How to break the situation of shortage of HPV vaccine in Shenzhen?

 How to break the situation of shortage of HPV vaccine in Shenzhen?

On August 25, the Shenzhen Center for Disease Control and prevention held the lottery for the nine price HPV vaccine in the same month, which was also the 14th lottery for Jiang Yao in recent two years, but she still failed to win the lottery. Next year, Jiang Yaos age will reach the 26 year old red line, and the number of times she can participate in the lottery of the nine price HPV vaccine will also start the countdown.

On the 25th, a staff member of the Immunization Planning Institute of Shenzhen CDC revealed that in August, there were 222951 applications for the nine price HPV vaccine, slightly less than the number of nearly 240000 applicants in the previous phase. However, the number of people who won the lottery in this phase increased by 1000 compared with the previous period, with the largest number of historical sources, with a total of 5761 places.

However, according to the above data, the winning rate of the lottery is still only 2.58%.

The World Health Organization estimates that there are more than 470000 new cases of cervical cancer in the world every year, and the number of new cases of cervical cancer in China accounts for about 28% of the total number of cases in the world. Due to the discovery of the relationship between HPV and the etiology of cervical cancer, cervical cancer has become a clear cause of cancer, which also makes the majority of women have a great fear of HPV infection.

As the first line of defense for disease prevention, HPV vaccine has been widely used in the world. In 2016, 2017 and 2018, bivalent, tetravalent and 9valent HPV vaccines were introduced in China. However, due to the large demand and limited production in China, HPV vaccine, especially the nine valent vaccine, is facing a difficult situation.

Vacillating nine valent HPV vaccine

On the afternoon of August 25, Shi Li received a winning lot message from Shenzhen Health Commission, which means that she has obtained the qualification of appointment for nine price HPV vaccine. Shi Li told reporters at first finance and economics that this is the best news she has received this year. On the same day, Shi Li made a reservation for the vaccine near home in the Yaohao system of the WeChat public official account of the Shenzhen Health Protection Committee.

Shenzhen Longhua District shangtangdao Community Health Service Center (hereinafter referred to as social health center) vaccine inoculation point of medical staff, Ms. Chen told reporters that the probability of winning the lottery of nine price HPV vaccine is too low. On the contrary, the quadruple price HPV vaccine is still available in the social health center where it is located. She is making an appointment and can be vaccinated the next day.

Ms. Chen also understands that, after all, the prophylactic effect of the nine valent HPV vaccine is the best at present.

Bivalent vaccines are mainly targeted at HPV 16 and 18; bivalent vaccines are targeted at HPV 6, 11, 16 and 18; bivalent vaccines are targeted at HPV 6, 11, 16, 18, 31, 33, 45, 52 and 58. HPV 16 and HPV 18 belong to two high-risk viruses. More than 80% of cervical cancer in Chinese population is caused by these two viruses.

Tao Lina, a vaccine expert, told the first finance and economics reporter that currently, in terms of the prevention of cervical cancer, the divalent and tetravalent HPV vaccines can theoretically achieve 84% of the prevention rate, and the nine valent vaccine can achieve 92% of the prevention rate, a difference of 8% between the two, but at the same time the price is also very different, so these vaccines have their own advantages.

According to the Shenzhen Health Commission, the current nine price HPV vaccine needs to be paid at its own expense. The price is 1323 yuan per dose (including 1298 yuan of vaccine fee and 25 yuan of vaccination service fee). The whole course of vaccination is 3 doses, with a total of 3969 yuan. However, the price of bivalent HPV vaccine is 605 yuan per dose and 1815 yuan for three doses; the price of tetravalent HPV vaccine is 823 yuan per dose, with a total of 2469 yuan for three doses. Bivalent and tetravalent HPV vaccines can be used for medical insurance.

It is reported that at present, a total of three enterprises have approved the listing of HPV vaccines in the world, including four and nine valent vaccines from MSD of the United States, bivalent vaccines of GSK and domestic bivalent vaccines of Wantai Canghai in Xiamen.

That is to say, at present, there is only one manufacturer of four and nine valent vaccines in the world.

