Merck's Gardasil® Becomes First and Only HPV Vaccine Approved for Males in China
MSD
Pharmaceutical R&D and Manufacturer
Quadrivalent Human Papillomavirus Vaccine (Saccharomyces cerevisiae) Multiple New Indications Approved for Marketing in China
Shanghai, China, January 8, 2025 — MSD (the corporate name of Merck & Co., Inc., located in Rahway, New Jersey, U.S.) announced Gardasil1®[Quadrivalent Human Papillomavirus Vaccine (Saccharomyces cerevisiae)] has received approval from the National Medical Products Administration for several new indications, applicable for males aged 9-26. The approval of these new indications marks Gardasil® as the first and currently the only HPV vaccine in China approved for use in males.
Gardasil®The new indication approved this time is applicable for males aged 9-26 to prevent anal cancer caused by HPV16 and HPV18, genital warts (condyloma acuminata) caused by HPV6 and HPV11, as well as the following precancerous or atypical lesions caused by HPV6, HPV11, HPV16, and HPV18: Grade 1, Grade 2, and Grade 3 Anal Intraepithelial Neoplasia (AIN).
"We are very pleased to witness Gardasil®It has been six years since the approval of multiple new indications in China, which is undoubtedly a milestone breakthrough. This also marks Gardasil...®"MSD's HPV vaccine has become the first and currently the only one approved in China that is suitable for males, marking a new step forward in advancing China’s public health initiatives!" said Anna Van Acker, Senior Vice President of MSD Global and President of MSD China. "Since its approval in China, MSD's HPV vaccine has protected the health of 51 million Chinese women. We have every reason to believe that the approval of this new indication will continue to protect more eligible males. MSD will also honor its commitment to being rooted in China and benefiting China by continuing to work closely with all sectors of society to enhance public awareness of diseases caused by HPV. We deeply understand the urgency of promoting the cause of joint prevention for both men and women against HPV, and we will strengthen our cooperation with the government to significantly improve the accessibility and affordability of the HPV vaccine, supporting the implementation and advancement of the Healthy China 2030 strategy."
"The approval and market launch of the new indication for the HPV vaccine represents another milestone in the country's response to the Healthy China 2030 initiative. HPV vaccination is an effective method for preventing HPV-related diseases and serves as a primary prevention measure against diseases associated with HPV infection."2HPV vaccine can not only prevent cervical cancer, but also prevent anal cancer and genital warts caused by HPV infection.3." Qiao Youlin, Distinguished Professor at the School of Population Medicine and Public Health, Peking Union Medical College, stated, "Compared to women, male HPV infections receive little attention. However, globally, the prevalence of genital HPV infections in men is higher than in women.3Recently, the International Papillomavirus Society (IPVS) has actively called on countries to adopt a gender-neutral vaccination program as soon as possible, promoting HPV vaccines equally to eligible boys and girls. This initiative aims to expand vaccine coverage and maximize herd immunity effects, further responding to the WHO's "Global Strategy to Accelerate the Elimination of Cervical Cancer," which sets the interim target of achieving the "90-70-90" goals by 2030.4。”
Persistent infection with high-risk types of HPV may not only lead to cervical cancer but also anal cancer, vaginal cancer, vulvar cancer, penile cancer, oropharyngeal cancer, and precancerous lesions, among other diseases.5Anal cancer originates in the skin cells near the anal verge or in the transitional zone cells between the anus and rectum (anal canal). According to World Health Organization data projections, the number of new cases and deaths from anal cancer worldwide will increase year by year from 2022 to 2025.67Relevant data shows that 88% of anal cancers are attributed to persistent HPV infection.8Genital warts (condyloma acuminata) refer to another common disease caused by HPV.9, prone to recurrence, and about 90% of genital warts are associated with low-risk HPV6 and HPV11 infections.10。
"HPV infection is one of the significant public health issues globally."11Vaccination is the best way to prevent cervical cancer and other HPV-related cancers.12HPV infection can mostly be cleared by the immune mechanism on its own, so most HPV infections are transient and asymptomatic. However, persistent infection with certain types of HPV can lead to precancerous lesions.5." Professor Wang Qianqiu, Director of the Clinical Prevention and Treatment Department of the Chinese Academy of Medical Sciences Dermatology Hospital (Institute) and the STD Control Center of the Chinese Center for Disease Control and Prevention, added, "HPV transmission occurs through multiple pathways of direct or indirect contact, and trauma or skin damage are also important factors for HPV infection.13。”
"The approval and market launch of the new indication for the HPV vaccine is exciting news for all sectors of society. This will also provide more innovative solutions for the prevention of HPV infection-related diseases, including cancer, for a wide range of eligible women and men." Dr. Li Zhengqing, Senior Vice President of MSD Global and President of MSD China Research and Development Center, emphasized: "As the world's first company to launch the nonavalent and quadrivalent HPV vaccines, MSD has been exploring the potential of HPV vaccines in preventing various HPV-related diseases across different populations based on rigorous clinical studies and extensive real-world data over many years. MSD is currently conducting multiple clinical trials for new indications of the HPV vaccine in China, hoping that the research results from China will benefit more people in need and improve public health in China."
1.Gardasil®Previously approved indications in China: for the prevention of diseases caused by high-risk HPV16 and 18 in females aged 9 to 45.
● Cervical Cancer
● Grade 2 and Grade 3 cervical intraepithelial neoplasia (CIN2/3) and adenocarcinoma in situ (AIS)
● Grade 1 cervical intraepithelial neoplasia (CIN1)
Clinical trials in Chinese women have not yet confirmed the protective effect of this product against low-risk HPV6 and HPV11 related diseases.
2. Gynecologic Oncology Branch of Chinese Medical Association, Colposcopy and Cervical Pathology Branch of Chinese Society of Eugenics, Martin, et al. Clinical Application of Human Papillomavirus Vaccine
Chinese Expert Consensus [J]. Peking Union Medical Journal, 2021, 12(2): 189-201.
3. Teng Qiuli, Niu Maoyuan, Liu Yuying, et al. The Harm of HPV Infection to Men and the Protection of HPV Vaccination for Men [J]. Chinese Journal of Immunology, 2022(004)038
4.Garland SM, Bhatla N, Woo YL, et al. IPVS STATEMENT on HPV vaccination: No longer supply constraints: Towards achieving WHO vaccine targets. Vaccine. 2024;42(26). doi:10.1016/j.vaccine.2024.126400
5. Expert Consensus on Immunoprophylaxis of Human Papillomavirus-Related Diseases Such as Cervical Cancer. Chinese Journal of Preventive Medicine. 2019;53(8):761-803
6. "MSD Manual for the General Public" - Anal Cancer
7. IACR Cancer Tomorrow, 2024
8. Yuan Meiwen, et al. Chinese Journal of Epidemiology. 2022, 43(5): 702-708.
9. Pennycook KB, McCready TA. Condyloma Acuminata. [Updated 2023 Jun 21]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK547667/
10.Chinese Medical Association Dermatology and Venereology Branch, et al. Chinese Journal of Dermatology and Venereology. 2021;35(4):359-374.
11. Zhu Kongxin, et al. Real-world Study on the Effectiveness of HPV Vaccines. Chinese Journal of Microbiology and Immunology, 2023, 43(3) 230-238.
12.WHO Human papillomavirus and cancer
13.Chinese Medical Association, et al. Guidelines for Primary Diagnosis and Treatment of Viral Warts (2022) [J]. Chinese Journal of General Practitioners, 2022, 21(10): 904-913
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This content is supported by MSD China and may not be forwarded without authorization. 01-2025-CN-HPV-02090