Start the free vaccination of HPV vaccine in many places: Why do you choose bivalent vaccine and is the production capacity sufficient?
"Free HPV vaccination for school-age women" adds another province, this time in Jiangsu, where the permanent population ranks fourth in the country in 2022.
On the evening of March 22nd, the WeChat official of Jiangsu CDC reported that in order to implement the "Healthy China 2030" strategy, promote the comprehensive prevention and treatment of cervical cancer and promote the construction of healthy Jiangsu, the Provincial Health and Wellness Commission, the Provincial Department of Education and the Provincial Women’s Federation jointly held a kick-off meeting in Nanjing on March 20th to deploy the free HPV vaccination for school-age girls in the province in 2023.
Cervical cancer is the fourth largest malignant tumor affecting women’s health in the world, and it is also the second largest female malignant tumor in China. Vaccination with human papillomavirus (HPV) is an effective means to prevent cervical cancer. According to the "Notice on Printing and Distributing the Action Plan for Accelerating the Elimination of Cervical Cancer (2023-2030)" issued by National Health Commission in January this year, by 2025, the HPV vaccination service for school-age girls will be promoted on a pilot basis; The screening rate of cervical cancer in school-age women reached 50%; The treatment rate of patients with cervical cancer and precancerous lesions reached 90%.
Since the first government-led HPV vaccine free vaccination project was launched in Ordos City three years ago, up to now, Guangdong, Hainan, Jiangxi, Fujian, Tibet and Chongqing provinces have also started or announced that they will launch a global HPV vaccine free vaccination plan.
A number of industry experts believe that since the listing of HPV vaccine in China, the vaccination amount has been increasing year by year, but there are still some problems such as limited vaccination coverage, unbalanced distribution and the market chasing high-priced vaccines. Globally, more than 70% of cervical cancer cases are related to high-risk HPV16 and HPV18 subtypes, and bivalent vaccine is just enough to effectively prevent these two infections. Because of China’s large population, the government must be careful to use the limited vaccine resources and local finance to the people who need protection most. This requires accelerating the government-led HPV vaccination program to guide the vaccine market to develop in a more benign direction.
HPV public vaccine is gradually spread out.
Last year, Wuxi, Lianyungang, Nanjing and Yangzhou, Jiangsu Province, successively launched the pilot project of free HPV vaccination for school-age girls, with a total of 64,000 people vaccinated.
According to the "Work Plan for Free Vaccination of HPV Vaccine for School-age Girls" in Jiangsu Province, in 2023, at least 246,700 girls born after September 1, 2009 and in the first half of the year will be vaccinated with domestic bivalent HPV vaccine for free. In order to ensure the smooth implementation of the project, the provincial finance at all levels will invest 172 million yuan.
CBN noted that as early as last December, Jiangsu Province issued the "14th Five-Year Plan" for the development of women and children, and proposed to "encourage qualified areas to promote HPV vaccination with emphasis on girls aged 9-15".
In January this year, Jiangsu Province issued the "List of 55 livelihood facts in 13 categories to guarantee and improve people’s livelihood in 2023", and "Free HPV vaccination for school-age girls" was included, which means that the vaccination project will be promoted throughout the province.
"The project is led by the Provincial Health and Wellness Committee, and launched in the whole province in conjunction with the Provincial Department of Education and the Provincial Women’s Federation. It aims to raise the awareness of cervical cancer prevention and control and prevent and reduce the occurrence of cervical cancer through HPV vaccination." Jiangsu Provincial Health and Health Commission said.
In addition to Jiangsu, according to the work report of Hainan Provincial Government this year, "HPV vaccination for school-age women" was also included in the 10 practical matters for the people determined by the provincial party committee and the provincial government in 2023.
Official website, the People’s Government of Hainan Province, released a message in early February, further clarifying the vaccination plan: this year, the project will be implemented in 18 cities and counties in the province (except Sansha City), and in 2023, the target of vaccination will be girls aged 13-14 years and a half in the first dose, and girls who are contraindicated in vaccination or who have been vaccinated with HPV will not be included in the vaccination scope. In 2023, it is planned to vaccinate 55,800 girls, according to "0— 6 "Two-dose immunization program, complete two injections in the same year, and ensure that" all should be connected ". At the same time, the project will also vaccinate domestic bivalent HPV vaccine for school-age female soldiers in need.
Up to now, according to incomplete statistics, in less than three years, Hainan, Jiangxi, Tibet, Fujian, Jiangsu, Guangdong, Chongqing and other provinces, as well as Erdos, Linxia Hui Autonomous Prefecture, Qingdao, Jinan, Dezhou, Jiaozhou, Yantai, Shijiazhuang, Handan, Tangshan, Chengdu, Mianyang, Aba Tibetan and Qiang Autonomous Prefecture, Zhengzhou, Ningbo and other places are promoting public HPV vaccination projects.
Looking back on the progress of HPV vaccine at public expense, in August 2020, the first government-led HPV vaccine free vaccination project in China was launched in Zhungeer Banner, Erdos City, Inner Mongolia.
Six months later, in March 2021, China launched the pilot project of healthy city innovation, and encouraged the cities participating in the pilot project to study and carry out government-led HPV vaccination according to their own conditions. Up to now, among the first batch of 15 healthy cities, 9 cities including Shenzhen, Xiamen, Chongqing, Ordos, Jinan, Chengdu and Wuxi have officially launched the HPV vaccine immunization program.
