It has been a while since Moderna and Pfizer started studies involving vaccines against COVID-19 in children. However, the Food and Drug Administration (FDA) advised that companies should increase the number of participants in these studies, as a precautionary measure to detect rare side effects.
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The companies had studies in mind involving about 1,500 children ages 5 to 11, but the FDA pointed out that the size and scope of their pediatric studies were inadequate to detect rare side effects. Therefore, the study will include 3,000 participants from 5 to 11.
A spokesman for Moderna confirmed to The New York Times that the company plans to expand its testing “to enlist a larger security database that increases the likelihood of detecting rarer events.”
Moderna’s clinical trial began recruiting patients in March with the overall goal of enrolling 6,795 participants aged between six months and 12 years. Pfizer is on a faster schedule than Moderna and may be able to meet FDA expectations for a larger trial and still file an order to expand its vaccine’s emergency authorization through the end of September.
Pfizer has previously said it expects to have results for the 5- to 11-year-old group in September, with results for children ages two to five soon thereafter. The results for children aged six months to two years are expected for October or November.
In the US, the FDA even authorized emergency use of Pfizer’s vaccine for children ages 12 to 15 in April; so far, the Modern vaccine has only been released to people aged 18 and over.