Girl Rejects Gardasil, Loses Path to Citizenship

Citizenship Dashed by Gardasil

If Simone does not become a permanent resident by her 18th birthday in January, she willl have to reapply as an adult and wait five years before she can even be eligible for citizenship.

"I kind of feel like they may be experimenting with immigrants to see how we will react and then give the vaccine to citizens," said Simone. "I told Nanny that if it is such a great vaccine, why isn't it mandatory for everyone?"

Gardasil must be administered before the age of 26 to be effective, according to FDA guidelines. It protects against HPV types 6, 11, 16 and 18. Almost 70 percent of cervical cancer cases and 90 percent of genital warts are linked to these four strains.

About 12,000 women a year are diagnosed with cervical cancer, which kills about 4,000 annually, according to the CDC.

The vaccine can cause fainting, redness and inflammation at the site and fever. The most dangerous side effect, which has alarmed some gynecologists, is an increase in blood clots, which, according to an article in the Journal of the American Medical Association (JAMA), may have caused 32 unconfirmed deaths.

In an accompanying editorial, the journal complained about the lack of concrete evidence that the vaccine is effective.

When Gardasil was added to the vaccine list last year, it drew anger and protests from immigration advocates, who argued that it placed an unfair financial burden on women. A three-shot series of the vaccine can cost between $300 and $1,400.

Some health care policy experts suggested the requirement was excessive and unnecessary. Of the 14 required vaccines, 13 are designed to combat infectious diseases that are considered highly contagious. But Gardasil targets a virus spread through sexual contact.

Though 18 states are currently debating whether to make the vaccine mandatory, none, so far, require it.

"I am most definitely surprised and I would love to know how it ever became policy," said Dr. Jacques Moritz, director of gynecology at St. Luke's-Roosevelt Hospital in New York City. "I wonder if the drug company could have had any influence."

"It's a voluntary vaccine, and for the U.S. government to make it a mandatory decision to come to this country is crazy," he told ABCNews.com. "It has no public health value that has been shown."

Merck & Co., which makes Gardasil, said it had no involvement in the enactment of the mandate.

"Merck recognizes that many individuals and groups are concerned over this requirement and emphasizes that, while we encourage all women to be educated about HPV-related diseases, the company does not support mandatory vaccination of new female immigrants," said Merck spokeswoman Pam Eisele.

The company said it has an "extensive and ongoing" safety-monitoring program and does not believe that reported deaths have been caused by Gardasil.

"Nothing is more important to Merck than the safety of our medicines and vaccines," she told ABCNews.com. "We are confident in the safety profile of Gardasil.

The company garnered $1.4 billion in sales last year. According to the business publication Medical Marketing and Media, the company has "captured lightning in a bottle" with its direct-to-consumer marketing to mothers and their daughters, encouraging them to talk to their doctors about protection from HPV.

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