In encouraging news, Moderna has announced that its COVID-19 vaccine is both safe and effective at generating a strong immune response in children aged 6 to 11. This information is likely to bring relief to many parents eager for more data on the vaccine’s safety for younger kids.
Results from Moderna’s clinical trial revealed that children who received both doses exhibited antibody levels 1.5 times greater than those found in young adults one month post-vaccination. The trial included 4,753 children over an eight-week span, with each dose containing 50 micrograms of vaccine—half the amount used for adults.
However, it’s essential to note that Moderna has not released the complete dataset, and the findings have yet to undergo peer review. These results were disclosed just a day before a Food and Drug Administration (FDA) panel was set to evaluate vaccine data for children aged 5 to 11.
While Moderna submitted findings in June regarding adolescents aged 12 to 17, the FDA is still analyzing that data and has not granted approval for this age group yet. This delay might be related to studies indicating a potential increase in a rare side effect called myocarditis, which is inflammation of the heart muscle, particularly among boys and young men. In July, the FDA requested that Pfizer and Moderna broaden their trials to better identify and report lesser-known side effects.
According to Moderna, the majority of side effects reported by children aged 6 to 11 were mild to moderate, with fatigue, headache, fever, and injection site pain being the most common. Moreover, an independent panel will continue to assess the vaccine’s safety in trial participants for an additional year following the second dose.
Currently, Moderna is actively recruiting participants for trials involving children aged 2 to 5 and those between 6 months and 2 years. Approximately 5,700 children in the U.S. and Canada are enrolled in these trials. Moderna plans to submit the results to the FDA and other regulatory agencies shortly.
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Summary
Moderna’s COVID-19 vaccine has demonstrated a strong immune response in children aged 6 to 11, with most side effects being mild. The company is continuing to recruit participants for younger age groups as it prepares to submit findings to regulatory authorities.
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