Global Vaccine Race To Meet The "Turning Point": Eight Products Have Been Dropped Out Of The Emergency Use Industry Giants One After Another

In the first quarter of 2021, with the blinding of the third phase clinical trials of the new crown vaccine under development in the world, the largest vaccine R & D race in human history began to usher in a "turning point".

According to the latest report of the United Nations on January 19, there are 52 new crown vaccines on the WHO vaccine registration platform, and 162 vaccines are in the pre clinical evaluation stage. At present, a total of 8 new coronal vaccines have been approved for emergency use in many countries. At the same time, some industry giants including MSD and Pasteur announced the termination of vaccine research and development.

In this battle of hope, China and the United States have always been in the first echelon of vaccine programs. Not only are there rich technical routes, but also many projects have been approved. 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. According to academician Zhong Nanshan at the "Guangzhou laboratory science and technology to help grassroots epidemic prevention and control" launch activity on January 31, more than 20 million people in the world have been vaccinated with the two new crown inactivated vaccines of national medicine and Kexing. In addition, as of the end of January, more than 10 countries have approved the registration and listing 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 the global new crown vaccine mass vaccination, this one-year-old epidemic is ushering in "the dawn of the end". However, the increasing number of new variant coronavirus infections in the United Kingdom and South Africa may slow the process.

China's new crown vaccine is becoming a global public product and entering more countries. IC photo

Eight vaccines reach the "end point" first

According to statistics, as of February 1, among more than 200 new crown vaccine projects in the world, 8 new crown vaccines have been approved for the market or obtained emergency use rights, namely, the new crown vaccine of sinopharma group, the new crown vaccine of China Kexing biological Co., Ltd., the new crown vaccine jointly developed by Pfizer and German bio new technology company, the new crown vaccine of Moderna in the United States, Oxford University of England and AstraZeneca pharmaceutical The new crown vaccine jointly developed by the company, Russia's "satellite V" new crown vaccine, Russia's "epivac corona" vaccine and India's "covaxin" new crown vaccine. In addition, Novavax, Johnson & Johnson and other enterprises have made public the data of phase III clinical trial of new crown vaccine, and important progress has been made in China's phase III clinical trial of kangxinuo vaccine.

These vaccines are mainly divided into five technical routes: 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 that have been started in the world, namely, mRNA vaccine, adenovirus vaccine and inactivated vaccine. Various technical routes have their own advantages and disadvantages: the process of virus inactivated vaccine is the simplest, but the immune titer is relatively low; the adenovirus vaccine is well tolerated, but some people have adenovirus antibodies, which will lead to vaccine failure; the production speed of mRNA vaccine is the fastest, but it is easy to degrade.

Among them, the two new coronal vaccines made in China belong to inactivated vaccines. Inactivated vaccine refers to the 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 biological Co., Ltd. both said that the production capacity was expected to exceed 1 billion doses this year. However, there are difficulties in P3 level operation, separation and purification in the production of this kind of vaccine. It is worth mentioning that who is currently in the late stage of evaluation of the two companies' new crown vaccines.

At present, Pfizer vaccine, Moderna vaccine and AstraZeneca vaccine are still the main vaccines in foreign countries, especially in European and American markets.

Pfizer vaccine and Moderna vaccine are both mRNA vaccines. At the end of last year, Pfizer vaccine and Moderna vaccine 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 US $19.5 per needle and US $39 per person; the 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; the production capacity is expected to reach 500-1 billion doses this year.

According to a doctor who works in the United States and has been vaccinated with two doses of Pfizer vaccine, he told 21st century economic news: "after two doses of vaccine, we really feel serious weakness and headache, especially the second dose."

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, following Pfizer and Moderna. The price is 4-5 USD / injection and 8-10 USD / person, which is relatively cheap compared with mRNA vaccine.

In addition to the above five vaccines, Russia's "satellite V", "epivac corona" vaccine and India's "covaxin" new crown vaccine have also attracted extensive attention of the international community. Among them, "satellite-v" is Russia's first new crown vaccine, 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, "epivac corona" was registered in Russia. It is worth mentioning that there is a big difference between the two vaccines. The former is adenovirus vector vaccine, which takes two different human adenoviruses as vectors respectively, which has high protection rate for severe cases; the latter belongs to synthetic peptide vaccine, which is composed of artificially synthesized virus protein fragments, which has strong resistance to virus mutation and can be reused indefinitely.

It should be noted that the effectiveness of the eight vaccines is different. 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 protective effects according to different regions: the protective effect of Indonesia was 65.3%, that of Brazil was 50.38%, and that of Turkey was 91.25%. The effective rate of AstraZeneca new crown vaccine was relatively low, with an average efficacy of 70%, while the protection rate evaluated by the European drug administration was only 59.5%. In addition, the Russian side said that the effectiveness of the "satellite-v" vaccine was 91.4%, and that of the "epivac corona" phase 1 trial showed that the immune efficacy was as high as 100%. India has yet to disclose the results of clinical trials of the "covaxin" crown vaccine.

