Global New Crown Vaccine Race To Enter The Second Half: Production Capacity Competition

With the increasing number of new coronal vaccines that have completed the third phase of clinical trials, the global vaccine competition has entered the second stage: large capacity competition.

Vaccine from R & D to industrialization needs to go through five stages, including research and development stage, registration stage, production stage, circulation stage and use stage. With the approach of 2021, a number of new crown vaccine products which are in the forefront of global research and development will be granted emergency use authorization or approval, and China's new crown vaccine is about to enter the harvest period, and the next stage of vaccine mass production will become an important part of the competition against the virus.

Bernstein analysts predict that in the covid-19 vaccine development track, the top five companies will have sales of $38 billion next year, and the first listed companies will account for more than 50%. Analysts predict that Pfizer will reach $14.3 billion in covid-19 vaccine sales next year, followed by Moderna's $10.9 billion, AstraZeneca's $6.4 billion, Novavax's $3.9 billion and Johnson & Johnson's $3.0 billion.

The analyst team forecasts that the total sales of covid-19 vaccine will reach US $23.1 billion by 2022, US $12.6 billion by 2023 and US $8.5 billion by 2024. Assuming that vaccination needs to be strengthened every three years, the market for new vaccines will shrink to about 6 billion US dollars by 2025.

According to the calculation of the number of orders, the penetration rates of the United States, the United Kingdom, the union of four European countries and Japan are 100%, 100%, 65% and 100%, respectively. Considering that China's epidemic situation tends to be stable, but the global epidemic is still in the stage of pandemic and China is accompanied by regional recurrent outbreaks, the penetration rate of new coronal vaccine in China is generally assumed to be 6 The corresponding market size is about 84 billion yuan. According to China's new crown vaccine project in clinical trial stage, according to the existing design capacity limit of about 1.8 billion doses, which can meet the demand of 900 million people, and considering the time required for some enterprises to release production capacity, there is still a gap in the supply of new crown vaccine projects in domestic and developing countries in a short time.

Capacity upgrade accelerated

Under the huge market space and urgent market environment, new crown vaccine is bound to become the place that domestic and foreign major companies must compete for.

At the most concerned production capacity level, manufacturers under the five major vaccine technology routes are also accelerating the layout. "Inactivated vaccine", "recombinant genetic engineering vaccine", "adenovirus vector vaccine", "nucleic acid vaccine" (mRNA vaccine and DNA vaccine) and "attenuated influenza virus vaccine" are almost simultaneously developed.

So far, the progress of mRNA vaccine is the fastest in the world. The new crown vaccine product jointly developed by Germany's biontech Se and Pfizer has been used urgently in many European countries. In the Chinese market, byntact and Fosun Pharmaceutical have reached a cooperation, and it is expected to deliver the first batch of 1 million doses of new crown vaccine to Hong Kong in the first quarter of 2021.

In addition, Ugur Sahin, chief executive of Pfizer's partner baintyco, said this week that it was seeking various efforts to make next year's new crown vaccine production exceed the 1.3 billion doses previously promised. In an interview, Ugur Sahin said that by January or February next year, it may be known whether and how much production can be increased. "I believe we have the ability to expand capacity, but we don't have specific figures yet."

On December 21, the first domestic production workshop of new coronal mRNA vaccine was started in the vaccine Industrial Park of Yuxi high tech Zone, with an investment of 280 million yuan and a production capacity of 120 million doses per year in the first phase. It is expected to be put into use in August next year.

On December 16, Fosun Pharmaceutical Group and Germany's baintyco announced that they had reached an agreement on the supply and production of bnt162b2 in China. Once the vaccine was approved for marketing in China, the two sides expected to supply at least 100 million doses of bnt162b2 to China in 2021.

In addition, Yang Xiaoming, chairman of Sinopharm Group China Biotechnology Co., Ltd., once said that Sinopharm's new crown vaccine production capacity in Beijing and Wuhan workshops could reach 300 million doses / year. The construction of phase II workshop is expected to be completed by the end of the year, and the production capacity of new crown vaccine will reach 1 billion doses / year in 2021. The technical route of vaccine developed by CBI is inactivated vaccine. It is estimated that the production capacity of Kexing bio, which is also inactivated seedlings, will reach 100 million by the end of 2020, and 300 million per year thereafter.

On the technical route of adenovirus, Kangtai biological will soon build a production system with an annual output of 300 million. The second phase production system with an investment of 575 million yuan has a design capacity of 200 million pieces / year. Abroad. The gamaleya Research Institute, which is jointly produced by many countries, is in the third phase of clinical stage, with an annual output of 500 million vaccines / year. In addition, the production system under construction by Johnson & Johnson has a design capacity of 1 billion tubes / year; the Oxford University / AstraZeneca vaccine project has a design capacity of 3 billion tubes / year.

On the line of recombinant protein subunit, domestic Zhifei biology is in phase 2 clinical new crown vaccine design capacity of 300 million units / year.

