Parents should be the ones to decide if their daughters should receive the new HPV vaccine providing protection against some strains of the human papillomavirus that cause most forms of cervical cancer and genital warts, say Catholic religious and medical leaders.

National interest recently intensified in the Merck-manufactured Gardasil vaccine, approved June 8, 2006 by the U.S. Food and Drug Administration for use in girls and women 9-26 years of age, when Texas Governor Rick Perry issued an executive order Feb. 5 requiring the HPV vaccine for girls entering sixth grade in the fall of 2008.

On Feb. 20, the Texas Catholic Conference of bishops issued its statement calling for a rescinding of the executive order allowing "the public debate to go forward on this important healthcare issue." Coincidentally, that same day, the Travis County District Court ruled the governor had no constitutional authority to issue an executive order speeding up a coal plant case.

"The precedent has been set to overturn executive orders of the Texas governor, and, because of that, suits have been filed to overturn Governor Perry's order mandating HPV," said Jennifer Carr, TCC associate director. Currently, a bill to override the measure is rapidly moving through the state House of Representatives.

According to the TCC statement, the bishops "appreciate the seriousness of this healthcare issue" since "HPV is the most common sexually transmitted infection in the world and in the United States."

The Texas bishops noted the HPV vaccine is currently recommended by the CDC Committee on Immunization Practices, the American Academy of Pediatrics and the National Catholic Bioethics Center based in Philadelphia. However, the bishops said they concur with an NCBC statement released last summer rejecting mandated vaccinations.

"Although the NCBC considers HPV vaccination to be morally acceptable, it has also recommended that civil authorities should leave this decision to parents and not to make such immunization mandatory at this time," the Texas bishops wrote. "We feel strongly about the necessity for an open and public debate," added Andrew Rivas, TCC executive director.

The Catholic Medical Association, the nation's largest professional organization of Catholic doctors with 1,000 members, took a similar position in mid-January with their statement on implementation of the HPV vaccine. "The CMA encourages the use of this safe, effective and ethically acceptable vaccine but at the same time rejects efforts at the federal level, and in some states, to mandate that girls be vaccinated against HPV," wrote CMA officials.

Not unethical, but…
According to John Brehany, CMA executive director and ethicist, the fact that HPV is spread primarily by sexual contact does not render vaccination against it unethical. "Healing and preventing diseases, no matter what their source, are acts of mercy and a moral good," said Brehany.

However, CMA member Paul Cieslak, MD, asserted that "making school attendance conditional on HPV vaccination does not make sense, because girls who are not vaccinated pose no threat, as they would with communicable diseases such as mumps, measles and polio, to other children attending school."

The Centers for Disease Control and Prevention estimates that about 6.2 million Americans become infected with genital HPV each year, and that over half of all sexually active men and women become infected during their lifetime.

"For most women, the body's own defense system will clear the virus and infected women do not develop related health problems," stated FDA officials in a press release announcing the licensing of the new Gardasil vaccine. "However, some HPV types can cause abnormal cells on the lining of the cervix that years later can turn into cancer. Other HPV types can cause genital warts."

According to the FDA, the vaccine is effective against HPV types 16 and 18, which cause approximately 70 percent of cervical cancers and against HPV types 6 and 11, which cause approximately 90 percent of genital warts.

Gardasil is a recombinant vaccine (containing no live virus) that is given as three injections over a six-month period at an average total cost of $350 for the shot series. Immunization with Gardasil is expected to prevent most cases of cervical cancer due to HPV types included in the vaccine if administered to women before potential exposure to the virus. Women must still receive regular cervical cancer screening since Gardasil does not protect against HPV types not included in the vaccine.

Results of studies conducted in 21,000 HPV uninfected women between the ages of 16 and 26 in the U.S. and abroad showed that Gardasil was nearly 100 percent effective in preventing precancerous cervical lesions, precancerous vaginal and vulvar lesions, and genital warts caused by infection with HPV types 6, 11, 16 and 18.

Among the approximately 1,200 younger females ages 9-15 given the vaccine, their immune response was as good as that found in those ages 16-26. Test results done on women already infected with some HPV types included in the vaccine showed that the vaccine is only effective when given prior to infection.

The FDA reported the safety of the vaccine was evaluated in approximately 11,000 individuals. Most adverse experiences in study participants who received Gardasil included mild or moderate local reactions, such as pain or tenderness at the injection site.

"It looks like it's a safe vaccine," said the CMA's Brehany. "What we don't know is its long-term effectiveness. It may be necessary for women to get booster shots."

Parental rights
The father of a seven-year-old daughter, Brehany defends parents' rights to carefully discern how best to protect their daughter(s)' health. "It's unconscionable to override parents' objections," said Brehany, who points out that cervical cancer rates have declined a great deal in the U.S. (approximately 3,700 U.S. cervical cancer deaths a year) due to the effectiveness of cervical cancer screening Pap smears.

Brehany says he is also concerned about how the vaccine is promoted. "It's possible to give the impression that the HPV vaccine is an answer to teenage promiscuity," he said.

Carol Hogan, California Catholic Conference communications director, agreed it could send a message to teens that society expects they will become sexually active as early as seventh grade. "It takes away the parental perogative for children to be chaste," said Hogan.

Although hundreds of thousands of Gardasil vaccines have been administered in the U.S. since the FDA issued its approval last summer, and lawmakers in at least 31 states have introduced measures supporting widespread use of the vaccine, the majority public health opinion seems in favor of a slower approach.

In California, according to a Los Angeles Times article Feb. 25, Assemblyman Ed Hernandez (D-Baldwin Park) said he is undaunted by the controversy in Texas over Gov. Perry's order mandating the vaccine and will continue promoting a similar HPV vaccination mandate in California.

Dr. Jean Lauricella, a pediatrician for 26 years practicing medicine at the Pasadena Children's Medical Group, said she has administered hundreds of doses of the vaccine to her patients as soon as it was given FDA approval last summer. A parishioner at Assumption of the Blessed Virgin Mary Church in Pasadena, Dr. Lauricella is enthusiastic about the new vaccine. "It's very exciting to see in our lifetime a vaccine to prevent cancer," said Dr. Lauricella.