FDA Files for Priority Review of Pfizer’s RSV Vaccine Candidate to Prevent Complications in Infants
The U.S. Food and Drug Administration (FDA) has accepted a filing for approval of Pfizer’s respiratory syncytial virus (RSV) vaccine candidate, RSVpreF (PF-06928316) for priority review. The vaccine, if approved, would be the first immunization approved for administration in pregnant individuals to help protect against the complications of the virus in infants from birth through 6 months.
RSV is a common respiratory illness that usually causes mild, cold-like symptoms, but can become serious, especially for infants and older adults. An estimated 58,000 children under 5 years old and 60,000 to 160,000 adults 65 years and older are hospitalized each year due to an RSV infection, according to the Centers for Disease Control and Prevention.
Pfizer’s maternal immunization regulatory submission is supported by the positive top-line results from the phase 3 MATISSE trial, which evaluated the efficacy, safety, and immunogenicity of RSVpreF against medically attended lower respiratory tract illness (MA-LRTI) and severe MA-LRTI in infants born to healthy women vaccinated during pregnancy. Results showed vaccine efficacy of 81.8% (CI, 40.6-96.3) against severe MA-LRTI in infants from birth through the first 90 days of life. A 6-month follow-up period revealed an efficacy rate of 69.4% (95% confidence interval: 44.3-84
At the upcoming CDC Advisory Committee on Immunization Practices meeting on February 23, the data will be presented. Additionally, it will be presented at the ReSViNET Foundation's 2023 Global Conference on Novel RSV Preventive and Therapeutic Interventions.
“If approved, RSVpreF would help protect infants at their first breath from the devastating effects of this infectious disease, which though well-known, has been particularly evident throughout this RSV season,” said Annaliesa Anderson, Ph.D., Senior Vice President and Chief Scientific Officer, Vaccine Research & Development, Pfizer. We anticipate advancing the assessment of Pfizer's RSV maternal vaccine candidate with the FDA and other regulatory bodies, with the aim of exploiting its potential to positively influence global health by staving off RSV in infants.
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