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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
Endorsement to proceed given by the independent Data and Safety Monitoring Board based on preliminary Phase 2 safety and tolerability dataModerna expects to
About this update from Moderna, Inc.
[{"type":"text","content":"Endorsement to proceed given by the independent Data and Safety Monitoring Board based on preliminary Phase 2 safety and tolerability dataModerna expects to enroll approximately 34,000 participants in multiple countriesRSV causes severe disease burden among older adults and young children; there is no approved vaccine to prevent RSVCAMBRIDGE, 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. This study is known as ConquerRSV.\"RSV is one of the most widespread respiratory viruses, causing severe disease and hospitalization in older adults, and yet there is no vaccine available on the market,\" said Stéphane Bancel, Chief Executive Officer of Moderna. \"We believe that our vaccine candidate against RSV has the potential to protect against over 1 million infections globally each year[1], improving quality of life for those at high-risk of becoming infected and reducing the burden on health care systems. An mRNA vaccine against RSV could have a positive impact on individuals, communities, and global public health. Our ultimate goal is to combine our RSV vaccine with our COVID-19 and flu boosters into a single dose booster.\"RSV is a common respiratory virus that generally causes cold-like symptoms. While most people who contract RSV recover in approximately one to two weeks, the virus can be serious for young children and older adults. For these higher-risk groups, RSV is a leading cause of severe respiratory illness, including pneumonia and respiratory distress.The burden of illness caused by RSV is substantial; each year in the United States, RSV causes approximately 177,000 hospitalizations and 14,000 deaths in adults 65 and older, resulting in an estimated $3 billion in annual medical costs.RSV tends to be a seasonal illness, with infections in the United States and countries with ...