A trial of Moderna’s norovirus vaccine in the U.S. has been put on hold by the FDA over a reported case of neurological disorder.
The phase 3 study is evaluating the candidate, dubbed mRNA-1403, across two norovirus seasons. The trial is already fully enrolled in the Northern Hemisphere—with the first patient dosed last September—and Moderna is preparing for enrollment for the other norovirus season in the Southern Hemisphere.
The goal is to recruit around 20,000 participants aged 60 years and older as well as 5,000 participants between the ages of 18 and 59. The trial’s aim is to assess mRNA-1403’s ability to protect against moderate to severe norovirus acute gastroenteritis in adults, with “a focus on the older age group that is at greatest risk of severe outcomes…