For those who have not yet received the HPV vaccine, the Shenzhen Health Commission has indicated that both bivalent and tetravalent HPV vaccines can prevent more than 70% of cervical cancer, and the quadruple valent HPV vaccine can also prevent more than 90% of genital warts. At the same time, even the nine valent vaccine can not 100% prevent cervical cancer, so no matter how many vaccines are vaccinated, cervical cancer screening should be carried out regularly, including HPV test and cytology test.

Can domestic HPV vaccine break through the market?

In China, the vaccination age of domestic and imported bivalent HPV vaccine is 9-45 years old, that of imported HPV vaccine is 20-45 years old, and that of imported HPV vaccine with nine price is 16-26 years old. According to the age range of 9 to 45 years old, the number of women of suitable age for HPV vaccine in China may exceed 300 million to 400 million.

According to the data of China Academy of Commerce and industry, the number of HPV vaccines issued by CFDA in 2017 was 1.46 million, 7.13 million in 2018 and 10.8754 million in 2019. According to the vaccination program of three injections per person, the supply of these vaccines is far from meeting the actual demand.

According to the data of China Thailand securities, HPV vaccine has become the first vaccine category with sales of more than 10 billion yuan in China in 2019. In 2019, about 10.88 million copies of HPV vaccine will be issued in batches. According to the bidding price of the three main varieties, the total market value will exceed 10 billion yuan. Among them, there were 2.01 million copies of GlaxoSmithKline bivalent vaccine, 5.54 million pieces of mosartan tetravalent vaccine, and 3.32 million pieces of mosartan nine valent vaccine.

Tao Lina said that the main reason for the popularity of the nine price HPV vaccine is the great global demand for such vaccine. In particular, many countries have included the vaccine as a free vaccine, requiring more than 80% of its residents to be vaccinated. At present, the production capacity of the producers is limited, so the supply is in short supply.

On December 31, 2019, the State Drug Administration announced that it had approved the application for bivalent human papillomavirus vaccine (E.coli) (trade name: Xinkening) of Xiamen Wantai Canghai Biotechnology Co., Ltd. (hereinafter referred to as Wantai company), with the price of 329 yuan / piece, which is applicable to women aged 9-45 years. Among them, women aged 9-14 years only need to be vaccinated with 2 injections, while women aged 15-45 years need to be vaccinated 3 stitches.

It is reported that the vaccine is the first domestic cervical cancer vaccine jointly developed by Wantai company and Xiamen University and transformed by Wantai company, which means that Chinas cervical cancer vaccine has ended its history of relying on import only.

In the middle and late April, Wantai company announced that the first batch of Xinkening was 93643, which had obtained the approval certificate of biological products issued by the State Food and drug administration, and Xinkening officially entered the market.

It is worth mentioning that other domestic enterprises are also focusing on the development of cervical cancer vaccine, such as Watson biological (300142. SZ). On June 15, Watson bio announced that the bivalent cervical cancer vaccine independently developed by Shanghai Zerun Biotechnology Co., Ltd., its holding subsidiary, submitted a production application to the State Food and Drug Administration and was accepted. In April this year, the phase III clinical study of the vaccine was completed and the clinical trial report was obtained.

Can the research and development of domestic HPV vaccine alleviate the domestic demand for this kind of vaccine?

As far as I know, the domestic bivalent HPV vaccine has performed well in the market, and is quite popular. The competitiveness of domestic HPV vaccine should not be worse than that of imported vaccine in the future, or even better, said Tao Lina. Because the domestic medical team has a better understanding of the needs of the Chinese market, and it has more advantages in terms of price. In addition, domestic HPV vaccine manufacturers may cooperate with local governments in the future to reduce the cost of HPV vaccination for local people, and even provide them free of charge. However, when imported vaccines enter China, they are not so flexible.

The launch of domestic bivalent cervical cancer vaccine has a milestone significance, but from a purely technical point of view, this domestic vaccine can only be regarded as moderate, and there is no special bright spot. Tao Lina believes that at present, more people in the market are still more interested in the nine valent HPV vaccine, and it will take time for this kind of vaccine to make a breakthrough and increase the supply.

(Jiang Yao and Shi Li are pseudonyms)

Author: Huang Qiong

Source: Qiao JunJing, editor in charge of first finance and Economics_ NBJ11279