"Chinese Vaccine" Goes Out Of The Country: WHO Pre Certification Dongfeng Help "Along The Road" Along The Disease Prevention And Control

The "one belt and one way" public health cooperation is accelerating.

On the last day of 2019, the State Food and Drug Administration announced that it had approved the first domestic HPV vaccine (Xiamen Wan Tai Hai Hai bio) and the first domestic 13 valent pneumonia combined vaccine (Yunnan Watson Biology) registration application. In the future, two heavy domestic vaccines will appear in the Chinese vaccine market.

It is understood that in the next three years, domestic vaccines will also be listed in batches including diploid rabies vaccine, EC reagent and tuberculosis vaccine. In the industry view, China is not only the world's largest vaccine producer, but also the vaccine industry will usher in high-quality development. Feng Zijian, deputy director of the China Center for disease control, pointed out that China has gained huge benefits from immune prevention, and the Chinese government has the will and responsibility to help other countries.

At present, some vaccine products in our country have entered the list of international purchase and exported to the countries along the belt. In December 1, 2019, the formal implementation of the vaccine law also encouraged vaccine manufacturers to produce and export vaccines according to international procurement requirements.

At the same time, China's vaccine national regulatory system will be evaluated by WHO (WHO) for the third time in March 2021. At present, more than 20 vaccine products in China are or are intending to declare pre certification of WHO vaccine products, which means that more domestic vaccines will be exported to many countries including "one belt and one road" along the way.

In response, a North vaccine manufacturer told the twenty-first Century economic report that the declaration of WHO vaccine product pre certification means that the possibility of entering the WHO procurement list could be followed, but it does not mean that all products can be peataged. It needs to see the market demand (supply relationship) and brand influence.

The largest vaccine producer in the world

Vaccines are the most economical and effective means to prevent and control infectious diseases, and their findings profoundly affect the development of human society.

The effective social cost of effective prevention is far lower than that of disease treatment. The development and application of vaccines are considered to be one of the high rate of investment. According to data from the US Centers for Disease Control and Prevention (CDC), considering the cost of treatment and the decline of productivity in the United States, the annual cost of newborn immunization in the United States can directly save nearly $13 billion 500 million per year, saving the total social cost of $70 billion by 4 million. If the cost-benefit ratio (CBR) is used to accurately measure the economic value of the vaccine, the CBR of the vaccine industry can reach 1:16-44, that is, investment of 1 yuan, and the benefit of 16-44 yuan can be obtained.

Watson bio pointed out that the vaccine has already entered the era of big products worldwide. In the past two years, with the approval of large vaccine varieties, China has entered the era of big products. The volume of EV71 vaccine, the sale of HPV vaccine and the volume of domestic vaccine have made the domestic vaccine market expand rapidly. China has surpassed Japan to become the second largest vaccine market in the world after the United States.

At present, there are more than 40 vaccine manufacturers in China. It can produce 63 kinds of vaccines, prevent 34 kinds of infectious diseases, and produce more than 1 billion doses a year. It is one of the few countries in the world that can rely on their own ability to solve all the planned immunization vaccines. In 2018, the total number of vaccines issued in the country was about 539 million. Among them, the total number of vaccines issued by the two categories was about 208 million doses.

Guoxin Securities research report pointed out that with the continuous listing of large varieties in recent years, China's market is approaching from a high homogeneity, poor competition pattern and low price mode to a high price and large variety of overseas market models.

In the next three years, domestic vaccines will also be listed in batches including diploid rabies vaccine, EC reagent and tuberculosis vaccine. In the view of the industry, China is not only the largest vaccine producer in the world, but also the vaccine industry will have a high quality development.

Guarding World Health: encouraging exports along the "one belt" road

Feng Zijian, deputy director of the China Center for disease control, pointed out that China has gained huge benefits from immune prevention, and the Chinese government has the will and responsibility to help other countries.

The "Beijing area" health cooperation and the "healthy Silk Road" communique of China said that China will establish an "open belt" health policy research network with an open attitude and in accordance with the principle of mutual learning and mutual benefit and win win. It will promote the monitoring, prevention and control of major communicable diseases, coordination and cooperation in health emergencies, and the establishment of a "one belt, one road" public health cooperation network.

In the view of Lawrence Rodewald, director of vaccine project at WHO representative office in China, the coverage of vaccines in the "one belt and one way" public health cooperation is a major positive for the global health service. The global vaccine action plan launched by WHO aims to increase the supply of vaccine manufacturers and reduce the mortality of children under 5 years of age.

