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| |  Herpes Zoster Vaccine and Placebo Show Similar Safety Profile in Elderly Patients: Presented at AGS By Ed Susman ORLANDO, Fla -- May 14, 2010 -- The safety profiles of patients aged 60 years or older receiving vaccination against herpes zoster and those receiving placebo appeared essentially the same after 42 days and after 182 days, researchers said here at the 2010 Annual Meeting of the American Geriatrics Society (AGS). The study was performed to determine if a substudy reporting an increase in adverse events was a real finding or just a statistical aberration. According to Alexander V. Murray, MD, PharmQuest, Greensboro, North Carolina, he and his colleagues were unable to find any increases in adverse events. "The zoster vaccine safety profile was similar to what was reported in previous clinical trials," he said during a poster presentation on May 13. "The serious adverse event risk of 1.51 from the SPS Adverse Event Monitoring substudy was not repeated." Dr. Murray said that the study was also performed "because the US Food and Drug Administration wants this kind of postmarketing information." In the short-term analysis, 11 patients died within 42 days of receiving the vaccine or placebo -- 6 in the vaccine group, including 2 from cancers, and 5 in the placebo group, including 1 stroke, 1 myocardial infarction, 1 case of meningitis, and 2 cases of respiratory failure. Overall, there were 24 fatalities in the zoster vaccine group after 182 days, compared with 17 deaths in the placebo group, but that difference was not statistically significant, Dr. Murray said. The investigators determined that none of the deaths could be attributed to the vaccine. Of the 5,979 patients in the study analysis who received the zoster vaccine, 340 serious adverse events were reported at the 182-day post-treatment mark, compared with 300 serious adverse events that occurred in the 5,990 placebo-treated patients, a difference that did not attain statistical significance, Dr. Murray said. Within the 42-day follow-up period, 84 participants who received the zoster vaccine reported a serious adverse event compared with 67 individuals who received placebo injections, a difference that did not reach statistical significance. Two individuals in the zoster vaccine group reported vaccine-related serious adverse events -- uveitis that was seen on day 5 and sciatica that developed on day 4. One person reported lumbar radiculopathy in the placebo group. Funding for this study was provided by Merck & Co., Inc. [Presentation title: Safety & Tolerability of Zoster Vaccine in Adults >=60 Years Old. Abstract A13]
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