Why is there 5 technical routes for the development of a new coronavirus vaccine?
Ask about the new crown vaccine
According to statistics released on the official website of the World Health Organization on October 2, 42 vaccines under development worldwide have been approved to enter the clinical trial stage, of which 11 vaccines independently developed by my country have entered the clinical trial stage.
What's more worth mentioning is that these 11 vaccines have achieved full coverage of 5 technical routes into clinical trials.
The 5-way "team" has a comprehensive layout and is very forward-looking
The epidemic is the "starting gun" for vaccine research and development.
"In the early days of the outbreak, the Ministry of Science and Technology made a comprehensive layout of 5 technical routes. I think it is very forward-looking." said Yang Xiaoming, chairman of Sinopharm China Biotech. Now all 5 technical routes have entered clinical trials. The stage also fully demonstrated that the scientific research layout at that time had an advanced strategic vision.
According to the data, in order to maximize the success rate and speed of my country's new crown vaccine research and development, the scientific research team quickly determined the five main technical routes: inactivated vaccines, adenovirus vector vaccines, attenuated influenza virus vector vaccines, recombinant protein vaccines, Nucleic acid vaccines (including RNA vaccines and DNA vaccines).
At the same time, five technical routes are laid out with a clear goal, which is to ensure success.
If you compare vaccine research and development to a battle, you need a sharp knife squad, a main force, an airborne unit...Different vaccines have different characteristics, give play to different advantages, and create a combination of different organizational systems in cooperation. The ultimate goal is only one-attack Down the "hill".
There are 5 technical routes supported by the emergency research project. Each technical route has 1-3 teams for research and development. Each technical route is formed by multiple units, from enterprises to universities, scientific research institutes and high-level biology Safety laboratories, top national academic institutions, and high-tech companies in the life sciences field invest in research and development day and night.
how is the progress?
It depends on the data!
data!
data!
On September 25, at a briefing on the progress of the new crown virus vaccine work held by the State Information Office, Wu Yuanbin, director of the Department of Social Development and Technology of the Ministry of Science and Technology, took the lead in bringing good news.
He said that of the 4 vaccines that entered phase III clinical trials, 3 were inactivated vaccines and 1 was an adenovirus vector vaccine.
Recombinant protein vaccines, nucleic acid vaccines, and attenuated influenza virus vector vaccines are undertaking phase Ⅰ and phase Ⅱ clinical trials.
It may be difficult for ordinary people to distinguish phase I, phase II, and phase III of clinical trials.
Wang Junzhi, deputy head of the expert team of the research team for vaccine research and development, and academician of the Chinese Academy of Engineering, explained that Phase I proved its safety; Phase II continued to ensure safety, and more importantly, to ensure its effectiveness. The main tests are whether antibodies can be produced, how much and what. When did it happen, how long it lasted, etc.
In the third stage, in the epidemic area, a large number of people are vaccinated to observe whether there is any substantial protective effect.
Simply understand, vaccines need to answer the questions of whether it is safe for the body (safety), whether the immune system can be trained to recognize the virus (effectiveness), and the effect of small-scale "actual combat" (phase III clinical trials). Approve the market in batches and vaccinate the public.
The important basis for "pass" or not is: data!
Including adverse reaction rate, neutralizing antibody production and other relevant data.
Because it is a randomized double-blind trial, the data will only be known after a certain stage of the trial is completed.
For example, the unblinded data in the phase I/II clinical trials of the inactivated vaccine of China Biotech showed that the safety after vaccination was good and there was no serious adverse reaction.
The immunogenicity results showed that after different procedures and different doses of vaccination, the vaccine group vaccinated all produced neutralizing antibodies, and the positive conversion rate of neutralizing antibodies in some groups reached 100%.
According to reports, the current four inactivated vaccines supported by the emergency response project have been approved to enter clinical trials, and three of them have entered the phase III clinical trial stage, which are my country's dominant varieties.
Entering epidemic areas, China's vaccines have demonstrated protective effectiveness in actual combat.
The two inactivated vaccines of China Biotech have carried out phase III clinical trials in the Middle East, South America and other places. Tens of thousands of people have been inoculated, and no serious adverse reactions have been observed. The inactivated vaccines of Beijing Kexing Zhongwei Company are in South America, Southeast Asia and other places. , The adenovirus vector vaccine jointly developed by the Academy of Military Medicine and Cansino has carried out Phase III clinical trials in Europe and Asia.
Objectively speaking, as of now, no one has obtained the clinical phase III experimental data of the new coronavirus vaccine, and its performance in small-scale "actual combat" is still unknown.
"Based on the data we have obtained during the vaccine development and clinical trials, I am very confident." Yang Xiaoming said, "Our inactivated vaccines should be the world leader in terms of progress and quality indicators."
Multiple types of vaccines complement each other, and "reserve a few hands" in response to cunning viruses
In actual clinical applications, there are changing situations.
The so-called "difficult to adjust", a single vaccine is difficult to fully adapt.
Because of this, it is important to stock vaccines of different technical routes.
"Vaccines of different technical routes have their own advantages and disadvantages, and they are highly complementary in clinical use." InBev, CEO of Suzhou Aibo Biotechnology Co., Ltd., said that the real world situation is ever-changing, such as the characteristics of the elderly. One vaccine may be more suitable; and the same person may also need to receive different vaccines at different times, or people of different ages and physical conditions may receive different vaccines; in addition, if a person has been injected with other vaccines such as flu vaccine, which vaccines are suitable Combination also needs to be considered.
Different publics have different situations. Once a vaccine is not applicable under certain conditions, another candidate vaccine can be a "back-hand".
Putting people's health in the first place makes these considerations in the early stage of China's new crown vaccine development and deployment.