Background Influenza causes substantial morbidity in adultsand children with asthma, and vaccination can prevent influenzaand its complications. However, there is concern that vaccinationmay cause exacerbations of asthma.
Methods To investigate the safety of the inactivated trivalentsplit-virus influenza vaccine in adults and children with asthma,we conducted a multicenter, randomized, double-blind, placebo-controlled,crossover trial in 2032 patients with asthma (age range, 3 to64 years). The order of injection of vaccine and placebo wasassigned randomly, with a mean of 22 days between the injections.Each day during the two weeks after each injection, the patientsrecorded peak expiratory flow rates, symptoms thought to berelated to the injection, use of asthma medications, unscheduledhealth care visits for asthma, and asthma-related absences fromschool or work. The primary outcome measure was an exacerbationof asthma in the two weeks after the injections.
Results The frequency of exacerbations of asthma was similarin the two weeks after the influenza vaccination and after placeboinjection (28.8 percent and 27.7 percent, respectively; absolutedifference, 1.1 percent; 95 percent confidence interval, –1.4percent to 3.6 percent). The exacerbation rates were similarin subgroups defined according to age, severity of asthma, andother factors. Among symptoms thought to be associated withthe injection, only body aches were more frequent after thevaccine injection than after placebo injection (25.1 percentvs. 20.8 percent, P<0.001).
Conclusions The inactivated influenza vaccine is safe to administerto adults and children with asthma, including those with severeasthma. Given the morbidity of influenza, all those with asthmashould receive the vaccine annually.
Source Information
The Writing Committee (Mario Castro, M.D., M.P.H., Allen Dozor, M.D., James Fish, M.D., Charles Irvin, Ph.D., Steven Scharf, M.D., Ph.D., Mary Ellen Scheipeter, R.N., B.S.N., Janet Holbrook, Ph.D., M.P.H., James Tonascia, Ph.D., and Robert Wise, M.D.) assumes responsibility for the overall content of the manuscript.
Address reprint requests to Dr. Castro at Washington University School of Medicine, Box 8052, 660 S. Euclid Ave., St. Louis, MO 63110-1093, or at mcastro{at}im.wustl.edu.
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