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Merck's HPV vaccine, Gardasil, has been linked to reports of serious, life-threatening side effects including blood clots, seizures, pancreatitis, paralysis, increased risk of Guillain-Barre Syndrome, and death.
Gardasil is a vaccine designed to guard against four types of Human Papillomavirus ( HPV), two that can cause genital warts and two that may lead to cervical cancer. It has been on the market since 2006 and is approved for use in girls and women ages 9-26. In October 2009, the U.S. Food and Drug Administration (FDA) cleared the vaccine for use in males ages 9-26 also.
HPV is a sexually transmitted virus. It is passed on through genital contact and/or by skin-to-skin contact. There are many types of HPV and not all of them cause health problems. Two specific strains of HPV cause about 70% of cervical cancer and two other strains cause about 90% of genital warts. The vaccine is designed to mimic HPV and help the body create a resistance to it. Gardasil is usually administered in three separate doses. Once a patient gets the first shot, she will usually receive a second shot two months later, and a third shot approximately six months after the first one. More than 26 million doses of Gardasil have been distributed in the U.S.
Among the 26 million people who received the vaccine, there are more than 15,037 reports of bad reactions following the vaccine, including reports of hospitalization, permanent disability, life-threatening illness, and death. In addition, many groups have raised other issues about the vaccine. Research published recently in The New England Journal of Medicine questions the effectiveness of the vaccine in preventing cervical cancer. Other studies raise concerns about whether the vaccine was sufficiently tested before distribution.
Complications reported following administration of the Gardasil vaccine range from fever, muscle pain and injection site irritation to serious life-threatening injuries and death. According to the Centers for Disease Control (CDC) as of September 1, 2009, there have been 44 U.S. reports of death among females who have received the vaccine. Other serious adverse events may include the following:
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