US-based MedImmune LLC announced on Friday that it has received approval from the US Food and Drug Administration (FDA) for FluMist, an influenza vaccine for self- or caregiver-administration.
FluMist is approved for the prevention of influenza disease caused by influenza virus subtypes A and B in individuals aged 2 to 49 years of age. It is sprayed into the nose. FluMist was initially approved by the FDA in 2003 for use in individuals aged 5 to 49 years of age, and in 2007 the FDA approved the use of the product to include children aged 2 to 5.
This is the first vaccine intended to prevent influenza that does not need to be administered by a health care provider.
Peter Marks, MD, PhD, director of the FDA's Center for Biologics Evaluation and Research, said: "Today's approval of the first influenza vaccine for self- or caregiver-administration provides a new option for receiving a safe and effective seasonal influenza vaccine potentially with greater convenience, flexibility and accessibility for individuals and families. Getting vaccinated each year is the best way to prevent influenza, which causes illness in a substantial proportion of the US population every year and may result in serious complications, including hospitalisation and death. This approval adds another option for vaccination against influenza disease and demonstrates the FDA's commitment to advancing public health."
Merck's CAPVAXIVE shows promising immune responses in adults at risk of pneumococcal disease
GSK PLC announces acceptance of NDA for gepotidacin by US FDA
Sanofi in talks to sell Opella stake
Orlance receives research grant to develop Enhanced Seasonal Influenza Vaccine
Anixa Biosciences plans Phase 2 breast cancer vaccine study
MedImmune's FluMist nasal spray influenza vaccine receives US FDA approval
Gavi signs agreement with Bavarian Nordic for Mpox vaccines
Valneva seeks label extensions for chikungunya vaccine in Europe and Canada
MinervaX and Wacker Biotech collaborate on GBS vaccine manufacturing
Merck's GARDASIL 9 shows promise in preventing HPV infection in Japanese males
OSE Immunotherapeutics initiates Phase 3 trial for cancer vaccine Tedopi
Pfizer names new Regional President for Middle East, Russia and Africa
LakeShore Biopharma names new chief executive officer
Valneva and Pfizer report positive Phase 2 booster results for Lyme disease vaccine