CDC Reviewing Merck & Co.'s Gardasil Vaccine Has Had Nearly 8,000 Reports of Adverse Reactions to Thousands of Reactions to Cervical Cancer Vaccine Reported
Nearly 8,000 reports of adverse reactions to Merck & Co.'s Gardasil vaccine have been filed with the U.S. Centers for Disease Control and Prevention since June 2006, news reports said Tuesday.
Reaction totals for the vaccine -- used to prevent the sexually transmitted human papillomavirus (HPV) that's been linked to cervical cancer in girls and women -- include 15 reports of death and 10 confirmed deaths, but none of the deaths has been tied to the vaccine, CNN said.
Other adverse reactions include reports ranging from injection site pain, nausea and dangerous blood clots to paralysis stemming from a neurological disorder called Guillain-Barré syndrome. The CDC said it's still studying these reports.
The vaccine was approved in 2006 for girls as young as 9 years old. Merck said more than 26 million doses of the vaccine have been distributed worldwide, including almost 16 million in the United States.
The company said the vaccine is safe and effective. In a statement cited by CNN, Merck said a report of an adverse reaction "does not mean that a causal relationship between an event and vaccination has been established -- just that the event occurred after vaccination."
The company and the CDC said they would continue to evaluate the reaction reports.
HPV is believed to infect about half of sexually active women in North America, the Canadian Broadcasting Corp. reported, making it the most prevalent sexually transmitted disease in modern times. Only a relatively small number of those infected go on to develop cervical cancer.