Thousands of adverse reactions to cervical cancer vaccine reported

THURSDAY July 10, 2008 (foodconsumer.org) -- Thousands of adverse reactions to Merck & Co.'s Gardasil, the only cervical cancer vaccine available in the U.S., have been reported to the U.S. Centers for Disease Control and Prevention since June 2006, according to media reports.

Gardasil, a vaccine indicated to protect against development of cervical cancer due to the infection of sexually transmitted human papillomavirus was linked with 15 reports of death and ten confirmed deaths, but there is no proof that the deaths were actually caused by the vaccine.

The vaccine was tested in trials of mostly mature women, but often used in teen girls as young as 9 years old. Trial results showed that this medication, which is administered in three shots for $360 as reported earlier, was able to prevent precancerous lesions which would otherwise potentially lead to cervical cancer. But the long term effect and safety remains unknown.

Among the reported adverse reactions are injection site pain, nausea, and dangerous blood clots and paralysis due to a neurological disorder.

CNN cited Merck's statement that reports of adverse reactions do not mean that an event was caused by the vaccine, even when the reaction occurred after vaccination.

Gardasil earns Merck as estimated more than $1.5 billion a year in the United States. Earlier the company lobbied states to mandate school girls as young as 9 years old to get shots, triggering resentment from those who advocate parents' medical rights.

Cervical cancer is caused largely by HPV. While HPV is common, most people can clear the virus without any treatment. Only a very small number of women would develop the rare malignancy. Those who received the vaccine are not exempt from Pap smear tests, still needing the screening to diagnose cervical cancer since Gardasil can’t prevent 100% of cervical cases.

By Ben Wasserman, and edited by Heather Kelley.
Jul 10, 2008 - 10:40:37 AM