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Cervical cancer vaccines are divided into two, four, and nine. The higher the price, the higher the prevention ratio. The domestically vaccinated bivalent and tetravalent vaccines have already withdrawn from the US market, not because of safety or vaccine efficacy, but because of price issues. The World Health Organization currently has no preference for recommendations for these three vaccines.
This article is reproduced from the "People's Daily", the original title: cervical cancer vaccine, two-price four price enough? (Minsheng three questions).
The nine-valent vaccine did not enter China, and it was related to the vaccine registration system and was stuck in clinical trials. Experts suggest that the reform of the vaccine registration system should be promoted, and national epidemiological investigations should be carried out as soon as possible to find out the main types of viruses infected by women, and launch corresponding multi-valent vaccines to better protect women's health.
Ask the price of two-price four-price nine, what is the difference between the three vaccines
Cervical cancer is caused by human papillomavirus (HPV) infection, and it is the female malignant tumor with the second highest incidence of breast cancer. There are about 100,000 new cases each year in China, and about 30,000 women die each year from this cancer. Currently, there are three HPV preventive vaccines worldwide that have been approved by the US Food and Drug Administration for bivalent HPV (containing HPV 16 and 18 virus L1 proteins) and tetravalent HPV (containing 6, 11, 16 and 18). Vaccine L1 protein) and pentavalent HPV (containing types 6, 11, 16, 18, 31, 33, 45, 52 and 58).
With the approval of the State Food and Drug Administration, China is currently vaccinated with bivalent and tetravalent HPV vaccines. The post-marketing surveillance data and clinical trial data in China show that the two vaccines are safe for use in foreign countries for about 10 years. The available evidence does not suggest a safety concern for the HPV vaccine.
More than 170 different types of HPV are currently known. Professor Qiao Youlin, director of the Cancer Epidemiology Research Office of the Cancer Hospital of the Chinese Academy of Medical Sciences, said: "The HPV virus is widespread, but only about 10 high-risk types are most closely related to human malignancies. Six low-risk types are associated with wetness. Among them, HPV 16 and 18 are the two most risky strains, and more than 70% of cervical cancers are associated with the two types of virus infection. In other words, vaccination covers 16 and 18 HPV vaccines, which can prevent about 70%. Cervical cancer; the nine-valent HPV vaccine increases the prevention rate to 90%."
"Choose which vaccine to vaccinate can be considered according to factors such as the availability and affordability of the vaccine." Yu Wenzhou, chief physician of the Center for Immunization Planning of the China Center for Disease Control and Prevention, said that in the recommendations of the 2009 US Immunization Strategy Implementation Committee, there were no vaccines for the two vaccines. Choice of preferences. The two HPV vaccines marketed in the country provide high levels of protection against HPV16 and HPV18 and have similar efficacy in preventing cervical cancer. There is currently no preference for recommendations for the three vaccines in the World Health Organization's position paper on HPV vaccines. Individuals can voluntarily vaccinate according to the type and price of vaccines currently available.
Ask when to vaccinate cervical cancer vaccines
"Inoculation of HPV vaccine will not cause cancer, nor will it affect fertility." Yu Wenzhou said that all three vaccines use DNA recombination technology, and the vaccine does not contain live biological products or viral DNA, so it is not infectious. The HPV vaccine also contains no antibiotics and preservatives. In animal experiments, no direct or indirect adverse effects of HPV vaccine on reproduction, pregnancy, and embryonic development have been found. However, as a preventive measure, pregnant women are not recommended to receive HPV vaccine.
In response to news of adverse reactions due to vaccination, Qiao Youlin pointed out that the previous inactivated or attenuated live vaccine is to inject the virus into the body and stimulate the body to produce an immune response. The virus in this vaccine may have the possibility of toxic reactivation; through genetic engineering The altered HPV vaccine is a protein shell that does not contain infectious DNA and is not infectious. However, the vaccination of HPV vaccine may cause some adverse reactions, such as local redness and pain, and systemic symptoms such as fever, dizziness, and nausea. These are the common reactions of the body to heterologous proteins after intramuscular injection, and it does not mean that the vaccine is not safe. .
The sooner you vaccinate, the more effective the vaccine is, the more cost-effective it is. The World Health Organization requires that HPV vaccines need to be vaccinated as much as possible before sexual activity, ie before the first exposure to HPV infection.
