FDA, CDC Continues Their Support of HPV Vaccine Gardasil

Merck clings to FDA, CDC endorsement in light of JAMA article

In the wake of new safety data on Merck’s human papillomavirus vaccine, both FDA and the Centers for Disease Control and Prevention have issued a statement supporting the product. “Based on the review of available information by FDA and CDC, Gardasil continues to be safe and effective, and its benefits continue to outweigh its risks,” the agencies said, calling the vaccine an “important cervical cancer prevention tool.”

Earlier this week the Journal of the American Medical Association published an analysis of safety data that found the most common serious side effect was fainting, though some more severe adverse event occurred in Gardasil patients, including more than two dozen deaths. But the FDA and CDC say there’s no evidence the deaths or other severe effects were actually caused by the shot, and the agencies emphasize that they have reviewed the same safety data repeatedly.

In response to the government support, Merck sought to reassure parents, encouraging them to “look to the CDC and FDA, and to the advice of their own physicians” to help them decide whether to have their children vaccinated. “We hope that the many parents who may have been frightened this week by misleading reports understand that Merck people are parents, too,” Dr. Richard Haupt, who heads up the Gardasil program, said in a statement. “Our own children are vaccinated with Gardasil.”

– see the FDA/CDC statement
– read the release from Merck
– get the story in the Wall Street Journal

PG

Author: H. Sandra Chevalier-Batik

I started the Inconvenient Woman Blog in 2007, and am the product of a long line of inconvenient women. The matriarchal line is French-Canadian, Roman Catholic, with a very feisty Irish great-grandmother thrown in for sheer bloody mindedness. I am a research analyst and author who has made her living studying technical data, and developing articles, training materials, books and web content. Tracking through statistical data, and oblique cross-references to find the relevant connections that identifies a problem, or explains a path of action, is my passion. I love clearly delineating the magic questions of knowledge: Who, What, Why, When, Where and for How Much, Paid to Whom. My life lessons: listen carefully, question with boldness, and personally verify the answers. I look at America through the appreciative eyes of an immigrant, and an amateur historian; the popular and political culture is a ceaseless fascination. I have no impressive initials after my name. I’m merely an observer and a chronicler, an inconvenient woman who asks questions, and sometimes encourages others to look at things differently.