Counting ｜ Can an HPV vaccine that works with a shot change the situation that a shot is hard to find？
"One shot of HPV vaccine can effectively prevent cervical cancer, which is equivalent to two or three shots." This is the latest suggestion from the Advisory Expert Group on Immunization Strategy (SAGE) of the World Health Organization (WHO).
As a female malignant tumor, the incidence rate is second only to that of breast cancer. Cervical cancer is the only cancer with clear etiology-HPV-induced lesion. It is also the only cancer that human beings can prevent at present-vaccination with HPV vaccine.
However, due to low production capacity and insufficient supply, many people have not been vaccinated with this vaccine so far. # I am anxious about producing HPV vaccine # The topic that HPV vaccine is hard to find has repeatedly become a hot search.
SAGE’s latest assessment can change this situation?
What does it mean that HPV vaccine is effective with one shot?
At present, there are five HPV vaccines approved for marketing in the world, all of which need 2 or 3 injections. The suggestion that one shot is enough representsUnder the premise of constant production capacity, the vaccination speed of HPV vaccine will be more than twice as fast as it is now.
However, SAGE’s suggestion is not the final conclusion. WHO said that before the formal revision of the position paper on HPV vaccine, a meeting will be held to discuss the interests.
Even if the WHO revised the vaccination program recommendations in the future and adopted them in China, it will take a long time.According to the policy of National Medical Products Administration, if the vaccine needs to be changed, it needs to perform a series of clinical data support to ensure that the vaccine is effective for the local population in China. This process is often calculated in years.
Moreover, although studies have shown that the protective effect of single-dose HPV vaccine is really good, so far, single-dose HPV vaccine still lacks the support of clinical data. SAGE would make such a "quick" suggestion, considering the current situation that HPV vaccine is out of stock. Nothemba (Nono) Simelela, Assistant Director-General of WHO, said: "This single-dose proposal is likely to enable us to achieve the goal of eliminating cervical cancer faster."
WHO in the "global strategy to accelerate the elimination of cervical cancer" proposed cancer eradication methods are:By 2030, 90% of girls will be vaccinated with HPV before the age of 15. However, due to the shortage of vaccines, this figure will reach 13% in 2020.
China also faces similar problems.
According to the estimation of Song Yifan and others from the Immunization Planning Center of China Center for Disease Control and Prevention, since GlaxoSmithKline became the first HPV vaccine approved for marketing in China in July 2016,By the end of 2020, the HPV vaccination rate of school-age women in China will be 2.24%.Although the vaccination rates in Beijing, Shanghai and other cities are among the highest in China, they only reach 7% and 8%.
It took only a few short years for COVID-19 vaccine to go from research and development to marketing to mass inoculation. Compared with this, the vaccination rate of HPV vaccine has grown slowly. Why? The answer is that production capacity can’t keep up.
Although the history of HPV vaccine research and development has been more than 30 years,But today, only four vaccine manufacturers in the world are producing HPV vaccines.Moreover, before Wan Tai Bio and watson biological’s domestic bivalent vaccines went on the market, for a long time, the whole world relied on GlaxoSmithKline and Merck to provide vaccines.
As the only four-valent and nine-valent HPV vaccine supplier in the world at present, Merck promised in early 2022 to substantially increase the supply of HPV vaccine to China. However, compared with hundreds of millions of school-age women in China, the supply that Merck can increase is still "a drop in the bucket".
And it may be China vaccine enterprises that can finally solve this supply and demand problem.
Domestic HPV vaccine, production capacity soared
On the last day of 2019, Xinkening, a bivalent domestic HPV vaccine developed by Wan Tai Biotech, was approved for marketing, with a price of 329 yuan/needle, which can be vaccinated by women aged 9 to 45. At that time, sirrah, which was also a bivalent HPV vaccine, needed 580 yuan for one shot and could not be vaccinated under 20 years old.
Cheaper price and wider vaccination age allowed Xinkening to surpass sirrah in the first year of listing.Quickly seized the domestic bivalent HPV vaccine market. By 2021, Wan Tai Bio will issue 10.66 million bivalent HPV vaccines a year.
With the recent listing of the second domestic bivalent HPV vaccine, Wozehui, the shortage of HPV vaccine is expected to be further alleviated. Watson biological, who is responsible for the production of Wozehui, said that "a modern production base with a capacity of 30 million doses of HPV bivalent vaccine has been built".
However, compared with bivalent HPV vaccine, which is more and more easy to get, many people want to get tetravalent or even nine-valent HPV vaccine.
The so-called "price" refers to the number of HPV virus models prevented by vaccines. At present, more than 200 HPV models have been discovered, not all of which will cause cancer.Most cases of cervical cancer are infected with one of 14 high-risk HPV.The bivalent HPV vaccine covers two of the most common, and the nine-valent vaccine covers seven of them and two low-risk HPV.
Because the higher the valence, the more kinds of HPV viruses can be prevented, which makes Jiuvalence the most tight HPV vaccine at present.
How hard is it to grab nine prices? Let’s take a look at Shenzhen, which uses the lottery method to decide the vaccination opportunity: The results of the third phase of the nine-valent HPV vaccine lottery in 2022 show that there are 527,000 applicants in this period, while the index is only 21,000, and the winning rate is only 4%.
