In the first quarter of 2021, as the three-phase clinical trials of new crown vaccine under development in the world have been uncovered, the biggest vaccine R & D competition in human history has begun to usher in a “turning point”.
According to the latest report of the United Nations on January 19, there are 52 new coronal vaccines on the WHO vaccine registration platform, which are in the stage of clinical evaluation, and 162 vaccines are in the stage of preclinical evaluation. At present, a total of 8 new crown vaccines have been approved for emergency use in many countries. At the same time, some industry giants, such as Mercer, Pasteur, have announced the termination of vaccine research and development.
In this war of hope, the Sino US vaccine project has always been in the first echelon. It has not only rich technical routes, but also many approved projects. At the same time, the vaccination scale is also leading the world.
According to statistics, as of 6:00 a.m. on January 31, 62 countries around the world had received more than 94.4 million doses of new crown vaccine, with an average of 4.47 million doses per day. On January 31, academician Zhong Nanshan disclosed at the launching activity of “Guangzhou laboratory science and technology helps grassroots epidemic prevention and control” that more than 20 million people around the world have been vaccinated with two new crown inactivated vaccines, Sinopharm and Kexing. In addition, by the end of January, more than 10 countries in the world had approved the registration and marketing or emergency use of China’s new crown vaccine. China’s new crown vaccine is becoming a global public product and entering more countries.
With the launch of global mass vaccination of new crown vaccine, the epidemic that lasted for one year is ushering in the “dawn of the end”. However, the increasing number of new coronavirus infections in the UK and South Africa may be a drag on this process.
Global vaccine racing to meet the “inflection point”: 8 products are out of the emergency use industry
China’s new crown vaccine is becoming a global public product and entering more countries. IC photo
Eight vaccines reach the “destination” first
According to statistics, as of February 1, among the world’s more than 200 new crown vaccine projects, 8 new crown vaccines have been approved for marketing or emergency use, including Sinopharm new crown vaccine, China Kexing biological new crown vaccine, Pfizer new crown vaccine jointly developed with German biotechnology company, Moderna new crown vaccine, Oxford University and AstraZeneca The company jointly developed new crown vaccine, Russia’s “satellite V” new crown vaccine, Russia’s “epivaccorona” vaccine and India’s “covaxin” new crown vaccine. In addition, Novavax, Johnson & Johnson and other enterprises have disclosed the data of phase III clinical trials of new crown vaccine, and China’s phase III clinical trials of kangxinuo vaccine have made important progress.
These vaccines mainly include inactivated vaccine, recombinant subunit vaccine, adenovirus vector vaccine, attenuated influenza virus vector vaccine and nucleic acid vaccine. At present, there are three kinds of vaccines in the world, including mRNA vaccine, adenovirus vaccine and inactivated vaccine. Each technology route has its own advantages and disadvantages: inactivated virus vaccine process is the simplest, but the immune titer is relatively low; adenovirus vaccine is well tolerated, but some people have adenovirus antibodies, which will lead to vaccine failure; mRNA vaccine production speed is the fastest, but it is easy to degrade.
Among them, the two new coronal vaccines made in China are inactivated vaccines. Inactivated vaccine is a kind of vaccine prepared by physical or chemical treatment, which makes the virus lose its infectivity and replication, but retains the activity of the virus that can cause human immune response. It can reduce the possibility of virus escape. Previously, the chairman of Sinopharm group and Kexing biology said that the production capacity is expected to exceed 1 billion doses this year. However, there are difficulties in P3 level operation and purification in the production of this kind of vaccine. It is worth mentioning that who is in the process of evaluating the new vaccines of the two companies, which is in the late stage of evaluation.
At present, Pfizer vaccine, Moderna vaccine and AstraZeneca vaccine are still the main vaccines in foreign countries, especially in European and American markets.
