China FosunParma Speeds up COVID-19 Vaccine
China FosunParma Speeds up COVID-19 Vaccine
China FosunParma Speeds up COVID-19 Vaccine. On November 12, China Fosun Pharmaceutical announced that on November 11, Shanghai Fosun Pharmaceutical Industry Development Co., Ltd. (hereinafter referred to as “Fosun Pharmaceutical Industry”), a subsidiary of the company, received the “Notice of Acceptance”, which was approved The mRNA vaccine BNT162b2 used to prevent new coronavirus pneumonia was accepted by the State Drug Administration for clinical trial registration review.
On November 9th, three days ago, Fosun’s global partners for COVID-19 vaccines, German biotech company BioNTech and Pfizer announced that they had jointly developed this mRNA (messenger ribonucleic acid) vaccine In large-scale trials, 90% of infections were prevented.
The reporter of “China Business News” learned during the interview that Fosun Pharma was authorized by BioNTech of Germany in March this year to exclusively develop, register and commercialize its proprietary mRNA technology in mainland China, Hong Kong, Macau and Taiwan. Fosun’s new coronavirus vaccine developed by the platform against the new coronavirus, and the BNT162b1 clinical trial was launched in China in July, and the progress is positive.
After the release of new developments, the pricing of COVID-19 vaccines in the future has also become a matter of widespread public concern. On the afternoon of November 6, at the “Explore mRNA Technology” seminar jointly organized by Fosun Pharma and BioNTech, Hui Aimin, Senior Vice President of Fosun Pharma, President and Chief Medical Officer of Global R&D Center, and the media including our reporter During the exchange, it was revealed that the price of the COVID-19 vaccine is not expected to be too high after it is launched.
Behind the exciting news, more questions about vaccine effectiveness, quality and safety, production technology and storage conditions look forward to answers.
Fosun overweights mRNA vaccine development
Fosun Pharma mentioned in the announcement that BNT162b2 is the second mRNA vaccine against new coronaviruses introduced by Fosun’s pharmaceutical industry in the region based on this cooperation. The vaccine is a preventive biological product and is intended to be mainly used for 18-85 years old. Prevent the population from COVID-19 pneumonia. As of the announcement date, BNT162b2 is in phase III clinical trials in the United States, Germany, Argentina, Brazil, South Africa, Turkey and other countries, and has been certified by the US FDA (the US Food and Drug Administration) fast track review. As of the announcement date, no preventive vaccine against the new coronavirus developed based on the mRNA technology platform has been approved for marketing globally.
According to a Reuters report, the above-mentioned vaccine started a phase III clinical trial in early August and was carried out among 43,538 participants. Only 94 cases have been infected so far. Among these more than 40,000 people, about 42% are of different races. Clinical trial data showed that a comparison of people who received the vaccine and people who received a placebo showed that the effective rate of the vaccine reached more than 90% 7 days after the second dose of vaccination. This means that the new coronavirus can be immunized 28 days after the initial vaccination. Currently, this vaccine has no obvious safety issues. In the next few weeks, the phase III clinical data of the vaccine, including efficacy and safety data, will be fully announced.
According to Wu Yifang, Chairman and CEO of Fosun Pharma, on March 13, Fosun Pharma and BioNTech signed a cooperation agreement and obtained BioNTech’s license to exclusively develop and commercialize BioNTech’s development based on the mRNA platform in Mainland China, Hong Kong, Macau and Taiwan. Vaccine products.
Public information shows that BioNTech is a start-up company focused on innovation, listed on NASDAQ in 2019. As a high-tech biotechnology company, the company now has more than 1,800 employees, focusing on a new generation of immunotherapy.
Ryan Richardson, Chief Strategy Officer of BioNTech, said that Fosun Pharma has strong capabilities in clinical research and commercialization. Through Fosun Pharma’s strong commercial development capabilities, fast and powerful distribution network and understanding of the Chinese market, combined with BioNTech’s advanced mRNA technology, it will effectively promote the development and marketing of mRNA COVID-19 vaccines.
“From a historical perspective, the development of vaccines is a long process, with an average of 10 years. Under the epidemic, we expect to be able to reduce 10 years to one year or even shorter. This is indeed a challenge for us as human beings. , It is also a big challenge to our current science and technology.” Hui Aimin said.
The most critical challenge is capacity
Ryan Richardson pointed out that for the current COVID-19 vaccine project, the most important thing is speed. The most critical challenge is to expand production capacity and must achieve large-scale production. Different from the production level of vaccines used in clinical trials in small batches, the use of 100 million and billion-level vaccines has very high requirements for production.
“This means that not only the vaccine production process must be done well, but also the supply of raw materials must keep up. This requires synchronization of the supply chain and expansion of supply capacity.” According to Ryan Richardson, the acquisition of the Marburg plant can promote the increase in the production capacity of the COVID-19 vaccine. Up to 750 million doses per year, “This is a very large supplement to our production capacity.”
After large-scale production, how to guarantee product transportation? Wu Yifang added that after the vaccine enters the country, it must be placed in the -70°C warehouse as soon as it leaves the airport. “We have built a cold storage at -70℃ near the airport. The cold chain transportation is in charge of the partner Sinopharm Holding Co., Ltd. to ensure that it will be transported to vaccination points across the country at -70℃. The vaccination points are equipped with medical-grade cryogenic Refrigerator, the temperature can be guaranteed at the inoculation point.”
