sweden has paused the use of the Moderna vaccine for younger age groups after reports of cases of heart inflammation in young adults.
Moderna said the majority of the side effects in the trial, which had 4,753 participants, were mild or moderate in severity, with fatigue, headache, fever and injection site pain the most common.
The vaccines used in the trial were 50 microgram doses, half the strength used in the primary vaccine series for adults. The 50 microgram dose is also authorized for use as a booster shot.
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