As the Food and Drug Administration prepares to approve the first vaccine against infections that cause a majority of cervical cancers, religious conservatives are rallying to keep the vaccine from being mandatory for public school students.
Gardasil has been proven effective in blocking the sexually transmitted human papillomavirus, or HPV, that causes cervical cancer in 70% of cases, and is projected to save the lives of over half the nearly 300,000 women worldwide who die of the disease each year. HPV, the most common sexually transmitted virus, affects more than 50% of sexually active adults and is spread through contact with an infected person’s genital skin, mucus membranes or bodily fluids.
Religious activists worry that the new vaccine’s effectiveness in protecting against an otherwise life-threatening virus could undermine their efforts to promote sexual abstinence before marriage.
Unlike the FDA’s controversial decision in late 2003 to reject the recommendations of its own advisers and deny an application for an over-the-counter emergency contraception pill, approval is expected for the cervical cancer vaccine. On May 18, an independent advisory committee voted 13-0 to endorse the vaccine, and the FDA is expected to issue a final approval next week.
In contrast to the political battle surrounding the emergency contraception pill, religious conservatives have not moved to block approval of the new drug, but have focused instead on how it would be marketed and distributed. Two prominent religious conservative groups, the Family Research Council and Focus on the Family, have said they do not oppose the vaccine’s approval but would oppose making it mandatory for public school students.
Because the vaccine, which is administered in three shots over a six-month period, is expected to cost $300 to $500, some health advocates are recommending that it be linked to school admission, which would increase the likelihood of it being covered by insurance.
A vaccine utilization committee of the Centers for Disease Control and Prevention is scheduled to meet June 29, and could vote on whether to recommend universal use of Gardasil in females. But it is up to the individual states to decide whether to make the vaccination mandatory.
Merck & Co., the maker of Gardasil, conducted a two-year trial involving sexually active women in 13 countries and found that the drug provided 100% protection against the two HPV strains that cause 70% of reported cases of cervical cancer, the second most prevalent cancer among women.
The drug company recommends that the vaccine be administered to females ages 9 to 26, but says it works best when administered before the onset of sexual activity.
Religious conservatives have objected to the notion of vaccinating girls at such a young age. “Because parents have an inherent right to be the primary educator and decision maker regarding their children’s health, we would oppose any measures to legally require vaccination or to coerce parents into authorizing it.” said Moira Gaul, policy analyst for the Family Research Council, in a February statement before the FDA’s Advisory Committee on Immunization Practices.