"Sexual behavior, may be infected with the virus, and then vaccination, the protection effect is poor." Gao Yunong, director of the Department of Gynecologic Oncology, Peking University Cancer Hospital, said that after sexual activity is not necessarily infected with the virus, vaccination is still effective. Vaccination is a primary prevention, which fundamentally prevents cervical cancer, a fatal disease. Those who can be vaccinated with cervical cancer should be vaccinated as much as possible.
Can the HPV vaccine be freely vaccinated? After the expert advisory committee passed the argument, the National Health and Family Planning Commission and the Ministry of Finance proposed to incorporate the vaccine into the national immunization program. The HPV vaccine belongs to the second category of vaccines, but at present, there are more types of vaccines that need to be included in the national immunization program. "The second type of vaccine will be included in the national immunization program, there will be a priority order." Yu Wenzhou said that HPV vaccines are expensive, and there is no domestic manufacturer to produce this vaccine. Therefore, it is difficult to incorporate national immunization programs in the short term. In the future, the second type of vaccine may be promoted into the national immunization planning process in various ways, such as national financial support or through medical insurance.
What is the shortcoming of vaccine development and registration in China?
The HPV vaccine has been approved in the country, bringing the gospel to the majority of women. However, many people still want to go abroad for vaccination because they are worried that the domestic vaccine is the "eliminated goods" that the United States has eliminated.
Yu Wenzhou said that in 2014, the US Food and Drug Administration approved the listing of the nine-priced HPV vaccine. In February 2015, the US Immunization Strategy Implementation Committee did not have any preference for the selection of three HPV vaccines. Because the US Centers for Disease Control and Prevention negotiated prices with vaccine manufacturers, the prices were basically the same. In 2016, the US market used nine-priced HPV. After April 2016, all contracted contracts were only nine-priced HPV, that is, two-price and The four-valent HPV vaccine has voluntarily withdrawn from the US market. Bivalent and tetravalent HPV vaccines have withdrawn from the United States not because of their vaccine safety issues, nor because of vaccine efficacy.
The HPV vaccine was approved by the US Food and Drug Administration in 2006 and is recognized by the World Health Organization. The HPV vaccine is listed late in China, which is related to China's vaccine registration system and should promote the reform of the vaccine registration system.
"Nine-priced HPV vaccine is a new drug and needs to be registered in China." Yu Wenzhou said that drug registration needs to be applied and clinical trials are carried out in China. After the clinical trial is completed, the vaccine can be listed by approval of the State Food and Drug Administration. The length of the registration cycle depends on the completion of the clinical trial.
Qiao Youlin said that the long approval path for HPV vaccine is stuck in clinical trials. According to the requirements of the State Food and Drug Administration, as a vaccine against cancer, its effectiveness should be measured by the statistically significant proportion of cervical cancer or precancerous lesions in the vaccine group and the control group. That is to say, it is required that in the test subject, a certain number of confirmed cancers or cervical intraepithelial neoplasia cases in the control group not using the vaccine are significantly more than the use of the vaccine group, in order to prove that the vaccine has a preventive effect on the user. Generally speaking, it takes about 1 year for a new imported drug or vaccine to be approved from the application to the clinical trial. It takes an average of 5 years to get approved for Chinese patients.
"China's vaccine research and development level, especially cervical cancer vaccine development, there is a gap compared with foreign advanced countries." Yu Wenzhou said that China will introduce a nine-priced HPV vaccine as soon as possible, and accelerate the registration of domestic HPV vaccine registration. Several vaccines will coexist for some time, and it is possible to develop more types of HPV vaccines.
Qiao Youlin said that at the end of 2017, the nine-priced HPV vaccine developed by four manufacturers has been approved by the State Food and Drug Administration for clinical trials. When and which clinical trials can finally be registered by the State Food and Drug Administration. Approval is not known.
Gao Yunong said that China should conduct a national epidemiological investigation as soon as possible, find out the main types of viruses infected by women, find the true types of high-risk viruses, and launch corresponding multi-valent vaccines to better protect women's health.
Yu Wenzhou said that HPV vaccination is for older children and adults. HPV vaccination will promote the development of adult immunization in China, and the country will develop HPV vaccination guidelines as soon as possible to guide HPV vaccination. In general, China's vaccine development should focus on the needs of the public, speed up the development of new vaccines; develop joint vaccines to optimize the immunization program for children in China; develop adult vaccines, and promote adult immunity, such as adult influenza vaccine, pneumonia vaccine, herpes zoster vaccine, etc. Vaccination.
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