Among them, Pfizer vaccine and Moderna vaccine are both mRNA vaccines, which were approved for emergency use at the end of last year. They are not only the first and second new crown vaccines approved in the United States, but also the first and second new crown vaccines approved by the European Drug Administration (EMA). The former is priced at 19.5 US dollars per needle and 39 US dollars per person, and its production capacity is expected to reach 1.3 billion doses by the end of this year. The latter is priced at US $25-37 per needle and US $50-74 per person, and its production capacity is expected to reach 500-1 billion doses this year.
According to a doctor who works in the United States and has received two doses of Pfizer vaccine, he told the 21st Century Business Herald: “after receiving two doses of Pfizer vaccine, I really feel serious weakness and headache, especially the second one.”
Unlike Pfizer vaccine and Moderna vaccine, AstraZeneca vaccine belongs to adenovirus vector vaccine. The vaccine was authorized for emergency use in the UK at the end of December last year and became the third new crown vaccine approved by the European Union on January 29 After Pfizer and Moderna. The price is 4-5 US dollars per injection and 8-10 US dollars per person, which is relatively cheap compared with mRNA vaccine.
In addition to the above-mentioned five vaccines, Russia’s “satellite V”, “epivaccorona” vaccine and India’s “covaxin” new crown vaccine have also attracted wide attention of the international community. Among them, “satellite-v” is the first new coronal vaccine in Russia, which was approved by the Russian government in early August 2020, and has been registered in Hungary, Iran, Tunisia and other countries. Then in October, “epivaccorona” was registered in Russia. It is worth mentioning that there are great differences between the two vaccines. The former is an adenovirus vector vaccine, which uses two different human adenoviruses as vectors respectively, and has high protection rate for severe cases; the latter is a synthetic peptide vaccine, which is composed of artificially synthesized virus protein fragments, and has strong resistance to virus mutation and can be reused indefinitely.
It should be noted that the effectiveness of the above eight vaccines is different. The effective rates of Pfizer and Moderna were 95% and 94.1% respectively. The effective rate of the new crown vaccine developed by Sinopharm group was 79.34%. Kexing vaccine showed different protection effects according to different regions: the protection effect of Indonesia was 65.3%, the overall protection rate of Brazil was 50.38%, and that of Turkey was 91.25%. The effective rate of AstraZeneca new crown vaccine is relatively low, with an average efficacy of 70%, while the protection rate assessed by the European drug administration is only 59.5%. In addition, the Russian side said that the effectiveness of “satellite-v” vaccine was 91.4%, and the immune effectiveness of “epivaccorona” phase 1 test was as high as 100%. India has yet to disclose the results of the clinical trial of the “covaxin” vaccine.
“In addition to becoming the world’s largest vaccination, the new crown vaccine may also have an impact on the restructuring of the entire vaccine industry. In the past, people had more concerns about the mRNA vaccine, but now it has been accepted all of a sudden. Although there are still restrictions, it has a huge impact on the entire vaccine industry.” A vaccine industry researcher in South China told reporters of the 21st century economic report.
In addition to the above eight vaccines approved, a number of new crown vaccine projects around the world have also made breakthroughs in the near future.
Novavax, a biotech company, announced on January 28 that its covid-19 recombinant protein vaccine had been tested in the UK for phase 3. The effective rate of the vaccine was 89.3%, making it the fifth vaccine to enter the final phase of the trial and the first recombinant protein vaccine to complete phase 3 clinical trials. In addition, the data showed that it also had efficacy against the variant viruses in the UK and South Africa.
Following Novavax vaccine, J & J also released phase III clinical data of its new crown vaccine. It is worth mentioning that, unlike other vaccines that need to be injected twice on the market, Johnson & Johnson vaccine only needs to be injected once. However, the performance of the vaccine varies from country to country. It is 72% effective in the United States, but only 57% and 66% effective in South Africa and Latin America, where the new coronavirus variant is rampant.
