ResVax Vaccine Continues to the RSV Finish Line
Novavax, Inc. announced various updates on its global licensure plan for the ResVax vaccine candidate, which prevents Respiratory Syncytial Virus (RSV).
ResVax is an RSV fusion protein recombinant nanoparticle vaccine with aluminum phosphate as an adjuvant.
ResVax is being developed by Novavax to protect infants from RSV disease via maternal immunization, which may offer the best method of protection from RSV disease in infants through the first months of life.
Previously, Novavax announced on March 1, 2019, the Prepare™ Phase 3 clinical trial failed to meet its main goal of preventing medically significant RSV lower respiratory tract infection.
Novavax made the following statements on June 10, 2019, in a press release:
- The U.S. Food & Drug Administration (FDA) has recommended that Novavax conduct an additional Phase 3 clinical trial to confirm efficacy against 'medically significant' RSV disease in infants born to mothers vaccinated with ResVax.
- Novavax has recently held meetings with several European national regulatory agencies to solicit input on the Prepare trial and possible pathways to licensure in Europe. The next step will be to seek formal scientific advice this fall from the European Medicines Authority, the agency responsible for licensing vaccines for the European Union.
- Bill & Melinda Gates Foundation, which provided an $89.1 million grant in support of the Prepare trial, continues to work with Novavax on a path to introduce ResVax to low and middle-income countries around the world.
"We remain encouraged by the ResVax efficacy observed with more severe RSV disease and hospitalizations. These data, coupled with the favorable safety profile of ResVax, demonstrate a positive public health benefit that warrants continued development to address the global unmet medical need in preventing serious RSV disease," said Stanley C. Erck, President and Chief Executive Officer of Novavax, in a company press release.
"We aim to identify pathways to licensure that allow pregnant women globally to be vaccinated so that their babies are protected from the serious short- and long-term consequences of RSV disease."
Previous RSV vaccine news:
- Insights for Developing RSV Vaccines
- Intranasal RSV Vaccine Candidate Generated Durable Immune Response
- When Are Infants Most Vulnerable to Asthma?
Globally, RSV is the leading viral cause of severe lower respiratory tract disease in infants and young children.
In the USA, RSV is the leading cause of hospitalization of infants, with estimated annual hospitalizations of up to 57,000.
While RSV can impact all infants, babies under 6-months of age are among those at highest risk, as approximately 77 percent of all first-year RSV infections occur before 6 months. In the U.S., the total economic burden is $2.7 billion annually.
Novavax, Inc., is a late-stage biotechnology company that drives improved health globally through the discovery, development, and commercialization of innovative vaccines.
- Novavax Provides Updates on the Global Pathways to Licensure for ResVax
- A Study to Determine the Safety and Efficacy of the RSV F Vaccine to Protect Infants Via Maternal Immunization
- Respiratory Syncytial Virus Seasonality — United States, 2014–2017
- Wall Street Is Betting on a Future RSV Vaccine Approval