ResVax - Model RSV F - Aluminum Adjuvanted Vaccine
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ResVax is our aluminum-adjuvanted RSV F vaccine for infants via maternal immunization. RSV is the most common cause of lower respiratory tract infections (LRTI) and the leading viral cause of severe lower respiratory tract disease in infants and young children worldwide. In the United States, RSV is the leading cause of hospitalization of infants and, globally, is second only to malaria as a cause of death in children under 1 year of age. There are currently approximately 18 million children in the United States between 6 months and 5 years of age. In the United States, RSV is responsible for approximately 57,000 hospitalizations of children under 5 years of age annually, the vast majority of which occur in infants less than 1 year of age, and especially those under 6 months of age.
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Data from our Prepare trial, which was initiated in December 2015, was announced in February 2019. The Prepare trial was conducted to determine whether ResVax reduced incidence of medically significant RSV-positive LRTI in infants through a minimum of the first 90 days of life and up through the first 6 months of life. While these data did not meet the trial’s primary efficacy endpoint, it did demonstrate efficacy against a secondary endpoint by reducing RSV LRTI hospitalizations in treated infants. ResVax is thus the first RSV vaccine to show efficacy in a Phase 3 clinical trial, and in addition, to show important effects against a variety of prespecified exploratory endpoints and post hoc analyses. This included an approximately 60% reduction in RSV-related severe hypoxemia and an approximately 74% reduction in RSV-related, radiographically confirmed pneumonia through Day 90. As in previous clinical trials, ResVax also showed favorable safety and tolerability results. In light of the fact that the trial failed to meet its primary endpoints, the FDA and European Medicines Agency (EMA) recommended that we conduct an additional Phase 3 clinical trial to confirm efficacy. The Bill & Melinda Gates Foundation (BMGF) has supported the Prepare trial for ResVax through a grant of up to $89.1 million; BMGF continues to financially support our efforts to conduct certain follow-up analyses of the Phase 3 data. We are currently in discussions with multiple potential commercial partners about the opportunity to bring ResVax to market globally. In addition, we are continuing to determine regulatory licensure requirements and pathways in the United States, the European Union, and other locations.
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