Vaccine Updates: FDA Approves Self-Administered FluMist, Updated Novavax COVID-19 Vaccine
Key Insights
The FDA has approved FluMist, a nasal spray flu vaccine, for self- or caregiver-administration, making it the first flu vaccine with this capability, indicated for individuals aged 2 to 49 years.
Novavax's updated COVID-19 (search) vaccine has received FDA emergency use authorization for individuals aged 12 years and older, set to be available in pharmacies and grocers across the United States.
GSK reported positive topline data from a phase 3 study for co-administration of its RSV (search) vaccine (Arexvy) with its shingles (search) vaccine (Shingrix) in adults 50 years and older.
The FDA has approved several key vaccine updates, including a first-of-its-kind self-administered flu vaccine and an updated COVID-19 (search) vaccine, alongside positive data for RSV (search) and shingles (search) co-administration and a WHO prequalification for an mpox (search) vaccine.
Self-Administered FluMist Approved
The FDA has approved FluMist, a nasal spray influenza (search) vaccine, for self- or caregiver-administration. This marks the first time a flu vaccine has been approved for administration outside of a healthcare setting. FluMist is indicated for individuals aged 2 to 49 years for the prevention of influenza virus subtypes A and B. The vaccine contains weakened, live strains of the influenza virus. It was initially approved in 2003 for those aged 5-49, with the approval expanded in 2007 to include children aged 2-5.
Updated Novavax COVID-19 Vaccine Authorized
Novavax announced that the FDA has granted emergency use authorization (EUA) to its updated COVID-19 (search) vaccine for individuals aged 12 years and older. The updated vaccine will be available at pharmacies and grocery stores throughout the United States, pending release by the Center for Biologics Evaluation and Research.
GSK Reports Positive Co-Administration Data for RSV and Shingles Vaccines
GSK has announced positive topline data from a phase 3 study evaluating the immunogenicity, reactogenicity, and safety of its respiratory syncytial virus (RSV (search)) vaccine (Arexvy) when co-administered with its recombinant zoster vaccine for shingles (search) (Shingrix) in adults aged 50 years and older. The results will be submitted for publication in a peer-reviewed journal and will support regulatory submissions to the FDA, European Medicines Agency, and other regulatory bodies.
WHO Adds First Mpox Vaccine to Prequalification List
The MVA-BN (Imvanex) vaccine has been added to the WHO’s prequalification list. Manufactured by Bavarian Nordic, the vaccine is a two-dose injection given four weeks apart and is intended for adults. It is the first mpox (search) vaccine to be added to the list and is indicated for active immunization against smallpox (search), mpox, and related orthopoxvirus infections and disease in adults. The WHO also noted that the vaccine can be used off-label in individuals under 18 years of age and in pregnant and immunocompromised individuals, particularly in outbreak settings where the benefits outweigh the potential risks.