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According to the website of the State Drug Administration today, the State Drug Administration has conditionally approved the new crown vaccine registration applications of Cansino Biotech Co., Ltd. and Sinopharm Zhongsheng Wuhan Company. It is reported that the team of Academician Chen Wei of the Academy of Military Medicine of the Academy of Military Sciences and Kansino Biosciences jointly developed a recombinant new coronavirus vaccine (type 5 adenovirus vector). According to the news, the vaccine only needs one shot.

new crown vaccine

According to the website of the National Medical Products Administration, the vaccine is the first domestically-made adenovirus vector new coronavirus vaccine approved and is suitable for preventing the disease (COVID-19) caused by the new coronavirus infection.

new crown vaccine

According to the relevant provisions of the "Vaccine Administration Law" and "Drug Administration Law", the State Food and Drug Administration conducts emergency review and approval in accordance with the special drug approval procedures, and approves the application for listing registration with conditions. The State Food and Drug Administration requires the vaccine marketing license holder to continue to carry out relevant research work, complete the conditional requirements, and submit follow-up research results in a timely manner.

Sinopharm China Biosciences has started the large-scale production of the new crown vaccine. Each dose of vaccine has an electronic ID card that traces the flow of the vaccine throughout. Where the vaccine reaches and who is vaccinated will be recorded.

It is understood that the new crown vaccine packaging is divided into light inspection, rotary rod labeling, boxing, weighing, and coding systems to ensure the quality and safety of the vaccine.

Yang Xiaoming, Chairman of Sinopharm Group China Biotechnology, introduced that the regulatory code is equivalent to the "electronic ID card" of vaccines, which is divided into three levels: each vaccine is individually coded, every 10 vaccines is composed of a medium package code, and contains multiple medium packages The large package and then code.

Through the supervision code, you can check whether the vaccine production, warehousing, storage, delivery, transportation and other processes meet the standards, and track the person receiving the injection.

The size of my country's new crown vaccine market may be nearly 100 billion

China Securities Investment said that at this stage, orders for the new crown vaccine have been placed. According to the order volume, the country’s penetration rate is calculated. The United States, the United Kingdom, the European Union of four countries and Japan are respectively 100%, 100%, 65% and 100%. Taking into account the epidemic situation in my country Stable, but the world is still in the pandemic stage and my country is accompanied by repeated regional epidemics. It is estimated that the penetration rate of my country's new crown vaccine is generally assumed to be 60%, and the corresponding market size is about 84 billion yuan.

According to the agency, according to my country’s current clinical trial phase of the new crown vaccine project, according to the existing design capacity limit is about 1.8 billion doses, which can meet the demand of 900 million people. Considering the time required for the release of production capacity of some enterprises, it will be available in a short time. There are still gaps in the supply of new crown vaccine projects to the domestic and developing markets.

   China's new crown vaccine is not only the fastest in the world, but also the safest. It is reported that tens of thousands of people have been vaccinated with related vaccines, and they are all very safe.

   On November 6, the 3rd Hongqiao International Health Technology Innovation Forum was held in the 3rd CIIE Pavilion. At the forum, Liu Jingzhen, Chairman of Sinopharm Group, said when talking about topics related to the new crown vaccine, there are currently hundreds of thousands. People were vaccinated urgently with two new inactivated vaccines under Sinopharm Group. There was no serious adverse reaction. The number of people who left the country after vaccination reached 56,000, and none of them have been infected.

   Prior to this, Sinopharm issued a document through its WeChat public account "Sinopharm Group", saying that up to now, two new crown inactivated vaccines of China Biological are currently undergoing phase III clinical trials in multiple countries in an orderly manner, and the sample population has now covered 125 Nationality, 50,000 people were enrolled, and no serious adverse reactions were found.

   This phase III clinical trial has created many global firsts in terms of the number of people enrolled in the group, the country and population of sample coverage, the guarantee of medical resources, and the advanced facilities.

   Although my country's new crown vaccine has not yet been launched on a large scale, some cities can already accept user appointments in advance. For example, some cities in Zhejiang previously stated that starting from October 20th, appointments for the new crown vaccine will be opened for everyone, but the order of injections is in the order of appointment.

   The notice shows that the emergency vaccination procedure for the new crown vaccine is 2 doses, 14-28 days apart, the recommended interval is 28 days, and the vaccination age is 18-59 years old. The price of the vaccine is 200 yuan/bottle (bottle), two doses totaling 400 yuan, and the vaccination service fee is 28 yuan per dose.

