Moderna negotiates with U.S. regulators to expand pediatric research on COVID-19 vaccines
The drugmaker said on Monday that Moderna is in talks with US regulators to expand the scale of an ongoing trial that tests its COVID-19 vaccine in children aged 5 to 11.
The company stated that the purpose of discussions with the U.S. Food and Drug Administration (FDA) is to register a larger safety database, which increases the possibility of detecting rare events.
A company spokesperson told Reuters that Moderna expects to launch a plan to support authorization in the winter of 2021 or early 2022.
Earlier in the day, New York Times Report U.S. regulatory agencies have required mRNA-based vaccine manufacturers Pfizer-BioNTech and Moderna to expand the scale of trials.
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The report stated that they claimed that the research was not strong enough to detect rare side effects, including myocarditis, myocardial inflammation and pericarditis, and inflammation of the inner lining around the heart.
Pfizer said it did not provide any updates to its previously specified timetable. The company has previously stated that it expects to obtain data on children aged 5 to 11 in September.
The report quoted people familiar with the matter as saying that health regulators have asked these companies to include 3,000 children in their trials, almost twice the number of participants in the initial study.
The US FDA did not immediately respond to Reuters’ request for comment.