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Nanoparticle RSV Vaccine Wins ‘Fast Track’ Designation
The FDA has granted “fast track” status to a respiratory syncytial virus (RSV) F-protein nanoparticle vaccine candidate for the protection of infants via maternal immunization.
Maternal immunization represents a strategy to protect newborn infants through the transfer of maternal antibodies via active transport mechanisms in the placenta, thereby providing the infant with the benefit of the mother’s full repertoire of antibodies at the time of birth. The biology of maternal immunization is well understood and accepted, and maternal immunization is a recommended practice for several marketed vaccines, such as tetanus, pertussis, and seasonal influenza.
The vaccine’s developer (Novavax, Inc.) is one of several companies that have initiated a maternal immunization clinical development strategy for pregnant women using a new vaccine candidate. Novavax initiated the development of its RSV F vaccine for maternal immunization in 2012 and has completed two clinical studies in women of childbearing age. In September 2014, the company initiated another study meant to 1) evaluate the safety and immunogenicity of the RSV F vaccine in pregnant women; 2) quantify the transfer of vaccine-induced RSV antibodies to infants; and 3) assess the safety and RSV-specific antibody levels in infants through 1 year and 6 months of life, respectively.
The Fast Track Drug Development Program was established under the FDA Modernization Act of 1997. A “fast track” designation is intended for products that treat serious or life-threatening diseases or conditions, and that demonstrate the potential to address unmet medical needs for such diseases or conditions. The program is intended to facilitate development and expedite review of drugs to treat serious and life-threatening conditions so that an approved product can reach the market expeditiously.
RSV is a major respiratory pathogen with a significant burden of disease in the very young and in the elderly. In healthy adults, RSV infections are generally mild to moderate in severity, but are typically more severe in infants and young children as well as in adults more than 60 years old.
Globally, RSV is a common cause of childhood respiratory infection, with a disease burden of 64 million cases and approximately 160,000 deaths annually. Severe RSV disease results in 3.4 million hospital admissions per year globally and disproportionately affects infants younger than 6 months of age. In infants, toddlers, and young pre-school and school-age children, RSV infections result in the need for frequent medical care, including emergency room and office visits, and are associated with increased recurrent wheezing that can persist for years.
Moreover, it has been estimated that between 11,000 and 17,000 elderly and high-risk adults die of an RSV infection or its complications annually in the U.S., and that up to 180,000 are hospitalized for serious respiratory symptoms.
Currently, no approved RSV vaccines are available for any of these populations.
Source: Novavax, Inc.; November 20, 2014.