Cambridge: Moderna, Inc. has announced topline results from a Phase 3 pivotal trial evaluating the efficacy of mRNA-1647, the Company's investigational cytomegalovirus (CMV) vaccine.
The study did not meet its primary efficacy endpoint of preventing CMV infection in seronegative female participants of childbearing age (16-40 years of age). Moderna will discontinue its congenital CMV clinical development program.
"The announcement is disappointing for families and healthcare professionals who have been eagerly awaiting a CMV vaccine to prevent congenital CMV, a leading infectious cause of birth defects," said Stéphane Bancel, Chief Executive Officer of Moderna. "The majority of the data from this trial is still forthcoming, and we will share our full results with the scientific community

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