China's new crown vaccine: Is it safe? Is it valid? Is that enough?

Medical network January 26th, a new crown hit, a virus and all mankind's "war" broke out.
as a powerful weapon against the disease, the vaccine has been high hopes of countless people.
in this battle for vaccine research and development, China National Pharmaceutical Group China Biotechnology Co., Ltd. (referred to as China Bio) as the representative of China's enterprises have been in the forefront.
the new crown vaccine was developed? From the approval of projects to research and development, construction, production, listing, why only took more than 330 days? How on earth should we look at the "scientific gold content" of China's new bio-crown inactivated vaccine? China has nearly 1.4 billion people, what kind of coverage is needed... Recently, with a series of hot-button issues, Xinhua Daily Telegraph reporters in-depth dialogue with China Bio Chairman, the national "863" program vaccine project chief scientist Yang Xiaoming, in response to public concerns.
The tradition of "testing drugs on your own" is a tradition: "About 60 tubes of blood have been pumped in 9 months": "China's vaccine centennial" book tells people that vaccine research and development is never a simple matter, but a life-threatening struggle.
the same is true of this new crown vaccine research and development? A: Yes, I was the first person to be vaccinated against our vaccine on March 23 last year, and as the first group of "test-takers", there were no abnormalities after the new corona inactivated vaccine, that is, the place where the injections were given a little pain.
because of regular antibody testing after vaccination, I have been pumped about 60 tubes of blood in 9 months, because there are more blood indicators to be observed regularly.
can detect antibodies in the second week after the first shot, and high antibody levels can be detected about 2 weeks after the second shot.
a hundred years, the dedication of China's biological products workers has continued.
, "testing drugs by self" is a tradition.
clinical trials of the new corona inactivated vaccine, tens of thousands of subjects, many of them biologics, were vaccinated.
these special volunteers, like the legendary Shen Nong, practice the responsibility and responsibility of a biological product man with their own practical actions, and of course, based on confidence in our research and development and production technology.
In order to help the early launch of the new coronavirus inactivated vaccine, China Bio launched voluntary vaccination at the end of March 2020, and dozens of volunteers, including the main party and government officials of the fourth-tier enterprises of the State Pharmaceutical Group, rolled up their sleeves and volunteered to take part in human pre-testing.
chinese biological people have a saying: do dare to give their families a vaccine.
is our pursuit, but also our self-confidence.
from the project was approved to research and development, listing a total of more than 330 days: "unprecedentedly short time" asked: This chinese biological new crown vaccine from research and development to the market how long? What are the key nodes? A: The vaccine took more than 330 days from the time it was approved to the time it was approved for research and development and went on the market.
China's biological new crown vaccine from research and development to market, there are several major nodes: First, on April 12, 2020, Wuhan Institute of Biological Products research and development of the new crown inactivated vaccine the world's first into the I./II. phase clinical trials, April 27, Beijing Institute of Biological Products research and development of new crown inactivated vaccine also entered the I./II. phase clinical trials.
was officially approved on June 23, 2020 for the UAE International Clinical Trial, known as Phase III.
third is the domestic emergency use, Wuhan Institute of Biological Products on June 30, 2020 obtained emergency use permits, Beijing Institute of Biological Products on July 23.
thursday is an emergency use abroad, with the UAE first approving emergency use on September 14, 2020, followed by Bahrain on November 3 and Egypt on January 2, 2021.
is an internationally registered listing, the United Arab Emirates on December 9, 2020 approved the official listing, Bahrain on December 13 approved the official listing.
is the first conditional listing in China on December 30, 2020.
China's new coronavirus inactivated vaccine, from the start of science and technology to approved clinical trials, we took 98 days, from the clinical to Wuhan, Beijing, both have completed the I./II. phase clinical trials, it took 78 days, and then from phase III. clinical trials into the group, to the conditional listing approved, it took 168 days.
vaccine research and development speed is very fast: "take a day as a few days" asked: as the first echelon of vaccine research and development, in a short period of time to come up with a vaccine, rely on what? A: The rapid development of China's new bio-crown inactivated vaccine is largely due to the country's institutional advantages.
from global experience, a vaccine used to take more than 10 years to develop to market, with more than 1 billion investments.
faster, it will take five to six years.
