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

November 20, 2014 Novavax, Inc., 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 …

Novavax: Meet the decision makers

Novavax is a clinical stage vaccine developer who has been at the forefront of vaccine technology since it was founded in 1987. Based in Geithersburg, Maryland, in the US, Novavax specialises in the development and production of recombinant protein nanoparticles to produce  vaccines and virus like particles (VPLs) and recombinant protein micelles. Next Page >

One Year Follow-up from RSV F-Protein Vaccine Candidate Phase 1 Elderly Trial Demonstrates Sustained Levels of Immune Response

Sustained levels of RSV F antibody and palivizumab-competing antibody responses demonstrated over a 4 to 6 month period  Results support accelerating development plans for “seasonal” elderly RSV vaccine  Phase 2 clinical trial in elderly anticipated to start in late-2014/early-2015 May 12, 2014 Novavax, Inc. today announced follow-up data from its dose-ranging Phase 1 clinical trial of its respiratory syncytial virus (RSV) …

New Experimental Vaccine Produces Immune Response Against Middle East Respiratory Syndrome Coronavirus (MERS-CoV)

April 30, 2014 The University of Maryland School of Medicine (UM SOM) and Novavax, Inc. today announced that an investigational vaccine candidate developed by Novavax against the recently emerged Middle East Respiratory Syndrome Coronavirus (MERS-CoV) blocked infection in laboratory studies. UM SOM and Novavax also reported that a vaccine candidate against Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV) developed by Novavax …

Novavax Announces Positive Top-Line Data from Dose-Confirmatory Phase 2 Clinical Trial of its RSV Vaccine Candidate in Women of Childbearing Age

Vaccine candidate was well-tolerated with no vaccine-related serious adverse events Highest immune responses observed with a single dose of vaccine combined with aluminum phosphate adjuvant Women with the lowest baseline levels of RSV neutralizing antibodies had the largest increases following immunization, consistent with prior data Palivizumab-like antibodies exceeded levels observed in previous trials  High levels of antibodies developed within 14 days after …

Novavax Appoints Dr. Cindy Oliver as Senior Vice President, Process Development Operations

April 7, 2014 Novavax, Inc., a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of recombinant nanoparticle vaccines and adjuvants, today announced the appointment of Cynthia N. Oliver, Ph.D. to the position of Senior Vice President, Process Development Operations, effective April 8, 2014. Dr. Oliver will be responsible for all process development activities, with a specific focus on …

Novavax announce promising RSV vaccine Phase II results

Novavax have reported positive results of a Phase II clinical trial of its respiratory syncytial virus (RSV) vaccine candidate as a maternal immunization strategy. Novavax say that the randomized, blinded, placebo-controlled, dose-ranging Phase II clinical trial of the RSV F protein nanoparticle vaccine candidate accomplished the trial's protocol-specified objectives and supports progression to the next stage. Maternal immunization is a …