How was China’s COVID-19 vaccine “refined”

On December 31, 2020, The State Council jointly prevention and control press conference announced that the novel Coronavirus inactivated vaccine of Sinopac China Biology had been approved to be listed with conditions by THE State Food and Drug Administration.
At a time when the global COVID-19 epidemic is raging again in winter, the news that China’s first COVID-19 vaccine is on the market has indeed injected confidence and hope into the fight against COVID-19. It is a crucial step for China in its fight against COVID-19.

A staff member checks the packaging quality of novel Coronavirus inactivated vaccine at sinopharmaceutical Research Institute in Beijing, Capital of China, Dec. 25, 2018.

In the case of novel Coronavirus, only vaccine can achieve the true sense of “herd immunity” in the absence of a specific drug, so as to prevent the virus from spreading.
A vaccine, however, is unlikely to come by surprise.
The industry has a “double Tenth law”, that is, to develop a vaccine, the investment of 1 billion yuan, 10 years.
It will take at least one year to prove and approve a project.

Vaccines are creative products, and there is no guarantee of success.
And biological of China, Beijing institute of biological products will be finished within 10 months or so, to do a lot of experiments, the go program a don’t lack, behind it is a powerful new vaccine project research and development team, created a breakthrough research and innovation, contributing to global vaccine research and development for China’s plan and Chinese power.

A staff member checks the packaging quality of novel Coronavirus inactivated vaccine at sinopharmaceutical Research Institute in Beijing, Capital of China, Dec. 25, 2018.

Development breakthrough: From 0 to 1 behind “Let’s do it!”
When Wang Hui, then deputy director of the Beijing Institute of Biological Products, received a call from Yang Xiaoming, chairman of China Biology and chief scientist of the Ministry of Science and Technology’s “863” vaccine project, it was the COVID-19 outbreak in Wuhan on January 19, 2020.

Since then, Wang has been in charge of the Beijing Institute of Biology’s COVID-19 vaccine program.
She rushed to the Virus Disease Prevention and Control Center of Chinese Center for Disease Control and Prevention at the first time to learn about the novel Coronavirus strain isolation;
And in the first time to transfer the most capable force to organize scientific research team to carry out vaccine research and development work.

On New Year’s Eve, Zhao Yuxiu, director of vaccine Research Room II, was preparing to have a family reunion dinner at her in-laws’ home in Baoding when she received a call from Wang Hui: “Novel Coronavirus will be ready to study the vaccine immediately.”
Just after the family reunion dinner, Wang Hui called again and said, “Come back to the house all night to discuss the vaccine research plan.”
On the first day of the New Year, Liang Hongyang, deputy director of vaccine Room 6, had just returned to Beijing to put down his luggage and received a call from Wang Hui, deputy director of The Beijing Research Office: “Novel Coronavirus novel collection ready to develop a vaccine”.

Six people for one day, “team” rushing formed – maike vaccine research two office yu-xiu zhao, vaccines, head of the six rooms, previously with maike r&d inactivated polio (IPV) team backbone sang, six room Liang Hongyang, deputy director of the vaccine in the youngest manager of quality control (QC) expert ding ling li and animal experiment, responsible for this will be coronavirus inactivated vaccine development.
Although time is tight, they work in an orderly and close manner.
They each have a team behind them to support them.

Party Secretary Zhu Jingjin encouraged, “To overcome the novel Coronavirus, we must have the spirit of ‘giving up the one to the other’.”

China Biotechnology invested 2 billion in the research and production of novel Coronavirus vaccine.
In order to increase the insurance coefficient, it was decided to start the development of inactivated vaccine and gene recombination vaccine simultaneously.

Inactivated vaccine is a traditional vaccine with mature technology and technology, controllable quality and good safety. It is still the main force in the vaccine market at present.
Although new vaccines such as the recombinant gene vaccine are advanced in technology and theoretically more suitable for the urgent development of vaccines, only a genetically engineered recombinant yeast hepatitis B vaccine has been really successful so far.
Two legs, more stable.

“We have a detailed strategy and a rigorous vaccine development schedule.
From experimental design, quality control, process flow, to workshop construction, every step is to do our best to consider every detail, and the relevant requirements of international and national standards.
This is also based on our decades of accumulated experience and international leading technology platform.”
Maike said.

In a large conference room on the sixth floor of the complex, Mr. Wang calls it a “combat headquarters.”
Every night at 10 o ‘clock, the “six-person r&d team” meets here.

