BioCentury
ARTICLE | Regulation

Watchdog rebuffed on Gardasil

August 20, 2007 7:00 AM UTC

The not-for-profit National Vaccine Information Center called for a warning about Gardasil based on an analysis released last week suggesting the HPV vaccine is associated with an increased risk of serious adverse events when given concomitantly with other vaccines. But the Centers for Disease Control and Prevention said events haven't risen above background rates, and thus it is unlikely to take any action without more evidence, which might come when Merck & Co. Inc. completes studies looking at whether such a link to its vaccine is causal or merely coincidental.

Between Gardasil's approval on June 8, 2006, and May 31, 2007, there were 2,227 reports to the federal Vaccine Adverse Event Reporting System (VAERS) related to Gardasil, according to NVIC. Of those reports, 87% of the patients received Gardasil alone, and the rest received at least one of 27 additional vaccines during the same office visit...