The world-class race to develop a vaccine against COVID-19 has attracted scientists from the Russian Federation, Great Britain, India, the United States, China and the countries of the European Union. Subtotal – the end of the 3rd stage of clinical testing. The beginning of mass production does not seem so far away. Both state prestige and a billion-dollar market are at stake.
The billion-dollar vaccine
What is the dynamics of promoting basic research projects regarding the development of an effective vaccine against coronavirus? With the beginning of the autumn period and the arrival of numerous tourists from distant countries, where they spent their summer holidays, the whole world is expected to record another wave of coronavirus infection. According to analysts from Johns Hopkins University, on the morning of October 4, there were more than 34.8 million cases of COVID-19 infection. The statistics data include more than 1 million deaths (exact estimates as of 10/04/2020 – 1,032,235 people). An anti-record was recorded a week earlier. Globally, the number of infected increased by 360,956 cases per day. This negative trend draws public attention to the development of major research projects designed to develop an effective vaccine against coronavirus. Based on the National Research Center (SIC) of Epidemiology and Microbiology named after NF Gamalei’s research has already led to a positive result. Sputnik V is a drug that has been transferred to the testing phase in practice, although its volumes are still limited.
We will open our concise overview of developments in the global vaccine industry with Russian developments, because the flagship drug “Sputnik V” of the Research Center for Epidemiology and Microbiology. NF Gamalei has already entered the testing phase in practice, although its scope is still limited. According to the latest data presented to the general public by the Deputy Mayor of Moscow, Anastasia Rakova, this drug was administered to more than 5.7 thousand subjects. According to the Ministry of Health of Russia, by the end of October, a trial vaccination with the drug will be made to almost 40 thousand citizens. It is this amount that is optimal to comply with the international standards set for the third stage of clinical testing. The head of Rospotrebnadzor in her speech on NTV said that September 30 is a landmark date when Sputnik V entered the post-registration testing phase. This means that Moscow has already passed to the second stage of vaccine administration. It was also noted that the mass use of the drug on the territory of the Russian Federation will be carried out next year. So far, vaccination has been carried out for doctors and people at risk. The first deliveries of the vaccine to Egypt have been agreed. The preliminary number is 25 million copies. The agreements were signed at a meeting between Pharco and RDIF ( Russian Direct Investment Fund ) representatives . Prior to that, agreements were already signed regarding the supply of the vaccine to India (100 million copies), Mexico (up to 50 million copies), Nepal (25 million copies), Brazil (up to 50 million copies), Uzbekistan (35 million copies). The next main event, which the head of Rospotrebnadzor highlighted in her speech, was the end of the second phase of clinical testing of another drug. Its development is carried out by the scientific center “Vector” from Novosibirsk. Representatives of the Ministry of Healthcare and Rospotrebnadzor previously said that the drug EpiVacCorona, which is being developed by the Novosibirsk Scientific Center, will have time to register by mid-autumn. After the completion of registration activities, clinical testing of the third stage can begin. Elderly people (over 60 years old) will be selected as subjects. Representatives of departments also announced the release of the first batch of a production sample. This event is scheduled for November. Representatives of the Federal Service for Intellectual Property reported that the Novosibirsk center had already received the necessary patents for the vaccine they had developed. The press service’s statement is dated September 30. In addition, the Head of Rospotrebnadzor announced the continuation of clinical testing of the third drug from the Russian-made coronavirus. The development is carried out by representatives of the Federal Scientific Center for Research and Development of Immunobiological Preparations named after V.I. M.P. Chumakov of the Russian Academy of Sciences (RAS). The researchers plan to finish testing in mid-November. It is worth noting that the statement of the head of the production department of this center says that the vaccine has permission from the Ministry of Health, which regulates clinical testing. For this, volunteers must be selected, starting from October 1. The review, which appeared on September 30 in the popular British edition of The Guardian, contains parts of a speech by the head of the Russian Direct Investment Fund Kirill Dmitriev. It should be noted that RDIF acts as the main curator of cooperation between the Russian Federation and other countries regarding drugs for coronavirus. According to him, the use of the drug on people from high-risk groups is already being carried out on the territory of the Russian Federation. According to the plan, at the beginning of winter, it is expected to release about 10 million copies of the vaccine per month. The head of the RDIF also noted that such volumes of production would make it possible to vaccinate most of the country’s citizens in six months. In addition, the plans include licensing the production of the Sputnik V vaccine in other countries, including India. According to Kirill Dmitriev, in 2021, the production volume of the drug will reach 500 million copies. China’s ambitious vaccination claims Vaccine projects are developing extremely rapidly in China, which has become the