FDA Approves HPV Vaccine genre: Hip-Gnosis & Little Red Ribbon-Hood & Six Degrees of Speculation

The Food and Drug Administration has approved Merck's cervical cancer vaccine, Gardasil. The vaccine has garnered significant attention from the religious right as many feel the vaccine might encourage children to engage in sexual activity. See prior Thought Theater postings on the controversial nature of the vaccine here.

June 8, 2006 — The U.S. Food and Drug Administration announced today that it has approved Gardasil, a vaccine that prevents infection by some strains of the human papillomavirus, which can cause cervical cancer if left untreated.

Gardasil will protect against at least four of the 10 known cancer-causing strains, Merck said. About 270,000 women worldwide die from cervical cancer each year; about 4,000 die in the United States.

HPV is the most common sexually transmitted infection in the United States, with about 20 million people currently estimated to have it, according to the National Institute of Allergy and Infectious Diseases.

Now that the vaccine has received approval for use, the next step will be for another committee to make usage recommendations. Much of the controversy surrounding the vaccine relates to the age at which the vaccine should be administered. Some religious groups have sought to prevent the vaccine from being part of any schools health requirements.

"There is a great debate because medically speaking, it is clear it would best be given to very young girls before they become sexually active, even if they intend to be abstinent," Johnson said.

The ACIP will make a recommendation for the age requirement of Gardasil after the FDA licenses the vaccine for certain age groups. The committee also will recommend whether children should be vaccinated as a school requirement, although states are not required to follow ACIP guidelines.

"Then the state decides whether it should be a school entry law, [so] these laws will vary state to state," said Curtis Allen, spokesperson for the CDC. The recommendations of the ACIP are important since doctors practicing in the U.S. should follow them.

The FDA has been the subject of concern by some groups that have accused the organization of allowing political considerations to impact health decisions. The delayed approval of the morning after contraception pill has been the most notable instance. The Bush administration's focus on abstinence may well become an issue as the recommendations for the vaccine are finalized.

Daniel DiRito | June 8, 2006 | 2:54 PM
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