Moderna in talks with U.S. regulators to expand COVID-19 vaccine pediatric study
Discussion with U.S. Food and Drug Administration meant to enroll larger safety database
Moderna 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 (FDA) 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 that U.S. regulators have asked mRNA-based vaccine makers Pfizer-BioNTech and Moderna to expand the size of the trial.
WATCH | Benefits of COVID-19 vaccine outweigh low risk of heart inflammation, experts say
They claimed the strength of the studies was inadequate to detect the rare side effects, including myocarditis, an inflammation of the heart muscle and pericarditis, an inflammation of the lining around the heart, the report said.
Pfizer said it has not provided any updates to its previously stated timelines. It had previously said it expects to have data for children aged between 5 and 11 in September.
The health regulator has asked the companies to include 3,000 children in their trials, almost double the original number of study participants, the report said, citing people familiar with the matter.
The U.S. FDA did not immediately respond to Reuters' request for comment.