cause of the global pandemic. Last week, Deputy Director of the National Administration for the Registration of Medical Products (the main biomedical regulator of the PRC) Yang Sheng stated that the 4 experimental drugs simultaneously entered the final clinical testing phase. Each of them has been tested on volunteers both in China and in ten other states. In the near future, it is expected that these states will receive permits for the mass production of the drug. Yang Sheng also said that China is actively developing 5 types of vaccines. Each species is tested and verified. In total, 11 Chinese-made drugs are currently at different stages of clinical testing. In addition, Shen said that according to the plan, China should release 610 million copies by the end of this year. Next year, production volumes will reach 1 billion copies. Two basic PRC projects for the production of a vaccine against coronavirus are preparing to complete the third phase. The Beijing Institute of Biological Products is working on the first project. Research is overseen by the state-owned Chinese biopharmaceutical company Sinopharm. Private firm CanSino Biologics is working hard on the second project. It was created on the basis of the State Institute of Biotechnology and the Military Academy of Medical Sciences. It is important to note that the PRC is among the states that have made a decision on an emergency vaccination against coronavirus at the official level. This means the vaccine does not have to go through the final phase of clinical testing. It is also worth noting that the United Arab Emirates has already started vaccination of the population with Chinese-made drugs since September 14. Unofficial estimates state that about 350,000 volunteers have already been vaccinated in the PRC. First of all, the vaccination is given to those citizens who plan to leave the country for work or study. It is also worth noting two promising developments from India. The first project resulted in the Covaxin vaccine from Bharat Biotech. This development is currently undergoing the second phase of clinical testing. The second project is developing the ZyCoV-D vaccine from Zydus Cadila. According to information from Indian media, the project has entered the third phase of testing. Deadline – until November 3 If we are talking about Western countries, then their plans for the development of drugs are based on Bigpharm research. Experts note that active biostartups can provide tangible help in this matter. In addition, all promising drugs created by biopharmaceutical companies in the West (in the UK and the United States) receive large material, organizational and technical assistance within the framework of the national program Operation Warp Speed (OWS, “Operation Superlight Speed”). This antivirus project was presented to the public in the summer. It is worth recalling that the goal of this public-private program is to accelerate the process of creating, scaling up the release and active use of vaccines against coronavirus. Moreover, the program is applicable to therapeutic and diagnostic drugs. The launch was carried out by the US President in mid-May. As material aid, the United States Congress transferred about $ 10 billion to the OWS account. The Advanced Biomedical Testing and Development Authority received about 6.5 billion, and the rest went to R&D applications within the National Institutes of Health system. Statistical data from the official website of the program say that the plans of the coordinators include an early exit to the level of industrial production. They claim to be able to produce 300 million copies of a drug that is safe and effective. This volume of production is able to fully provide US citizens with the vaccine. The first batch of the drug should be released early next year. The first phase of the OWS program included the selection of 10-15 drugs from 100 existing ones. Further, the list of vaccines was reduced to 7 options. At the moment, the exact number of vaccines involved in testing has not been disclosed. At the same time, the official Internet resource of the program contains clear figures regarding the total funding indicators listed to the developer firms. After reviewing the data provided, we can summarize: the curators of the program have already chosen the leaders of this race – they are the Department of Health and the Department of Defense of the United States. Johnson & Johnson (Janssen), a biopharmaceutical corporation, received the first major payment for the development of a vaccine. The grant was $ 456 million. In addition, at the end of the summer, this project received re-financing, which amounted to $ 1 billion. In mid-April, the Ministry of Health gave approximately the same financial grant (483 million) to the relatively young firm Moderna Therapeutics Inc., which is developing the mRNA1273 vaccine. Experts note that quotations of the company’s shares on the Nasdaq during 9 months of 2020 increased by approximately 3.5 times. At the moment, the market value of Moderna is estimated at $ 28 billion. When creating this promising drug, Moderna scientists are using a radically new method: protein compounds for the project are artificially grown in human muscles (stem cells). Further, the genetic information of the protein is temporarily stored in an intermediate substance – messenger RNA (mRNA). It is the messenger that translates the genetic code of DNA into cellular compounds. For months, Moderna’s development has been replicated by the media as a leader in the vaccine race. In part, it was possible to draw conclusions about this and on the material credits of OWS. On July 26, the companies were awarded a second financial aid grant. Its size under the program itself was $ 472 million. This money was allocated for the third stage of clinical testing, which began the next day after receiving the grant. Two weeks