MSD's nine-valent HPV vaccine approved for use in males in China

United States-based global pharmaceutical company MSD said on Monday that China's National Medical Products Administration has approved the use of multiple new indications of Gardasil®9, its nine-valent HPV vaccine, in males between 16 and 26 years old.

The approval made the product the first and only nine-valent HPV vaccine approved for use in both males and females in China, marking a new beginning in the "gender-neutral prevention" stage against HPV-related cancers and diseases.

Gardasil®9 covers nine HPV types. With this approval, the vaccine is indicated in males for the prevention of anal cancer, genital warts, and some precancerous or dysplastic lesions caused by certain HPV types.

Anna Van Acker, senior vice-president of MSD and president of MSD in China, said, "Since the first approval of GARDASIL®9 in China in 2018, we've been committed to providing more health solutions for Chinese populations, empowered by the approvals of the age cohort extension of 9 to 45 years old, the two-dose regimen for those between 9 and 14, and the latest male indication."

"This undoubtedly reflects the government's increasing efforts and commitment to accelerating the elimination of cervical cancer, expanding vaccine accessibility, and providing diverse health choices for the broader Chinese populations," she said.

"HPV infections are not gender-specific. With the approval of the new indication, we hope to not only protect more women, but also benefit more men, more families, more communities and eventually the entire society, and jointly create a future free from HPV-related diseases," she said.

HPV vaccines are the only vaccines that effectively prevent cancers globally so far. By the end of 2024, over 300 million doses of GARDASIL®9 have been inoculated worldwide. In China alone, more than 33 million women have received the vaccination.

HPV infection is a major challenge in global public health. According to the World Health Organization, approximately 80 percent of men and women are infected with at least one HPV type in their lifetime.