“There were two big whiteboards in the meeting room,” Says Wang.
Each of us wrote down the data and task performance of the day, and then analyzed and discussed accordingly.
If not, do the experiment again or redesign the strategy.
Where feasible, discuss what to do next.
Make strategic adjustments based on the results of each day’s experiment.
There must be no mistake, there must be new progress every day.
And then one layer at a time.
Hundreds of people participate every day, and thousands of experiments are going on at the same time.
Every day.”

Considering that everyone could not go home, the company provided a camp bed for each team member or just slept on the sofa, often working for more than ten hours without falling asleep. When a new sample came, they immediately got up and started to work on the next step.
Zhao Yuxiu now recalls saying, “This is revolutionary friendship!”

On December 25, a cold chain truck loaded with novel Coronavirus inactivated vaccine set off from The Beijing Institute of Biological Products of Sinopharmaceutical Group, China.

Innovative breakthrough: In the face of unknown, breathtaking and challenges, the working mechanism of the whole project team and r&d team is unprecedented, with all human, material and financial resources centering on the project.
“The research and development went on so quickly because the production department was also involved in the research and development process, and each team member concentrated their resources and technical advantages to give full play to their own role.”
Zhao yuxiu said.

Every day, team members face a variety of unknown, thrilling and challenges.
Wang Hui, for example, pointed out that before the clinical trial of vaccine, a complete pre-clinical study should be carried out, among which there must be a challenging experiment ona monkey, that is, to inoculate the monkey with vaccine, then cut open its trachea and infuse millions of viruses into it, so as to test whether it will be novel Coronavirus.
If it doesn’t, the vaccine is protective.
If you get it, you need to go further.

“This is a very sharp experiment.”
Due to time constraints, the vaccine research team turned the series experiment into a parallel experiment, from the first experiment to the 80th experiment, and now divided it into four groups of 20 at the same time, Wang said.
“None of us knows if a vaccine will protect us, but we’re taking a gamble.”

The solution is designed to meet global standards, and team members hammer out every detail of the experiment overnight.
For example, the amount of virus applied by pharyngeal swabs and anal swabs of monkeys was analyzed comprehensively, and all physiological signs of monkeys, such as liver, lung and reproduction, were analyzed comprehensively, and the measurement of challenge virus in monkeys was fully considered.
“If the consideration is not perfect and sufficient, a small detail may lead to the failure of the experiment,” Wang stressed.

“Once the monkeys get vaccinated, we kowtow to them every day.
We are afraid of the unknown.
But the results were good, and even the monkeys that got the low-dose vaccine were better protected.”
Maike said.

In addition to such near-misses, Wang hui and his research and development team also experienced many setbacks, failures and despair.
They often try 10 schemes, then pick one or two that work and move on.
They think of all the possibilities in advance, and then make a thorough design, even though it may take two or three times as much work.
Speaking about his feelings at the time, Liang said, “The pressure was so great that every link could not go wrong.”

Zhang Jin recalled, “The novel coronavirus inactivated vaccine was developed along the same technical route as the polio inactivated vaccine, and we immediately made a new improvement on the original production process.
We used the rest time to consult literature to provide a more adequate theoretical basis for the smooth development of the vaccine.
When problems arise in the vaccine development process, we immediately look for them and try to solve them.
In less than a month, we prepared the clinical samples, which were verified by the People’s Procuratorate of China and passed all the tests.”

The execution of the whole experiment was resolute, but the whole process was extremely difficult.
But in the end, the design of the whole project proved to be reasonable.

Beijing from early February 2020 vaccine project, to start April 28th Ⅰ period and Ⅱ period clinical trial, Beijing team to withstand the extreme challenges, ran out of the “fire mountain speed” in the field of scientific research;

On June 28, 2020, Beijing new crown inactivated vaccine developed by stage Ⅰ, Ⅱ jie blind clinical trial, the results showed that the vaccine group, all vaccinated produce high degree of antibody, and no obvious adverse reactions;

On July 22, relevant government departments legally included two novel Coronavirus inactivated vaccines developed by Chinese biotechnology into the scope of emergency use, and the novel coronavirus inactivated vaccines are intended for people leaving the country, medical personnel, epidemic prevention personnel, border inspection personnel and basic operation guarantee personnel of the city.

At December 31, conference, national medicine group China biological President yong-lin wu is introduced, its group, China’s new crown inactivated vaccines in the united Arab emirates and bahrain, and other countries on a large scale Ⅲ phase of clinical trial, immunization number has more than 60000 people, inoculation sample covers 125 nationality, completed the evaluation stage of protection data, safety and effectiveness indicators over the listed standards set by the world health organization (who) and approved by our country conditional listed under the scheme of work, can form effective protection in large scale.

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