Gardasil Safety: Questions and Answers
Experts Weigh In on Safety Concerns About HPV Vaccine Gardasil
WebMD News Archive
Vaccine Not to Blame?
"VAERS receives unconfirmed reports of possible side effects" that may
require further study, Iskander tells WebMD. That is, the reports don't show
whether Gardasil caused the reported problems. Publicity tends to increase
VAERS reports, and Gardasil has gotten a lot of publicity, says Iskander.
The serious reported events are about half of what's average for vaccines
overall, according to the CDC.
The CDC hasn't been able to establish Gardasil's role in 10 of the deaths
reported to VAERS; patient information wasn't available for the other five
"Nonserious events" such as pain at the injection site and fainting made up
93% of the reported Gardasil adverse events in the VAERS database, says
He notes that teens are particularly likely
to faint after any vaccination, not just with Gardasil. The CDC recommends that
health care providers
observe patients for 15 minutes after vaccination with any vaccine. As for the pain reports, Gardasil "does
seem to cause a bit more discomfort to some people, compared to some of the
other vaccines given to teenagers," says Iskander.
Merck, which continues to monitor Gardasil's adverse events, stresses the
fact that adverse event reports don't amount to proof of cause and effect.
Karen Smith-McCune, MD, PhD, associate professor of the department of
obstetrics, gynecology, and reproductive science at the University of
California, San Francisco, agrees that the VAERS data don't amount to
But Smith-McCune, who has daughters in the age range for Gardasil
vaccination, says she's waiting to see the final, published results from
Gardasil's phase III clinical trials before she decides whether to let her
daughters get vaccinated.
Merck presented those results to the CDC's Advisory Committee on
Immunization Practices (ACIP) in February and plans to publish the findings
later this year, Merck spokeswoman Amy Rose tells WebMD by email.
"That's great," says Smith-McCune. "Until we see the published,
peer-reviewed final results from phase III trials, we don't have the gold
standard of evidence for safety and efficacy."
Smith-McCune co-wrote an editorial in The New England Journal of
Medicine in May 2008 recommending a cautious approach to the promising and
apparently safe vaccine.