It was only months ago that debate raged as to whether or not Gardasil, the vaccine against HPV, should be offered to young women and female adolescents or not. Now the FDA must decide whether or not it should approve its indication for use in young men.
For young women and girls, much of the opposition centered around whether or not the vaccine might promote promiscuity. For males, however, different questions have come into play. These are questions of cost efficiency as well as safety and efficacy. Not as many questions have surfaced regarding promiscuity in young men and boys.
Gardasil protects against the Human Papilloma Virus, the most common sexually transmitted disease, and of which there are almost 50 different sub-types. We know that, in women, HPV can lead to genital warts and cervical cancer, a disease which afflicts about 10,000 women in the US annually, and kills about 3700. Merck & Co., the maker of Gardasil asserts that, in males, it is aimed at protecting against genital warts and lesser known malignancies like penile and anal cancer, in addition to cancer of the throat and mouth. It is estimated that HPV engenders more than 250,000 cases of genital warts and almost 7500 cancers in males annually; and that it may be responsible for about 1000 deaths.
Immunizing males would decrease, not only the incidence of these diseases, but the spread of them, as well. As the virus is often asymptomatic, its vaccine might provide immeasurable benefit to public health, as people will no longer unwittingly infect their partners.
Critics against the FDA decision to approve Gardasil for females starting at age 9, worry that this may subtly endorse early sexual activity. AT one time, Merck pushed to place Gardasil among the immunizations required for school attendance. However, this position was abandoned as many felt that this should be a decision left to parents.
Merck conducted a study encompassing over 4000 males from 16 to 23, which found Gardasil to be 90% effective in preventing infection with 4 different HPV types including genital warts and pre-malignant lesions. Much of the decision will reside in whether or not it would be a cost effective program.
Initial data suggests that it would cost about $500.00 for the three injections and office visits. Both the CDC and the American Academy of Pediatrics will consider cost-efficacy in giving their decisions.
While many still contend that the decision should be made only by the parent, we must keep in mind that the Hepatitis B vaccine is a mandatory vaccine, and is generally given to infants and children. Most states require it for school entry. This is given to prevent Hepatitis B, which is commonly spread through sexual contact. While it can be spread through blood transfusions, it is not presumed that most of the general public will ever have a transfusion, and be at risk.
Therefore, the underlying assumption is that adolescents should be protected against a virus that has the potential to cause hepatitis and/or liver cancer, in the event that sexual activity begins early.
Federal health officials and Merck representatives contend that the vaccine is safe. Yet some experts would like to see further evidence about the longevity of its protection, as well as its safety.