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Novavax' RSV F-protein nanoparticle vaccine gets FDA fast track status

PBR Staff Writer Published 21 November 2014

Biopharmaceutical firm Novavax has received fast track designation from the US Food and Drug Administration (FDA) for its RSV F-Protein nanoparticle vaccine candidate (RSV F vaccine) for protection of infants via maternal immunization.

Maternal immunization is a strategy to protect newborns 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, while it is a recommended practice for several marketed vaccines such as tetanus, pertussis and seasonal influenza.

The company has also started a maternal immunization clinical development strategy for pregnant women using a new vaccine candidate.

Novavax president and CEO Stanley Erck said: "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.

"Most importantly this designation may allow for an improved timeline to licensure and therefore use of this important vaccine"

The company started development of its RSV F vaccine for maternal immunization in 2012 and has completed two separate clinical trials in women of childbearing age.

In September 2014, the company started a trial in pregnant women to assess the safety and immunogenicity of the RSV F vaccine in pregnant women, to quantify transfer of vaccine-induced RSV antibodies to infants, as well as to evaluate the safety and RSV-specific antibody levels in infants through one year and six months of life, respectively.