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CDC Says Gardasil For Boys Should Be Optional

Oct 22, 2009 | Parker Waichman Alonso LLP

Yesterday, the U.S. Advisory Committee on Immunization Practices voted against recommending routine Gardasil vaccination for boys. The voting does, however, allow physicians the option of recommending the vaccine for boys and men, said AJC/HealthDayNews. The Committee reports its findings to the U.S. Centers for Disease Control and Prevention (CDC).

The drug was approved by the U.S. Food & Drug Administration (FDA) for boys and men aged nine through 26 for the prevention of genital warts, and the FDA approved Gardasil’s use in females in 2006, a hotly debated topic among patient advocates.

The Gardasil vaccination prevents some forms of the Human Papillomavirus (HPV) that cause cervical cancer. AJC noted that HPV has also been associated with some rare throat, genital, and anal cancers and genital warts. Gardasil’s controversy originated when Merck & Co. attempted to make the vaccine mandatory, and because of continuing questions about its safety.

Proponents of the vaccine claim that expanding Gardasil’s use for males is beneficial since it is believed that males transmit HPV to females. Also, since HPV is linked to certain cancers, vaccinating males is believed by some to aid in the reduction of the rate of cervical cancer, said AJC.

Regardless, the cost efficacy of vaccinating males might not be as beneficial as hoped. We recently wrote about a new study that questioned the cost-effectiveness of HPV vaccination for males. According to a press release from Harvard School of Public Health (HSPH), researchers there found that if HPV vaccine coverage and efficacy are high in girls, a universal recommendation to vaccinate young boys is unlikely to provide comparatively good value for resources, compared with vaccinating girls only.

"This study found that while vaccine coverage and efficacy are high in girls, including boys in an HPV vaccination program generally exceeds what the U.S. typically considers good value for money," said lead researcher Jane Kim, assistant professor of health decision science, quoted AJC.

The FDA announced earlier this year that the Gardasil label was 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. Roughly 13 percent of Gardasil side effects reported to the Vaccine Adverse Event Reporting System (VAERS) describe fainting.

Meanwhile, we recently wrote that Gardasil may have played a role in two fatal cases of amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig’s disease, citing researchers from the ALS Center at the University of California San Francisco Medical Center. According to WebMD, the researchers looking into the cases can’t confirm a connection, but are hoping that by raising awareness, they will learn of any other incidents of ALS that have followed Gardasil vaccination.

As of June 2009, 15 million girls had received Gardasil, with more than 14,000 recipients reporting adverse reactions. The complaints included reports of dizziness numbness, and blood clots. Health regulators are also looking at 43 reports of fatalities that occurred following Gardasil administration.