Drug Information & Wellness Center

FDA is announces the licensure of the first vaccine in the United States for humans against the H5N1 influenza virus, commonly referred to as avian influenza or "bird flu." (April 2007)There have not been any human cases of avian influenza in the United States or North America, but there have been cases in other parts of the world such as Asia and Africa. According to statistics provided by the World Health Organization, from 2003 through April 11, 2007, there have been 291 laboratory-confirmed cases in humans, of whom, 172 died. Each additional case provides the virus an opportunity to improve its ability for human-to-human transmission and develop into a pandemic strain.

Manufacturer: The vaccine is manufactured by sanofi pasteur Inc. of Swiftwater, PA and has been purchased by the federal government for inclusion within the Nation's National Stockpile.

Scope:The approval and availability of this vaccine is an important step in enhancing the Nation's readiness against a possible pandemic and enhances our ability to protect those at increased risk of exposure to the H5N1 virus.

Indications and Usage:Influenza Virus Vaccine, H5N1, is an inactivated monovalent influenza virus vaccine, indicated for active immunization of persons 18 through 64 years of age at increased risk of exposure to the H5N1 influenza virus subtype contained in the vaccine.

Adverse reactions: Most common (>10%) adverse reactions are pain at injection site, headache, malaise, and myalgia.

Warnings and Precautions:History of a hypersensitvity reaction to chicken or egg proteins or life-threatening reactions to previous influenza vaccinations.

Dosage and Administration:Immunization consists of two 1 mL (90 µg) intramuscular injections, a 1 mL dose given on day 1 followed by another 1 mL dose given approximately 28 days later (window 21 to 35 days).  

    REPORT BY:

    M.Mudassir Ali

    5th Proff. Pharm.D

    REFERENCE:

    FDA

    SUPERVISOR:

    M.Atif Yazdani

    Lecturer (Clinical pharmacy)

    I.U.B