What is the current progress of the recombinant new crown vaccine developed by the Chinese Academy of Military Sciences?
What are the characteristics of this vaccine?
After the successful phase III clinical trial, how long will it take to go public on a large scale?
Who is suitable for vaccination?
Does the vaccine have a preventive effect on the mutated new coronavirus?
What is the current position of my country's vaccine research and development in the world?

new crown vaccine

In response to these issues, a reporter from Xinhua News Agency recently interviewed Chen Wei, the winner of the national honorary title of "People's Hero", an academician of the Chinese Academy of Engineering, and a researcher at the Academy of Military Medicine of the Academy of Military Sciences.

"What are the characteristics of the recombinant new crown vaccine developed by the Academy of Military Sciences?"

Chen Wei: We have independent intellectual property rights for this vaccine, which means that we do not need to look at the faces of others to develop our vaccine at any time and on any occasion. When the subsequent vaccine is put into production and application, we can also let the Chinese people get the vaccination as soon as they need it at a lower price.

This is a technologically advanced virus vector vaccine. Its outstanding feature is that it can have both humoral immunity (antibody and neutralizing antibody) and cellular immunity. Since the virus is a parasite, it cannot grow or reproduce by itself. It needs to reproduce in human cells. Therefore, cellular immunity is essential for virus prevention and control. We launched the world's first phase I clinical trial on March 16, and published the phase I clinical trial data on the "Lancet" on May 22. All 108 people vaccinated developed antibodies. The editor-in-chief of "The Lancet" commented on this as "The vaccine is safe and well tolerated. It is the world's first clinical data. A single injection can quickly trigger immunity, which is an important milestone." In this process, we Testing methods and testing indicators have been announced to the world, so that scientific research colleagues in other countries will avoid some detours and speed up vaccine research.

On July 20th, we announced Phase II clinical data for the first time to the world. Phase I and Phase II clinical trials have proved the effectiveness and safety of the vaccine. In June, our vaccine has been vaccinated in specific populations.

Phase III clinical trials are currently being effectively advanced. As the domestic epidemic has been effectively controlled, we need to go abroad to advance Phase III clinical trials and conduct larger-scale vaccine effectiveness and safety evaluations.

"After the Phase III clinical trial is successful, how long will it take to go public on a large scale?"

Chen Wei: Generally speaking, the development of a vaccine has to go through phase three clinical trials, and the test results meet the relevant requirements before preparing for mass production. However, our recombinant COVID-19 vaccine has been prepared for large-scale mass production since the Phase I clinical trial. From the current point of view, the goal of annual output of 300 million is achievable, and we are working hard to expand production capacity. After the Phase III test results come out, our production capacity will also keep up, and we will be ready to vaccinate the people on a large scale at any time and strive for seamless integration.

"Which people do you think are suitable for priority vaccination?"

Chen Wei: First of all, people who are in direct contact with the new coronavirus or have the possibility of close contact, such as those closely related to epidemic prevention, especially front-line medical staff, virus-related researchers, and front-line customs staff. In addition, people with underlying diseases are also our focus. There are also people who are willing to vaccinate themselves.

Regarding the vaccination group and vaccination time, we only put forward opinions and suggestions, and the relevant departments make overall decisions. We mainly prepare high-quality vaccines and can use them in time when the country needs them. This is our responsibility.

"How long will the recombinant new crown vaccine provide effective protection after vaccination?"

Chen Wei: It has only been more than half a year since the new coronavirus was isolated. How long is the validity period of the vaccine? There will not be too many data in the world. It must be data within one year. Our vaccine entered the world's first phase I clinical trial in March, and we only have data within half a year. From the current point of view, the injection in March is still effective. How long can its protection last? We are still advancing related research. At present, we can only speculate based on similar vaccines in the past. For example, the Ebola vaccine will decrease its immune response after the first injection for six months. The second needle is enhanced and can be effective for two years. This is data that can be used as a reference.

"If the new coronavirus mutates, will the vaccine fail?"

Chen Wei: We are a genetically engineered vaccine. We just find the most useful gene and make it into a vaccine. Judging from the current data analysis, the probability of a change in the gene we selected is very low. Up to now, our recombinant new coronavirus vaccine can completely cover the mutated new coronavirus.

In addition, because we are genetically engineered vaccines, once mutations occur and the protective effect is affected, we can use the current vaccines as the basic immunity, and quickly build a more targeted vaccine to boost it, just like giving Software upgrades and patches are the same. This is also the reason why so many countries in the world are making genetic engineering vaccines-it is a new generation of technology and a sunrise technology that we need to vigorously develop in the future.

"What do you think of our country's new crown vaccine development process in the world?"

Chen Wei: There is no doubt that our country is in the first phalanx of the world's new crown vaccine research and development. We currently account for more than half of the vaccines announced by the WHO that have entered phase III clinical trials. This data is already very telling.

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