In addition to Jiangsu, among the provinces where the above-mentioned cities started the HPV vaccine immunization program, Fujian and Guangdong provinces have also expanded the coverage of the project to the whole province, while Shijiazhuang, Tangshan, Zhengzhou, Hainan, Jiangxi, Tibet and other places that are not in the above-mentioned pilot list have also announced the free vaccination of HPV vaccine in the whole region.
For example, Guangdong proposed that from 2022 to 2024, the financial plan will add about 600 million yuan for free vaccination of HPV vaccine. From 2022, free vaccination will be given to girls under the age of 14 who have a student status in Guangdong Province and have entered the first grade of junior high school since September and have not been vaccinated with HPV vaccine.
Why bivalent seedlings are key?
At present, HPV vaccine has not been included in medical insurance in China, and with the aging of vaccination in many places, the three-needle nine-valent vaccine vaccinated at one’s own expense has become a tight existence in the market. But in the eyes of the industry, if China wants to achieve the "90-mdash; 70— The goal of "90" urgently needs to promote the government-led bivalent vaccine inoculation plan.
The so-called "90— 70— 90 ",that is, 90% of girls complete HPV vaccination before the age of 15; 70% of women are screened by efficient detection methods before the age of 35 and 45; 90% of women diagnosed with cervical diseases are treated. In 2020, there will be 109,000 new cases of cervical cancer and 59,000 deaths in China, accounting for one fifth of the global total.
At present, HPV vaccines are divided into bivalent, tetravalent and nonavalent. All HPV vaccines contain VLPs (virus-like particles) for high-risk HPV types 16 and 18; Among them, the nine-valent vaccine contains VLPs against high-risk HPV31 types 31, 33, 45, 52 and 58.
According to the "Human Papillomavirus Vaccine: WHO Position Paper" updated by WHO last year, it is estimated that HPV16 and HPV18 together cause 71% of cervical cancer cases in the world. Of the remaining 29% cases of cervical cancer, 6% were caused by HPV45, 4% by HPV31, 4% by HPV33, 3% by HPV52 and 2% by HPV58.
In this document, WHO cited research that bivalent vaccine is also highly effective against HPV-16 and HPV-18-related infections and cervical lesions. "A study observed the population-based cancer registration data of women under the age of 30 and found that after the bivalent HPV vaccine was included in the national immunization program, cervical cancer could be nearly eliminated among women who were vaccinated at the age of 12-13."
Jiangsu CDC also explained why the domestic bivalent HPV vaccine was chosen for the public vaccination program: in China, about 70% of cervical cancer cases are related to the infection of two subtypes of high-risk HPV16 and HPV18. The HPV vaccination project for school-age girls uses domestic bivalent HPV vaccine, and the 9-14-year-old subjects need to be vaccinated twice, which can effectively prevent the infection of the above two subtypes and is the most cost-effective vaccine.
Du Heng, senior project officer of Bill & Melinda Gates Foundation Beijing Representative Office, believes that enterprises will make production capacity layout and arrangement according to market demand. If the government does not guide, enterprises will only pay attention to the commercial market, leaving production capacity for high-priced vaccines and people with higher ability to pay, and will not give priority to key people aged 9-15.
However, the reporter noted that the main target groups of HPV vaccination recommended by WHO include girls aged 9-14 who have not had sex. However, in Jiangsu, Hainan and other places, the age range of the first dose of HPV vaccine for school-age women included at public expense is about 13~14 years old.
For this phenomenon, Zhao Fanghui, director of the National Cancer Center and the Epidemiology Research Office of the Cancer Hospital of China Academy of Medical Sciences, conducted a comparative study of school-age women in the age group of 9-14, and found that given the limited vaccine and funding resources, it would be more beneficial to vaccinate the 14-year-old girl twice first than to vaccinate other age groups first. "The key point of optimizing the prevention and control strategy of cervical cancer in China lies in ‘ Treatment-oriented ’ To ‘ Prevention first ’ Change, increase the initial investment, and introduce vaccines in the small age group of 9-15 years old as soon as possible. "
With more provinces including bivalent HPV vaccine in the scope of public vaccination, can China’s production capacity be covered?
Chai Yan, director of management consulting at IQVIA, said that there are two companies in China that can produce HPV vaccines, each with a total production capacity of 30 million/year, but at present, the production capacity of the two companies is not full. According to the preliminary forecast, in 2023, the demand for bivalent seedlings in China will be 100 million. Theoretically speaking, if the two manufacturers make full efforts, they can meet the demand of most consumers for bivalent vaccines in recent years.
"Based on this, it is expected that after 2025, China will usher in a new stage of HPV vaccine development. By then, a number of domestic vaccines will be listed one after another, greatly improving the overall supply of HPV vaccines in China and improving the accessibility of vaccines. " Chai Yan said.
Du Heng also believes that promoting the inclusion of HPV vaccine in immunization program can fundamentally solve the problems of vaccine quality, supply and price. Government-led vaccine public market can make enterprises have a stable source of bulk orders, and then have the confidence to expand production capacity. In order to ensure large-scale production and supply, they are more willing to invest more R&D and human resources in quality control to improve product efficiency. The government and people can also benefit from this and get high-quality and low-cost cervical cancer vaccine.