Vaccines for Sexually Transmitted Diseases (STDs) are tricky. But it is a business that Merck and GlaxoSmithKline have invested significant capital, and assumedly expect a large return. Merck’s Gardasil has been on the market for about 3 years and targets four strains of human papillomavirus that are linked to cervical cancer. While it is currently approved for girls and women aged 9 to 26, the FDA recommended approval this week for boys and men of the same age range.

It is interesting to see how much impact this potential label expansion will have. Earlier this year, Merck lowered its revenue projections for 2009 to $1.1 billion and the company is scrambling to grow a market that seems to have reached a threshold. While the company may still be pushing for mandated vaccination, they have reached most of the girls that will likely be vaccinated. The >$300 cost in this economic environment probably does not help the matter either. In addition, the public may be weary of a vaccine that does not yet have long-term data and may have hidden side effects.

When it comes to boys, will parents choose to vaccinate them? Is the risk of genital warts high enough to warrant such an expensive vaccine? Merck is a marketing powerhouse, but preventing genital warts conveys a very different sentiment than preventing cervical cancer. The high cost and lack of long-term data are still issues. Competition from GlaxoSmithKline’s Cervarix will also present a challenge. For these reasons, I think it will be very difficult for Merck to capitalize on a label expansion for boys, especially relative to the amount they invested to carry out these studies and to go through the approval process. Time will tell if they are able to work some magic.

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