It was the first to report that the trial was successful BioNTech- Pfizer cooperative vaccine , It is expected to be the first vaccine approved for sale
Last week , Germany 、 Two teams in the United States have reported new coronal vaccines 90% The effectiveness of the above . Although China is the first to enter the third phase of clinical trials , But so far, no specific data analysis results have been published . European media began to question this .
Actually , The answer is simple , First, China's vaccines do not need capital speculation , Two is The domestic epidemic has subsided for months , Clinical trials can only be conducted mainly abroad . Analysts point out that , This has seriously affected the R & D progress .
Pfizer CEO We've sold our shares for two rounds , What is the progress of vaccines in China ？
Vaccine development in China is also good
News about China's development of a new crown vaccine , It goes back to 11 month 6 Japan , That is Germany BioNTech And Pfizer announced its BNT162b2 The vaccine is effective 90% Three days before . Liu Jingzhen, chairman of Sinopharm group, said at a public event that , At present, hundreds of thousands of people have been vaccinated urgently with two new crown inactivated vaccines under the group which are undergoing phase III clinical trials , There were no serious adverse reactions , The number of people leaving the country after vaccination reached 5.6 ten thousand people , There is no infection at present .
Phase III clinical trial of Kexing biological vaccine , It is expected that 11 Medium term data analysis results will be announced before the end of the month
According to the information released by Sinopharm group , The third phase clinical trial of its new crown vaccine is mainly conducted in UAE 、 Bahrain 、 Egypt 、 Jordan 、 Peru 、 Argentina 、 Morocco and other countries , More than 5 ten thousand . And outside of clinical trials , Hundreds of thousands of Chinese residents accepted it " Emergency vaccination ". Chairman Liu Jingzhen said ," Among them, those who leave the country after vaccination , Yes 5.6 ten thousand people , There is no case of infection ";" No matter from the experimental data of scientific research , Or is it used around the world , The efficacy of the new coronal vaccine was proved ."
however , Liu Jingzhen's remarks , It was criticized by Professor Jin Dongyan of Biochemistry Department of the University of Hong Kong . He said in an interview with the BBC , It's generally accepted that it's a clinical trial , It's not oral . This is an example " It belongs to the unscientific practice of the stone age ", As a reference , It can't be conclusive . Jin Dongyan thinks that , What vaccine research in China needs to do now is to speed up the third phase of clinical trials ," Talk about data ".
Liu Jingzhen, chairman of Sinopharm group
However , Whether it is the two inactivated vaccines developed by sinopharma group 、 Or is it an inactivated vaccine developed by Beijing Kexing biological Co., Ltd 、 Or is it the adenovirus vector vaccine developed by conoconazole , The interim analysis data of phase III clinical trial have not been released so far . Despite the current global total 11 In the third phase of clinical trials , China occupies 4 mat , And with the advantage of early start , The third phase of clinical trial was initiated ; however , Because the epidemic situation in China has been relatively quiet for several months , Clinical trials can only be conducted mainly abroad . Analysts point out that , This has seriously affected the R & D progress .
When will China's vaccine interim data be released
Robert, Germany · robert koch institute 、 The European drug administration and other authorities have pointed out that , Vaccine development itself is relatively simple , But the subsequent experimental phase , It will take at least a year to a year and a half . Usually , After months of animal testing , The vaccine has to go through at least three phases of clinical trials before it can be approved for marketing . among , The first phase of clinical trial is mainly used to evaluate safety , The scale of the experiment was dozens of people , For at least a month , The researchers will observe whether volunteers have adverse reactions after vaccination . The scale of phase II clinical trials ranged from hundreds to thousands , The researchers will evaluate different vaccination methods 、 Vaccine effectiveness at different doses , Find the best solution . This phase takes at least two to three months .
Vaccine development itself is relatively simple , But the subsequent experimental phase , More complicated
The third phase of clinical trials will be further expanded to thousands to 20000 people , Researchers will assess the effectiveness and safety of the vaccine in more detail . This phase takes about three to six months . If phase III clinical trial is successful , The vaccine will also undergo follow-up tests after marketing , If there is a problem, it may also be recalled .
Phase III clinical trials are considered to be a critical phase . At this stage , Researchers will set several important time nodes , For medium-term data analysis . such as ,11 month 16 Good news came out of the day Moderna The vaccine , That is, the cumulative number of subjects infected with new coronavirus reached 95 Human hour , The medium-term data analysis was carried out , Results found ：95 people ,90 People are all located in " Placebo group ", Only the subjects who actually received the trial vaccine but were unfortunately infected with the new crown virus were 5 people . Therefore, its effectiveness is 90/95, namely 94.5%.
11 month 16 Good news came out of the day Moderna The vaccine
If all subjects were infected with new crown, the number of people who had been infected with the new crown would never reach the predetermined node , It is impossible to carry out rigorous medium-term data analysis .11 month 16 Japan , Zhongnanshan, the leading figure in the prevention and control of epidemic in China, said in a public speech , Pfizer vaccine " Can stop 90% The infection of , In fact, the level of vaccine research and development in Guangdong and even China is similar , But the results of the first phase will not be released ."
Zhong Nanshan, the leader of epidemic prevention and control in China ： Pfizer vaccine and China's vaccine research and development level is similar
According to Reuters , In Indonesia 、 Turkey 、 Inactivated vaccine developed by Beijing Kexing biological research and development of the third phase clinical trial in Brazil , It is expected that 11 Release interim data analysis results at the end of the month .