, the new crown vaccine can be on the market for more than 330 days, we can be said to be a miracle.
the development of the new crown inactivated vaccine so quickly depends on the country's strong institutional advantages.
the whole vaccine research and development process has been strongly supported by many ministries in the country, including the Ministry of Science and Technology, the Health Commission, the Drug Administration, the Ministry of Industry and Information Technology and so on.
Departments adopt the emergency status of research and development and approval procedures, many technical routes carried out in parallel, the vaccine research and development review agencies will review the process from "series" to "parallel", so that vaccine research and development, approval time is minimized.
the same time, Chinese biology is competing internally.
chinese biology launched a "back-to-back" technology competition for the new crown vaccine, directly promoting the development of the same vaccine between two different enterprises.
Wuhan Biological Institute and Beijing Biological Institute to undertake research and development projects, in the same arena on two tracks to compete, the reform of this new mechanism, to maximize the competitive momentum of researchers, but also for vaccine research and development "double insurance" laid a foundation.
in order to improve efficiency, we have adopted a number of "series" to "in-line" and "in-line" mode of work, without investment in the research and development process.
animal trials in mice, in order to find the right dose for injections more quickly, we changed the usual method of testing to three groups of different doses of the trial at the same time.
this requires the research team to work overtime and use the day as a few days.
research and development is not only technical work but also physical work, a short period of time to come up with a vaccine, relying on the research and development team to fight for time spirit.
China's new bio-crown inactivated vaccine has five characteristics: "Inactivated vaccine is a traditional and modern technology" asked: In the many technical routes of the vaccine, why did Chinese organisms finally choose the inactivated technology route? A: China's bio-new crown inactivated vaccine has the characteristics of technical safety, protective effectiveness, population universality, convenient storage and transportation and accessibility of capacity, the safety is very good, the effectiveness data exceed the preset target of clinical research, cold chain storage and transportation conditions in line with the national conditions of most countries around the world, sufficient capacity to meet a wide range of vaccination use.
at the same time, different from the past inactivated vaccine production technology, Chinese biology using advanced cell culture technology, purification technology and quality control methods, high production efficiency, quality control indicators fully reached the international advanced level.
To date, most of the vaccines that have been successfully marketed worldwide are inactivated vaccine products, including polio vaccine (a new class of drugs), hand, foot and mouth disease vaccine (a new drug), forest encephalitis vaccine (a new class of drugs), haemorrhagic fever vaccine, etc.
new corona inactivated vaccine cultures the whole virus and then prepares it into an inactivated vaccine through inactivation and purification, with complete antigen components and more comprehensive protection.
china's bio-new crown vaccine was approved for emergency use in July 2020, millions of doses of the new crown vaccine have been completed on a voluntary, informed and consensual basis.
more than 70,000 of them went to work in affected areas in more than 100 countries overseas, and no cases were reported among those vaccinated in the same working and living environment.
addition, vaccine access is also a very important reference indicator.
In terms of accessability, inactivated vaccines have their own advantages of storage and transportation convenience, storage and transportation conditions are 2 degrees C to 8 degrees C, which is consistent with China and many countries existing vaccine storage conditions and transport conditions, do not need to reconstruct cold chain system facilities, can reduce costs on a large scale.
"For vaccine safety, inoculators need not worry" Q: Recently, the UK found a variant of the new coronavirus is of concern, the new crown vaccine for the mutated virus is effective? A: From the data we have collected so far, all the antibodies produced by our inactivated vaccine can be covered by viruses isolated in different parts of the world.
, which was reviewed by the National Drug Administration, showed that vaccine protection was 79.34 per cent effective, higher than the World Health Organization target of 50 per cent.
generally speaking, most vaccines are more than 70% effective and can be marketed in China.
with relatively low general protection rates for respiratory diseases, our new crown vaccine is "excellent."
the end of 2020, the State Drug Administration approved the conditional listing of the inactivated new crown vaccine for Chinese organisms.
"conditional listing" is equivalent to leaving "homework" for enterprises, mainly to continuously monitor the persistence of observation antibodies and so on.
people need not worry about the safety of the vaccine.
January 13, 2021, the State Council joint prevention and control mechanism issued a briefing, China has carried out a total of key populations of new coronavirus inactivated vaccination more than 10 million doses, proving that the new coronavirus inactivated vaccine has good safety.
Many front-line research and development personnel "mentally and physically have been tested" asked: in the course of the development of the new crown vaccine, countless front-line workers quietly paid, achieved the rapid success of the vaccine on the market, behind what is the unknown moving story? A: On New Year's Day 2020, one of our researchers was given the task of developing a new crown vaccine.
