Is the use of the nine-valent HPV vaccine for bivalent and tetravalent HPV vaccines?

The State Drug Administration has conditionally approved a nine-valent human papillomavirus vaccine (hereinafter referred to as a nine-valent HPV vaccine) for the prevention of cervical cancer. At this point, all HPV vaccine varieties that have been on the market worldwide are available in China, which can better meet the different needs of the public for vaccination and provide a new and effective means for the prevention of cervical cancer.
The nine-priced HPV vaccine has been on the market. Is there any use of the second- and fourth-valent vaccines that were listed before? The State Food and Drug Administration invited experts to interpret this.
1. Who can vaccinate the nine-valent HPV vaccine?
The imported nine-priced HPV vaccine approved for marketing in China is suitable for women aged 16-26. The previously available bivalent HPV vaccine is 9-45 years old; the four-valent HPV vaccine is 20-45 years old. To date, the age range of the applicable population approved by the three listed HPV vaccines based on the submitted clinical study data varies.
2. Why is the vaccination population of the nine-priced HPV vaccine limited to women aged 16-26?
Unlike bivalent and tetravalent HPV vaccines, the market for nine-valent HPV vaccines is directly registered in China for clinically urgently needed drugs using overseas clinical data. The reason why the current approved population is set for this age group is based on the following three aspects:
First, the key clinical trial subjects supporting the marketing of the vaccine were women aged 16 to 26 years; the global clinical data of registered clinical studies and the East Asian Chinese population showed the same protective effect, reflecting that their benefits outweighed the risks. Second, female pediatric subjects aged 9 to 15 years used an immunogenic bridging test, and the clinical research data of the East Asian Chinese population was limited. Third, women over the age of 26 have greater exposure to HPV infection, and there is no evidence that the vaccine has protective effects in this age group.
In 2018, the World Health Organization (WHO) proposed the global goal of eliminating cervical cancer, and recommended three HPV vaccine clinical applications based on vaccine accessibility. In the latest position paper, it is clear that the available evidence shows that three listed HPV vaccines have very similar protective effects against cervical cancer.
3. The nine-priced HPV vaccine is on the market. Can you choose a bivalent or tetravalent HPV vaccine?
There are 14 genotypes of high-risk HPV associated with cervical cancer. The currently marketed bivalent and tetravalent HPV vaccines involve two high-risk types (HPV-16 and HPV-18). High-risk HPV-16 and HPV-18 are the most common HPV genotypes in the world, accounting for more than 70% of all invasive cervical cancer cases.
The bivalent and tetravalent HPV vaccines have been clinically used in more than 100 countries abroad for more than 10 years. It has been proven to have the same good protective effect on HPV-16 and HPV-18, at least for about 10 years. The tetravalent HPV vaccine has two lower-risk types of HPV-6 and HPV-11 than the bivalent HPV vaccine, thus increasing the indication for preventing condyloma acuminata than the bivalent HPV vaccine. Seven high-risk types are covered in the nine-valent HPV vaccine, and the preventive and protective effect on cervical cancer is increased by about 20% compared with the bivalent and tetravalent vaccines.
Consumers should choose the appropriate vaccine according to their age and economic situation under the guidance of a doctor, and vaccinate them in a regular vaccination institution according to the vaccine instructions.
4. After inoculation of HPV vaccine, can you not do cervical cancer screening?
The HPV vaccine is the world's first vaccine to prevent cancer. It takes 8 to 10 years from HPV infection to cervical cancer. During this period, if the lesions caused by HPV infection can be prevented early, or diagnosed and treated correctly, the lesion can be controlled to develop into cancer.
Since the HPV vaccines that are currently on the market do not cover all high-risk genotypes, and the protection effect of existing vaccines on infected people is unknown, some elderly people are outside the age range of vaccines, in order to better prevent cervical cancer, The latest WHO guidelines recommend that vaccination with HPV is an integral part of a comprehensive approach to the prevention of cervical cancer. It is not a substitute for routine cervical cancer screening and does not replace other measures to prevent HPV infection and sexually transmitted diseases.
Early screening techniques for mature cervical cancer in female physical examination programs, including cervical smear examination, cervical liquid-based thin layer cytology (TCT), colposcopy, etc., are secondary prevention measures other than primary prevention of vaccines. . In order to protect the health of women, we can not ignore the regular screening of cervical cancer.
5. What are the precautions for HPV vaccination?
The vaccination of the nine-valent HPV vaccine, like other vaccines, should strictly follow the vaccination targets, immunization procedures, vaccination instructions and precautions in the instructions. The following conditions have been stated in the precautions: vaccination should be avoided during pregnancy. If the woman has or is preparing for pregnancy, it is recommended to postpone or discontinue the vaccination. After the gestation period, vaccination should be carried out; lactating women should be used with caution.