After the four-valent HPV (human papillomavirus) vaccine was opened to men, on April 14, Merck China announced that Gardasil® 9 [nine-valent human papillomavirus vaccine (brewer's yeast)] (hereinafter referred to as "nine-valent HPV vaccine") has been approved for marketing by the National Medical Products Administration for multiple new indications and is suitable for males aged 16 to 26. This means that China has ushered in the first nine-valent HPV vaccine that can be used for male vaccination.

Gardasil® 9 has become the first and currently the only approved nine-valent HPV vaccine in China that can be used for males and females of appropriate age, marking that China has officially entered a new stage of "joint prevention of HPV-related cancers and diseases for both men and women".

Although men do not develop cervical cancer, they are the main carriers of HPV virus. Globally, the male genital HPV infection rate is higher than that of women. HPV infection may cause male infertility, genital warts, respiratory papilloma and other benign diseases and some malignant tumors. So far, 75 countries and regions in the world have national immunization plans involving HPV vaccination for adolescent males, and 141 countries and regions have involved vaccination for adolescent females.

According to Merck, Gardasil® 9 covers nine HPV types, namely 6, 11, 16, 18, 31, 33, 45, 52 and 58. The approved indication for men can prevent anal cancer caused by HPV16 and 18, genital warts (condyloma acuminatum) caused by HPV6 and 11, and the following precancerous lesions or atypical lesions caused by HPV6, 11, 16 and 18: grade 1, grade 2 and grade 3 anal intraepithelial neoplasia (AIN).

Professor Lu Yihan, deputy director of the Epidemiology Teaching and Research Section of the School of Public Health of Fudan University, said in an interview with the International Financial News that the approval of the vaccine is good for the overall prospects of HPV vaccination, but there is still a long way to go for men to get HPV vaccination. The current situation is that men of appropriate age are seriously lacking in knowledge about HPV infection, related diseases, and vaccination, and what is even more lacking than knowledge is that they do not have the awareness of "I also want to get HPV vaccination." In the future, more accurate and effective health knowledge education should be carried out to cultivate men's vaccination awareness and establish the awareness of "joint prevention of men and women". This is a long-term work that HPV vaccines need to carry out.

Anna Van Acker, global senior vice president of Merck and president of Merck China, said, "HPV vaccine is currently the only vaccine in the world that can effectively prevent cancer. By the end of 2024, the cumulative number of Gardasil®9 vaccinations worldwide has exceeded 300 million doses; in China, Gardasil®9 has also provided protection for more than 33 million women of appropriate age. But in fact, HPV infection is not gender-specific. We are well aware of the urgency of promoting the cause of HPV prevention for both men and women. We hope that through the approval of new indications, we can protect the majority of women while benefiting more men, benefiting families, communities and even the entire society, and working together to build a future without HPV-related diseases."

Which men are recommended for vaccination? Industry insiders pointed out that most HPV infections are usually asymptomatic, and most can be cleared naturally through the human immune mechanism, but a small number of infected people may also develop into persistent infections and eventually develop into precancerous lesions and invasive cancer. For example, some special populations such as MSM, HIV-infected people and spouses, and people with one HPV positive, all these high-risk groups need to be vaccinated.

The World Health Organization disclosed that as of 2019, about 690,000 new cancers worldwide were directly related to HPV infection. At the same time, relevant studies show that from 2007 to 2015, the number and incidence of HPV-related cancers in China increased year by year.

Related studies show that HPV6/11/16 are common infection types in Chinese men. Persistent infection with certain types of HPV can cause a variety of cancers, including anal cancer. Data from the World Health Organization predicts that new cases and deaths of anal cancer will increase year by year worldwide from 2022 to 2050. Relevant data show that 88% of anal cancers are attributed to persistent HPV infection. Low-risk HPV can cause genital warts, also known as condyloma acuminatum, which are prone to recurrence, and about 90% are related to low-risk HPV6 and HPV11 infections.

"HPV vaccination is one of the effective ways to prevent HPV-related diseases and cancer, and is one of the primary preventive measures for preventing and controlling HPV-related diseases. Preventing HPV infection can not only reduce the burden of cancer, but also reduce the pressure on public health and medical systems." Qiao Youlin, distinguished professor and researcher at the School of Population Medicine and Public Health of Peking Union Medical College, believes that "HPV infection is not gender-specific, and the natural clearance rate of men after infection is lower than that of women. Men may also develop diseases such as anal cancer and genital warts due to persistent HPV infection. On the one hand, HPV vaccination for both men and women can help achieve herd immunity, and on the other hand, it can prevent HPV-related diseases in men. It can also further respond to the call of the WHO's "Global Strategy for Accelerating the Elimination of Cervical Cancer", accelerate the realization of the "90-70-90" phased goal7, and help ultimately achieve the global goal of eliminating HPV-related cancers and diseases. . ”

Dr. Li Zhengqing, Global Senior Vice President of Merck and President of Merck China Research and Development Center, emphasized: "As the world's first company to launch a nine-valent HPV vaccine, Merck will continue to invest in research and development to continuously explore the potential of HPV vaccines to prevent related diseases in different populations. So far, Gardasil® 9 is the only nine-valent HPV vaccine that has obtained clinical research data in the male population and has undergone 10 years of real-world vaccination tests overseas. Merck is currently conducting a number of clinical studies on HPV vaccines in China, hoping to obtain more research results in China and benefit more people in need. ”

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