"In addition to becoming the world's largest vaccination vaccine, the new crown vaccine may also have an impact on the restructuring of the entire vaccine industry. In the past, there were more concerns about the mRNA vaccine, but now it has been accepted. Although there are still restrictions, it has a huge impact on the entire vaccine industry." A vaccine industry researcher in South China told the reporter of the 21st century economic report.

In addition to the above eight vaccines approved, there are also a number of new crown vaccine projects around the world, which have also made breakthrough progress in the near future.

Novavax, a biotech company, announced on January 28 that its covid-19 recombinant protein vaccine had an effective rate of 89.3% in the UK, becoming 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 show that it has the same efficacy against the variants of viruses in the UK and South Africa.

Following the Novavax vaccine, J & J also released phase III clinical data of its new crown vaccine. It is worth mentioning that, unlike other vaccines on the market that require two injections, Johnson & Johnson only needs one injection. However, the performance of the vaccine varies from country to country. It is 72% effective in the United States, but only 57% in South Africa and 66% in Latin America, where the new coronavirus variant is rampant.

In addition, new news has also come from the adenovirus vector vaccine developed by the team of academician Chen Wei of the Academy of Military Sciences and kangxinuo biology. According to the announcement released on February 1, the recombinant new coronavirus vaccine developed by kangxinuo biological Co., Ltd. has been vaccinated to more than 40000 subjects. The interim analysis shows that it has successfully reached the preset main safety and effectiveness standards, and there is no serious adverse event related to the vaccine. Therefore, we can continue to promote the phase III clinical trial.

Industry giants announced the termination of vaccine research and development

As the global vaccine R & D race entered the "second half", some arrived on schedule, while others dropped out.

On January 25, eight months after the development of the two new coronal vaccines, mersadon, one of the four major vaccine giants in the world, announced that it would stop developing v590 and v591 candidate vaccines for the new crown, and instead concentrate 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 the two new coronal vaccines is lower than that after natural infection and other new coronal vaccines in phase 1 clinical study. In addition, according to evaluateparma, Merck's share price fell by 12% in 2020, with a market value loss of $24.6 billion. As a result, MSD became the first multinational pharmaceutical giant to announce the termination of the new crown vaccine research and development project.

In addition, the Pasteur Institute of France announced on January 25 that a major new crown vaccine research and development project would be terminated due to the disappointing results of clinical trials. The Pasteur Institute, which detailed the reasons for this, said that in the initial human clinical trials, the test vaccine was well tolerated, but the immune response was not as good as that observed in naturally recovered patients and in people who had received the authorized vaccine.

In addition to R & D, the current mass production of approved vaccines is also a key issue of market concern. Recently, Pfizer and AstraZeneca have been in dispute over the delivery of vaccines.

On January 15, Pfizer, together with German biotechnology company, announced that it would "adjust the production process" of Pfizer vaccine production base in Pierce, Belgium, which would affect vaccine delivery to EU countries in the next four weeks or so. Such unilateral breach of contract immediately aroused strong dissatisfaction in several European countries. Denmark, Sweden and other countries successively put pressure on Pfizer and German bio new technology company; Italy, Poland and other countries also successively issued statements saying that if Pfizer failed to deliver the new coronavirus vaccine as scheduled in the contract, it would 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 reduction in production capacity at a production plant. According to the disclosure, about 80 million doses of vaccine were originally scheduled to be delivered to the EU by the end of March, but the delivery volume in the first quarter will be reduced by about 60% to 31 million doses. In response, the European Union publicly said that AstraZeneca's delay in supplying sufficient new crown vaccines to EU Member States was "unacceptable". At the request of the European Commission, Belgian regulators also conducted a surprise inspection of 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 in the face of complaints about unfair treatment of its own purchase of vaccine. After negotiation, AstraZeneca promised to increase 9 million doses of new crown vaccine, a total of 40 million doses, and the delivery date will also be one week ahead of schedule. Pfizer has promised to increase production by no less than 50% globally. However, the delivery is still less than expected.

By the end of January, more than 10 countries in the world have approved the registration and listing of China's new crown vaccine or emergency use. 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, the Philippines, Myanmar, Cambodia, Laos, Sri Lanka, Mongolia, Palestine, Belarus, Sierra Leone, Zimbabwe and Equatorial Guinea, according to the Ministry of Foreign Affairs on February 1. The next step will be to assist 38 other developing countries in need of vaccines.

?