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World 3rd mRNA COVID-19 vaccine will start Phase-3 trials in Mexico soon
World 3rd mRNA COVID-19 vaccine will start Phase-3 trials in Mexico soon. On May 11, Mexican Foreign Minister Marcelo Ebrard announced that the mRNA COVID-19 vaccine ARCoV developed by a Chinese company will start a phase III trial in Mexico from the 30th of this month. It is expected that 6,000 volunteers will participate.
Ebrard tweeted: “The Chinese side has officially notified us that they will start in Mexico (Phase III trial) and are currently waiting for approval from the Mexican drug regulatory agency.”
The ARCoV vaccine was jointly developed by Yunnan Watson Biotechnology Company (hereinafter referred to as Watson Bio), Suzhou Aibo Bio, and the Institute of Military Medicine of the Academy of Military Sciences. The overseas phase III clinical trials will be launched in May. According to Reuters, this is China’s first mRNA vaccine to enter Phase III clinical trials.
In order to fight the epidemic, the Mexican government is advancing a vaccination plan and has signed vaccine purchase agreements with China Kexing, Sinopharm and Cansino.
Hong Kong’s “South China Morning Post” quoted data from the online database ClinicalTrials.gov on the 12th, showing that in phase III clinical trials, Watson Bioplans to recruit about 28,000 volunteers over the age of 18 worldwide, of which at least 25% are volunteers Over 60 years old.
These volunteers will be randomly assigned to the study group and the control group, and receive two doses of experimental vaccine or placebo, 28 days apart. The health of the volunteers will be monitored for 12 months.
According to the report, the preliminary study of this clinical trial is expected to be completed by the end of October.
According to public information, Watson Biosciences developed the ARCoV vaccine in 2020, and obtained the drug clinical trial approval from the National Medical Products Administration in June of that year, and then entered the phase II clinical trial phase. It is reported that the first two phases of clinical data are relatively satisfactory.
ARCoV vaccine has independent intellectual property rights, and its core raw materials and key equipment have been localized. In December 2020, Watson built China’s first mRNA COVID-19 vaccine production workshop. The ARCoV vaccine is expected to be completed and put into production within 8 months, with a first-phase production capacity of 120 million doses/year.
In March of this year, Huang Zhen, co-founder of Watson Biotech, said that the company has contacted Mexico, Colombia, Indonesia, Pakistan and Turkey and may start trials in the second half of this year. He also said that the interim analysis data of the trial will be available at the end of this year.
In April this year, in an exclusive interview with CCTV, the founder of Aibo Biotech, Dr. InBev also revealed that the vaccine will officially start an overseas multi-center clinical trial as early as May, with the first choice or in South America, “will conside
r the local epidemic situation, Countries that lack research and development capabilities and vaccine supply are given priority considerations, so that they can effectively help local control the epidemic.”
mRNA, or Messenger RNA (messenger ribonucleic acid), is a messenger that transfers genetic information from DNA to protein, and provides instructions for human cells to produce target proteins (antigens), thereby activating the human immune response and resisting the corresponding virus. Compared with other types of vaccines, the biggest advantage of mRNA vaccines lies in the short production links and R&D cycle, relatively simple process, and rapid production.
Up to now, two mRNA vaccines have been approved globally, namely BNT162b2 developed by BioNTech in Germany and Pfizer and mRNA-1273 developed by Moderna in the United States. However, the storage and transportation temperature conditions of the two are relatively harsh, requiring minus -70 degrees (BNT162b2) and -20 degrees (mRNA-1273) respectively.
It is expected that compared with the previous two vaccines, the difference between the ARCoV vaccine is that it can be stored at 2-8 degrees Celsius. In the animal test published in the medical journal “Cell”, in order to evaluate the thermal stability of ARCoV, the team of Professor Qin Chengfeng of the Academy of Military Medical Sciences stored the vaccine at room temperature for up to 7 days, and then injected it into mice to still be effective. This allows ARCoV to greatly reduce the challenges of cold chain transportation.
Up to now, China has 5 manufacturers of new coronavirus vaccines approved for conditional marketing or emergency use. Among them, three inactivated vaccines (Beijing Biology, Wuhan Biology, and Kexing) and one adenovirus vector vaccine (Kangsino) are conditionally approved for marketing; in addition, there is one recombinant new coronavirus vaccine (CHO cell). The Zhikewei vaccine was approved for emergency use.
“Everyone should pay attention to mRNA vaccines. It provides humans with unlimited thinking.”
On April 10, Gao Fu, director of the Chinese Center for Disease Control and Prevention, appealed at the 2021 National Vaccine and Health Conference that mRNA technology is effective for infectious diseases, AIDS, and genetic diseases. , Rare diseases, and tumors will provide various opportunities. It is hoped that when developing classic traditional vaccines, the benefits that mRNA vaccines may bring to humans will be taken into consideration.
Gao Fu said in the report that we must pay attention to mRNA vaccines. We cannot ignore mRNA vaccines just because there are already several new coronavirus vaccines in our country. Innovative thinking is needed to create mRNA vaccines creatively.
In addition to the ARCoV vaccine, the development process of China’s Fosun mRNA COVID-19 vaccine is also proceeding smoothly.
On March 13, 2020, Fosun Pharmaceutical Industry signed a “License Agreement” with Byentec, and was authorized to conduct clinical trials, market applications and commercialization in mainland China, Hong Kong, Macao and Taiwan based on its proprietary mRNA technology platform. , Vaccine products against the new coronavirus.
On May 10, Fosun issued an announcement on the Shanghai Stock Exchange stating that its holding subsidiary Fosun Pharmaceutical Industry intends to invest in a joint venture with BioNTech in Germany to realize the localized production and commercialization of mRNA COVID-19 vaccine products.
(source:internet, reference only)