4hw.com.cn, on April 28, the State Drug Administration had the conditions to approve the listing of nine valent human papillomavirus vaccine (hereinafter referred to as HPV vaccine) for the prevention of cervical cancer, which can prevent more than 90% of cervical cancer and other related cancers.
HPV is the abbreviation of "human papillomavirus". There are more than 100 members of HPV family, some of them are closely related to malignant tumors and are called high-risk HPV. Women who have sex are 40 to 80 percent more likely to have one type of HPV in their lifetime. However, more than 80% of HPV infection will be eliminated within 8 months, and only a few persistent high-risk HPV infection for more than 2 years can cause cancer.
HPV vaccine is the world's first vaccine to include cancer as an indication in the specification.
The nine valent HPV vaccine approved in mainland China is made of virus like particles composed of major capsid proteins of HPV 6, 11, 16, 18, 31, 33, 45, 52 and 58, which are highly purified and mixed.
The vaccine is suitable for 16 to 26 year old women and is used to prevent cervical cancer, vulvar cancer, vaginal cancer, anal cancer, genital warts, persistent infection, precancerous or atypical lesions caused by HPV.
So far, all kinds of HPV vaccines that have been launched and used in the world are available in the mainland, which can better meet the different needs of the public for vaccination, and provide new and effective means for the prevention of cervical cancer.
Why is it 'conditional approval' for the nine price vaccine to go on the market?
Some analysts have pointed out that the approval speed of the vaccine market is like "rocket". Mosadon's 9-valent vaccine was approved for clinical use in the mainland in November 2017, and its application for listing was accepted on April 20, 2018. Only eight days later, it was qualified for listing.
Why is this time so fast? According to the official website of the State Drug Administration, after receiving the application for import registration of nine price HPV vaccine, the State Drug Administration has included it in the priority review procedure, communicated with enterprises on the overseas clinical data and post marketing safety monitoring of products for many times, and accepted the overseas clinical trial data conditionally based on the approved data of four price HPV vaccine The overseas clinical data are bridged, and the import registration of the product is approved conditionally in the shortest time.
At the same time, the State Food and drug administration requires enterprises to formulate risk management and control plans and carry out post IPO research as required.
When will Zhejiang be able to get the ninth price vaccine?
Yesterday was a legal holiday, and the Centers for disease prevention in Zhejiang Province and Hangzhou city have not released official information.
However, the relevant person in charge said that the nine price HPV vaccine can really be vaccinated from the market, procurement to the public. The process can refer to the original two price and four price vaccines. Moreover, the approval speed of this vaccine launch is very fast, and the time for everyone to get the nine price vaccine is probably faster than before.
The express sorted out the time nodes for approval, purchase and vaccination of bivalent and quadrivalent vaccines--
In late July 2016, the cervical cancer vaccine was approved to be listed in the mainland;
At the end of July 2017, the first bivalent cervical cancer vaccine approved in the mainland was officially launched;
In November 2017, the community health service center can get bivalent vaccine;
In late January 2018, tetravalent vaccine can be administered.
Do women of school age wait for nine price listing?
The newly approved nine price adaptive population is 16-26-year-old women, and the existing four price adaptive population is 20-45-year-old women.
If the age is between 20-26, you can make four or nine prices. Do you want to wait until the ninth price is listed?
In an interview with the media, Wu Chenggang, deputy director of the Institute of immunology of Guangdong provincial CDC, suggested that 'the tetravalent cervical cancer vaccine has a protective effect on 70% of cervical cancer. In fact, there is no need to specially wait for the nine price vaccine to go on the market. The cervical cancer vaccine should be vaccinated as soon as possible. '
At present, the community in Hangzhou is very nervous about getting the four price vaccine
Some time ago, I took my baby to get vaccinated. From time to time, I met a mother who asked the doctor in the community health service center, 'do you have a quadruple cervical cancer vaccine?' the doctor replied, 'yes, there is, but I need to register. I'll let you know when the next batch arrives. Next batch, about a month later. '
The vaccinator at a community health center in Shangcheng district said: 'when the bivalent vaccine came out, we didn't hit many people and we didn't get in much. Later, with four prices, there were more people to beat. We have to wait more than a month for registration. '
"For most women, the awareness of cervical cancer prevention is after sexual experience, so the four prices are more widely targeted. I'll take a taxi here. Thirty or forty year old & lsquo; mature women & rsquo; are the most. 'said the doctor.
Is it OK to make a price of nine if you are over 26 years old?
If you want to make nine price or four price if you want to make nine price listing later, but you are over 26 years old, will the community give you a call?
'not as far as I know. The community health service center will use the vaccine according to the instructions, what age to get the vaccine, and see the ID card before getting it. "The community vaccination doctor said.
Are the nine price vaccines listed on the mainland the same as those in Hong Kong?
The express previously wrote about the HPV vaccine. Experts said: 'there are bivalent and tetravalent vaccines in the mainland, and in Hong Kong and other places, there are nine valent vaccines. '
Many friends around me think that the most common type of virus to be vaccinated is to be vaccinated. They flew several times to Hong Kong to vaccinate.
