Novavax (NASDAQ: NVAX) 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.
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. Specifically, Fast Track designation facilitates meetings to discuss all aspects of development to support licensure and it provides the opportunity to submit sections of a Biologics License Application (BLA) on a rolling basis as data become available, which permits the FDA to review modules of the BLA as they are received instead of waiting for the entire BLA submission. In addition, priority review (6 month review versus standard 10 month review) is a potential benefit that may be available to Novavax' RSV F vaccine in the future.