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U.S. Requiring Controversial Vaccine

Homeland Security becomes the first governmental body to mandate immunization -- for young female immigrants -- against human papilloma virus.
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The Department of Homeland Security, against the recommendation of the Centers for Disease Control, is requiring girls and young women who immigrate to the U.S. to get a controversial vaccine for a cervical cancer virus.

Homeland Security's U.S. Citizenship and Immigration Services, or USCIS, is the first government agency to mandate that all females ages 11 to 26 years old be vaccinated against

human papillomavirus, or HPV

. There is no requirement for any other visa holders or U.S. citizens.

Since Homeland Security implemented the vaccination policy, the estimated 233,000 females ages 11 to 26 who entered the country as prospective citizens paid about a combined $52 million for one dose, based on the $223 cost for one treatment borne by the typical U.K. emigrant and average numbers taken from the Department of Homeland Security's "Yearbook of Immigration Statistics" over a four-year period.

Although one dose satisfies the Homeland Security vaccination protocol, three vaccinations, given over six months, are needed to be effective, according to



, maker of the vaccine.

Jon Abramson, an infectious diseases expert and chairman of the CDC's Advisory Committee for Immunization Practices, or ACIP, when Homeland Security implemented the requirement in April 2007, advised against making the HPV vaccine mandatory at the time.

"I am stunned. It was not the intention of the policy to mandate vaccination of immigrants," Abramson said, adding that vaccination policies are designed to protect the populace, not individuals. "This is not a disease that is communicable like SARS or pandemic flu or even measles."

The vaccine from Merck is Gardasil, the drugmaker's bestseller.




Cervarix, a rival treatment, is not available in the U.S. because it is still under evaluation by the Food and Drug Administration. Cervarix, however, is licensed in 64 other countries.

Gardasil, approved by the FDA in June 2006, is designed to be effective against four of about 100 types of HPV, two of which are responsible for the development of approximately 72% of cervical cancers in the U.S. Worldwide sales of Merck vaccines totaled $995 million in the second quarter, with Gardasil accounting for about a third of the amount.

Some medical experts have expressed concern about the vaccinations. It's not clear how long the vaccination will be effective or whether a booster shot will be needed, they say. At the same time, there is a lack of information about the vaccination's effectiveness when combined with other immunizations. The National Vaccine Information Center has warned about the possibility of adverse reactions to Gardasil, saying the CDC has assumed, but not tested, whether combining Gardasil with other vaccinations is safe.

More than 20 states, including Virginia and Texas, backed down from plans, supported by Merck, to make the vaccines mandatory for their residents after the CDC and citizens groups fomented opposition. Parents and medical experts grew concerned about the safety of the vaccine, the perceived encouragement of sexual activity by young people, removal of choice, and the appropriateness and benefits. Texas refused to approve the governor's executive order to mandate vaccination, and Virginia and Washington, D.C., have opt-out clauses.

No opt-out provision exists for immigrants. USCIS enforces the vaccination guidelines of the CDC prepared by the Division of Global Migration and Quarantine, which refers to the Immigration and Nationality Act, or INA, as the legislation requiring the recommendations of the ACIP to be implemented.

"It is not a deliberated decision on a vaccine-by-vaccine basis either by CDC or ACIP," CDC spokesman Curtis Allen said.

Homeland Security spokesman Bill Wright had no comment on the vaccination mandate.

A list of diseases for which vaccination is required can be found in section 212 of the INA. It calls for "vaccinations against vaccine-preventable diseases" recommended by the CDC's ACIP.

The State Department's form DS-3025, or "vaccination documentation worksheet," says vaccination against "Human Papillomavirus is required for U.S. immigrant visa applicants."

ACIP recommends routine vaccination for all 11- and 12-year-old girls in the U.S., not only immigrants, based on considerations including studies suggesting the HPV vaccine is safe and effective at that age. Vaccination is also recommended for females 13 to 26 years old who have not been previously vaccinated or completed the full series.

Condemnation of the immigration policy is widespread, from Abramson, who said he didn't know the policy was introduced under his chairmanship, to Charlotte Haug, editor in chief of the influential

Journal of the Norwegian Medical Association

, who said "this is very surprising and makes no sense. Whether this vaccine works is still being discussed."

Merck isn't aware of Homeland Security's policy, according to spokeswoman Amy Rose.

According to the CDC's Morbidity and Mortality Weekly Report, HPV infection rates in the U.S. are 6.2 million a year, and 3,700 deaths are attributed to cervical cancer. Pap-smear screening and treatment have effectively reduced cervical cancer incidence by 75% and death rates by 70% since the 1950s, and must be continued even after an HPV vaccination. According to a

New York Times

article, the vaccine costs from about $400 to about $1,000, depending on the country and the fees for doctors' visits.

The "CDC Immigration Requirements, Technical Instructions for Vaccination -- 2007" says that "because completion of the vaccine series often requires several months, immigrant visa applicants are not required to have received all doses of the ACIP-recommended vaccines prior to departure."

"This absolutely makes no sense," said Haug, who holds a doctorate in infectious diseases. "The only research done shows that three doses are required to be effective."

Gregg Sylvester, Merck's senior medical director of adult and adolescent vaccines, confirmed the vaccine was only tested using three doses, which is standard practice.

Sylvester said the first dose introduces the vaccine to the immune system, the second boosts the immune system and generates substantial numbers of antibodies that will decline after time, and the third is intended to stimulate the body into producing massive numbers of antibodies that provide the immunity.

In an Aug. 21 editorial in the

New England Journal of Medicine

, Haug identified areas for concern about Gardasil, including the fact that, despite licensing in 2006, several clinical trials that had not been completed and reported until mid-2007 left several questions unanswered.

"What we don't know is what benefit there is since HPV is so common and our own immune system clears 99% of these viruses," she said in an interview. "We co-exist with viruses."

The CDC, conceding there may be a case for a change in the law, said the intention of the recommendation of ACIP was to provide advice and guidance to parents.

The question that remains unanswered is, Who is accountable for making the decision to require immigrants to be vaccinated against HPV? There are six governmental departments, agencies or committees involved, and ACIP doesn't support the decision even though, under the INA, it is its recommendations that ought to be followed.

Gavin Magor joined Ratings in 2008, and is the senior analyst responsible for assigning financial strength ratings to health insurers and supporting other health care-related consumer products, including Medicare supplement insurance, long-term care insurance and elder care information. He conducts industry analysis in these areas. He has more than 20 years' international experience in credit risk management, commercial lending and analysis, working in the U.K., Sweden, Mexico, Brazil and the U.S. He holds a master's degree in business administration from The Open University in the U.K.