FDA advisors support Gardasil for males, Cervarix for females

Yesterday was the busiest day in months for news on HPV vaccines, as the FDA Vaccines and Related Biological Products Advisory Committee met to consider applications by GSK for initial U.S. licensure of its HPV vaccine, Cervarix, for girls and women ages 10 to 25, and by Merck for an expanded licensed indication for its vaccine, Gardasil, for males (ages 9 to 26 -- the same age range for which it has been approved for use in females since 2006). Information and extensive materials related to the meeting are available here and here.

The committee found both vaccines to be safe and effective in their target populations, actions likely to mean FDA approval in the coming months for Cervarix (already available in over 100 countries) for women and Gardasil for both sexes. (The usual caveat: agencies such as FDA are not obligated to follow the recommendations of their advisory committees, but they almost always do in these circumstances.)

Here is coverage of the meeting from the New York Times, Philadelphia Inquirer, and Associated Press. Also of note are press releases from GSK and Merck on yesterday's news.

Assuming FDA follows the recommendations voted on yesterday, we are likely to see in 2010 a spirited advertising campaign by each manufacturer asserting superiority of its product over the competition. (This is an easier case for Merck to make, given the additional protection Gardasil provides against genital warts in both sexes. Early indications are that GSK will argue that Cervarix provides better protection against cervical cancer-causing HPV strains, including 'cross-protection' against additional strains not included in either vaccine.)

Also on the horizon is a decision by CDC (namely, the Advisory Committee on Immunization Practices) in the coming months regarding its recommendation for HPV vaccination. The history of the ACIP suggests that it is highly unlikely that the group will preferentially recommend one vaccine over the other for use in females. Instead, the current recommendation will probably be reworded to reflect the availability of both products and the slight differences between them with respect to administration.

More interesting will be its recommendation (or lack thereof) regarding male vaccination with Gardasil. Merck will no doubt be pushing for a universal recommendation that all males within the target age group receive the vaccine, and it will certainly have support from some corners of the medical and public health communities. However, the cost of the vaccine and the non-life-threatening nature of genital warts may make justifying universal vaccination of males difficult. (Another argument sure to surface is the indirect benefits for women resulting from male vaccination -- targeting a potential reservoir of cervical cancer-causing HPV. Despite its logical appeal, this strategy has not fared well in cost-effectiveness and other economic studies of HPV vaccination.)

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Speaking of male vaccination, our colleague Arthur Caplan co-authored (with Sarah Hull) a paper in the latest issue of Public Health Genomics titled, "The Case for Vaccinating Boys against Human Papillomavirus," (free abstract, subscription required for full text). As the title suggests, the authors argue for universal male vaccination against HPV, paying special attention to ethical arguments for such a policy.