December 12, 2005 -- FDA Reports Few Adverse Effects from Nasal Flu Vaccine

In the first two years after the federal Food and Drug Administration (FDA) licensed a trivalent, live, attenuated influenza vaccine for intranasal administration to healthy persons 4 to 49 years of age, more than two and a half million persons received the nasal vaccine. There have been no reported fatalities and only 460 reports of adverse reactions such as anaphylaxis, according to a review by FDA and the Centers for Disease Control and Prevention (CDC) of all adverse effects reported in the 2003-2004 and 2004-2005 flu seasons. The reviewers stressed that clinicians giving the vaccine, FluMist, manufactured by MedImmune Vaccines Inc., of Gaithersburg, MD, should be careful to follow package inserts regarding administration and patient eligibility—the vaccine is recommended only for healthy people belonging to the specific age group, which includes school-age children. The review, “Adverse Events Reported Following Live, Cold-Adapted, Intranasal Influenza Vaccine,” was published in the December 7 issue of the Journal of the American Medical Association.