On January 9, 2024, MSD announced that its second dose vaccination program for the nine valent human papillomavirus (HPV) vaccine targeting women aged 9-14 has been approved by the National Medical Products Administration (NMPA) of China. This approval means that on the basis of the previous three dose vaccination program for women aged 9-45 (months 0, 2, and 6), a new two dose vaccination program for women aged 9-14 (months 0, 6, and 12) will be added. This new progress not only helps to expand the coverage of vaccines, but also improves the convenience of vaccination, which is of great significance for preventing HPV infection and reducing the incidence of cervical cancer.
Regarding this approval, Li Zhengqing, Senior Vice President Global and President of Research and Development in China at MSD, said, "We continue to actively conduct clinical trials aimed at collecting and analyzing data on efficacy and safety in the Chinese population. The core goal of these efforts is to validate and expand the scope of the beneficiary population, and the second dose vaccination program will also play an important role in improving public health in society."
The first vaccine that can prevent cancer
Cervical cancer, as one of the main threats to women's health worldwide, has always been a focus of medical research and public health policies. According to the report of ICO/IARC on HPV and related diseases in China in 2023, the incidence rate and mortality of cervical cancer will rank the third among women aged 15-44 in China in 2020. In 2020, there will be 109741 new cases of cervical cancer in China, and 59060 deaths, accounting for 18.2% and 17.3% of the total number of global diseases and deaths, respectively. Among them, about 98% of cervical cancer cases are related to high-risk HPV infection. Therefore, the prevention of HPV is particularly crucial.
The launch of the HPV vaccine has made cervical cancer the only cancer that can be prevented early and is expected to be completely eradicated, marking a milestone in the history of human cancer prevention and treatment; Sup2;. Currently, there are three types of HPV vaccines available on the market in China: bivalent, quadrivalent, and nine valent. Women aged 9 to 45 in China can choose according to their needs; Sup3; ˉ。
Low vaccination rate for HPV vaccine in girls aged 9-14
There are over 200 members in the HPV family, some of whom are closely related to malignant tumors and are known as high-risk HPV. Getting vaccinated against HPV is an effective method for preventing HPV infection and related diseases. The bivalent HPV vaccine covers two types of HPV16/18 ˉ。 The quadrivalent HPV vaccine covers four types of HPV6/11/16/18. The nine valent HPV vaccine covers nine types of HPV6/11/16/18/31/33/45/52/58; Sup3;.
Li Zhengqing pointed out that "HPV infection often goes through a long process of development. Although most HPV infections are cleared by the body, a few infections may develop into persistent infections. Untreated persistent infections may develop into cancer years or decades later. The role of HPV vaccines is to block this infection process at the source by stimulating the body to produce a specific immune response against HPV to achieve this goal."
It is worth noting that the overall HPV vaccination rate for women aged 9-45 in China from 2018 to 2020 was relatively low, with the vaccination rate for girls aged 9-14 being almost negligible; Sup2;. Taking Shanghai as an example, as of the end of 2019, only 2.83% of women aged 9-45 in Shanghai had received the HPV vaccine throughout their entire life cycle, while among girls aged 9-14,< 1%; Sup3; ′.
The article "Systematic Evaluation of Chinese Mainland Residents' Attitudes and Behaviors towards HPV Vaccination" published on China Public Health found that the reasons for people's unwillingness to vaccinate against HPV before and after 2016 had changed from not knowing about HPV vaccine to worrying about side effects of vaccination.
Regarding this, Li Zhengqing stated, "HPV vaccines that have been approved for marketing in China are all approved by the national drug regulatory authorities. The safety monitoring of HPV vaccines usually begins with pre marketing research and continues throughout the entire lifecycle of the vaccine after its launch."
At the same time, in order to continue clinical research, collect and verify more data, and further confirm the safety and efficacy of the vaccine, Li Zhengqing stated that Merck East is collaborating with Peking University to conduct epidemiological investigations and studies of HPV in China; At the same time, some real-world studies are being conducted in the Ningbo area to comprehensively collect and analyze data on the safety and efficacy of vaccines after their launch.
The second dose vaccination program can improve vaccine accessibility
Research has also found that the risk of HPV infection is lower before sexual activity begins, and the HPV vaccine has a better protective effect on uninfected individuals. Therefore, from the perspective of sexual exposure, the younger age group with a higher degree of unexposed will achieve the best preventive effect.
The 2022 "HPV Vaccine: WHO Position Paper" states that in order to prevent cervical cancer, WHO recommends that the primary target of HPV vaccination be girls aged 9-14 who have not engaged in sexual activity; Sup2;. In addition, the WHO first proposed a global action initiative to eliminate cervical cancer in 2018; Sup2;, And in November 2020, the Global Strategy for Accelerating the Elimination of Cervical Cancer was released, aiming to achieve the goal of 90% of girls completing full HPV vaccination before the age of 15 by 2030; Sup2& Amp; Sup2;. The Women and Children's Department of the National Health Commission of China has stated that China will fully support the implementation of this strategy; Sup2;.
