China’s novel coronavirus vaccine production starts cdmo mode to help fill the global demand gap

In Israel, the country with the highest vaccination rate of novel coronavirus vaccine in the world, the number of confirmed cases of novel coronavirus vaccine dropped sharply, which also confirmed the fact that the current novel coronavirus vaccine can block the novel coronavirus virus

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But the problem is that the global supply of new vaccines is difficult to meet the demand

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A novel coronavirus pneumonia vaccine market scale and scale is released according to the global health innovation center of Duke University

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With the estimated dose of 2 doses per person, 11 billion doses of the novel coronavirus vaccine will be needed to achieve 70% of the world’s population vaccination and reach the threshold of group immunity

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As a result, vaccine production worldwide “needs to expand on an unprecedented scale.”

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On April 29, Zhang Yuntao, vice president of Sinopharm China biology, said at the joint prevention and control press conference of the State Council that in order to further guarantee the supply of novel coronavirus vaccine, Sinopharm China biology Co., Ltd

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has made overall arrangement of domestic resources to expand the production capacity of original solution of novel coronavirus vaccine and the ability of preparation subpackaging

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At present, Sinopharm China biology is making use of its affiliated Changchun, Lanzhou, Chengdu Shanghai and other research institutes of biological products will expand the production capacity of novel coronavirus vaccines by increasing their packaging capacity

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This also means that China’s domestic vaccines have launched the cdmo (full contract customized development and production) mode to effectively expand production capacity

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The World Health Organization believes that insufficient supply and uneven distribution of vaccines are still the biggest threat to ending the most serious stage of the pandemic and promoting global recovery

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As long as the virus continues to spread anywhere, trade and travel will continue to be disrupted, economic recovery will be further hampered, and continued transmission also means that more variants of the vaccine may escape

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At a press conference held in Geneva on April 9, who director general Tam Desai said that in the first 100 days of this year, the world received 700 million doses of the vaccine, but 87% of them were concentrated in rich countries

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Of the 220 countries and economies in the world, 194 have started vaccination, and 26 have not

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According to public statistics, in the current global distribution of novel coronavirus vaccine, nearly one out of four people in high-income countries is vaccinated

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But in low-income countries, only one in 500 people is vaccinated

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The novel coronavirus vaccine access mechanism, which is committed to the equitable distribution of vaccines around the world, had expected to distribute nearly 100 million doses of vaccines by the end of March

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However, due to the significant reduction in supply, only 38 million doses have been distributed at present

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On April 25, at the Baida Zhougudui agricultural products wholesale market in Hefei City, Anhui Province, merchants vaccinated at the temporary vaccination point specially set up in the market

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Xinhua News Agency Photo

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In order to increase the production of Xinguan inactivated vaccine, China’s Xinguan vaccine enterprises are looking for resources to expand production while increasing their own production capacity“ According to the provisions of the marketing license holder system, Beijing Institute of biological products has entrusted Lanzhou Institute of biological products, Chengdu Institute of biological products, Changchun Institute of biological products and other enterprises to undertake the sub packaging task of Beijing Institute of biological products Xinguan vaccine preparation, which is also in line with international practice

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” Zhang Yuntao said

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Cdmo is a kind of outsourcing service of drug R & D and production, which is widely used in the production of small molecule drugs and biological drugs

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However, before that, the production mode of cdmo has not been started in China’s vaccine field

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The cdmo model of vaccine, first of all, is vaccine research and development, and enterprises carry out vaccine design and early research and development

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They can produce the vaccine themselves and entrust cdmo enterprises to carry out clinical production in the preclinical and clinical production stages, and then the person in charge of vaccine marketing license shall register and declare the vaccine

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After the registration and approval of vaccine production, marketing licensors can entrust part or all of the production capacity to vaccine cdmo enterprises

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The traditional vaccine production mode is that vaccine marketing licensors have to undertake all the work from vaccine research and development to plant construction, process validation, vaccine marketing registration to production and quality management, and continuous improvement of process and quality

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Only the vaccine enterprises with strong strength can undertake the heavy task from R & D to production, and even the vaccine giant enterprises have the problem of insufficient power in the supply of high-quality and low-cost vaccines

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Once the emergency situation occurs, it is difficult to fully meet the global demand for vaccines in time“ Its disadvantage is that innovative vaccine R & D enterprises generally have insufficient production capacity or production quality management ability, which eventually leads to that only powerful vaccine enterprises can undertake the heavy responsibility of the whole value chain

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Under this COVID-19, you can also see that vaccine licensees are unable to meet the global demand for vaccines in a timely and adequate manner

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Dong Jian, senior vice president of YaoMing biology, said

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But cdmo model can achieve the rapid expansion of production“ As far as we know, vaccine cdmo enterprises have provided more than half of the production capacity of the novel coronavirus vaccine approved by foreign countries, which has made a very important contribution to the global epidemic prevention and control

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For example, Pfizer, AstraZeneca and other vaccines are all provided by cdmo

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The capacity of other companies is provided by cdmo to varying degrees

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” Dong Jian

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Once China’s novel coronavirus vaccine enters the cdmo mode, it is expected to become an important vaccine supply force in the world

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It will also help to change the problems of insufficient supply and unfair distribution of novel coronavirus vaccine, and it will be possible to block the novel coronavirus virus.

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According to public statistics, the total capacity plan of the world’s top suppliers of new vaccines is about 8.9 billion doses

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Among them, the potential annual planned capacity of moderna2021 is expected to be 600 million doses; The planned capacity set by biontech and Pfizer is 2 billion doses; Sinopharm novel coronavirus vaccine can reach 1 billion, Kexing Zhongwei has an annual production capacity of 2 billion, and Zhifei biological novel coronavirus vaccine has an annual production capacity of 300 million doses

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The supply of novel coronavirus vaccine was further affected by the suspension of AstraZeneca and Johnson & Johnson vaccines in many countries around the world due to thrombosis or death after vaccination

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According to public data, AstraZeneca has signed a contract volume of 1.4549 billion doses, involving 15 purchasing countries (entities); At present, Johnson & Johnson has signed a contract volume of 1.1 billion doses, involving three purchasing countries (entities)

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The supply gap undoubtedly gives Chinese vaccine enterprises the opportunity to go out

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Novel coronavirus pneumonia outbreak has been carried out by China’s vaccine enterprises in the whole process, including cooperation in epidemiological research, research and development of vaccines, cooperation in clinical trials, product sales agency cooperation, production cooperation, and bioactive materials to the countries concerned, and the construction of vaccine production lines abroad with multinational cooperation

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In the vaccination process, we cooperated with other countries to track the immunization effect and provide service cooperation in the analysis and disposal of vaccination reaction

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All this has laid a foundation for the overseas market of China’s novel coronavirus vaccine enterprises

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According to Yang Guang, general manager of Kexing holding (Hong Kong) Co., Ltd., international cooperation has also accelerated the localization of production and supply of Klebsiella vaccine

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Since 2020, Kexing Xinguan vaccine has passed GMP certification in China, Indonesia, Brazil, Chile and Halal certification in Indonesia

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In addition, the phase III clinical trials carried out by Chinese novel coronavirus vaccine companies abroad are more conducive to promoting the cdmo model

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For example, before novel coronavirus pneumonia outbreak, there were few vaccine companies overseas clinical trials except Conchino’s Ebola virus vaccine

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Now, China has carried out clinical trials of several vaccines in the United Arab Emirates, Brazil, Pakistan, Peru and other countries.

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