The US Food and Drug Administration (FDA) has granted Fast Track Designation to Novavax’s respiratory syncytial virus (RSV) F-Protein nanoparticle vaccine candidate (RSV F Vaccine) that can be used to protect older adults of 60 years of age and above.
The number of older adults who die of RSV infection or its complications is estimated to reach up to 16,000 every year in the US, with nearly 900,000 medical interventions for a total economic burden of disease of approximately $28bn.
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Novavax president and chief executive officer Stanley C. Erck said: "The FDA’s granting of Fast Track designation for our RSV F Vaccine in older adults underscores its recognition of RSV as a significant unmet medical need in this large population segment.
"This joins our prior Fast Track designation for the RSV F Vaccine for the protection of infants via maternal immunisation.
"Fast Track designation could allow for an expedited timeline to licensure, accelerating the access to this vaccine for the most vulnerable populations."
In December last year, the US-based biopharmaceutical company fully enrolled the Resolve Phase III clinical trial of its RSV F Vaccine in 11,850 older adults, with the primary efficacy objective to prevent moderate to severe RSV-related lower respiratory tract disease as defined by the presence of several lower respiratory tract symptoms.
Novavax research and development president Dr Gregory M. Glenn said: "RSV is a widespread disease that causes infections of the lower respiratory tract.
"While RSV affects individuals of all ages, it acutely impacts older adults and infants. Our Phase III Resolve trial will examine the efficacy of our RSV F Vaccine and further define the burden of disease in older adults.
"We look forward to announcing data from the trial in the third quarter of this year."
Image: Electron micrograph showing the Respiratory Syncytial Virus (RSV) pathogen. Photo: courtesy of CDC / Dr Erskine Palmer.
