In a large randomized, double-blind, placebo-controlled study that evaluated the general safety of the live herpes zoster vaccine (Zostavax, Merck) in adults aged 60 or older, the safety profile of ZOSTAVAX was similar to that of placebo with respect to serious adverse events.
In a large randomized, double-blind, placebo-controlled study that evaluated the general safety of the live herpes zoster vaccine (Zostavax, Merck) in adults aged 60 or older, the safety profile of Zostavax was similar to that of placebo with respect to serious adverse events (SAEs). The likelihood of experiencing an SAE was similar among those who received the vaccine and those who received placebo. These new data were presented at the 2010 American Geriatrics Society Annual Scientific Meeting in Orlando.
In this trial, there was no statistically significant difference in the estimated risk of SAEs between people who received Zostavax and those who received placebo, in both the 42-day and 182-day (6-month) follow-up periods. Both study groups had similar overall safety profiles with respect to SAEs. This study did not assess the frequencies of AEs that were not serious. These trial results are similar to the overall vaccine safety findings seen in other clinical studies with Zostavax, including the pivotal phase 3 Shingles Prevention Study (SPS).
“We are pleased to have these new data that add to the existing body of evidence that supports the safety profile of Zostavax,” said Paula Annunziato, MD, senior director, Vaccines Clinical Research, Merck. “Zostavax provides an important public health benefit to help prevent shingles in older adults, and it is important that healthcare providers have information about the vaccine's benefits and safety to share with their patients.”
Zostavax is the only shingles vaccine licensed for use in the United States, and is indicated for the prevention of herpes zoster (shingles) in people 60 years of age and older. It is not indicated for the treatment of zoster or postherpetic neuralgia (PHN). The U.S. Centers for Disease Control and Prevention (CDC) recommends a single dose of Zostavax for all appropriate people 60 years of age and older regardless of whether they have had a prior case of shingles.
Customers will experience backorders, or periods where they are unable to place orders for Zostavax throughout 2010 and possibly into 2011. Merck's goal is to have systems in place that will increase its manufacturing capacity and supply so that it can ensure a reliable supply of Zostavax in the future, according to a company press release.