Is the Gardasil Cervical Vaccine Safe?

Two years after gaining federal approval, there are renewed concerns over the safety of Gardasil, the first vaccine developed to prevent cervical cancer caused by HPV, or human papillomavirus. Between June 8, 2006 and April 30, 2008 there were 7,802 "adverse event" reports submitted to the Vaccine Adverse Event Reporting System (VAERS), a national program that monitors the safety of vaccines. In these reports, the vaccine is being blamed for health problems ranging from nausea to paralysis-to even death.

After receiving a vaccine, anyone can report a health problem in VAERS, but that only means that the event occurred after a vaccination and does not establish a causal relationship between an event and the vaccination. Scientific research must determine if the problem was caused by the vaccine or was merely a coincidence. According to the CDC website, less than 7 percent of the adverse events reported were for serious side effects, about half the average for vaccines overall. Of the 15 reports of death received by VAERS, only 10 contained adequate information for further analysis. After further review of the reports, the CDC could not establish a causal relationship between the vaccine and death. The agency does note that during the testing of Gardasil, before it was licensed, 10 people in the test group that received the HPV vaccine and 7 in the placebo group died during the trials, but none of the deaths were considered vaccine-related.

VAERS has also received 31 reports of Guillain-Barre' Syndrome (GBS) after Gardasil vaccination in the United States. Guillain-Barre' is a rare disorder in which the body's immune system attacks part of the peripheral nervous system, sometimes causing paralysis. Of the 10 confirmed GBS cases, five reported vaccination with Gardasil and Menactra (a vaccine for the prevention of meningococcal disease) at the same time. Of the remaining 21 reports, 7 did not meet the case definition for GBS when evaluated by the Clinical Immunization Safety Assessment (CISA) group, one had symptoms of GBS prior to vaccination, four have yet to be confirmed and nine are pending additional follow-up.

Merck and Co. Inc., the manufacturer of the vaccine, say they have distributed more than 26 million Gardasil vaccines worldwide, including almost 16 million in the United States. They estimate that about 8 million girls and women have received the vaccine in the U.S. since its approval in 2006, but because the U.S. does not have a national registry for immunization and vaccination, this estimate cannot be substantiated.

A recent CNN article spoke of one young woman who believes the vaccine made her sick. According to the article, her name is Jesalee Parsons of Broken Bow, Oklahoma, who received the shot on February 27, 2007. Her lawyer, Michael McLaren said she soon after developed a fever and pain. The next day, she felt pain in her chest and abdomen. Her mother, Laura Parsons, said Jesalee spent weeks in the hospital and underwent two surgeries after developing pancreatitis. She says she feels "let down by the government" and feels they should have studied the drug more before approving its use.

The CDC says Gardasil has been tested in more than 11,000 females 9 to 26 years of age in many countries around the world, including the United States. According to these studies, the HPV vaccine is safe and causes no serious side effects, with the most common side effect being injection site pain.

Merck says it could be a coincidence that the girl got sick after receiving the vaccine, and says it will continue to evaluate reports of adverse reactions, according to the CNN article.

For more information on reporting adverse events after vaccines, call VAERS at 1-800-822-7967 or visit http://vaers.hhs.gov/contact.htm.