This situation is also expected to be solved by domestic vaccines in the future.
At present,At least 14 kinds of HPV vaccines from pharmaceutical companies in China have entered the clinical research stage or been approved in clinical trials, and nearly half of them are 9-valent HPV vaccines.Among them, the fastest-growing nine-valent vaccines have entered the clinical phase III, which means that the domestic nine-valent vaccines are getting closer and closer to the end of the market.
In addition to the nine-valent, higher-priced HPV vaccines have also entered clinical trials. According to the data released by Shenzhou Cell, the tetravalent HPV vaccine they developed covered all 12 high-risk HPV subtypes published by WHO, and the prevention rate of cervical cancer increased from 90% to 96%.
So many companies are scrambling to develop HPV vaccine, which is also related to the profit potential of this market. With a bivalent HPV vaccine, the revenue of Wan Tai Bio’s vaccine business increased by 360.75% in 2021.
The more intense the domestic vaccine "rolls", the higher the chance of ordinary people hitting HPV vaccine in the future.
Price is the key to popularize HPV vaccine.
In addition to increasing the production of HPV vaccine,The entry of domestic vaccines will also bring a significant impact, which is to reduce the price of HPV vaccine.
The single price of Xinkening is 43.3% lower than that of imported bivalent HPV vaccine. Wozehui, which went on the market in March 2022, further reduced the bivalent purchase cost, with a price of 319 yuan each.
SAGE recommended a single dose of HPV vaccine, not only considering the problem of low vaccine productivity, but also considering the high cost of vaccination.
A survey published in China Public Health last December showed that three-quarters of the women interviewed in Guangzhou were willing to take HPV vaccine.But more than 70% of people can’t accept spending more on HPV vaccine than 1000 yuan.
This means that in addition to the domestic bivalent HPV vaccine, the current imported tetravalent and nonavalent vaccines are too expensive for most people.
If you don’t want to wait, the cost will be higher. Because there is a 26-year-old age limit for the 9-valent HPV vaccine in China, many girls are worried that they will not be able to fight at the end of the queue for too long, so they will pay extra money to go to private hospitals to fight at the spot price of 9-valent HPV vaccine, and the final cost is often twice the guiding price.
However, the state that HPV vaccine is rare will not last forever.Zhang Jun, deputy dean of the School of Public Health of Xiamen University, said that the domestic HPV vaccine is expected to be in short supply for about three years, and then the supply will exceed the demand, and the price will drop sharply, and it will enter the era of national immunization planning.
Although the HPV vaccine has not been included in the national immunization program or medical insurance coverage, National Health Commission encourages qualified areas to pilot free vaccination of HPV vaccine first and gradually promote it.
At present, dozens of cities in China have started to pilot free HPV vaccination programs.The target population of primary vaccination is mostly girls around the age of 14.
And this is also the best age for HPV vaccination. Some scholars have analyzed the effect of HPV vaccination in the UK from 2006 to 2019 and found that,The incidence of cervical cancer in women who are vaccinated with HPV vaccine at the age of 12 ~ 13 is 87% lower than that in those who are not vaccinated;Vaccination at the age of 14 ~ 16 reduced the incidence by 62%. At the age of 16 ~ 18, the vaccination rate was only 34% lower.
But missing the best age doesn’t mean it won’t work. And even if you are over 26 years old, you may still be priced at nine in the future. Merck has started the phase III clinical trial of nine-valent HPV vaccine in China, and the suitable age group of nine-valent HPV vaccine is expected to be relaxed to 9-45 years old.
Perhaps, the post-90s generation will be the only generation in China with age anxiety because they can’t get the nine-valent HPV vaccine.
References:
1.WHO-《One-dose Human Papillomavirus (HPV) vaccine offers solid protection against cervical cancer》， https://www.who.int/news/item/11-04-2022-one-dose-human-papillomavirus-(hpv)-vaccine-offers-solid-protection-against-cervical-cancer
2. National Medical Products Administration -HPV vaccine and prevention of cervical cancer, https://www.nmpa.gov.cn/directory/web/nmpa/yaopin/ypjgdt/20190722080001877.html.
3. Song Yifan et al.-Estimated Vaccination Rate of Human Papillomavirus Vaccine for Women Aged 9-45 in China from 2018 to 2020.
4. China News Network-"Multinational enterprises in urgent need of HPV vaccination for Chinese people: will greatly increase supply", https://www.chinanews.com.cn/cj/2022/01-11/9649162.shtml.
5. Beijing News-"After 17 years of research and development, the second domestic HPV vaccine was approved. Will there be a shortage of vaccines in the future?" 》， https://www.bjnews.com.cn/
6. Shenzhen Health and Health Commission-"1564 young ladies won! In March, the results of Shenzhen nine-valent HPV vaccine lottery were released! 》， https://mp.weixin.qq.com/s/
7. The Paper-"The world’s first 14-valent HPV vaccine entered the second clinical phase in China. Is it safe after" adding "? 》， https://m.thepaper.cn/
8. Wan Tai Biology-Wan Tai Biology Annual Report 2021
9.Milena Falcaro et al.-The Effects of the National HPV Vaccination Programme in England, UK, on cervical cancer and grade 3 cervical intraepithelial neoplasia incidence: a register-based observational study》