Medication Guide App

MedImmune responds to FluMist complete response letter

GAITHERSBURG, MD., Feb. 7 -- MedImmune announced that it has completed the submission of information requested by the FDA for FluMist (Influenza Virus Vaccine Live, Intranasal), an influenza vaccine delivered as a nasal mist. The information submitted responds to the five questions raised by the FDA in a Complete Response Letter issued on January 29, 2003.

If approved by the FDA, FluMist would be the first and only intranasal influenza vaccine in the United States, and would be marketed by MedImmune and Wyeth Pharmaceuticals as part of an ongoing global collaboration agreement.

FluMist is a live, attenuated vaccine delivered as a nasal mist being developed by MedImmune for the prevention of influenza. Clinical trials suggest that FluMist is effective in reducing the incidence of influenza in healthy children and adults. FluMist also offers certain potential advantages in its administration by nasal spray, such as eliminating the unpleasantness of needle-based injectable vaccines and local injection site reactions.

According to the Centers for Disease Control and Prevention and the American Lung Association, 20 to 50 million people are infected annually in the U.S., causing 70 million
lost work days(1), 38 million lost school days(2), and 20,000 to 50,000 deaths per year (primarily in the elderly)(3).  The annual burden of the disease to society has been estimated at $15 billion.

    1 Adams PF, Hendershot GE, Marano MA.  Current estimates from the National
      Health Interview Survey, 1996 National Center for Health Statistics.
      Vital Health Sta. 10(200) 1999
    2 Adams PF, Hendershot GE, Marano MA.  Current estimates from the National
      Health Interview Survey, 1996 National Center for Health Statistics.
      Vital Health Sta. 10(200) 1999
    3 CDC.  ACIP/MMWR. 2002; 51 (no, RR-3):1-31

Source: MedImmune  www.medimmune.com

Posted: February 2003


View comments

Hide
(web5)