Merck's Quadrivalent HPV Vaccine Receives CDE Acceptance for New Indication in China, Likely for Prevention of HPV Infections in Males

On July 11, the CDE website showed that MSD's quadrivalent human papillomavirus vaccine (Saccharomyces cerevisiae) new indication application for marketing was accepted, presumably for the prevention of male HPV infection.

MSD's quadrivalent HPV vaccine is prepared from purified virus-like particles (VLPs) of the major capsid (L1) proteins of HPV types 6, 11, 16, and 18. It is currently approved in the United States for use in females aged 9-26 to prevent cervical cancer, vulvar cancer, vaginal cancer, anal cancer, and genital warts, as well as cervical, vaginal, vulvar, and anal intraepithelial neoplasia. It is also approved for use in males aged 9-26 to prevent anal cancer, genital warts, and anal intraepithelial neoplasia.

In May 2017, the vaccine entered the Chinese market for females aged 20-45. In November 2020, the target population was expanded to include females aged 9-45. The trade name is Gardasil, and it follows a three-dose immunization schedule. It is used to prevent cervical cancer, grade 2 and 3 cervical intraepithelial neoplasia (CIN2/3), adenocarcinoma in situ (AIS), and grade 1 cervical intraepithelial neoplasia (CIN1) caused by high-risk HPV types 16 and 18.

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