At the news conference of the Standing Committee of the National People's Congress held in June 29, 2019, Jiao Hong, director of the State Administration of drug control, said that at present, some of the vaccine products in China have entered the list of international procurement, and have been exported to the countries along the belt, which have contributed to the health of the people of the world.

In 2017, WHO and Nepal health departments assessed the effect of vaccines imported from China. The results showed that the incidence of Japanese encephalitis in Nepal fell by 80%. With the proposal of the "one belt and one way" initiative, China and the countries along the "along the way" have more cooperation and contacts in the field of medicine and health. At present, the Japanese encephalitis vaccine from Chengdu has also been exported to 11 countries, reaching tens of millions of times a year.

It is also understood that many enterprises in China are making contributions to the immunization plan. For example, in December 2018, the National Institutes of health in Pakistan began the production of measles vaccine after nearly 7 years of interruption. The concentration of the vaccine is coming from Beijing min Hai Biotechnology Co., Ltd., a wholly owned subsidiary of Shenzhen biological products Limited by Share Ltd, Shenzhen. This is the first time that China has exported measles vaccine concentrate to Pakistan.

In 2018, Watson bio subsidiary Yuxi Watson obtained the import approval and corresponding purchase order of the 7 million 800 thousand dose AC polysaccharide vaccine issued by the Ministry of health of Egypt. Yuxi Watson said that the supply had been completed according to the order.

In 2019, the Ministry of health of Egypt added the purchase orders of 7 million 200 thousand doses of AC polysaccharide vaccine to its expanded immunization programme in 2019. At the same time, it increased the import approvals and the corresponding purchase orders for 600 thousand doses of ACYW135 polysaccharide vaccine to Watson, Yuxi.

At the same time, vaccine related enterprises are also actively involved in the "one belt along the road" national immunization project support. For example, AUCMA, a cold chain enterprise, signed a contract with Global Good, a research and Development Organization launched by Bill Gate and Gao Zhi in 2013, to jointly develop and popularize vaccine cold chain equipment for developing countries. The two sides have developed a vaccine refrigeration equipment Arktek. Arktek can keep the vaccine at a suitable temperature for up to 35 days or longer without using ice, without any external energy such as batteries, solar energy or propane.

In October 2015, AUCMA and Global Good further deepened their cooperation, and the two sides developed second products, namely, Yuan refrigerator (Metafridge). The fridge can provide a stable refrigerating temperature under four hours of daily power supply to ensure the safety of the vaccine.

Arktek and Yuan refrigerators went through the PQS certification of WHO in January 2015 and November 2016. This means that Arktek and Yuan refrigerators have become the cold chain products approved by WHO, and AUCMA has also become a designated supplier of UN agencies.

In December 28, 2019, 1600 Arktek and 950 yuan refrigerators purchased by the Ministry of commerce were shipped to Pakistan for China's Pakistan vaccine refrigeration project. As of December 2019, plus the aid products for Pakistan, Arktek and Yuan refrigerators have deployed more than 3000 units in Nigeria, India, Senegal, Kenya, Haiti, Afghanistan, Mali, Nepal, Guinea, South Sultan, Burma, Turkey, Congo gold, and Turkey.

"Along the road" along the line of vaccine demand is huge.

However, so far, the export volume of Chinese vaccines is not large.

From twenty-first Century to 2018, China's vaccine exports totaled 272 million US dollars, and the export volume from 2014 to 2018 was 38 million US dollars, 46 million US dollars, 58 million US dollars, 56 million US dollars and 74 million US dollars, respectively, from the 2014 2014 to 2018.

Another part of the Chinese Medical Insurance Association, including human vaccine data, showed that in 2018, the total amount of human vaccines exported to China was $122 million in 2018, and the amount in Asia amounted to US $63 million, ASEAN $19 million, Middle East 22 million US dollars, Africa $17 million, Europe $41 million. Most of the domestic vaccines exported to France, India, Egypt and Thailand were exported to US $40 million and US $22 million respectively, and Egypt and Thailand both amounted to US $12 million. Many other countries along the belt and road have only exported 1 million to 2 million dollars or less.

