In encouraging news for parents, Moderna has revealed that its COVID-19 vaccine is safe and elicits a robust immune response in children aged 6 to 11. This announcement, made on Monday, likely comes as a relief to many families eager for more information on the vaccine’s safety for younger age groups.
Children participating in Moderna’s clinical trial, which involved 4,753 participants over an eight-week timeframe, showed antibody levels 1.5 times greater than those found in young adults a month after receiving both doses. Each shot contained 50 micrograms of vaccine, which is half the dosage given to adults.
However, it is crucial to note that Moderna has not released the full dataset, and the findings have yet to be published in a peer-reviewed journal. This announcement comes just before a Food and Drug Administration (FDA) panel is set to review vaccine data for children aged 5 to 11.
Moderna’s vaccine is still under review for adolescents aged 12 to 17, as the FDA is assessing data that suggests a possible increased risk of myocarditis (inflammation of the heart muscle) among boys and young men. In July, the FDA requested that both Pfizer and Moderna expand their trials to identify and report on less common side effects.
According to Moderna, most side effects experienced by children aged 6 to 11 were mild to moderate, with common symptoms including fatigue, headache, fever, and pain at the injection site. Following the second dose, an independent panel will continue to monitor safety in trial participants for an additional year.
Currently, Moderna is also conducting trials for younger age groups, including children aged 2 to 5 and those between 6 months and 2 years. So far, around 5,700 children in the U.S. and Canada have been enrolled in these trials, and Moderna plans to submit the results to the FDA and other regulatory agencies soon.
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Summary
Moderna’s COVID-19 vaccine has demonstrated a strong immune response in children aged 6 to 11, with antibody levels significantly higher than those of young adults. The vaccine appears safe, with mostly mild side effects reported. Trials for younger children are ongoing, and results will soon be submitted to regulatory authorities.
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