Behind the ＂Fake HPV Vaccine＂ Incident： Experts suggest cooling the online celebrity vaccine.
The recent exposure of "Hainan Boao Yinfeng Kangyang International Hospital involved in the vaccination of fake nine-valent HPV vaccine" has poured a pot of cold water on the vaccination boom of HPV (human papillomavirus) vaccine.
Over the past few years, in the upsurge of public opinion, the nine-valent HPV vaccine has gradually become a vaccine "online celebrity". An endless stream of cross-border vaccinators even once "stopped supplying" the nine-valent HPV vaccine in Hong Kong.
On April 28th, 2018, under the great expectation, the nine-valent HPV vaccine was officially approved for listing in Chinese mainland at the speed of rocket.
Before listing, the huge demand crowd gave birth to chaotic outbound vaccination intermediaries, and illegal smuggling was also common. This industrial chain is still active today.
The "fake nine-valent HPV vaccine" incident uncovered the gray side of the HPV vaccine business.
According to the notification of Hainan Provincial Health and Health Commission on April 28th, Hainan Boao Yinfeng Kangyang International Hospital (hereinafter referred to as "Yinfeng Hospital") was suspected of illegally vaccinating 38 people with HPV vaccine in January 2018. The "victim" of the incident said that these vaccines may be illegally smuggled or may come from a pharmaceutical factory in Siping, Jilin.
In addition, 32 of them are over the recommended vaccination age of nine-valent HPV vaccine (16-26 years old), that is to say, they do not fully understand the protective effect of HPV vaccine. Why do these older women spend nearly 10,000 yuan chasing the nine-valent HPV vaccine of unknown origin?
Many experts told The Paper that we should treat the value of the nine-valent HPV vaccine more rationally and need to cool down the "online celebrity" vaccine.
Hainan Boao Yinfeng Kangyang International Hospital, sealed by qionghai city Health and Health Commission on April 29th.A Hard-to-Find Nine-valent HPV Vaccine "Myth"
Since it was approved on April 28 last year, the strong demand for nine-valent HPV vaccine has triggered an appointment boom in various places, and Beijing, Shenzhen, Hangzhou, Guangzhou and other places have all experienced the phenomenon of "one needle is hard to find".
On April 29th, The Paper called the Hubei Provincial Center for Cervical Cancer Prevention and Treatment, and the outpatient department said that it was normal to make an appointment every Monday on the Internet because "there are only a dozen needles at nine prices every week".
In many cities, booking a nine-valent HPV vaccine requires a lottery. For example, in Nanning, Guangxi, after winning the lottery, the applicant will be informed of the specific inoculation place and time. If the inoculation is not completed within the specified time, it will be included in ‘ Blacklist ’ You must not participate in the lottery within half a year. "
In Shenzhen, from November last year, it was changed from "grab the number to make an appointment" to "shake the number to make an appointment". There were 95,111 valid applicants in the first lottery, and only 1,305 applicants won the lottery, with a winning rate of 1.37%.
Behind the "one needle is hard to find" is the publicity upsurge of HPV vaccine that lasted for several years, which even shaped the nine-valent HPV vaccine into a "myth".
Since the bivalent HPV vaccine was approved in 2016, titles such as "Ten years waiting, cervical cancer vaccine was finally approved" and "Chinese people waited for ten years, cervical cancer vaccine should not be missed" appeared in the media and occupied the circle of friends.
In fact, HPV vaccine has been listed in the United States, Australia and other countries as early as 2006. In 2013, Professor Qiao Youlin from China Academy of Medical Sciences and Institute of Oncology of Peking Union Medical College and his research team published a study in the international authoritative magazine Vaccine, saying that if the cervical cancer vaccine was absent from China for seven years, 380,000 women would miss protection opportunities and become cervical cancer patients in the future if effective intervention measures such as screening were not applied.
This research has attracted the attention of the domestic media. Since 2014, there have been reports in China about the long waiting time of cervical cancer vaccine. Until the first HPV vaccine was approved in China in 2016, the listing of tetravalent HPV vaccine in China has also caused widespread concern.