Sister Xiao Lin got a nine price vaccine in 2016. At that time, the price was 4500 Hong Kong dollars for a set of three injections, which was reserved for a week and then printed; netizen "shearer" hit 6800 Hong Kong dollars in March this year, with an appointment period of one month.
Yesterday, I contacted a Hong Kong vaccine agency and said that the current price is 7600 Hong Kong dollars. It is normal to call it in July and August. If you add money, you can call it in June.
A sister who just went to Hong Kong last week said that she was going to fight in the mainland. "I often run in Shanghai and Hong Kong. This time, I went to a clinic where my baby had been vaccinated. I said that I would not accept temporary customers, even if I had files. There are too many people going to vaccinate in the mainland. First of all, they need to ensure the supply of residents in their jurisdiction. Moreover, the price given to the local residents is not the same as that given to us. '
I was given the nine price vaccine by the Hong Kong agency to people over the age of 9, including boys. The nine price vaccines approved for listing in the mainland are suitable for women aged 16-26.
Are the two vaccines the same for different people?
Consulted the manufacturers of mainland and Hong Kong vaccines, and the relevant people replied that it is possible that the vaccines in the two places are the same or different.
Why do you say that? 'vaccines are different from medicines. There is no patent problem. As long as the technology is in place, any manufacturer can produce them. So maybe it's a different vaccine. '
"The vaccine is aimed at the population according to the clinical trials. For example, a vaccine has been tested in a certain place in the clinical trials of 9-45-year-old population, and the adapted population is in this range. But in another place, only 16-26 year olds have been done, so the adaptive population is in this range. In this way, the mainland and Hong Kong may also be listed in the same vaccine. '
Seven questions and answers about HPV vaccine
1. How many years can the vaccine work?
It is not entirely clear. In 2007, the HPV vaccine went on the market, and in 2012, the results showed that there was no problem in the protection ability five years after vaccination.
Nordic studies have shown that there is no problem with the ability to protect 10 years after vaccination. Mathematicians have built a mathematical model to show that there is no problem in the protection capacity 50 years after vaccination. Therefore, it can be said that it is a conclusion to maintain the protection ability for 10 years after vaccination, while 50 years is a conclusion. It needs time to test whether it is correct or not.
2. Why has vaccination always mentioned before that women who do not have sex have a good effect?
Even if you have sex, you can still get vaccinated. The previous view was that after having sex, women's chances of being infected with HPV increased dramatically. If these women were vaccinated, it would be 'not so good' for the researchers who analyzed the results, and 'not so good' economically. Because, from the macro level, we need to do the biggest thing with the least money, and good steel should be used on the blade. However, it's just not very cost-effective, not without medical value. If you pay for vaccination, you don't need to consider the economic benefits.
3. Is it necessary to vaccinate over the age of 45?
The second price is for women aged 9 to 25, the fourth price is for women aged 20 to 45, and the ninth price is for women aged 16 to 26. Is it necessary for women over 45 to fight?
Before women have sex, the younger they are, the more cost-effective the vaccine is. Premenopausal women who have sex can fight if they need to. Theoretically, they can also prevent the infection of related viruses.
4. Can pregnant women and lactating women be vaccinated? What about pregnancy after vaccination?
At present, there is no data about pregnant women and lactating women, so it is not recommended to vaccinate pregnant women and lactating women against cervical cancer. In fact, the harm of HPV is not as great as you think. This part of women can wait for a period of time, and it is not too late to vaccinate against HPV after the fetus is born and weaned.
There is no adverse effect of vaccine on fetus. Therefore, if an unexpected pregnancy occurs within 6 months of vaccination, it can be closely observed to continue pregnancy.
5. Can men get the vaccine?
Although in theory, HPV vaccination is useful for men, there is no clear evidence to show how effective HPV vaccination can prevent cervical cancer in sexual partners, but it can prevent male genital warts, which is also a venereal disease caused by HPV.
Taking into account the ratio of input to income, most countries and the official documents of the World Health Organization (who) have not recommended male vaccination. At present, boys in Australia are injected free of charge.
6. After vaccinating, is it still used for cervical cancer screening?
Whether bivalent, bivalent or bivalent vaccines are inoculated, regular screening is still needed after vaccination. Existing vaccines, including the nine valent vaccine, do not prevent all high-risk HPVs. In addition, there may be a small number of high-risk HPV has not been identified, of course, there is no targeted vaccine.
In terms of the three-level prevention and control of cervical cancer, vaccination of cervical cancer vaccine belongs to the first level prevention and control (prevention and treatment of disease), while screening belongs to the second level prevention and control (treatment of primary disease), and the diagnosis and treatment of cervical cancer belongs to the third level prevention and control (treatment of disease). You can't take the second defense away because the first one is good (it's not perfect yet).
7. Some people call HPV vaccine anti-cancer vaccine. Is that right?
HPV vaccine is to prevent cervical cancer caused by high-risk HPV infection, not for patients already suffering from cancer, so it is not accurate to call it anti-cancer vaccine.