110 new crown vaccine races: 8 enter clinical trials, aiming for emergency use in September
The new crown virus R & D competition is still at the forefront of China and the United States.
As of May 11, the official website of the World Health Organization has filed 110 new coronary pneumonia vaccines under development, of which 8 have entered clinical trials. The surging news reporter sorted out and found that of the eight vaccines that have entered clinical trials, four are from the Chinese research and development team, three are from the United States, and one is from the United Kingdom. The technology platforms used are non-replicating viral vectors, RNA, inactivated vaccines and DNA.
Among the 102 registered vaccines that have not yet entered clinical trials, more technology platforms are used including DNA, non-replicating viral vectors, protein subunits, replicating viral vectors, and RNA. Among them, 9 are DNA technology platform vaccines, 13 are non-replicating viral vectors, 38 are protein subunits, 12 are replicating viral vectors, and 14 are RNA technology platforms. Other adopted technology platforms include inactivated vaccines, live attenuated viruses, Viroid-like particles.
China is at the forefront of research and development of new crown vaccines in the world. At present, at least more than 15 companies and scientific research institutions in China have launched scientific research on vaccine development, and 4 new coronavirus vaccines are undergoing clinical trials.
Among them, the adenoviral vector vaccine of the Academy of Military Medical Sciences of the Academy of Military Sciences has launched a second clinical trial on April 12. The inactivated vaccines developed by Sinopharm Group's Wuhan Biological Products Research Institute and Beijing Kexing Zhongwei Biotechnology Co., Ltd. in conjunction with the relevant scientific research institutions were approved for the combined phase 1 and 2 clinical trials on April 12 and 13, respectively. The new crown inactivated vaccine developed by China Bio-Beijing Bioproducts Research Institute was approved by the State Drug Administration for clinical trials, and the clinical trial was initiated on April 28.
In European and American countries, the new crown vaccines of three R & D teams have targeted the target of obtaining emergency use authorization this fall, and are accelerating clinical trials and R & D and production.
In the United States, Moderna, a Massachusetts-based biological company, announced on May 7 that its Phase II clinical trial of the new coronavirus vaccine has been approved by the US Food and Drug Administration (FDA). A new vaccine being studied by pharmaceutical giant Pfizer and German bio company BioNTech has been tested in the United States on May 4 or may be launched in September. Both teams studied messenger RNA vaccines.
In the UK, Oxford University research has attracted attention. Researchers say they can assess the effectiveness of the vaccine this summer, and the vaccine will be available in September.
China is at the forefront of new crown vaccine clinical trials
On April 12, an innovative recombinant vaccine product led by Academician Chen Wei of the Chinese Academy of Military Sciences led the development of a recombinant new coronavirus (adenovirus vector) vaccine in Wuhan. About 500 volunteers were vaccinated.
According to a report by China News Agency on April 26, Academician Chen Wei of the Academy of Military Medical Sciences of the Academy of Military Sciences revealed that 508 volunteers of the second clinical trial of recombinant adenovirus vector recombinant coronavirus vaccine have been injected and are now in the observation period. Successfully will be blind in May this year.
The inactivated vaccines developed by the Sinopharm Group's Wuhan Biological Products Research Institute and Beijing Kexing Zhongwei Biotechnology Co., Ltd. in conjunction with relevant scientific research institutions were approved by the combined clinical trials of Phase I and Phase II on April 12 and 13, respectively. The new coronavirus vaccine using the "inactivated" technology platform was the first to receive clinical research approval.
The new crown inactivated vaccine developed by China Bio-Beijing Bioproducts Research Institute was approved by the State Drug Administration for clinical trials, and the clinical trial was initiated on April 28. The new crown inactivated vaccine was jointly developed by China Bio Beijing Institute of Biological Products and China National Center for Disease Control and Prevention.
Prior to May 6, the Qinchuan team of the Institute of Medical Laboratory Animals of the Chinese Academy of Medical Sciences led a number of research teams to publish the world's first new crown vaccine animal test results in the internationally renowned journal "Science". The research confirmed that Beijing Branch The new inactivated vaccine developed by Xingzhongwei Biotechnology is safe and effective in the rhesus monkey model. This is the first publicly reported animal experimental study of the new crown vaccine. The Phase I and II combined clinical study was launched on April 16 in Suining County, Xuzhou City, Jiangsu Province.