Under the ardent expectation of the public, on April 28th last year, the nine-valent HPV vaccine was approved by National Medical Products Administration at "rocket speed". It took only eight days from the acceptance of the marketing application to the conditional approval, setting a new approval record.
Who can be vaccinated with nine-valent HPV vaccine? Why is the recommended vaccination age limited to 16-26 years old? How to rationally treat the role of HPV vaccine in preventing cervical cancer? These questions are rarely mentioned.
"There is indeed a phenomenon of over-promotion of HPV vaccine. According to the guidance of WHO, it is clear that even if HPV vaccine is vaccinated, cervical cancer cannot be completely avoided." Wang Yuedan, deputy director of the Department of Immunology of Peking University, told The Paper on April 29th.
Some experts also pointed out that the frequent reports of vaccine shortage in the media and online have stimulated more women’s desire for vaccination, thus pushing up the market demand and increasing the supply gap.
HPV vaccine is only part of the prevention strategy.
"Popular Science Questions and Reference Answers about HPV Vaccine" published in National Medical Products Administration official website explained that for most people, being infected with HPV virus is like "getting a cold in the cervix", so there is no need to be too nervous and afraid.
"More than 80% of HPV infections will be naturally cleared within 8 months, and only a few persistent high-risk HPV infections can cause cancer for more than 2 years. Among those who continue to be infected, only a few people will develop cervical precancerous lesions, and only a few of the latter will develop into cancer. " Mentioned in the above popular science question and answer.
Two experts, Hu Shangying and Qiao Youlin, from the National Cancer Center and Peking Union Medical College Cancer Hospital of China Academy of Medical Sciences, also emphasized that HPV vaccination should be a part of the comprehensive prevention strategy for cervical cancer and other related diseases in a paper "Interpretation of the 2017 WHO HPV vaccine position paper" published in the Chinese journal of preventive medicine. In addition to vaccination, it also includes health education for women to avoid risky behaviors, screening, diagnosis and treatment, training health workers, and improving the accessibility of effective screening and treatment services.
For women over the age of 26 who want to get a 9-valent HPV vaccine in China, Liu Fangxun, deputy director of the Department of Special Needs International Medicine of Peking University International Hospital, suggested that they can choose to get a 4-valent HPV vaccine and have a cervical cytology (TCT) examination every year.
The best time for HPV vaccination is before sex, that is, before the first exposure to HPV infection. Therefore, teenagers are the best age for HPV vaccination.
The recommended vaccination age of bivalent HPV vaccine in China is 9-25 years old women, tetravalent HPV vaccine is suitable for 20-45 years old women, and nonavalent HPV vaccine is suitable for 16-26 years old women.
However, the recommended vaccination ages are different in different countries and regions. In the United States, the applicable ages of these three vaccines were all from 9 to 26 when they were first approved. It was not until last October that the indications of the 9-valent HPV vaccine were revised after an average 3.5-year follow-up study targeting 3,200 women aged 27-45. The US FDA approved the application of the 9-valent HPV vaccine to expand the age adaptation range.
At present, there is not enough clinical trial data in China to prove that people who are vaccinated with nine-valent HPV vaccine over 26 years old can get the same protective effect as the recommended vaccination age. In Hu Shangying and Qiao Youlin’s aforementioned papers, it is also emphasized that the protective effect of vaccines on older women is lower than that of younger women.
On April 28th, 2018, National Medical Products Administration conditionally approved the marketing of nine-valent HPV vaccine for preventing cervical cancer. Unlike bivalent and tetravalent HPV vaccines, the nine-valent HPV vaccine is conditionally approved.
Why is it conditionally approved? The nine-valent HPV vaccine is based on the approved data of the previous four-valent HPV vaccine, and it can conditionally accept overseas clinical trial data and bridge with overseas clinical data. Therefore, it is possible to conditionally approve the import registration of products in the shortest time.
Among the foreign clinical trials presented in the China instructions of tetravalent HPV vaccine, there is only one phase III trial aimed at the age group of 27-45, and the result is that "the effectiveness of this product in preventing CIN2/3 (cervical precancerous lesion), AIS (adenocarcinoma in situ) or cervical cancer related to HPV16 and 18 in women aged 27-45 has not been confirmed yet".
