Intranasal RSV Vaccine Fast Tracked for Those Over 60 and Children Under 2
According to the Company, preclinical studies demonstrated that the vaccine induces serum antibody and mucosal antibody responses.
Respiratory syncytial virus
FDA Authorizes Direct-to-Consumer Test to Detect COVID-19, Influenza, and RSV
The test is the first non-prescription multi-analyte COVID-19 test that allows individuals to test nasal swab samples self-collected at home.
March 2022: Drug Pipeline Updates
A review of regulatory and drug development status updates.
RSV Vaccine Candidate for Older Adults Gets Breakthrough Therapy Designation
The RSVpreF vaccine candidate consists of 2 prefusion F proteins selected to optimize protection against RSV A and B.
Nirsevimab Looks Promising for Protection Against RSV for All Infants
Nirsevimab is a long-acting monoclonal antibody to the RSV fusion protein that has an extended half-life.
February 2022 Recap: Drug Pipeline Updates
A review of regulatory and drug development status updates.
FDA Grants Breakthrough Status to RSV Vaccine Candidate for Older Adults
MVA-BN RSV consists of 5 distinct RSV antigens to stimulate a broad immune response against both RSV subtypes A and B.
Sisunatovir Fast-Tracked for Serious RSV Infection
Sisunatovir is an orally administered RSV fusion inhibitor that binds to RSV-F protein on the viral surface inhibiting RSV replication.
Investigational Vaccine to Prevent RSV in Older Patients Gets Breakthrough Status
Janssen announced that the Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for their investigational prophylactic vaccine for the prevention of respiratory syncytial virus (RSV)-mediated lower respiratory tract disease in adults aged 60 years and older. RSV is a highly prevalent and contagious respiratory infection. It is the most common cause of bronchitis…
Higher RSV Hospitalization Risk in Preemies After 2014 Guidance
A decline in immunoprophylaxis was associated with an increased risk of RSV hospitalization among infants 29-34 weeks gestational age who were <6 months of age for both commercial- and Medicaid-insured.
