Moderna in talks with FDA to expand COVID-19 vaccine pediatric study

(Reuters) –Moderna Inc is in talks with U.S. regulators to expand the size of an ongoing trial testing its COVID-19 vaccines in children aged between five and 11, the drugmaker said on Monday.

The objective of the discussion with the U.S. Food and Drug Administration is to enroll a larger safety database, which increases the likelihood of detecting rarer events, the company said. Moderna expects to have a package that supports authorization in winter of 2021 or early 2022, a company spokesperson told Reuters. Earlier in the day, the New York Times reported the U.S. regulators have asked Pfizer…

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