Gardasil Mandate for Immigrants Draws Criticism

A vaccine designed to prevent cervical cancer is all that stands between Simone Davis and U.S. citizenship.

The 17-year-old Colchester, England native refuses to receive the Gardasil human papillomavirus (HPV) vaccine, and objects to its inclusion in a list of vaccinations required for immigrants seeking to become U.S. citizens.

 “I don’t want to get that shot,” said Davis, a Port St. Joe High School senior. “They’d have to take me kicking and screaming.”

Davis and her grandmother, Jeannie Davis, believe the government is “blackmailing” immigrant girls and women by forcing them to receive a vaccine with known adverse effects and questionable long-term efficacy.

All women between the ages of 11-26 must receive the vaccine as part of the mandatory immigration health exam, though Gardasil vaccination within the general population is largely voluntary.

The vaccine also protects against a sexually-transmitted virus, leading Christians like the Davises to question its appropriateness for young girls.

“Someone has to stand up and say, ‘This isn’t right. These girls are being forced,” said Jeannie Davis.

CDC Mandate

Though CBS and ABC news have devoted recent segments to examining the safety of the Gardasil vaccine, its July 2008 inclusion in a list of vaccines required by the U.S. Citizenship and Immigration Services (USCIS) received little fanfare.

Approved by the Food and Drug Administration (FDA) two years earlier, on June 8, 2006, the Gardasil vaccine protects against HPV strains 6, 11, 16 and 18.

Almost 70 percent of cervical cancer cases and 90 percent of genital warts are linked to these four strains.

The Advisory Committee on Immunization Practices (ACIP), a 15-member board tasked with making vaccine recommendations for the U.S. population, recommended a 3-dose vaccination for girls between the ages of 11-26.

Acting on the ACIP’s recommendation, the Centers for Disease Control (CDC) revised its “Technical Instructions to Civil Surgeons for Vaccination Requirements,” to require the Gardasil vaccine for immigrant females aged 11-26.

The requirement went into effect on July 1, 2008, though the CDC granted a 30-day grace period for medical exams conducted before Aug. 1, 2008.

Adverse Events

Jeannie Davis, herself a naturalized citizen and her granddaughter’s legal guardian, filed immigration paperwork on Simone Davis’ behalf in June of 2008.

By the time Simone Davis had her medical exam, the new requirements had gone into effect.

She received all her vaccinations except the Gardasil shot. Unfamiliar with the vaccine, Jeannie Davis asked the doctor to postpone vaccination until she had time to do some research.

Back at home, Davis, a Faith Christian School teacher, researched Gardasil on the Internet and was alarmed by reports of adverse health effects associated with the vaccine.

Before being licensed, Gardasil, manufactured by Merck & Co., Inc., was studied in five clinical trials on over 21,000 females between the ages of 9-26.

To detect side effects not identified in clinical trials, the CDC and FDA use three methods to monitor the vaccine’s safety.

Among them is the Vaccine Adverse Event Reporting System (VAERS), which tracks confirmed as well as anecdotal reports of vaccine side effects.

As of June 1, 2009, 25 million doses of Gardasil were distributed in the U.S. As of that date, VAERS reported 14,072 adverse events following vaccination.

Of those, 93 percent were identified as “non-serious” events, which included fainting, pain and swelling at the injection site, headache, nausea and fever.

The remaining seven percent indicated “serious” events such as Guillain-Barre Syndrome, a rare disorder that causes muscle weakness; blood clots and 43 deaths.

In a June 18, 2009 release entitled “Reports of Health Concerns Following HPV Vaccination,” the CDC noted the limitations of VAERS in identifying a direct link between the Gardasil vaccine and adverse health effects.

Of the deaths reported by VAERS, the CDC noted that only 26 were confirmed, and of those “there was no unusual pattern of clustering to the deaths that would suggest that they were caused by the vaccine.”

The CDC stood by its recommendation for women ages 11-26 to receive the vaccination to prevent four types of HPV.

No Long Term Studies

As she continued her research, Jeannie Davis was alarmed by more than Gardasil’s potential for adverse health events.

During an Aug. 19, 2009 interview with CBS News, Dr. Diane Harper, one of Gardasil’s top researchers, questioned the vaccine’s long-term effectiveness.

Current studies have found that those vaccinated with Gardasil are protected for five years, the CDC acknowledged.

If an 11-year-old is vaccinated with Gardasil, she will only be protected against HPV until she is 16, an age typically associated with sexual experimentation.

On CBS, Harper noted, “If we vaccinate 11-year-olds and the protection doesn’t last…we’ve put them at harm from side effects, small but real, for no benefit.”