Although the new coronavirus vaccine under various routes is still in the clinical stage, the fight against the new coronavirus has become a competition for speed. The leading role in the second half of vaccine race is to lay out production capacity in advance and solve the short-term gap.

The competition began in the second half

With the domestic and foreign new crown vaccine is about to be put into use, the second half of the production capacity and vaccination chain of all aspects of the layout competition also opened.

"At present, the production capacity gap of new crown vaccine will be very large, and domestic and foreign companies are accelerating the production of manufacturers. In the past, vaccine production has certain particularity and has a certain cycle lag. Generally, manufacturers will start production only after obtaining orders. Therefore, the pressure on production capacity will be relatively large, and there will be a certain period of submission of approval documents. At present, the new crown vaccine will be launched in the near future It must be in short supply. " A person from a vaccine industry in South China told the reporter of the 21st century economic report that "from the perspective of the supply of vaccine bottles which are widely discussed at present, the pressure will not be small. In the past, the supply of normal vaccine bottles is not sufficient. The surge in demand for new vaccines will inevitably bring about production pressure in the short term."

In fact, it is understood that in the vaccine production stage, vaccine enterprises complete the steps of production workshop construction, vaccine production and vaccine filling according to the approved vaccine technological process. The vaccine production workshop needs to be constructed in strict accordance with GMP standards, which has very high requirements for the construction subject; vaccine production involves the addition of fillers, culture media, adjuvants, trypsin and other raw materials; the vaccine filling mainly involves the use of medical consumables such as vaccine glass bottles, rubber plugs, pre filling syringes, etc., such as Xinguan vaccine developed by China Pharmaceutical Group, and the packaging form is pre filling syringe.

Take the production of new coronavirus inactivated vaccine as an example. The production of inactivated vaccine selects the chicken embryo of qualified age. After careful appearance inspection, inspection and disinfection, the chicken embryo is inoculated with new coronavirus, and then sent into the incubator with constant temperature. In the next few days, the virus will propagate in chicken embryo in large quantity; the chicken embryo full of virus will be sent to harvest after 12 to 18 hours of cold storage and cooling In the workshop, the head eggshell of chicken embryo was cut off, the probe was inserted into the chicken embryo accurately, and the liquid component in the chicken embryo was inhaled into the sealed container. Then the vaccine product is formed by inactivation, purification, ratio, filling and other steps.

After the production stage, the circulation stage mainly involves vaccine circulation enterprises and cold chain transportation equipment. In April 2016, the State Council adopted the decision of the State Council on Amending the regulations on the administration of vaccine circulation and vaccination, which stipulates that all procurement of vaccines should be included in the provincial public resources trading platform. The specific process is as follows: the city and county CDC will collect the demand and submit it to the provincial CDC. The CDC will organize the centralized procurement of the whole province through the platform, and determine the successful manufacturer, variety, specification and price. The production enterprises must complete the sales through the provincial trading platform, at the same time, they need to directly or entrust the logistics distribution enterprises to complete the vaccine distribution, and the whole process of cold chain transportation is required in the distribution process.

Vaccination is mainly completed in hospitals and centers for Disease Control and prevention, involving disposable syringes, cotton swabs and other small medical equipment and consumables.

The use stage of the vaccine belongs to phase IV clinical study, which can further investigate the efficacy and adverse reactions of the vaccine under the conditions of wide use; evaluate the relationship between the benefits and risks of the use of the vaccine in the general or special population; and improve the dosage. After the vaccination, the collection, transportation, disinfection and treatment of medical waste are the last step in the whole chain, transforming the medical waste into harmless residues and gases that meet the environmental protection standards.

In addition, the new crown vaccine industry chain involves many fields, with the characteristics of wide coverage, multi process and large business. The upstream of Xinguan vaccine industry chain is the packaging and raw materials of vaccines, mainly involving medical glass bottles, pre filling syringes, bottle caps, pharmaceutical excipients, etc.; the midstream is vaccine R & D and production, mainly involving relevant vaccine R & D and production enterprises; the downstream is the terminal use of vaccines and vaccine treatment, mainly involving the treatment of syringes and medical waste. In addition, the circulation of new crown vaccine runs through the whole process of the industrial chain, mainly involving cold chain equipment, cold chain transportation, cold chain circulation and cold chain logistics.

Pharmaceutical glass bottles are the first choice of packaging for vaccines, blood, biological agents and so on. Molding bottle refers to using mold to make liquid glass into medicine bottle, and tube bottle refers to medicine packaging bottle which uses flame processing equipment to make glass tube into certain shape and volume. For molded bottles, Shandong Pharmaceutical glass is the leader in the mold bottle segmentation field, accounting for 80% of the market share; for the control bottles, Zhengchuan shares is one of the leading enterprises in the domestic control bottle segmentation industry, with the production capacity of 8 billion medicinal glass tube bottles and 4 billion pharmaceutical bottle caps in 2019.

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