ResVax Demonstrated Significant Vaccine Efficacy Against Infant Pneumonia Early in Life
A biotechnology company announced new data from the Prepare™ Phase 3 clinical trial of ResVax™, an aluminum adjuvanted respiratory syncytial virus (RSV) fusion (F) protein recombinant nanoparticle vaccine.
ResVax is being developed to protect infants from RSV disease via maternal immunization, said Novavax, Inc., in a press release on August 12, 2019.
Geeta K. Swamy, M.D., Associate Professor of Obstetrics and Gynecology and Vice Dean and Associate Vice Provost for Scientific Integrity at Duke University, made a presentation regarding new observations based on the recently completed analyses of the 1-year safety data, based upon 4,636 pregnant women, at least 3,000 of whom have received the ResVax vaccine, and their infants.
This analysis included a 56.9 percent reduction in the incidence of serious adverse events (SAEs) diagnosed as pneumonia, with confirmation by chest x-ray, that extended through the first year of life.
A similar vaccine efficacy of approximately 50 percent was found for all SAEs with a clinical diagnosis of pneumonia, also extending over a year.
When x-ray confirmed pneumonia SAEs associated with detection of RSV were considered, efficacy was 72.9 percent through 180 days of life, the last time point at which active detection of RSV was carried out.
Louis F. Fries III, M.D., Chief Medical Officer of Novavax, INc., said, “Based on the incidence rate for clinical pneumonia SAEs in placebo subjects in the Prepare trial and the vaccine’s efficacy in reducing this rate, ResVax could have a public health impact, in terms of vaccine-preventable disease incidence or number of women needed to vaccinate to prevent one case of infant pneumonia, that is similar or in excess of pneumococcal conjugate vaccines for similar outcomes.”
“Such insights are valuable as we explore potential regulatory and clinical development paths forward to deliver an effective vaccine to address a serious global unmet need.”
Previously, during February 2019, Novavax announced the initial top-line data from Prepare.
Prepare is supported by an $89.1 million grant from the Bill & Melinda Gates Foundation.
Novavax, Inc. is a late-stage biotechnology company that drives improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases.
- New Data from Novavax Phase 3 Prepare™ Trial of ResVax™ Presented at 2019 IDSOG Annual Meeting
- Safety of Third Trimester Immunization with a Respiratory Syncytial Virus (RSV) F Protein Vaccine and Protection of Infants
- Novavax Announces Topline Results from Phase 3 PrepareTM Trial of ResVax™ for Prevention of RSV Disease in Infants
- A Study to Determine the Safety and Efficacy of the RSV F Vaccine to Protect Infants Via Maternal Immunization