MONDAY, Oct. 25, 2021 (HealthDay News) -- Moderna announced Monday that its COVID-19 vaccine safely triggers a strong immune response in children aged 6 to 11.
Company data shows that a month after receiving both doses of the vaccine, children's antibody levels were 1.5 times higher than those in young adults. The company did not release the full data on the shots and the results have not been published in a peer-reviewed journal.
"We are encouraged by the immunogenicity and safety profile of mRNA-1273 [Moderna's vaccine] in children aged 6 to under 12 years and are pleased that the study met its primary immunogenicity endpoints," said StÃ©phane Bancel, chief executive officer of Moderna. "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."
The trial included more than 4,700 children who received two shots of the vaccine 28 days apart. Each shot contained 50 micrograms of vaccine, half the adult dose. Most side effects were mild or moderate, and the most common were fatigue, headache, fever and pain at the injection site, according to Moderna.
The vaccine's safety will continue to be reviewed by an independent monitoring committee for 12 months after the second dose, The New York Times reported.
Moderna is still recruiting children aged 2 through 5, and 6 months to under 2 years for trials of the vaccine in those age groups. So far, the company has enrolled about 5,700 children in the United States and Canada in that trial.
On Tuesday, a U.S. Food and Drug Administration advisory committee is scheduled to weigh the use of the Pfizer coronavirus vaccine in children aged 5 through 11.
In June, Moderna submitted trial results for use of its COVID-19 vaccine in youth aged 12 through 17, but the FDA has not yet announced a decision for that age group, the Times reported.
Some research indicates that the Moderna vaccine may increase the risk of a rare side effect of heart muscle inflammation (myocarditis) in boys and young men. In July, the FDA asked both Pfizer and Moderna to increase the size of their trials to try to detect less common side effects, the Times reported.
Visit the U.S. Food and Drug Administration for more on COVID vaccines.
SOURCES: Moderna, news release, Oct. 25, 2021; The New York Times
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