China US vaccine war Who will be the winner ？
Brazil has announced that it will incorporate the new crown vaccine of keshing biology in Beijing into the national immunization program . The developing countries in Southeast Asia will become the priority vaccination countries of China . In many parts of the world, the epidemic situation is becoming more and more serious , China's vaccines are showing off .
Brazil has announced that it will incorporate the new crown vaccine of keshing biology in Beijing into the national immunization program
China has 4 Vaccine in III Phase II clinical trial . Inactivated new coronal vaccine developed by Kexing biological products CoronaVac Outside , There is also Sinopharm group and SINOCHEM （Sinopharm） Development of two new inactivated coronal vaccines , And the PLA Academy of Military Sciences and China kanghino biology Co., Ltd （CanSino Biologics） New recombinant coronal vaccine developed jointly .
PLA Academy of Military Sciences and China kanghino biology Co., Ltd （CanSino Biologics） New recombinant coronal vaccine developed jointly
China's president Xi Jinping 21 He attended the first stage of the 15th summit of G20 leaders in Beijing on the evening of the day and delivered an important speech . Xi Jinping emphasized , China actively supports novel coronavirus pneumonia vaccine and international cooperation , Has joined “ Novel coronavirus pneumonia vaccine implementation plan ”, We are willing to cooperate with other countries in developing vaccine research and development 、 production 、 Distribution and other links to strengthen cooperation . We will keep our promise , Help and support to other developing countries , Try to make vaccines available to people all over the world 、 Affordable public goods .
The British 《 The financial times 》 Express , China has begun to use vaccines as new ones “ foreign ” methods , Exert influence in Asia, Africa and Latin America in countries neglected by the United States . This is clearly a misunderstanding of China's willingness to provide help and support to neighboring countries .
China has 4 Vaccine in III Phase II clinical trial
The United States is already in 9 Month indicates not to join Covax Mechanism , meanwhile , Pfizer and BioNTech The novel coronavirus pneumonia vaccine is reported to be stored at zero centigrade. 70 Degree environment , But in general, medical clinics usually don't have refrigeration equipment that can reach this temperature , So when the two companies plan to deliver the goods , The vaccine will be loaded in a cold box , And keep it cold with dry ice . Medical staff need to replenish dry ice every five days , This will keep the vaccine for about two weeks .
Moderna A key advantage of vaccines is that , It doesn't need to be cryopreserved like the Pfizer vaccine , This enables transportation , Easier distribution , Increase flexibility in vaccination programs .Moderna I hope it can be in 2 to 8 It is stable at normal refrigerator temperature 30 God , Below zero 20 It can be stored for up to six months at centigrade .
The storage environment of vaccines has a great impact on governments' preparation for vaccination programs
The storage environment of vaccines has a great impact on governments' preparation for vaccination programs , If the novel coronavirus pneumonia vaccine must be stored in the super Low temperature Environmental Science , To transport them to remote or developing countries where electricity and dry ice supply are not necessarily sufficient , It's going to be difficult .
The biggest advantage of Chinese vaccine is convenient storage and transportation . also , China has opened production lines in countries such as Brazil .
Expert analysis , Vaccines in the United States , It can only be used in industrial countries , And the rest of the market , China has great advantages .
The European Union has begun to order vaccines in large quantities
19 Japan , German pharmaceutical factory BioNTech Express , It and Pfizer (Pfizer) Cooperative development of new crown vaccine injection , As soon as this year 12 It was approved by the United States and the European Union in June , It might even be in 12 Come out in the same month .
President of the European Commission (Ursula?von?der?Leyen) We welcome the news , In addition to BioNTech- Beyond Pfizer's cooperative vaccine , Approval is also expected Moderna Vaccines developed . She said , If there is no problem , The European drug administration is expected to grant the two vaccines a license for sale in late December . Although the EU drug administration is , We need to read all the experimental data , But von der lain is cautiously optimistic about the results .
Von der lain is cautiously optimistic about vaccines
At present, the European Union has ordered millions of vaccines from different manufacturers , Include BioNTech、Purevac, AstraZeneca (AstraZeneca)、 Sanofi (Sanofi) etc. . from BioNTech- Pfizer's vaccines include 9 Effective rate , The test data were then released Moderna Then there are 95% The efficiency of . As for the vaccine developed by AstraZeneca and Oxford University , AstraZeneca said on Thursday , At present, the clinical immune response in healthy elderly people is good , Spanking also has fewer side effects on young people .
It is reported that , Many European experts are optimistic about Chinese vaccines . meanwhile , As the world's major economy , Cooperation between China and Europe in the research and development of new crown vaccines , Expected to help global vaccine research and development “ To speed up ”.
Vaccines should become available to people all over the world 、 Affordable public goods .
As early as the beginning of the outbreak , Enterprises from China and Europe have been one after another “ Hand in hand ”, Joint development of new coronal vaccine . This year, 3 month , Shanghai Fosun Pharmaceutical Group and German biotechnology company （BioNTech） Reach the cooperation intention of vaccine research and development .
Actually , Facing the epidemic situation , There is no vaccine war , As China's national leaders have said , Vaccines should become available to people all over the world 、 Affordable public goods .
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