Harper also noted the success of the Papanicolaou (Pap) screening program in lowering cervical cancer fatalities in the U.S.

Cervical cancer is usually treatable if detected early by Pap tests, according to the American Cancer Society.

An Aug. 19, 2009 editorial in the Journal of the American Medical Association entitled “The Risks and Benefits of HPV Vaccination” championed the need for long-term studies to determine Gardasil’s effectiveness.

The piece, written by Dr. Charlotte Haug, defined HPV as the “most prevalent sexually transmitted infection,” with an estimated 79 percent infection rate over a lifetime.

Almost all HPV infections are eliminated by the immune system, though some women may develop precancerous cervical lesions that lead to cervical cancer.

“The net benefit of the HPV vaccine to a woman is uncertain,” noted Haug. “Even if persistently infected with HPV, a woman most likely will not develop cancer if she is regularly screened. So rationally, she would be willing to accept only a small risk of harmful effects from the vaccine.”

“It’s my body”

As Jeannie Davis weighed her granddaughter’s options, a motorcycle metaphor took shape in her mind.

There was something unseemly, she believed, about requiring young girls to receive a vaccination to prevent a sexually transmitted disease.

“You wouldn’t walk around with a crash helmet on if you weren’t going to ride a motorcycle,” said Davis.

Simone Davis is not sexually active. She believes the Bible prohibits premarital sex, and wears a silver promise ring as a sign of her celibacy.

“My point is, if a person is not sexually active and has zero chance of getting it, obviously, you say there’s no risk yet so I’m not going to risk an adverse reaction,” said Jeannie Davis. “But that choice has been taken away by the immigration service.”

Though the CDC recommends vaccination before the onset of sexual activity, Davis insists the mandate is “terribly inappropriate.”

While many of her schoolmates have had the Gardasil vaccine, Simone Davis also remains firm in her objections.

 “It should be my choice, not the government telling me I have to have it done,” said Davis. “It’s my body. I feel like one of their experiments.”

Denied

To bypass the Gardasil requirement, Jeannie Davis filed an Application for Waiver of Grounds of Inadmissibility in May on Simone’s behalf. She cited moral and religious objections to the Gardasil vaccine.

Last month, the Davises received a letter from the immigration office in Jacksonville, informing them that they needed to come in to finish up some paperwork.

Hopeful that the waiver had been accepted, the Davises arrived in Jacksonville eager to hear a good word.

When she entered the immigration office, Simone Davis encountered a young girl smiling broadly, which she took as a good omen.

“I said, ‘Hopefully that’s going to be me when we get out of here,’ said Davis. “We really did expect it to be the end of it.”

Once inside, both Simone and Jeannie Davis were required to submit separate affidavits noting their objections to the Gardasil vaccine.

Both cited religious and moral objections. They noted their disapproval of premarital sex and cited health risks associated with the vaccine.

In a letter dated Aug. 20, 2009 from the U.S. Department of Homeland Security in Jacksonville and the USCIS, Simone Davis’ waiver was denied.

“According to the record and your statements, you are not opposed to vaccinations in any form; rather, you are opposed only to the HPV vaccination,” the letter read.

“You have failed to establish that you qualify for the waiver of the health-related grounds of inadmissibility, under the circumstances that the Attorney General has provided by regulation.”

An appeal

The Davises’ current options are limited.

They can appeal the decision within 30 days of the letter’s date, or can file a blanket waiver.

For a blanket waiver to apply, a civil surgeon administering the medical exam would need to determine that the vaccination is not “medically appropriate.”

An immigration official in Jacksonville advised the Davises that the appeal process could last up to five years, further limiting Simone Davis’ options.

Though she could presumably remain in the U.S., Davis could not attend Pensacola Christian College, which has granted her a conditional letter of acceptance. She can only enroll once she has become a U.S. citizen.

For now, Jeannie Davis rises early every morning before work to send e-mails to those she hopes will be sympathetic to her granddaughter's plight.

She has emailed Gov. Charlie Crist and other elected officials, news organizations CBS and ABC, and the myriad contacts she’s gained through months of diligent research.

And the clock is ticking.

Through her online contacts with those familiar with immigration law, Davis has learned that the USCIS can begin removal proceedings, a thought that terrifies Davis.

“I was under a false sense of security that we had until January (Simone's 18^th birthday),” said Davis, noting that her granddaughter has no one to care for her in England.

“Where do they think they’re going to send her on her own?”

Simone Davis continues to hope for the best, putting faith in the woman who’s cared for her since she was 18 months old.

“I know that Nanny’s been really, really working hard on it,” she said. “We’re going to fight it, but we don’t know what will happen.”