An independent safety review committee reported study findings on nearly 190,000 females who received at least one dose of Merck’s Gardasil, a quadrivalent human papillomavirus vaccine (qHPV) at two managed care associations between August 2006 and March 2008.
The study found that there was no association between vaccination and a number of pre-specified health events including congenital abnormalities, miscarriages, 16 specified autoimmune and neurologic conditions (including Guillain-Barre syndrome), venous thromboembolism, and death within 6 months of each dose.
According to the data, fainting (syncope) on the day of vaccination and a skin infection within 14 days were associated with the vaccination. The safety review committee determined that the skin infection cases may also have been injection site reactions. Syncope and cellulitis are included in Gardasil’s labeling.
The safety and efficacy of Gardasil has been studied for more than a decade in more than 25,000 females and males and Merck has continued to monitor the safety profile of Gardasil since its licensure.
Release Date: May 17, 2011
Source: Merck Pharmaceuticals
Filed Under: Drug Discovery
