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More Women Saying No to Gardasil

Sep 15, 2009 | Parker Waichman Alonso LLP

Fewer young women and girls are getting the Gardasil vaccine.  According to a report on kfyrtv.com, safety concerns may be one of the reasons behind a drop-off in Gardasil vaccinations.

Gardasil prevents four strains of HPV, two of which cause 70 percent of all cervical cancers. The other two HPV strains are responsible for about 90 percent of genital warts. However, Gardasil has been the subject of controversy ever since it was approved in 2006. Recently, a new study in the Journal of the American Medical Association found that Gardasil has a higher incidence of blood clots reported. Last month CBS News reported that Merck is also looking into cases of ALS (Lou Gehrig’s Disease) reported after vaccination, and is monitoring the number of deaths reported after Gardasil is administered. Right now, that number stands at 32.

In June, the FDA announced that the Gardasil label had been updated to include more prominent warnings about fainting that can occur following administration of the vaccine. According to the agency, some Gardasil fainting victims have suffered from tonic-clonic (jerking) movements and seizure-like activity, and some have fallen resulting in traumatic injuries. According to the agency, roughly 13% of Gardasil side effects reported to its Vaccine Adverse Event Reporting System (VAERS) describe fainting.

According to the kfyrtv.com report, sales of  Gardasil declined by a third this year, with three out of four young women remaining unvaccinated.  Concerns about side effects are one reason fewer are being vaccinated, the report said.

Merck & Co. is trying to revive Gardasil sales  Recently, it asked the Food & Drug Administration (FDA) to approve it to prevent genital warts in boys and young men.  Last week, and FDA advisory panel recommended that the agency do so.

However, Merck has dropped its controversial campaign to convince states to make Gardasil  mandatory for young girls.  Such efforts were met with fierce opposition by many parents. While about 2 dozen states considered mandatory Gardasil initiatives, in the end only Virginia and Washington D.C. have instituted loose Gardasil mandates.  Merck quit lobbying for mandatory Gardasil in 2007.