Pfizer begins Phase 3 trial of RSV vaccine in adults
New York: Pfizer Inc. has recently announced the initiation of RENOIR (RSV vaccine Efficacy study iN Older adults Immunized against RSV disease), a Phase 3 clinical trial evaluating the efficacy, immunogenicity, and safety of a single dose of its respiratory syncytial virus (RSV) bivalent prefusion F subunit investigational vaccine candidate (RSVpreF) in adults ages 60 years or older.
"RSV is a significant cause of severe respiratory disease in older adults, and it can cause disability and death. There is an important unmet medical need for an effective vaccine that can help protect older adults against this highly-contagious disease," said Kathrin U. Jansen, Ph.D., Senior Vice President and Head of Vaccine Research & Development at Pfizer Inc. "The start of this Phase 3 study is an important step forward towards our goal of comprehensive immunization against RSV disease, which includes developing a potential first vaccine to help prevent RSV disease in adults as well as the ongoing efforts to help protect infants through maternal immunization, subject to regulatory approval of the candidate vaccine."
The risk of serious infection increases in older adults and for those with chronic heart or lung disease or a weakened immune system. In the U.S., it is estimated that more than 177,000 older adults ≥65 years of age are hospitalized and 14,000 of them die each year due to RSV.
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