7/26, 7:02 PM (Source: TeleTrader)
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FDA instructs Pfizer, Moderna to expand child studies - report

The United States Food and Drug Administration instructed Pfizer-BioNTech and Moderna pharmaceutical companies to expand the COVID-19 vaccine studies for the age group of 5 to 11 and double the number of trial participants to 3,000 children, the New York Times reported on Monday citing anonymous sources close to the matter.

The decision is a precautionary measure aimed at enlarging the focus group in order to detect vaccine's rare side effects that have been found among some vaccinated individuals under the age of 30. The side effects may include myocarditis and pericarditis, inflammation of the heart muscle and lining around the heart.

Pfizer is said to be on a faster track than Moderna, looking to get an emergency authorization for the vaccine for children above 5 years old by the end of September. Moderna is hoping to get approved for the same age group by winter 2021 or early 2022.

Breaking the News / LH