The intermediary chaos caused by huge demand
As a group of older women with more purchasing power and spending power, the irrational consumption demand for nine-valent HPV vaccine has also spawned intermediary industries such as "vaccination travel" and overseas vaccination.
Tourism websites and medical intermediary companies have launched nine-valent HPV vaccination services in neighboring countries and regions such as South Korea, Singapore, China and Hongkong.
In Hong Kong, the upsurge of HPV vaccination due to the "star effect" has also driven the consumption enthusiasm of some mainland women.
As early as November 2006, HPV vaccine was approved to be listed in Hong Kong. At the initial stage of listing, public acceptance was not high. According to the data of the Hong Kong Institute of Pharmacists, from November 2006 to 2014, only about 8.85% of women were vaccinated. This situation was reversed in 2015. In 2015, the HPV vaccine subsidy scheme in Hong Kong was fully launched, and eligible people could enjoy the subsidy price as low as HK$ 1,400 per person, with the subsidy rate exceeding 60%.
Hongkong also invited many stars to "help out", and G.E.M., Charlene Choi, Ekin Cheng and other stars participated in the production of public service advertisements for many times.
Substantial subsidies and celebrity endorsements and publicity have not only greatly increased the number of local vaccinators, but also attracted a large number of mainland women. However, public hospitals in Hong Kong are closed to mainlanders, and this huge consumer group is targeted by many private clinics and intermediaries.
In the qualified regular vaccination sites in China, age is a threshold, which blocks this part of the population over 26 years old. Moreover, before the nine-valent HPV vaccine is officially approved in Chinese mainland, it can only be inoculated abroad to get a wider range of titer protection.
An endless stream of cross-border vaccinators even once "stopped supplying" the nine-valent HPV vaccine in Hong Kong.
The Paper previously reported that from October 12 to December 1, 2017, Merck had directly suspended the supply of nine-valent HPV vaccine in major clinics in Hong Kong, and a large number of mainland consumers who went to Hong Kong for vaccination had disputes with vaccination institutions because of "broken needles".
After the unprecedented shortage, the risks of intermediary soliciting customers out of order, no contract documents and difficulties in safeguarding rights are exposed.
The age limit is not a problem in many intermediaries. An intermediary who went to Hong Kong to vaccinate the nine-valent HPV vaccine introduced to The Paper: "(Women) can fight if they have menstruation."
This chaos is also reflected in the incident of "suspected vaccination of fake nine-valent HPV vaccine" in Yinfeng Hospital.
The Paper interviewed 36 female vaccinators in this incident. According to the story, most of the 36 vaccinators were between 20 and 40 years old, and one of them was 49 years old at the time of vaccination. They all recommended each other through acquaintances, paid Wang Lina, who claimed to be the medical staff of Yinfeng Hospital, 900 yuan as the vaccination deposit in advance, and then swiped the card at the involved hospital or transferred 8,100 yuan online, paying a total of 9,000 yuan for the vaccination of this batch of nine-valent HPV vaccines.
"9000 yuan should be a random charge." Wang Yuedan said that according to the pricing of domestic nine-valent HPV vaccine, the current price of nine-valent HPV vaccine in the mainland is about 1,300 yuan/needle, and the price of completing three needles is less than 4,000 yuan.
In addition to the high premium, there are other risks in vaccination through informal channels in China.
According to Hong Kong Ta Kung Pao’s report on April 29th, doctors with unhealthy clinics in Hong Kong, in order to make huge profits, used the genuine nine-valent HPV vaccine produced by Merck Pharmaceutical Factory in the United States to attract mainland customers, and then replaced the genuine nine-valent HPV vaccine with parallel vaccines of unknown origin to vaccinate the guests.
"Which institution’s medical staff can fight (over age) means that it is in violation of regulations. If the institution can violate regulations in this place, it may also violate regulations in other links." Liu Fangxun, deputy chief physician of the Special Needs International Medical Department of Peking University International Hospital, told The Paper that vaccine management and cold chain transportation are closely linked in China, which is closely related to the quality and safety of vaccines. Inoculators should choose regular inoculation institutions.
Many places have seized HPV vaccine smuggling.