In addition, new news has come from the adenovirus vector vaccine developed by academician Chen Wei of the Academy of Military Sciences and kangxinuo biology. According to Conchino bio announced in February 1st, its research and development of the recombinant New Coronavirus vaccine has completed the vaccination of more than 4 subjects. The interim analysis showed that the main safety and effectiveness standards were successfully achieved, and no serious adverse events related to the vaccine occurred. Therefore, the three phase of clinical trials can be continued.
Global vaccine racing to meet the “inflection point”: 8 products are out of the emergency use industry
Industry giants successively announced termination of vaccine research and development
With global vaccine research and development racing into the “second half”, some people arrived at the finish line on schedule, and some seed players left behind.
On January 25, eight months after the research and development of two new crown vaccines, one of the four major international vaccine giants, MSD announced to stop the research and development of new crown candidate vaccines v590 and v591, and instead focused its vaccine research strategy and production capacity on two new crown treatment candidate drugs mk-4482 and mk-7110.
The reason is that the immune response of two new crown vaccines in phase 1 clinical study is lower than that of natural infection and other new crown vaccines. In addition, according to evaluateparma, in 2020, the stock price of Merck fell by 12% and the market value lost $24.6 billion. As a result, MSD became the first multinational pharmaceutical giant to announce the termination of the new crown vaccine R & D project.
In addition, the Pasteur Institute of France announced on January 25 that it would terminate a major new crown vaccine research and development project due to the disappointing results of clinical trials. The Pasteur Institute explained the reasons in detail. In the initial human clinical trials, the tested vaccine was well tolerated, but the immune response was not as good as that observed in naturally recovered patients and people who had received the authorized vaccine.
In addition to research and development, the mass production of approved vaccines is also the focus of the market. Recently, Pfizer and AstraZeneca have been in dispute over the delivery of vaccines.
On January 15, Pfizer and the German biotechnology company announced that they would carry out “production process adjustment” for Pfizer vaccine production base in Pierce, Belgium, which would affect the vaccine delivery to EU countries in the next four weeks or so. This unilateral breach of contract immediately aroused strong dissatisfaction from several European countries. Denmark, Sweden and other countries successively put pressure on Pfizer and German biotechnology company. Italy, Poland and other countries also successively issued statements saying that if Pfizer fails to deliver the new vaccine as scheduled in accordance with the contract, it may take legal measures.
AstraZeneca, on the other hand, said in a statement on January 22 that initial production would be lower than expected due to a drop in production capacity at a production plant. It is disclosed that about 80 million doses of vaccine were originally scheduled to be delivered to the EU by the end of March, but the current delivery volume in the first quarter will be reduced by about 60% to 31 million doses. In response, the European Union said publicly that AstraZeneca’s delay in supplying sufficient quantities of new crown vaccine to EU Member States was “unacceptable”. At the request of the European Commission, Belgian regulators also raided AstraZeneca’s new coronavirus vaccine production base near Brussels.
The European Union (EU) has also announced a strict export control plan for the new crown vaccine, increasing its efforts to compete for the new crown vaccine while complaining that it has been unfairly treated in purchasing vaccines. After negotiations, AstraZeneca promised to increase 9 million doses of the new crown vaccine, with a total of 40 million doses. The delivery date will also be advanced by one week. Pfizer has promised to increase production by no less than 50% worldwide. However, the delivery was still less than expected.
By the end of January, more than 10 countries in the world had approved the registration and marketing or emergency use of China’s new crown vaccine. China’s new crown vaccine is becoming a global public product and entering more countries. China is providing vaccine assistance to 14 developing countries, including Pakistan, Brunei, Nepal, Philippines, Myanmar, Cambodia, Laos, Sri Lanka, Mongolia, Palestine, Belarus, Sierra Leone, Zimbabwe and Equatorial Guinea, the Ministry of foreign affairs of China reported on February 1. The next step is to provide vaccine assistance to 38 other developing countries in need.