On June 11, the number of new confirmed cases of COVID-19 globally exceeded 150,000 in a single day.
The Americas are still suffering from the epidemic, while Europe and East Asia are struggling to get their feet out of the mud.
The world is waiting for the coVID-19 vaccine.
There are more than 160 vaccine candidates under development globally, according to the World Health Organization.
So far, 10 candidate vaccines have entered clinical trials, including 5 in China (1 adenovirus vaccine, 4 inactivated vaccines), 3 in the US (1 RNA vaccine, 1 protein subunit vaccine and 1 DNA vaccine), 1 in the UK (adenovirus vaccine) and 1 in Germany (RNA vaccine).
This means that China accounts for “half” of the vaccines going into clinical trials globally.
The latest cause attention to a domestic inactivated vaccine why highly anticipated?
How is the progress of Adenovirus vector vaccine led by Academician Chen Wei?
The health community will track the progress of vaccine research and development periodically and introduce the latest development of coVID-19 vaccine.
The fourth inactivated vaccine performed well in animal experiments
The so-called inactivated vaccine USES physical or chemical methods to inactivate the virus acquired in culture, making it lose its pathogenicity, while retaining the main antigenic characteristics of the virus and injecting it into the body to stimulate an immune response.
The research and development process of this type of vaccine is relatively traditional, but it is not easy, which requires screening the appropriate strain, culture substrate, culture mode, and selecting the appropriate virus inactivation method to complete the preparation of vaccine products.
An inactivated vaccine called BBIBP-CORV has been shown to be safe and effective in animal experiments, including in rhesus monkeys, according to an article published in cell on June 6 by Sinopharmacology China’s Beijing Institute of Biological Products, the Chinese Center for Disease Control and Prevention, and the Chinese Academy of Medical Sciences.
The person in charge of the inactivated vaccine is the Ministry of Science and Technology “863 plan” vaccine chief scientist Yang Xiaoming, Wang Hui, etc.
Notably, corresponding authors of the cell paper include Gao Fu, a member of the Chinese Academy of Sciences and director of the China CDC.
It has attracted intense attention in and out of the industry because of its “high potency” -2 g/ agent induces high levels of neutralizing antibody titers, thus providing protection against SARS-COV-2 attacks.
According to the relevant person in charge of the introduction, it has started the 1/2 phase clinical trial at present.
This is the fourth inactivated vaccine reported to enter clinical trials in China.
As early as April 12, national medicine group China wuhan institute of biological products and the institute of Chinese Academy of Sciences, wuhan virus joint application will be coronavirus inactivated vaccines approved to enter clinical trials, the first and second phase of the merger, become the second to enter clinical trials of new vaccines, is the world’s first into the new crown inactivated vaccine clinical trials.
At present, phase I clinical has been carried out in Henan Jiaozuo area.
In addition to Sinopharmacology, the inactivated vaccine developed by Beijing Kexingzhong Maintenance Biotechnology Co., Ltd. also entered the clinical trial on April 13, which was also carried out in combination with phase I and phase II: phase I clinical trial started on April 16 and phase II clinical trial started in early May.
Yin Weidong, head of the inactivated vaccine, was involved in the development of the SARS vaccine.
Preclinical results of the vaccine, published in the journal Science on 6 May, show that its inactivated vaccine proved safe and effective in animal models of rhesus monkeys.
In addition, the inactivated coVID-19 vaccine developed by the Institute of Medical Biology of the Chinese Academy of Medical Sciences was approved for clinical trials on May 13.
The first batch of volunteers have been enrolled and vaccinated in the phase I clinical trial officially launched in the Second Hospital of West China Hospital of Sichuan University on Wednesday.
Adenovirus vector vaccine enters validation “expiration date” phase
However, the adenovirus vector vaccine developed by Chen wei’s team is still the fastest in China.
The so-called adenovirus vector vaccine is to package the gene of a specific virus (such as novel Coronavirus) into the common viral shell that has been removed (such as adenovirus, measles virus, influenza virus, etc.), thus to send the gene of the target virus into the human cell and induce the human body to produce antibodies.
The adenovirus type 5 (Ad5) vector vaccine jointly developed by Academician Chen Wei of the Institute of Bioengineering, Academy of Military Medicine, Chinese Academy of Military Sciences and Chinese company CanSino is the first COVID-19 vaccine in the world to enter phase I and II clinical trials.
A second phase of clinical trial was approved on 13 April
The first group of 108 volunteers will be admitted to wuhan Special Nursing Center for quarantine and observation. They will take blood samples 28 days, 3 months and 6 months after the vaccination to evaluate the effect of the test.
On May 22, the results of a phase I clinical trial of adenovirus type 5 (Ad5) vector vaccine were announced: 108 healthy adults were vaccinated, rapid specific T-cell responses were observed on day 14, and humoral immune responses to SARS-COV-2 peaked on day 28, with no serious adverse events.
However, the ability to trigger the immune response does not necessarily mean that the vaccine will protect against a novel Coronavirus.
A randomized, double-blind, controlled phase II trial with 500 volunteers is currently underway in Wuhan to see if the phase I results can be replicated and if adverse events occur within six months of vaccination.
People over 60 also participated as subjects for the first time.
Outside China, the world there are 5 kinds of vaccine candidates in clinical trials, respectively, as Britain’s Oxford University cooperation with astrazeneca adenovirus vaccine, the U.S. national institute of allergy and infectious diseases, and biotechnology company Moderna cooperation of RNA vaccine, developed by American Novavax protein subunit vaccine, Germany BioNTech and Renaissance medicine and joint research and development of RNA Pfizer vaccine, DNA vaccine developed by American Inovio company.
Are there any signs of a shorter development cycle?
Although 10 teams from around the world won the preclinical study and entered the clinical trial phase, the fastest progress is currently in the phase II clinical trial phase.
Previous reports in the health sector have mentioned that the clinical phase II is mainly to test whether the human body will produce antibodies after vaccination, which needs to expand the sample size and target population, at least 200-300 people, and it will take more than half a year.
In the third phase, it is necessary to compare the infection rate of the population after vaccination with that of the population without vaccination to see whether the incidence rate is significantly reduced, which requires a larger sample size, generally thousands of people, and the minimum time is no less than 3 months.
Moreover, infectious diseases need to be observed for at least one epidemic cycle to obtain data on the rate of protection among susceptible populations.
There is no doubt that the development of coVID-19 vaccine is still a long and uncertain process.
Experts have their own predictions for the problem.
Zhang Wenhong, director of the Department of Infectious Diseases at Huashan Hospital affiliated to Fudan University, said that if one of the more than 100 vaccines under development is effective, the first successful vaccine may be available from March to June next year.
Zhong Nanshan of the Chinese Academy of Engineering said the vaccine could be used as an emergency as early as this autumn or the end of this year.
Gao Fu, director of the Chinese Center for Disease Control and Prevention, also predicted that the vaccine could be given to some special groups before the end of the year.