No Link Between Gardasil, Adverse Events, CDC Says

Main Category: Cervical Cancer / HPV Vaccine
Article Date: 24 Oct 2008 - 8:00 PST

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CDC officials on Wednesday said a federal study of reported deaths and serious adverse effects in girls and women who received Merck's human papillomavirus vaccine Gardasil shows that the events likely are not related to the vaccine, the Wall Street Journal reports. Gardasil is designed to protect against four strains of HPV, two of which account for about 70% of cervical cancer cases, the Journal reports. The study -- which is the first post-market safety study of Gardasil since the vaccine was approved in June 2006 -- was based on 375,000 doses of the vaccine administered from August 2006 to July 2008 to patients ages 9 to 26. The data were collected through CDC's Vaccine Safety Datalink program, which compiles data from several managed care organizations. Researchers compared rates of possible side effects in vaccine recipients with a similar group of patients who did not receive the vaccine. CDC said the agency and FDA "have determined that the HPV vaccine is safe to use and effective in preventing four types of HPV."

Health officials also released a tally of reports to the federal vaccine adverse events reporting system, which is run by CDC and FDA (Corbett Dooren, Wall Street Journal, 10/23). CDC received 10,326 reports of adverse side effects, of which "94% were reports of events considered to be non-serious, and 6% were reports of events considered to be serious," including 27 deaths, CDC said (Fox, Reuters, 10/22). Most vaccines have reported serious adverse events rates between 10% and 15% (Wall Street Journal, 10/23). Eleven of the deaths were attributed to other diseases, such as diabetes or meningitis, and not linked to the vaccine. The other deaths either are still under investigation or did not include enough information to assess, CDC said. Some of the serious events included Guillain-Barre Syndrome, a rare disorder that affects the body's muscle system. CDC said, "There has been no indication that the HPV vaccine increases the rate of GBS in girls and women above the rate expected in the general population, whether or not they were vaccinated." The agency said the reports of non-serious events included pain or swelling at the injection site, nausea, headache, fever or fainting. According to Reuters, the reports of non-serious events "simply show that someone fainted, became ill or had an allergic reaction around the time they also received the vaccine" and do not necessarily indicate a correlation. CDC in a statement said the agency, along with FDA, "will continue to closely monitor the safety of the HPV vaccine" (Reuters, 10/22).

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