On January 9, 2024, 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 to 14 using its nine-valent human papillomavirus vaccine (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 schedule for ages 9 to 45, Gardasil®9 will now include a two-dose schedule for females aged 9 to 14, providing more cost-effective and convenient health protection for eligible females and helping them avoid HPV-related cervical cancer and cervical lesions.
Gardasil®9For the prevention ofCervical cancer caused by HPV types 16, 18, 31, 33, 45, 52, and 58; Cervical intraepithelial neoplasia (CIN1/2/3) 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.2023 ICO/IARC China HPV and Related Diseases Report shows that in 2020 in China, 15~In 44-year-old women, the incidence and mortality of cervical cancer rank third among female tumors.[1]In China, approximately 98% of cervical cancer cases are caused by high-risk HPV.[1]`, Continuous high-risk type`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 HPV types among Chinese women are HPV 16, 52, and 58.[3,a]。
Chinese Academy of Medical SciencesProfessor Youlin Qiao from the School of Population Medicine and Public Health, Peking Union Medical College, stated：“9~14-Year-old girls are the primary target population recommended by the World Health Organization for vaccination.[4], they were vaccinated with HPVVaccineEasier to elicit a better immune response[5-10]Females who have not engaged in sexual activity will achieve the best preventive effects from the HPV vaccine.[11]。For China's 9~14For women of appropriate age, '0,6~12The two-dose vaccination schedule for 'Month' simplifies the vaccination process, frees up more vaccine resources, and will further increase the vaccination rate among young females in China, aiding in the accelerated elimination of cervical cancer in China.。”
Dr. Zhengqing Li, Senior Vice President of MSD Global and President of MSD China Research and Development Center, stated: "As the world's first to launchNine-valent and QuadrivalentMSD, the company behind the HPV vaccine, has continuously explored its prevention in different populations over the years based on strict clinical research and a large amount of real-world data.RelevantThe Potential of Diseases, explore more diversified vaccination strategies and target populations to enhance vaccine accessibility.。We currentlyConducting multiple clinical studies on new indications for HPV vaccines in China, hopingBenefit More People in Need with Research Results from China, safeguarding the health of the Chinese public."
Anna Tian, Senior Vice President of MSD Global and President of MSD China (Anna Van Acker) stated:"Eliminating cervical cancer is a shared vision of all humanity. This time, Gardasil®9Targeting 9-14The approval of the two-dose vaccination schedule for women demonstrates the Chinese government's determination to accelerate the elimination of cervical cancer, and also reflects MSD's commitment to rooting in China and benefiting China. MSD will continue to closely collaborate with the government, academic institutions, stakeholders, and partners, and enhance H through measures such as increasing supply to the Chinese market.PVCognitive aspects of related diseases andHPV VaccineTheAccessibility", contributing to the development of China's public health事业, striving 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 women in China, which searched multiple literature databases for studies 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 the Clinical Application of Human Papillomavirus Vaccines [J]. Peking Union 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 Health Publishing House, June 2023.
