Note: This makes me wonder whether Cervarix which is a human papillomavirus bivalent (types 16 and 18) marketed by GlaxoSmithKline will be studied the above indication. Cervarix is indicated for use in females age 10 through 25 to prevent cervical cancer, cervical intraepithelial neoplasia grade 2 or worse and adenocarcinoma in situ, and cervical intraepithelial neoplasia grade 1 caused by HPV types 16 and 18.
Gardasil is approved for the above indication based on data in a randomized, controlled trial in men who identified themselves as having sex with men. The result showed that Gardasil was able to demonstrate a 78% effectiveness in preventing anal intraepithelial neoplasia associated with HPV-16 and HPV-18. According to the FDA, anal cancer is the same in both female and male. The data can be extrapolated in female population. Hence, the new indication is applicable to both female and male.
Gardasil is a human papillomavirus quadrivalent vaccine. It was originally approved in 2006. Up until now, it's been indicated for the following conditions:
- It can be used in girls and women 9 through 26 years of age to prevent
- cervical, vulvar, and vaginal cancer caused by HPV types 26 and 28
- Genital warts caused by HPV types 6 and 11
- It can also be used as vaccine to prevent certain precancerous or dysplastic lesion caused by HPV types 6, 11, 16, and 18 indicated as followed:
- Cervical intraepithelial neoplasia grade 2/3 and Cervical adenocarcinoma
- Cervical intraepithelial neoplasia grade 1
- Vulvar intraepithelial neoplasia grade 2 and 3
- Vaginal intraepithelia neoplasia grade 2 and 3
- It can also be used in boys and men age from 9 through 26 to prevent genital warts caused by HPV types 6 and 11.
Dosing and Administration
- Gardasil is administered as intramuscular injection.
- It needs to be administered in a series of 3 doses: 0, 2 and 6 months.
- Most common adverse events: fainting, pain at the injection site, headache, nausea and fever.
- Due to possible syncope, patients need to be seated up for up to 15 minutes after vaccinaion.