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Moderna Initiates Phase 3 Portion of Pivotal Trial for mRNA Respiratory Syncytial Virus (RSV) Vaccine Candidate, Following Independent Safety Review of Interim Data

Moderna Initiates Phase 3 Portion of Pivotal Trial for mRNA Respiratory Syncytial Virus (RSV) Vaccine Candidate, Following Independent Safety Review of Interim Data

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Endorsement to proceed given by the independent Data and Safety Monitoring Board based on preliminary Phase 2 safety and tolerability data Moderna expects to enroll approximately 34,000 participants in multiple countries RSV causes severe disease burden among older adults and young children; there is no approved vaccine to prevent RSV CAMBRIDGE, MA / ACCESSWIRE / February 22, 2022 / Moderna, Inc. (NASDAQ:MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that the Data and Safety Monitoring Board (DSMB) for the RSV program has endorsed the start of the Phase 3 portion of the pivotal clinical study of mRNA-1345, the Company’s Respiratory Syncytial Virus (RSV) vaccine candidate, in adults 60 years and older. The DSMB’s endorsement comes after independent review of preliminary Phase 2 data, which suggest that the vaccine has an acceptable safety profile in older adults at the selected dose.

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