Research & Development
Moderna in talks with US FDA to expand its COVID-19 vaccine paediatric trial
27 July 2021 -

US pharmaceutical company Moderna Inc (Nasdaq:MRNA) is in talks with US regulators to expand the size of an ongoing trial testing its COVID-19 vaccines in children aged between five and 11, Reuters news agency reported on Tuesday.

Moderna stated that the objective of the discussion with the US Food and Drug Administration is to enrol a larger safety database, which increases the likelihood of detecting rarer events.

The country expects to have a package that supports authorisation in winter of 2021 or early 2022, a company spokesperson told Reuters.

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