U.S.: Female immigrants must get cancer vaccine

Safety, costs for 11- to 26-year-olds are questioned, but CDC supports rule

http://www.chron.com/disp/story.mpl/nation/6073178.html

By MARY ENGEL Los Angeles Times
10/24/2008

A cervical cancer vaccine that has been recommended only for U.S. residents has become a requirement for all new female immigrants ages 11 to 26, sparking an outcry over the order's safety and cost.

"It's outrageous," said Sara Sadhwani, project director for the Asian Pacific American Legal Center in Los Angeles. "It seems absolutely premature to mandate this for immigrant women."

The new requirement went into effect Aug. 1 and will affect more than 130,000 immigrants a year.

The U.S. Food and Drug Administration in June 2006 approved the vaccine Gardasil for females ages 9 to 26 to block strains of the human papillomavirus, or HPV, a sexually transmitted virus that can cause cervical cancer. About 4,000 women in the U.S. die of the disease each year.

The national Centers for Disease Control and Prevention recommended the vaccine for 11- and 12-year-old girls, with catch-up shots up to age 26. The vaccine works best if given early, before a young woman is sexually active and might have contracted the virus.

Unknown to many immigrant and health advocates, a 1996 immigration law directs the Citizenship and Immigration Services to require that new immigrants receive any inoculation recommended for U.S. residents by the CDC's immunization committee.

CDC spokesman Curtis Allen added that his agency's immunization committee, a panel of physicians that advises the CDC, did not consider the immigration implications of its recommendation.

"They made the recommendation based on the effectiveness and importance of the vaccine," he said. "That's their charge, and not immigration."

The CDC, Allen said, stands by its recommendation.

Reports of side effects
Although most medical organizations echo the CDC's advice that Gardasil be part of routine vaccinations, it has not been universally embraced. There have been some concerns about the vaccine's potential side effects. As of June 30, the FDA had received 9,749 "adverse events" reports from physicians and patients following Gardasil injections. Most involved pain at the injection site, headaches, nausea, fainting or fever.

The 6 percent that were deemed serious included 20 deaths as well blood clots and several cases of Guillain-Barre syndrome, an autoimmune disease that can lead to paralysis. There is no evidence that Gardasil caused the deaths or led to Guillain-Barre, the FDA says.

Still, some physicians believe that the vaccine's safety has not been proved. Dr. George Sawaya, a University of California, San Francisco obstetrician gynecologist, called the CDC recommendation "premature" because the vaccine is so new.

The vaccine blocks four strains of HPV, two of which cause about 70 percent of cervical cancers. A three-year study published last year in the New England Journal of Medicine said the vaccine reduced precancerous lesions by 17 percent.