Proper Name
Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted
Indication
For active immunization for the prevention of disease caused by the influenza A virus H5N1 subtype contained in the vaccine. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted is approved for use in persons (6 months and older) at increased risk of exposure to the influenza A virus H5N1 subtype contained in the vaccine.
Description
Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, for intramuscular injection, is a non-infectious, 2-component monovalent, AS03-adjuvanted vaccine.
Key Regulatory Milestones
11/2013 - Q-Pan H5N1 was licensed for influenza A virus H5N1
09/08/2014 - meeting was held between CBER and GSK to address GSK’s overall pediatric study plan that was part of the post-marketing pediatric requirements for the Q-Pan H5N1 BLA
09/09/2016 - FDA approval date
09/09/2016 - PDUFA Goal Date
Advanced Facts