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News of the Day ... In Perspective

2/27/2007

Merck suspends lobbying for human papillomavirus (HPV) vaccine; FDA issues warning on Rota Teq

Merck announced that it has suspended its campaign to persuade state legislatures to mandate Gardasil, the human papillomavirus vaccine, for schoolgirls, after running into unexpected opposition from parents and medical groups.

The American Academy of Pediatrics and the American Academy of Family Physicians questioned Merck’s timing. “They, along with some other folks in the public health community, believe there needs to be more time,” stated Richard Haupt, Merck’s medical director for vaccines, to ensure government funding and distribute more information.

Sales of Gardasil totaled $235 million through the end of 2006. After the announcement, Merck’s stock price dropped 35 cents (Star Telegram 2/20/07).

The National Vaccine Information Center has prepared an analysis of 82 adverse reactions to Gardasil that were reported to the Vaccine Adverse Event Reporting System (VAERS) in the first six months after licensing. One-fourth involved neurologic symptoms or syncope. Although vaccine advocates discount the “fainting spells” as being simply a reaction to the injection, some of these events involved observable seizure activity, and some may have been atonic seizures. Some of the reactions occurred when Gardasil was administered at the same time as other vaccines, such as hepatitis b or meningococcal vaccine.

Another Merck vaccine, the new rotavirus vaccine Rota Teq, approved months before Gardasil, is the subject of an FDA warning that it, like the earlier Wyeth vaccine RotaShield, may cause intussusception in infants. The 28 reported cases included 16 who required surgery (Andrew Bridges, Associated Press 2/13/07).

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