Data Support Safety of Herpes Zoster Vaccine
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A secondary report from the Shingles Prevention Study provides evidence that the herpes zoster vaccine is safe and well tolerated in older immunocompetent adults.
The randomized, placebo-controlled Shingles Prevention Study was conducted at 22 U.S. academic medical centers between 1998 and 2004. A total of 38,546 adults 60 years of age or older participated in the study; 6,616 were included in an adverse events substudy designed to provide detailed information about relatively high-frequency, vaccination-related events (such as local inoculation-site events).
The results showed that herpes zoster vaccine had no detectable effect on the rates of serious adverse events during the first 42 days after inoculation. Serious adverse events were reported by 1.4% of participants in both groups (255 of the vaccine recipients and 254 of the placebo recipients). Long-term follow-up (mean, 3.39 years) showed that rates of hospitalization or death did not differ between vaccine and placebo recipients. In the substudy, local inoculation-site events—most commonly transient erythema, swelling, pain, and tenderness—were reported by 1,604 (48%) vaccine recipients and 539 (16%) placebo recipients. For both groups, inoculation-site events occurred more commonly in younger participants (60 to 69 years of age) than in older patients (70 years of age or more).
The authors concluded that this safety profile supports the recommendation for routine use of herpes zoster vaccine in immunocompetent older adults.
Ann Intern Med. 2010;152(9): 545-54.