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Home HPV Vaccines HPV Vaccines Cervical Cancer Vaccines in the News

Cervical Cancer Vaccines in the News

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Recent media reports question side effects

Concerns about safety are inevitable with most any new vaccine or medication, and the first cervical cancer vaccine to reach the market is no

exception. Merck’s Gardasil® was approved in 2006 for the prevention of cervical, vulvar, and vaginal cancers. The vaccine is currently licensed for use with females ages 9-26 years. In July, a number of media outlets (notably U.S. News and World Report) ran stories that questioned if some serious “adverse events” (including paralysis) reported in individuals who received Gardasil® might in fact be related to the vaccine.

Keeping a Watchful Eye
It’s important to note that currently no evidence exists that scientifically links the vaccine to any serious complications, and both the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) regard Gardasil® as safe.

One mechanism used by FDA and CDC to monitor vaccine safety is the Vaccine Adverse Event Reporting System (VAERS). The system is apost-marketing safety surveillance program that collects reports of side effects, both minor and major, that occur in people who receive vaccines that are approved in the U.S. The system is passive in that it depends on clinicians filing reports of adverse reactions.

To date, CDC says that 94% of the side effects reported in those who received Gardasil® are minor and include fainting, discomfort at the injection site, nausea and headache, all of which are common with vaccines.
But what about serious adverse events? VAERS has received reports of 20 deaths in individuals after receiving the vaccine, and CDC says there’s nothing to suggest any of the deaths are connected to Gardasil®. In cases where autopsy and medical records were available, the fatalities were found to have occurred for reasons other than the vaccine.

VAERS has also received reports on Guillain-Barré Syndrome (GBS), a neurological disease that usually begins as tingling in the extremities and in some cases leads to paralysis. CDC says “To date, there’s no evidence that Gardasil has increased the rate of GBS above that expected in the population.” In other words, no greater incidence of GBS in those who have received the vaccine than what would occur randomly.

Is there any “there” there?
So what are we to make of a relatively small number of possible serious side effects, none of which are proven? HPV News medical advisor Gary Richwald, MD, MPH, has served as an expert witness on behalf of plaintiffs before the U.S. Court of Federal Claims (aka the “vaccine compensation court”) and isn’t sure there’s much cause for alarm. He says “Although there are limits to post-market surveillance, serious vaccine-related problems, if they exist, are likely to have been detected in view of 16 million doses of Gardasil® that have been distributed to date in the U.S.”

For more information, see CDC's fact sheet HPV Vaccine – Questions and Answers for the Public.