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Moderna Announces First Participant Dosed in Phase 3 Pivotal Registration Study of Its mRNA Cytomegalovirus (CMV) Vaccine
CMV is the most common infectious cause of birth defects in the U.S.; there is no approved vaccine to prevent CMV CMV is a latent virus that remains in the
About this update from Moderna, Inc.
[{"type":"text","content":"\nCMV is the most common infectious cause of birth defects in the U.S.; there is no approved vaccine to prevent CMV\n\nCMV is a latent virus that remains in the body for life after infection and can lead to lifelong medical conditions\n\nmRNA-1647 combines six mRNAs in one vaccine, which encode for proteins for the prevention of CMV infection\n\n CAMBRIDGE, Mass.--(BUSINESS WIRE)--\nModerna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced the first participant has been dosed in the Phase 3 pivotal registration study of mRNA-1647, the Company’s cytomegalovirus (CMV) vaccine candidate. This study is known as CMVictory.\n\n“CMV is a complex, latent virus and represents a significant unmet medical need. The CDC estimates that 1 in 200 babies are born with CMV, and approximately 1 in 5 of them will have devastating sequelae such as hearing loss, seizures, and blindness. We believe that our mRNA vaccine technology is well-suited to provide protection against this latent virus,” said Stéphane Bancel, Moderna’s Chief Executive Officer. “The start of the second Phase 3 study in our company’s history is an exciting milestone for Moderna and I would like to thank the Moderna team as well as our partners at clinical trial sites. This study will allow us to get closer to our goal of addressing this unmet need with a preventative mRNA vaccine against primary CMV infection.”\n\nCMV is a latent virus that remains in the body for life after infection. In adults, initial infection with CMV often goes undetected. The CDC estimates that over half of adults are infected by age 40. For most healthy individuals, CMV does not pose a long-term health risk, but it can lead to lifelong medical conditions. For some, including those with weakened immune systems or infants born with CMV infection, it can have serious consequences. A pregnant mother with an active CMV infection may pass the virus to her unborn child, resulting in congenital CMV infection. Although most infants with congenital CMV appear normal at birth, approximately 1 in 5 will have long-term health problems such as hearing loss, vision impairment, learning disabilities and decreased muscle strength and coordination.1,2 Some newborns with congenital CMV appear very ill at birth with jaundice, rash, liver and spleen enlar...