Girl Rejects Gardasil, Loses Path to Citizenship

Sept. 11, 2009— -- Born in Britain in 1992, Simone Davis got off to a rough start in life. Her biological mother abandoned her as a baby, and her father couldn't care for her.

At 3, her paternal grandmother Jean Davis got court orders giving her complete parental rights and responsibility to raise Simone until the age of 18.

Davis married an American in 2000 and moved them to Port St. Joe, Fla., but there was no equivalent guardianship in the United States. So for the last near decade, Davis has embarked on a quest to get Simone U.S. citizenship.

Now 17 and an aspiring elementary school teacher and devout Christian, Simone has only one thing standing in the way of her goal -- the controversial vaccine Gardasil.

Immigration law mandates that Simone get the vaccine to protect against the sexually transmitted human papillomavirus, which has been linked to cervical cancer.

But Simone, who has taken a virginity pledge and is not sexually active, doesn't see why she should have to take the vaccine, especially since it's been under fire recently regarding its safety .

And none of her American classmates is mandated by law to be vaccinated.

"I am only 17 years old and planning to go to college and not have sex anytime soon," said Simone. "There is no chance of getting cervical cancer, so there's no point in getting the shot."

Since 2008, the government has required that female immigrants between the ages of 11 through 26 applying for permanent resident or refugee status receive Gardasil, which was approved by the Food and Drug Administration in 2006.

Simone and her adoptive mother she still calls "Nanny" sought a waiver for moral and religious reasons and were recently rejected by the U.S. Citizenship and Immigration Services.

That ruling threatens to separate Simone and Davis, and could dash the teen's plans to attend Pensacola Christian College, where she was conditionally accepted.

They were given 30 days to appeal or the teen would face being "removed."

The 1996 Immigration and Naturalization Act requires girls and women within a specified age group to receive the vaccination against certain specified diseases "and any other vaccinations recommended by the CDC's Advisory Committee for Immunization Practices.

Gardasil was added to the list of vaccines in 2008.

"The decision to include HPV as a required vaccine was made by the CDC," said Citizenship and Immigration Services spokeswoman Chris Rhatigan.

"We follow the law," she told ABCNews.com. "The objection to a waiver would have to be to all vaccines, not just Gardasil."

The CDC is expected to publish new criteria to determine which vaccines should be recommended for U.S. immigrants in about a month, according to spokeswoman Christine Pearson.

Simone's struggle began in 2000, when U.S. authorities did not recognize the British adoption papers, and the process began anew.

"We never heard from her mother again after she sent a third birthday card, and was never given a contact address," said Jean Davis, who is now 63, divorced, and a teacher. "I had no idea where she was."

The Salvation Army Missing Person's Bureau traced Simone's biological mother, and the American adoption was finalized in 2006.

Local churches helped pay more than $1,700 immigration application fees for Simone's permanent residency status, the first step toward citizenship. For another $585, Davis can appeal, but says she doesn't have the money.

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.

Just this week, an advisory panel recommended that the FDA allow doctors to prescribe Gardasil to boys and men ages 9 to 26 to help prevent genital warts, which have been linked to the transmission of HPV.

Moritz, himself, has chosen not to have his 11-year-old daughter vaccinated, as long as good cervical cancer screening tests, like the Pap smear, exist.

"I'm pro-preventing cervical cancer," he told ABCNews.com. "But I'm not that pro that the physicians don't know the risks and side effects."

But Dr. Mark Einstein, associate professor of obstetrics and gynecology at the Albert Einstein College of Medicine and Montefiore Medical Center in New York, disagrees.

"Every scientific stakeholder has advocated for use of this vaccine," he told ABCNews.com. "The more serious side effects may not be vaccine related. The most recent report in the JAMA was positive, reinforcing the safety of a vaccine that been delivered to 26 million in the U.S."

Einstein said cervical cancer was "not just a Third World Disease." American women are struck in their "reprodictive prime," and radiation treatments can cause sexual dysfunction and child-bearing problems.

"I have a busy clinical schedule," said Einstein. "The death rate is low because the treatments are very effective. But the treatments are toxic and have very serious side effects through life.

"We have a lot of opportunity to prevent [cervical cancer] before it happens and shift the future of a disease," he said.

Einstein also debunks Simone's claim that she doesn't need the vaccine because she is not having sex.

"Quite frankly, from a science standpoint and outreach, everyone does ultimately as an adult have sex," he said.

But her adoptive mother, Jean Davis, said the issue is about more than chastity.

"All we want is the rights of a U.S. citizen," said Davis, who has scoured the Internet for research on Gardasil and sent letters to all her political leaders, including the president. "It's not mandatory for them to get this. That's our objection.

"My choice to make an informed decision for the health of my child has been taken away," she told ABCNews.com. "I have been like a crazy woman, I have been so upset about this. I am really in a panic."

"How can they call this America, the land of the free?" she asked. "Where are my parental rights?"