The second dose vaccination program provides more flexibility and convenience for these young girls, which is expected to improve the overall vaccination rate. Li Zhengqing also emphasized that being aware of such risks in the early stages and receiving vaccinations can benefit earlier. The new plan of using two doses of vaccination not only improves the convenience and compliance of vaccination, but also takes an important step towards the goal of eliminating cervical cancer, especially for our main vaccination population - girls aged 9-14. The implementation of this measure will greatly facilitate their vaccination process and provide more choices.
According to the Healthy China Action (2019-2030), by 2022 and 2030, the overall 5-year cancer survival rates will not be less than 43.3% and 46.6%, respectively; The awareness rate of core knowledge on cancer prevention and treatment shall not be less than 70% and 80%, respectively; The early diagnosis rate of key cancer species in high-risk areas has reached 55% or above and continues to increase; Basic implementation of regular cancer prevention physical examinations for high-risk populations; Sup2& Amp; Sup3;.
Merck is committed to eliminating HPV related diseases
High risk HPV infection is the main pathogenic factor for cervical cancer, and can also cause diseases such as vaginal cancer, vulvar cancer, anal cancer, penile cancer, oropharyngeal cancer, and related precancerous lesions. "Merck's vision is to eliminate HPV related diseases in China, which is why we continue to invest in research on HPV vaccines, from expanding the vaccination population to simplifying the number of doses, hoping to use scientific data to help more people benefit from HPV vaccines as soon as possible."
Li Zhengqing emphasized that China has always been one of Merck's most important markets globally, and China's public health is highly valued by Merck. "In order to ensure the supply of products in the Chinese market and meet the growing demand, the company headquarters has made dedicated resource allocation, and has continuously achieved positive improvements over time. In addition to resource allocation, Merck is also actively communicating with China's scientific community and drug regulatory agencies to better understand the epidemic situation and actual data in China."
Reference:
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11. Song Yifan, Liu Xiaoxue, Yin Zundong, et al. Estimated vaccination rate of human papillomavirus vaccine for women aged 9-45 in China from 2018 to 2020 [J]. China Vaccines and Immunology, 2021 (005): 027
Research Design: Using the China Immunization Program Information Management System to collect the number of doses of 2-valent, 4-valent, and 9-valent HPV vaccines (HPV2, HPV4, and HPV9) administered nationwide from 2018 to 2020, estimate the HPV vaccination rate among women aged 9-45, and analyze the correlation between vaccination rate and economic, health, and education related indicators by region.
Research results: From 2018 to 2020, a total of 21.5974 million doses of HPV vaccine were administered to eligible women aged 9-45 in China, with an estimated cumulative vaccination rate of 2.24%.
12. China Vaccine Industry Association Immunization Planning Standardization Management and Practice Branch Expert Consensus on Immunization Strategies and Practices for Human Papillomavirus Vaccine in Adolescent Women in the Yangtze River Delta Region [J] Chinese Journal of Preventive Medicine, 2023, 57 (2): 135-153
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Research Design: Collect the number of doses and AEFI cases of bivalent HPV vaccine (HPV2), bivalent HPV vaccine (HPV4), and 9-valent HPV vaccine (HPV9) administered to 9-45 year old women in Shanghai from November 2017 to December 2019 through the Shanghai Immunization Planning Information System and China AEFI Monitoring Information Management System. Descriptive analysis of HPV vaccination rate and AEFI reported incidence rate
Research results: From November 2017 to December 2019, women aged 9-45 in Shanghai received a total of 634300 doses of HPV vaccine, of which HPV2, HPV4, and HPV9 accounted for 7.5%, 58.3%, and 34.2%, respectively. The first dose and full course vaccination rates of HPV vaccine were 4.19% and 2.83%, respectively; The range of initial and full vaccination rates for each age group is 0.39% -7.97%, and 0.11% -4.25%, respectively
14. Yu Yanqin, Shi Zhengyang, Shi Jihai, Su Zheng, Fu Ying, Gao Jingru, Hao Jinqi, Qiao Youlin Systematic evaluation on the attitude and behavior of Chinese Mainland residents towards HPV vaccination [J] China Public Health, 2022, 38 (10): 1348-1354
C Study design: All the relevant studies on attitudes and behavioral factors related to HPV vaccination published in Chinese Mainland from January 1, 1995 to January 31, 2021 in Pubmed, Medline, CNKI and Wanfang databases were searched. Two researchers independently screened the literature and extracted data. The literature with a score of ≥ 5 points was included in the study, and Stata 12.0 software was used for statistical analysis.
Research results: The main reasons why the population is unwilling to receive the HPV vaccine, unwilling to vaccinate their children, themselves, and family, and unwilling to recommend HPV to others are vaccine safety and effectiveness, lack of understanding of HPV vaccines, high vaccine prices, and lack of understanding of vaccines, as well as fear of misleading others by speaking incorrectly.
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https://www.who.int/publications/i/item/who-wer9750-645-672
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http://www.nhc.gov.cn/fys/s3582/202301/04b918b28fb0418b9ca00dabcd29e1dc.shtml
22. WHO: A Future Without Cervical Cancer: The World's First Promise to Eliminate One Cancer
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23. Health Commission Healthy China Action (2019-2030)
https://www.gov.cn/xinwen/2019-07/15/content_5409694.htm?eqid=c77d9b5c0000462f000000066469a780
This content is supported by MSD China