U.S. FDA Grants Fast Track Designation to Novavax' RSV F-Protein Nanoparticle Vaccine for Protection of Infants Via Maternal Immunization

GAITHERSBURG, Md., Nov. 20, 2014 (GLOBE NEWSWIRE) -- Novavax, Inc. (Nasdaq:NVAX), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of recombinant nanoparticle vaccines and adjuvants, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to Novavax' RSV F-Protein nanoparticle vaccine candidate (RSV F vaccine) for protection of infants via maternal immunization.

"The FDA's granting of Fast Track designation to our RSV F vaccine for maternal immunization is an important step forward for the program. This achievement reflects the agency's recognition of the importance of this unmet medical need, their support for maternal immunization as an approach to protect infants from this important respiratory pathogen and the potential of our RSV F vaccine," said Stanley C. Erck, President and CEO of Novavax. "Most importantly this designation may allow for an improved timeline to licensure and therefore use of this important vaccine"

Maternal immunization represents a strategy to protect newborn infants through the transfer of maternal antibodies via active transport mechanisms in the placenta, thus providing the infant 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. Novavax is one of a number of companies to have initiated a maternal immunization clinical development strategy for pregnant women using a novel vaccine candidate. Novavax initiated the development of its RSV F vaccine for maternal immunization in 2012 and has completed two separate clinical studies in women of childbearing age. In September of this year, the company initiated a groundbreaking study in pregnant women to evaluate the safety and immunogenicity of the RSV F vaccine in pregnant women, to quantify transfer of vaccine-induced RSV antibodies to infants, and to assess the safety and RSV-specific antibody levels in infants through one year and six months of life, respectively.