Gardasil 9 is a vaccine approved for use in females ages 9 through 26 and males ages 9 through 15. It is approved for the prevention of cervical, vulvar, vaginal and anal cancers caused by HPV types 16, 18, 31, 33, 45, 52 and 58, and for the prevention of genital warts caused by HPV types 6 or 11. Gardasil 9 adds protection against five additional HPV types—31, 33, 45, 52 and 58— which cause approximately 20 percent of cervical cancers and are not covered by previously FDA-approved HPV vaccines.
The approval comes on the back of evidence of safety and efficacy (in terms of evoking an antibody response against the vaccine serotypes). The real test however, will be evident in the post-licensure period because cervical cancer, which is the primary targeted disease for this vaccine, has been on a rising trend in the past few years. Globally, there are 530,000 new cases and 275,000 deaths attributable to cervical cancer. How many of these are prevented by the initiation of this new vaccine would determine the real value of this vaccine. Whether this is a new move to inflate profit margins for pharmaceutical companies (yeah, I am becoming more and more cynical!) or whether there will be actual, tangible clinical benefit from this expanded coverage vaccine, only time can tell.
Another concern, specifically for the Indian context, of course, remains the cost issues. However, considering that HPV vaccine has yet to “catch on” in the Indian scenario, at least as far as the public sector is concerned, this may not be an immediate issue for now.
The FDA has approved the nine valent vaccine for the following:
- Cervical, vulvar, vaginal, and anal cancer caused by Human Papillomavirus (HPV) types 16, 18, 31, 33, 45, 52, and 58. (1.1)
- Genital warts (condyloma acuminata) caused by HPV types 6 and 11. (1.1)
- Cervical intraepithelial neoplasia (CIN) grade 2/3 and cervical adenocarcinoma in situ (AIS). (1.1)
- Cervical intraepithelial neoplasia (CIN) grade 1. (1.1)
- Vulvar intraepithelial neoplasia (VIN) grade 2 and grade 3. (1.1)
- Vaginal intraepithelial neoplasia (VaIN) grade 2 and grade 3. (1.1)
- Anal intraepithelial neoplasia (AIN) grades 1, 2, and 3. (1.1)
- Anal cancer caused by HPV types 16, 18, 31, 33, 45, 52, and 58. (1.2)
- Genital warts (condyloma acuminata) caused by HPV types 6 and 11. (1.2)
- Anal intraepithelial neoplasia (AIN) grades 1, 2, and 3. (1.2)