Phase I/II clinical trials of the new coronavirus (COVID-19) inactivated vaccine (Vero cells) developed by Sinopharm Group China Wuhan Bioproducts Research Institute Co., Ltd. are in pre-registration of "passed review" at the China Clinical Trial Registration Center status.
According to public information, this is the second new coronavirus vaccine registered in clinical trials in China after the team of Chen Wei, academician of the Chinese Academy of Engineering and researcher of the Academy of Military Medical Sciences, Academy of Military Sciences.
With the severe situation of the international epidemic situation, the development of new coronavirus vaccines has become more urgent.
After the outbreak, China chose five technical routes to accelerate the development of new coronavirus vaccines, including inactivated vaccines, genetically engineered recombinant subunit vaccines, adenovirus vector vaccines, attenuated influenza virus vector vaccines, and nucleic acid vaccines.
It can be seen that the five technical routes adopted by China cover the major types of new coronavirus vaccines under study worldwide.
The clinical trial registration information shows that the research and development registration title of the Wuhan Institute of Biological Products Co., Ltd. is "New Coronavirus (COVID-19) Inactivated Vaccine (Vero Cell) Randomized, Double-blind, Placebo Parallel Control Phase I/II Clinical test".
The official scientific name of the research project is randomized, double-blind, placebo, parallel controlled phase I/II clinical trial to evaluate the safety and immunogenicity of the new coronavirus inactivated vaccine (Vero cells) in healthy people aged 6 years and older.
At present, the clinical study has been approved by the ethics committee and is in the pre-registration state of "passed review".
"China Biotechnology has achieved important stage results in the development of new inactivated coronavirus vaccines, and is expected to provide a" killer "for winning the decisive battle against the epidemic."
At the press conference held on the afternoon of April 8th by the State Council Joint Defense and Joint Control Mechanism, Liu Jingzhen, chairman of Sinopharm Group, said.
According to Peng Mei News reported on April 12, Academician Zhong Nanshan once said in a meeting with South Korean epidemic prevention experts that now five vaccines in China are being developed at the same time, and adenovirus vector vaccines and fully inactivated vaccines are currently being carried out faster.
The first phase of clinical trials of adenovirus vaccines has begun, and clinical trials of fully inactivated vaccines will soon begin. "We need to observe for a period of time after the clinical trial, usually one to two years, but it may also be listed in advance due to the development of the disease."
On the evening of the previous day, on the evening of the 11th, organized by the People's Daily and other media, "New Coronavirus Pneumonia Anti-epidemic Frontier Cloud Seminar", China Bio Chairman Yang Xiaoming introduced that among the five technologies for developing new coronavirus pneumonia vaccines in China, Inactivated vaccines are progressing faster and the technology is more mature. "I believe that the new domestic coronavirus vaccine will meet you soon."
According to previous statistics from the World Health Organization (WHO), as of March 21, there are a total of 51 candidate vaccines under development in the world, and two of them have entered clinical trials.
One is the American biotechnology company Moderna announced on March 16 local time that the mRNA vaccine developed by the company began human trials.
The other is that the research team led by Chen Wei, academician of the Chinese Academy of Engineering and researcher of the Academy of Military Medical Sciences of the Academy of Military Sciences, adopted the adenoviral vector method, and the recombinant new coronavirus (2019-COV) vaccine developed through the clinical research registration review on March 16 Comment.
At 20:18 that day, it was approved to enter the clinical trial. As of now, the team of Chen Wei is recruiting volunteers for Phase II clinical trials for clinical trials.
In other words, the new coronavirus (COVID-19) inactivated vaccine developed by Sinopharm Group China Wuhan Bioproducts Research Institute Co., Ltd. may be the third new coronavirus vaccine in clinical trials in the world.
So how long will it take to develop an approved new coronavirus vaccine that can be used on a large scale?
Tedros Adhanom Ghebreyesus, Director-General of the World Health Organization, recently said that the development of a new coronavirus vaccine will take at least 12 to 18 months.
Anthony S. Fauci, director of the US National Institute of Allergy and Infectious Diseases, has previously stated that even if the initial safety trials of the vaccine are progressing well, it will take a year to a year and a half before its large-scale application.
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