“Expanding vaccine studies for ages 5-11”

by time news

In the US, the FDA has urged the manufacturers of the mRna vaccine to expand clinical studies on the effectiveness of the vaccine in the age group 5-11 years in order to analyze, and possibly prevent, the very rare side effects, such as myocarditis and pericarditis, which occurred in people under 30 already immunized. “The Food and Drug Administration – reports the ‘New York Times’ – indicated to Pfizer-BioNTech and Moderna that the size and scope of their pediatric vaccine studies were inadequate to detect rare side effects”.


The FDA’s plan is to include up to 3,000 children in the vaccine trial for the age group 5-11, “double the original number of study participants,” the New York Times points out. Pfizer had announced the first results for the 5-11 year range in September and soon after those for the 2-5 year range. Results for younger children, ages 6 months to 2 years, were expected in October or November. Now, with the urging of the FDA, the calendar could be delayed.

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