Wang Maochun, vice president of the Chinese Medical Insurance Association, told the twenty-first Century economic analysis reporter that the global vaccine market is mainly composed of GlaxoSmithKline, Mercedes, Pfizer and Sanofi. For the emerging market vaccine manufacturers, the low cost traditional vaccines are still the main market space to meet the national planned immunization of their country and other developing countries, and at the same time, the highly internationalized producers are gradually entering the mature markets such as Europe and America.

At present, there are two sources of large export orders for vaccine products in China. One is the direct purchase by governments of various countries, and the other two is the United Nations Children's fund and other agencies that are transported to help countries after they are procure.

In fact, there are huge demand for vaccines in developing countries, including many countries along the belt. Seth Bokely, chief executive of GAVI (global vaccine immunization alliance), said in an interview with the media that many vaccine varieties were in short supply. In order to ensure supply, more Chinese enterprises were expected to go abroad.

Wang Maochun pointed out that vaccine demand in developing countries accounted for 80% of the total global vaccine demand. Among them, the United Nations Children's Fund (UNICEF) accounted for about 40% of the total demand of developing countries.

WHO pre certification helps export volume of domestic vaccines

If China's vaccine industry wants to go abroad and enter more countries and regions along the belt, WHO pre certification will be an important threshold.

WHO pre certification is the United Nations action plan launched in 2001 to expand the choice of priority drug varieties. The goal is to ensure the quality, efficacy and safety of the International Fund for the procurement of medicines, and to serve patients in developing countries.

Tang Yi, a project representative of WHO's representative office in China who expanded the immunization program, pointed out that the pre certification by WHO means that WHO is authorized to recognize the safety and efficacy of the drug and vaccine. The United Nations procurement agency can include this drug and vaccine in its purchasing catalogue.

It is understood that in 2011 and 2014, China's relevant institutions have passed two assessments in a row. 4 vaccine products have been pre approved by WHO vaccine products and entered the international procurement list, which has been exported to more than ten countries and regions. Before 2011, when the State Food and Drug Administration had not yet passed the WHO vaccine regulatory system assessment, China's vaccine had not yet stepped out of the country, and even had no qualifying for WHO pre certification.

In October 2013, the live attenuated Japanese encephalitis vaccine produced by the Chengdu company under the Chinese biochip became the first Chinese vaccine approved by WHO. Zhang Lei, manager of the medical affairs department of Chengdu Biological Products Research Institute Co., Ltd., in an interview with the media, said that the Institute has spent nearly seven years in 2006 and invested nearly 800 million yuan. The factory facilities, including the Japanese encephalitis vaccine production workshop, SPF animal production workshop and other international standards, have been built. In 2013, the Chengdu encephalitis vaccine was approved by who. This is the first time that China's self-developed vaccine has been pre approved by WHO, which is of great significance for China to join the global vaccine supply chain. From 2014, eligible countries can apply to GAVI for funding the purchase of JE vaccine produced in China.

In June 2015, the influenza vaccine produced by Hua Lan bio was approved by WHO.

In December 2017, the oral two valent poliomyelitis attenuated live vaccine produced by China biotech Limited by Share Ltd Beijing beinsheng Biological Products Co., Ltd. was pre certified by WHO. The Inactivated Hepatitis A Vaccine "Kexi Lai Fu", which was independently developed by Beijing Kexing Biological Products Co., Ltd., was approved by WHO.

Watson, a biological director, told the twenty-first Century economic report that the vaccine approved by WHO can be imported into some international organizations. Many countries also recognize that some countries have some product registration procedures.

Wang Maochun pointed out that the purchase list of the United Nations agencies, international non-profit organizations and non-governmental organizations is an important channel for Chinese vaccines to enter the international market.

Zhang Lei pointed out that more and more Chinese vaccines have passed the pre certification of WHO vaccine products, and have entered the market along the "one belt and one way" market, which bears an important responsibility in the development cooperation between China and the countries and regions along the "one belt and one road".

Not long ago, in November 7, 2019, Shanghai Ze run Biotechnology Co., Ltd. ("Shanghai Ze run") signed the "9 price HPV vaccine development assistance agreement" with the Bill and Melinda Gates foundation. Shanghai Ze Ran has obtained the foundation's 2 million 500 thousand US project fund to accelerate the clinical research and industrialization progress of the "9 valent HPV vaccine", and to prepare for the "WHO pre certification" to supply bulk purchase of international organizations and supply the vaccine to low-income countries with low income from international organizations in order to improve their health status.

(Intern Liu Zhixi contributed to this article).