In order to join the first line of the fight against the epidemic, she urgently decided to leave her 2-year-old daughter, from her hometown in Anhui overnight driving back to Wuhan, after nearly 5 hours of running, finally arrived the night before the closure of the city, and was sent to the China Center for Disease Control and Prevention's high-grade biosecurity laboratory (P3 laboratory) to start work.
Because in the laboratory to wear very thick protective clothing, wear off once very time-saving, in order to save time, many of our first-line research and development personnel have let themselves eat as little as possible, drink less water, and even later wear diapers, three or four o'clock in the morning to take off protective clothing, back to the rest area, mental and physical have been tested.
Chinese vaccine has found a new "open way" for international clinical trial cooperation Q: This is the first time that a Chinese vaccine has been launched on a large scale overseas pre-market Phase III. A: In the past, due to the lack of internationalization, domestic biopharmaceutical companies have not conducted large-scale protective clinical research overseas.
can say that through this baptism, the Chinese vaccine has found a new "open way" of international clinical trial cooperation.
In overseas clinical trials, we work with countries such as the United Arab Emirates, Bahrain, Argentina, Egypt and Peru to take into account the willingness of countries to cooperate and the conditions for health care and scientific research, and these government departments are very supportive, with some national leaders and prominent dignitaries volunteering for vaccination.
clinical trials of China's bio-new crown vaccine strictly adopt the internationally accepted random, double-blind and controlled approach.
"Double blindness" means that researchers and vaccinators do not know whether everyone is given a placebo or a vaccine, and that placebo and vaccine are exactly the same from appearance to injection and later monitoring methods, minimizing the possible interference of human factors with the results of the trial.
In terms of the size of the people involved in Phase III. clinical trials, we have conducted the largest number of clinical trials in the world covering volunteer countries, with more than 60,000 people vaccinated in Phase III clinical trials, and the number of vaccinated volunteers covering 125 nationalities, the number of people covered and the countries to which they belong is the highest in the world.
In addition, the teams involved in clinical trials from China to overseas include not only the National Pharmaceutical Group and China Bio, but also professionals from the National Center for Disease Control and Prevention, the Henan Provincial Center for Disease Control and Prevention, and third-party clinical monitors.
working closely with our local partners and first-class research teams has yielded good results.
Establish a more stable group immune barrier: theoretically, "The number of people to be vaccinated in China ranges from 900 million to 1.2 billion" Q: China has nearly 1.4 billion people, what kind of coverage is needed to build a wall of immunization and protection through vaccination? A: Before the new coronavirus, China did not have a high-level biosecurity facilities.
We draw on the construction standards of high-grade pathogenic microbial laboratories and the characteristics of their own production processes, respectively, in Beijing and Wuhan, the new crown inactivated vaccine high-grade biological safety production workshop, after inspection and certification by the relevant departments of the state, has been put into large-scale production, this year is expected to reach more than 1 billion doses of production capacity.
Based on previous observations of the effectiveness of vaccinations, combined with the protection rates shown in clinical trials of the new crown vaccine, it is theoretically necessary to vaccinate about 70 to 85 percent of the population in order to establish a more stable group immune barrier.
, the number of people to be vaccinated in China ranges from 900 million to 1.2 billion.
the whole production line of the new crown vaccine: the equipment achieved 95% localization rate asked: How independent is our new crown vaccine production line? A: From January 23, 2020 in Wuhan, to March 23, 2020, I received my first vaccine in just 2 months.
chinese creatures can make vaccines so quickly, and this year's production capacity will reach 1 billion, it will not be easy worldwide.
Inactivated vaccine is a traditional, classic route, I would like to emphasize that inactivated route it is not "backward", the birth of the new crown vaccine, which contains a lot of innovative factors, including innovation in production process technology and quality standards.
the same time through the construction of this workshop, created the workshop construction of the "Fire God Mountain" speed, the realization of the entire production line equipment 95% of the localization rate.
In recent years, the relevant departments proposed to strengthen the enterprise-based scientific and technological innovation system construction, support vaccines, biotechnology and other related scientific and technological research, so that we in vaccine research and development, innovation, industrialization and related industrial chains have made improvements and breakthroughs, so that in such a short period of time to develop a new crown vaccine.
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