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In encouraging news, Moderna has announced that its COVID-19 vaccine is safe and elicits a strong immune response in children aged 6 to 11. This revelation comes as a relief to many parents eager for more information on the vaccine’s safety for younger age groups.
In the clinical trial, children who received both doses of the vaccine exhibited antibody levels 1.5 times higher than those of young adults one month post-vaccination. The study, which involved 4,753 children over eight weeks, administered shots containing 50 micrograms of the vaccine, which is half the dosage given to adults.
While the results are promising, it’s worth noting that Moderna has not yet published the complete dataset, and the findings have not undergone peer review. This announcement arrives just a day before an FDA panel is set to evaluate vaccine data for children aged 5 to 11.
Although Moderna submitted data regarding the vaccine for adolescents aged 12 to 17 back in June, the FDA is still in the process of reviewing this information. Delays might be linked to concerns about a rare side effect called myocarditis, which can cause inflammation of the heart muscle, particularly in boys and young men. As a precaution, the FDA requested Pfizer and Moderna to broaden their trials to monitor for less common side effects earlier this summer.
According to Moderna, the majority of side effects reported by children aged 6 to 11 were mild to moderate, with the most frequent reactions being fatigue, headaches, fever, and soreness at the injection site. Following the second dose of the vaccine, an independent panel will continue to monitor the safety of the vaccine among trial participants for an additional year.
Currently, Moderna is still recruiting participants aged 2 to 5 and those between 6 months to under 2 years for ongoing trials. Approximately 5,700 children in the U.S. and Canada have been enrolled in these studies. Moderna plans to submit the findings to the FDA and other regulatory agencies shortly.
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In 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 ongoing trials for younger age groups signify continued research and commitment to vaccine safety.
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