U.S. Requiring Controversial Vaccine

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.