In the case of Yinfeng Hospital’s "suspected illegal inoculation of fake vaccines", the source of these nine-valent HPV vaccines became questionable. Victims who had been vaccinated before said, "The vaccines injected in this batch include unknown potions produced by a factory in Siping, Jilin, and smuggled vaccines."
At present, Suzhou police have filed a case for investigation. However, the source of the vaccine that is of concern to the outside world has not been disclosed yet.
The Paper previously reported that hundreds of people were involved in the vaccine case of Yinfeng Hospital, which was designated by the Ministry of Public Security to supervise the case. Yinfeng Hospital and Qingdao Meibomen House Beauty Information Consulting Co., Ltd. were just one link.
According to public reports, cases of illegal entry of "HPV vaccine" have been seized in Shenzhen, Xiamen, Yantai and other places.
In May 2017, the airport office of Yantai Inspection and Quarantine Bureau intercepted a number of illegally brought HPV vaccines in the luggage carried by inbound passengers from Taiwan Province.
In September 2017, Zhuhai Gongbei Customs officers intercepted two men at the "no declaration channel" at the entry site of Gongbei Port, and found that their suitcases contained a large number of nine-valent vaccines for cervical cancer. This batch of vaccines is placed in three blue heat preservation bags and a transparent sealed bag, some of which are completely boxed and some are in bulk. It is understood that there are more than 220 vaccines in this batch, equivalent to about 130,000 yuan. The passenger concerned failed to provide the vaccine-related approval.
In December 2017, the inspection and quarantine staff of Xiamen Airport Inspection and Quarantine Bureau intercepted 201 illegally brought HPV vaccines from the luggage of passengers entering Malaysia.
In March 2018, the staff of Shenzhen Huanggang Inspection and Quarantine Bureau seized a group of 45 boxes of nine-valent cervical cancer vaccines brought by passengers at Futian Port, a large number. On-the-spot inspection found that the vaccines were only wrapped in simple plastic bags and packed in backpacks, and no low-temperature cold chain transportation measures were taken, which was easy to degenerate and fail. The passenger said that the vaccine was brought into the country to help people, and it was impossible to explain the source of the vaccine and failed to provide relevant quarantine approval certificates.
In November 2018, Xiamen Customs, affiliated to the Airport Customs, intercepted 201 illegally brought HPV (human papillomavirus) vaccines from the luggage of Malaysian inbound passengers, including 150 tetravalent vaccines and 51 nonavalent vaccines. Passengers failed to declare voluntarily and could not provide relevant quarantine certificates.
According to the current drug administration law, smuggled vaccines belong to the category of counterfeit drugs.
Lawyer Yin Qingli of Beijing Ross Law Firm analyzed that according to Article 39 of China’s Drug Administration Law, if the vaccine comes from abroad, no matter whether it is true or not abroad, as long as there is no import procedure, it can be identified as the scope of counterfeit drugs.
In an interview with The Paper, Yin Qingli said that if the "Yinfeng Hospital case" was related to companies and individuals who directly and intentionally violated customs regulations, evaded customs supervision, and transported the vaccines involved in the case in various ways or evaded customs duties, it was not in the form of purchasing by overseas citizens, and there was no special crime of smuggling vaccines and drugs in China, the related companies and individuals might be suspected of committing smuggling in the ordinary sense. If the vaccine in this case is brought to China by an individual through overseas purchasing and used clinically, the so-called overseas purchasing individual should be suspected of selling counterfeit drugs.
"Because of the serious harm of counterfeit drugs, on the one hand, it endangers people’s health and life, on the other hand, it also harms the national drug supervision system and market order, so the criminal law makes such a provision. "Yin Qingli explained to The Paper that it is not difficult to see from the above provisions that the crime of producing and selling counterfeit drugs is an act of crime, that is, whether the act of producing and selling counterfeit drugs causes harm to health or not constitutes this crime.
Regarding the grey areas where the revised Vaccine Management Law is concerned about whether it can effectively manage vaccine smuggling, a professional who has been engaged in the research of laws and policies related to drug management for a long time told The Paper that in principle, there are special provisions to follow the Vaccine Law, and no provisions are based on the Drug Management Law. "The draft vaccine law has not specifically stipulated the smuggling of vaccines. These incidents will test the integrity of the law." The above personnel said.