A Step Closer in the Fight Against Respiratory Syncytial Virus
Respiratory syncytial virus (RSV) is a contagious, common and pervasive cause of acute respiratory illness among older adults and young children.1 In the U.S. alone, each year, RSV infections in older adults account for approximately 177,000 hospitalizations and 14,000 deaths, and in children younger than five years old, nearly 2.1 million outpatient visits and 58,000 hospitalizations.2
The burden of this infectious disease is evident, but there is currently no U.S. Food and Drug Administration (FDA)- approved RSV vaccine on the market.
For more than five years, Pfizer has been advancing a novel vaccine candidate for RSV called PF-06928316 or RSVpreF.1 There has been significant progress in 2022 with Pfizer’s RSVpreF candidate:
- In December, Pfizer announced that the U.S. FDA accepted for priority review a Biologics License Application (BLA) for its RSV vaccine candidate, as submitted for the prevention of lower respiratory tract disease caused by RSV in individuals 60 years of age and older. Priority Review designation by the FDA reduces the standard BLA review period by four months. The Prescription Drug User Fee Act (PDUFA) goal date for a decision by the FDA on the RSVpreF application is in May 2023.7
- In November, Pfizer announced positive top-line data from the Phase 3 clinical trial (NCT04424316) MATISSE (MATernal Immunization Study for Safety and Efficacy) investigating RSVpreF when administered to pregnant participants to help protect their infants from RSV disease after birth.3
- In August, Pfizer announced top-line data from the Phase 3 clinical trial RENOIR (RSV vaccine Efficacy study iNOlder adults Immunized against RSV disease) when administered to adults 60 years of age or older.4
- In March, Pfizer announced two separate Breakthrough Therapy Designations from the U.S. FDA: one for the prevention of lower respiratory tract disease caused by RSV in individuals 60 years of age or older; and the second for RSV-associated lower respiratory tract illness in infants from birth up to six months of age by active immunization of pregnant women.5,6
Pfizer is currently the only company with an investigational vaccine with regulatory applications for both infants through maternal immunization and older adults to help protect against RSV disease.
"Pfizer recognizes the urgency to get an RSV vaccine to the market—it’s a priority for us, especially given the highly contagious nature of this infectious disease. If approved, our RSVpreF vaccine candidate has the potential to help protect older adults and infants from RSV.3,4 We look forward to advancing our dialogue with regulatory authorities to help bring a potentially transformative solution for RSV to at-risk populations,” said Annaliesa Anderson, PhD, Senior Vice President and Chief Scientific Officer, Vaccine Research & Development, Pfizer.
- One Step Closer in the Global Fight Against Respiratory Syncytial Virus (RSV). Pfizer.com. https://insights.pfizer.com/global-fight-against-rsv/?utm_source=Google&utm_medium=Search&utm_campaign=PfizerInsights&utm_content=RSV&gclid=Cj0KCQjwsrWZBhC4ARIsAGGUJupSTSjx9FLvW2jtGF_KEPhEd76ie8iykohcMLsj_AKTyJuUWuboDCwaAiuPEALw_wcB. Published 2022. Accessed October 26, 2022.
- Bracht M, Basevitz D, Cranis M, Paulley R. Impact of respiratory syncytial virus: the nurses perspective. Drugs RD. 2011;11(3):215-226.doi:10.2165/11593140-000000000-00000
- Pfizer Announces Positive Top-Line Data of Phase 3 Global Maternal Immunization Trial for its Bivalent Respiratory Syncytial Virus (RSV) Vaccine Candidate. Pfizer.com. https://www.pfizer.com/news/press-release/press-release-detail/pfizer-announces-positive-top-line-data-phase-3-global. Published 2022. Accessed December 12, 2022.
- Pfizer Announces Positive Top-Line Data from Phase 3 Trial of Older Adults for its Bivalent Respiratory Syncytial Virus (RSV) Vaccine Candidate. Pfizer.com. https://www.pfizer.com/news/press-release/press-release-detail/pfizer-announces-positive-top-line-data-phase-3-trial-older. Published 2022. Accessed December 12, 2022.
- Pfizer Granted FDA Breakthrough Therapy Designation for Respiratory Syncytial Virus Vaccine Candidate for the Prevention of RSV in Older Adults. Pfizer.com. https://www.pfizer.com/news/press-release/press-release-detail/pfizer-granted-fda-breakthrough-therapy-designation-0. Published 2022. Accessed October 26, 2022.
- Pfizer Granted FDA Breakthrough Therapy Designation for Respiratory Syncytial Virus (RSV) Vaccine Candidate for the Prevention of RSV in Infants from Birth up to Six Months of Age by Active Immunization of Pregnant Women. Pfizer.com. https://www.pfizer.com/news/press-release/press-release-detail/pfizer-granted-fda-breakthrough-therapy-designation. Published 2022. Accessed October 26, 2022.
- U.S. FDA Accepts for Priority Review the Biologics License Application for Pfizer’s Respiratory Syncytial Virus Vaccine Candidate for the Prevention of RSV Disease in Older Adults. Pfizer.com. https://www.pfizer.com/news/press-release/press-release-detail/us-fda-accepts-priority-review-biologics-license-0. Published 2022, Accessed December 12, 2022