Merck's Gardasil®9 Receives NMPA Approval for Two-Dose Schedule in Females Aged 9–14 in China

ShanghaiJanuary 9, 2024PR Newswire -- MSD (the trade name of Merck & Co., Inc., located in Rahway, New Jersey, USA) announced that the two-dose vaccination schedule (0, 6-12 months) for females aged 9-14 using its nine-valent human papillomavirus vaccine (recombinant Saccharomyces cerevisiae) (trade name: Gardasil®9) has been approved by the National Medical Products Administration of China. This approval means that, in addition to the previously approved three-dose vaccination schedule for ages 9-45, Gardasil®9 will now include a two-dose vaccination schedule for females aged 9-14, providing more cost-effective and convenient health protection for eligible females, helping them avoid HPV-related cervical cancer and cervical lesions.

Gardasil®9 is indicated for the prevention of cervical cancer caused by HPV types 16, 18, 31, 33, 45, 52, and 58; cervical intraepithelial neoplasia (CIN grades 1/2/3) and adenocarcinoma in situ (AIS) caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58; and persistent infection caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58.

Cervical cancer is one of the common malignant tumors in gynecology. According to the 2023 ICO/IARC China HPV and Related Diseases Report, in 2020, the incidence and mortality of cervical cancer ranked third among female tumors in women aged 15-44 in China.^[1]In China, approximately 98% of cervical cancer cases are caused by high-risk HPV.^[1]Persistent high-risk HPV infection may lead to diseases such as cervical cancer, anal cancer, vaginal cancer, vulvar cancer, penile cancer, and oropharyngeal cancer.^[2]HPV 16 and 18 are high-risk types of HPV that are widely prevalent globally, but there are differences in China. An epidemiological study aggregating data from 1.7 million Chinese women infected with HPV showed that the most common high-risk types among Chinese women are HPV 16, 52, and 58.^[3,a]。

Professor Youlin Qiao from the School of Public Health and Community Medicine, Chinese Academy of Medical Sciences/Peking Union Medical College, stated: "Girls aged 9-14 are the primary target group for vaccination recommended by the World Health Organization."^[4], they are more likely to elicit a stronger immune response when vaccinated with the HPV vaccine.^[5-10]Females who have not engaged in sexual activity will achieve the best preventive effect from the HPV vaccine.^[11]For eligible females aged 9-14 in China, the two-dose vaccination schedule of '0, 6-12 months' simplifies the vaccination process, frees up more vaccine resources, and will further increase the vaccination rate among younger females in China, aiding in the acceleration of cervical cancer elimination in China.

Dr. Li Zhengqing, Senior Vice President of MSD Global and President of MSD China Research and Development Center, stated: "As the world's first company to launch the nine-valent and quadrivalent HPV vaccines, MSD has been continuously exploring the potential of HPV vaccines in preventing related diseases across different populations based on rigorous clinical studies and extensive real-world data over the years. We are also investigating more diversified vaccination schedules and target groups to improve vaccine accessibility. Currently, we are conducting multiple clinical studies on new indications for HPV vaccines in China, hoping to benefit more people in need with research results from China, thereby safeguarding the health of the Chinese public."

Anna Van Acker, Senior Vice President of MSD Global and President of MSD China, stated: "Eliminating cervical cancer is a shared vision for all humanity. The recent approval of the two-dose regimen of Gardasil®9 for females aged 9-14 demonstrates the Chinese government's determination to accelerate the elimination of cervical cancer, as well as MSD's commitment to being rooted in China and benefiting China. MSD will continue to work closely with the government, academic institutions, stakeholders, and partners to enhance awareness of HPV-related diseases and improve the accessibility of HPV vaccines by increasing supply in the Chinese market. This effort aims to support the development of public health in China and strive to create 'a future without cervical cancer.'"

References:

[1] ICO/IARC HPV Information Centre. Human Papillomavirus and Related Diseases Report. China, 2023-03-10

[2] Expert Consensus on Immunoprophylaxis of Human Papillomavirus-Related Diseases Such as Cervical Cancer. Chinese Journal of Preventive Medicine. 2019

[3] Zhu B, Liu Y, Zuo T, Cui X, Li M, Zhang J, Yu H, Piao H. The prevalence, trends, and geographical distribution of human papillomavirus infection in China: The pooled analysis of 1.7 million women. Cancer Med. 2019 Sep;8(11):5373-5385. doi: 10.1002/cam4.2017. Epub 2019 Jul 27. PMID: 31350872; PMCID: PMC6718589.

a. Study Design: An epidemiological study aggregating HPV infections in 1.7 million Chinese women, which searched multiple literature databases for publications prior to October 31, 2018. Ultimately, 68 studies were included, and a random-effects model was used to analyze the prevalence of HPV infections.

[4] Human papillomavirus vaccines: WHO position paper, December 2022. Weekly Epidemiological Record No 50, 2022, 97, 645–672（https://www.who.int/publications/i/item/who-wer9750-645-672）

[5] Li Shuang, Li Mingzhu, Cong Qing, Yang Fan, Li Kemin, Song Kun, Yin Ruitie, Wang Xinyu, Zhang Guonan, Sui Long, Liu Jihong, Kong Beihua, Xie Xing, Wei Lihui, Ma Ding, Chinese Expert Consensus on Clinical Application of Human Papillomavirus Vaccine [J]. Chinese Medical Journal, 2021, 12(02): 189-201.

[6] Zhu F, Li J, Hu Y, et al. Immunogenicity and safety of the HPV-16/18 AS04-adjuvanted vaccine in healthy Chinese girls and women aged 9 to 45 years. Hum Vaccin Immunother. 2014;10(7):1795-1806. doi:10.4161/hv.28702

[7] Li R, Li Y, Radley D, et al. Safety and immunogenicity of a vaccine targeting human papillomavirus types 6, 11, 16 and 18: a randomized, double-blind, placebo-controlled trial in Chinese males and females. Vaccine. 2012;30(28):4284-4291. doi:10.1016/j.vaccine.2012.02.079

[8] Hu YM,Guo M,Li CG,et al.Immunogenicity nonin -feriority study of 2 doses and 3doses of an Escherichia coliproduced HPV bivalent vaccine in girls vs.3 doses in youngwomen[J].Sci China Life Sci,2020,63:582-591

[9] Van Damme P,Meijer CJLM,Kieninger D, et al.A phase Ill clinical study to comparethe immunogenicity and safety of the 9-valent and quadrivalent HPV vaccines in men[J].Vaccine,2016,34:4205-4212

[10] Lei JY,Ploner A,Elstrom KM,et al.PV Vaccination and the Risk of Invasive CervicalCancer [J]. N Engl J Med,2020,383:1340-1348

[11] Wang Linhong, Zhao Gengli. Comprehensive Prevention and Control Guidelines for Cervical Cancer (2nd Edition) [M]. Beijing: People's Medical Publishing House, June 2023.