HPV Vaccine - Safety

Safety

Gardasil is a 3-dose (injection) vaccine. As of 1 September 2009 (2009 -09-01) there have been more than 26 million doses distributed in the United States, and there have been 15,037 Vaccine Adverse Event Reporting System (VAERS) reports following the vaccination. Ninety-two percent were reports of events considered to be non-serious (e.g., fainting, pain and swelling at the injection site (arm), headache, nausea and fever), and 8 percent were considered to be serious (death, permanent disability, life-threatening illness and hospitalization). There is no proven causal link between the vaccine and serious adverse effects; all reports are related by time only. That is, they are only related because the effect happened some time after the vaccination.

As of 1 September 2009 (2009 -09-01), there have been 44 U.S. reports of death among females who have received the vaccine. None of the 27 confirmed deaths of women and girls who had taken the vaccine were linked to the vaccine. Guillain-Barré Syndrome (GBS), a rare disorder that causes muscle weakness, has been reported after vaccination with Gardasil. There is no evidence suggesting that Gardasil causes or raises the risk of GBS. Additionally, there have been rare reports of blood clots forming in the heart, lungs and legs.

As of 5 November 2009 (2009 -11-05) the CDC continues to recommend Gardasil vaccination for the prevention of four types of HPV. Merck, the manufacturer of Gardasil, will continue to test women who have received the vaccine to determine the vaccine's efficacy over a lifetime.

According to the Disease Control and Prevention (CDC) and the FDA, the rate of adverse side effects related to Gardasil immunization in the safety review were consistent with what has been seen in the safety studies carried out before the vaccine was approved and were similar to those seen with other vaccines. However, a higher proportion of syncope (fainting) and venous thrombolic events (blood clots) were seen with Gardasil than are usually seen with other vaccines. The FDA and CDC have reminded health care providers that, to prevent falls and injuries, all vaccine recipients should remain seated or lying down and be closely observed for 15 minutes after vaccination.