later, Moderna received one of the largest payments – $ 1.5 billion. It is worth noting that in the process of project development, the OWS program allocated larger grants.At the end of May, $ 1.2 billion was received by a joint project of Oxford University employees and scientists from the British-Swedish firm AstraZeneca. This project created a drug codenamed AZD1222. It can be considered the “British response” to the United States. At the moment, it is this development that acts as the most serious competitor to the leaders from America. However, in the fall, its third clinical stage, which started at the end of August, was suspended after the discovery of serious side effects in the subject. But the work of the British government regulators Oxford-Astra (Medicines Health Regulatory Authority) should be noted. They decided to neutralize the bureaucratization of the testing process for this case and, 7 days after the suspension, an order was given to resume clinical testing in the UK. This example of regulation was quickly adopted by the Indian authorities. There Oxford-Astra is held with the participation of the national company Serum Institute of India. But the regulators from the United States were insured or simply had the goal of suspending the activities of rivals from the UK. After all, the Oxford-Astra program did not start over in the United States. On the subject of increasing OWS rates, it is worth noting that in early July, the curators allocated a serious grant – $ 1.6 billion. It was received by a company that entered the race relatively recently. Back in the spring, this firm was not on the list of Novavax analysts. The third and final round of testing for the experimental drug Novavax was launched (concurrently with the UK and the United States) on 28 September. According to comments from The Times, this vaccine was among the 11 drugs globally that has reached the final stage of testing. Earlier this milestone was reached by the first HHS-sponsored drug from Johnson & Johnson. On July 31st, serious financial support from OWS (as stated on the official Internet resource, “about $ 1 billion”) was provided to one mysterious participant in the race. It was a Franco-British scientific project organized by Sanofi and GlaxoSmithKline (GSK). Previously, the rather mysterious absence of the project in the area of interest of the heads of the US program often worried the media representatives. The emphasis was on the fact that OWS Chief Scientific Adviser Moncef Sloughi previously served as a top manager of GlaxoSmithKline. This fact, in the opinion of the public, should have attracted OWS’s interest in this program. But, it is important to note that Sanofi-GSK has not moved to the third stage of testing to date. Finally, we should talk about the leader of the list of experimental drugs for coronavirus – the Pfizer project. This company is actively working in the framework of a project with an innovative company BioNTech from Germany. At the end of July, the maximum financial assistance was allocated to the project – $ 1.95 billion. According to Pfizer top managers, such a grant is needed not to support R&D, but for the rapid development of the industrial production capacity of their drug. The Pfizer vaccine has already passed two stages of testing, and it has long since started the third. A large number of citizens are involved in the tests on a voluntary basis. According to preliminary estimates, their number reaches 44,000 volunteers. Experts predict that this drug will be among the first to receive FDA (Food and Drug Administration) approval. Pfizer spokesman Albert Burla has announced the specific financial potential of their vaccine, while other experimental vaccine makers are silent about it. Many experts say that the estimated market size of drugs for coronavirus will be very significant, even taking into account the capacity of Bigpharm. According to Ronnie Gala, a leading specialist at investment firm Bernstein, the vaccine market could generate about $ 18 billion at the start. Pfizer-BioNTech is currently the primary focus of interest for the newly coronavirus-infected President of the United States. Pfizer has been called “a great company” by Donald Trump and Albert Burla a “great guy.” Such demonstratively positive comments of the US President regarding Pfizer are most likely due to Burla & Co.’s willingness to announce clear terms for the release of drugs. It is worth noting that other participants in the vaccine race do not risk divulging the time frame. Burla, in contrast, announced that his company would receive FDA approval by the end of October this year. The production release of the vaccine is planned to be launched immediately. The company has already signed an agreement with OWS to supply 100 million doses. It is worth noting that on September 22, FDA representatives unexpectedly presented a program of control recommendations and requirements. This document implies enhanced security requirements. Compliance with them is required to obtain a quick permit for the production release of the vaccine. The presidential administration in the United States has been quite active in responding to the FDA’s frustrating program. According to the US President, these changes have a political basis. That is, they are aimed at preventing Trump from reporting on the successful completion of the vaccine creation process before the presidential elections in early November. In addition, the president said that this program is approved by representatives of the White House, and they can reject the changes. Moreover, on September 23, the head of the CDC (United States Center for Disease Control and Prevention), Robert Redfield, inadvertently said that immunization against coronavirus of all US citizens would probably drag on until next summer. The specified dates were criticized by the US President, he called them “wrong.”