Gao Fu, director of the Chinese Center for Disease Control and Prevention, said in an interview with China International Television on April 23 that China is at the forefront of research and development of new crown vaccines, and there may be emergency use of new crown vaccines in September.
Moderna vaccine in cooperation with multiple US national agencies
Moderna's new coronavirus vaccine, based in Massachusetts-based biological company Moderna, is making rapid progress in 2020.
Compared with industry leaders, Moderna is not particularly large, with a market value of about $ 18 billion and fewer than 1,000 employees. However, the company's vaccine started its first human trial in the world in mid-March, thanks to cooperation with a series of important collaborators.
Moderna vaccines use synthetic messenger RNA to inoculate viruses. This method helps the body develop immunity and can be developed and produced faster than traditional vaccines.
The results of the study are expected to be obtained in the next few weeks, with the focus on showing whether the vaccine is safe and tolerable in healthy volunteers. The trial was initially tested on only 45 healthy young people, and then expanded to 105 participants, including elderly volunteers.
Moderna's vaccine is targeted for emergency use in the fall of 2020.
With the approval of US regulatory agencies, the 600-person test of the Moderna vaccine on two doses will begin soon. The key trials to test the efficacy of the vaccine will be launched in early summer of this year and will be conducted in parallel with other studies.
The vaccine was developed in cooperation with Moderna and the National Institute of Allergy and Infectious Diseases (NIAID) led by Anthony Fudge. Part of the funding for early research was provided by the Coalition for Epidemic Preparedness Innovations, which is a A global non-profit organization that supports multiple coronavirus vaccine projects.
At present, Moderna is working hard to increase its production capacity, increase the manpower of the factory and operate it 24 hours a day. The US Biomedical Advanced Research and Development Agency (BARDA) also pledged nearly US $ 500 million to Moderna in April to expand production scale. On May 1, Moderna signed a 10-year production agreement with a large Swiss manufacturer that can produce up to 1 billion doses of products per year.
Cooperation between American pharmaceutical giant Pfizer and German bio company BioNTech
According to a New York Times report on May 5, Pfizer and German pharmaceutical company BioNTech announced that their new coronavirus vaccine will begin human testing in the United States on May 4, and the test will be conducted on healthy volunteers. If the trial is successful, the vaccine will be ready for emergency use in the United States as early as September.
The clinical trials of Pfizer and BioNTech have been officially approved in Germany on April 22. This is also the first clinical trial of a new coronary pneumonia vaccine in Germany.
Similar to Moderna, the two companies jointly developed a candidate vaccine based on messenger RNA genetic material. Messenger RNA carries instructions for cells to make proteins. By injecting a specially designed messenger RNA into the body, vaccines can tell cells how to make coronavirus spike proteins without actually making people sick.
There is already a placebo group in the ongoing trial and plans to expand to 7,600 participants. Currently, Pfizer researchers are also testing the vaccine on primates to see if these animals will be infected. This work can support the vaccine by determining the level of immune response required to protect humans.
Research from Oxford University
The study of the new coronavirus vaccine at Oxford University in the United Kingdom is led by the Jenner Institute and has received strong support from major UK institutions including the British government.
The vaccine uses ChAdOx1 viral vector (a weakened version of adenovirus), and the technology platform is a non-replicating viral vector. The team proposed a best-case framework so that its vaccines can be put into use in the fall of 2020, but the team warned that this is "a highly aggressive schedule for the best-case scenario", and the actual situation may also have Variety.
Clinical trials have already begun in the United Kingdom. The first phase of the goal is to vaccinate 510 18-55 year-old volunteers. The early safety and effectiveness data for this part are expected to be released in May or early June.
The study has an adaptive design and will eventually recruit more than 5,000 people to participate in 2020. If this part is successful, the study will be expanded to people between 55-70 years old, and then spread to people over 70 years old. These volunteers will be randomized to receive an experimental vaccine or placebo.
Surging news reporter Cheng Tianmeng