Tao Lina, a vaccine expert who has worked at the Shanghai Center for Disease Control and Prevention for 15 years, told reporters that this mRNA vaccine usually requires -70°C storage and transportation. The validity period at this temperature is said to be 6 months, while the active vaccine is 2~ The validity period at 8°C is generally ≥2 years. “The vaccine can only be stable for 5 days at 2～8℃. If it is marketed, it will definitely be the most temperature-sensitive vaccine. The low temperature of any cold chain equipment of the existing inoculation unit will not be lower than -20℃, so if it cannot be vaccinated The unit is equipped with professional -70℃ ultra-low temperature equipment, then the organization and management of vaccination must be strengthened, that is, all vaccines must be vaccinated within 5 days after arrival, otherwise the vaccine must be scrapped. If this is a free vaccine, scrapping is acceptable; if It is a self-funded vaccine, and the loss of scrap is usually borne by the inoculation unit, which will greatly hinder the promotion of this vaccine.”
Competing for the “last mile”
In the process of vaccine research and development, in addition to Fosun’s mRNA vaccine, other domestic vaccine companies have shown high research and development capabilities.
On November 11, China National Pharmaceutical Group Co., Ltd. (hereinafter referred to as “Sinopharm Group”) announced that at present, Sinopharm’s China Bio-COVID-19 Vaccine Phase III clinical trial is progressing smoothly in the UAE, Bahrain, Egypt and other countries, and has entered the final sprint At this stage, more than 50,000 volunteers were vaccinated, and the sample population covered 125 nationalities.
The Sinopharm Group stated that the Phase III clinical trials of the COVID-19 vaccine in many countries are now nearing completion, and the data of the trials are better than expected. Sinopharm Sinopharm will promote accine research and development in strict accordance with relevant procedures, and will not omit any research and development process to ensure that it provides the safest vaccine.
In addition, on October 15th, the Jiaxing Disease Control Center of Jiaxing City, Zhejiang Province, issued a document “Instructions on New Coronavirus Vaccination”, introducing the new coronavirus vaccination. The price of the vaccine is 200 yuan/bottle (bottle), with a total of 400 yuan for 2 doses.
According to the above-mentioned official account information, the COVID-19 vaccine for emergency vaccination in Jiaxing City will be ordered by the provincial department from Beijing Kexing Zhongwei Biotechnology Co., Ltd. and distributed to designated vaccination units. The vaccine has not yet been officially registered for marketing, and has been approved for emergency vaccination in accordance with the law.
According to the press conference of the State Council’s Joint Prevention and Control Mechanism held on October 20, currently, 13 vaccines in some countries have entered clinical trials. Among them, four vaccines including inactivated vaccines and adenovirus vector vaccines have entered Phase III clinical trials. The four vaccines are progressing smoothly. Up to now, a total of about 60,000 subjects have been vaccinated. No reports of serious adverse reactions have been received, initially showing good safety.
“The safety of the vaccine is the least need to worry about”
For the upcoming COVID-19 vaccine, more questions look forward to answers. After the vaccine development time is greatly shortened, what is the quality and safety of the vaccine? What are the contraindications for people of different ages and physical conditions during injection?
“The safety of vaccines is the least need to worry about. The reason why people worry about vaccine safety is because people subconsciously look at vaccines based on the safety level of chemical drugs, which greatly overestimates the risk of vaccine adverse reactions. In fact, As a biological product for healthy people, vaccines have a safety standard that is much higher than that of therapeutic chemicals. This is an objective law, and this is true for all vaccines. Chemical drugs are highly safe due to their very different structures. Low, some rare adverse reactions are difficult to predict.” Tao Lina told reporters.
He said that conventional vaccines usually take more than 5-10 years to go on the market. The COVID-19 vaccine is developed by the strength of all mankind, and the vaccine’s effectiveness and safety are fully understood and scientific principles are not violated. The approval process has been compressed and adjusted to a certain extent, and the COVID-19 vaccine is expected to be officially launched before the end of December 2020. As the general public, we should believe that the government will not take the public’s health risks and introduce unreliable vaccines without certainty.
Taulina pointed out, “I think, no matter what kind of COVID-19 vaccine, if there is no evidence that the dose of children/adults/the elderly needs to be differentiated, the dose should be unified for the entire population, so that the vaccine can be fully utilized and waste. Similarly, if there is no clear Don’t use any disease as a contraindication to the vaccine, just avoid the acute attack of the disease. Again, if there is no evidence of allergy to the vaccine, The default is that you are not allergic to the vaccine and can be vaccinated directly.”
So, how long is the protection period of the COVID-19 vaccine on the human body and does it need to be refilled regularly?
Taolina pointed out that the COVID-19 virus is an RNA virus, and it is not surprising that it has mutated. On the one hand, the protection period of the vaccine on the human body depends on whether the key parts of the virus have mutated; on the other hand, it depends on the body’s immune response mechanism to the virus. Generally speaking, the protective effect of the vaccine can be maintained for several years or even life. The only vaccine that needs to be vaccinated every year is influenza vaccine. “It is still impossible to judge how long the COVID-19 vaccine will be valid for and whether it needs to be strengthened regularly, but I personally think that it is very likely that the protection period will be at least 2 to 3 years.”