A new global race
Which countries will receive the COVID-19 vaccine in the fall
Tatiana Lomskaya, Forbes, 13.06.2020
According to public statements by Russian officials, Russia may receive the COVID-19 vaccine one of the first – in the fall. But is it really leading the vaccine race?
The international race to create a coronavirus vaccine resembles the competition between the USSR and the USA for space exploration in the 1960s, The Wall Street Journal notes. Both China, Europe, and the United States are striving to present their developments as soon as possible: this will soften criticism of the authorities who failed to cope with the pandemic at an early stage. As a rule, it takes years to develop a vaccine, but in the case of COVID-19, scientists around the world hope to meet in a few months.
At the same time, European countries are more inclined to international cooperation: for example, in May, the European Commission announced an online marathon to raise funds for the development of a vaccine, which was attended by France, Germany, Japan, Canada, Saudi Arabia, Great Britain, Israel, Greece. By the end of the month, it was possible to raise more than €9.5 billion – more than planned. The COVID-19 vaccine should be a public good for the whole world, people should have equal access to it, French Prime Minister Edouard Philippe said.
But not everyone shares this point of view. The administration of US President Donald Trump intends to provide citizens of his country with priority access to vaccination this fall and has allocated more than $2 billion to both American and European pharmaceutical companies so that foreign developments are conducted in favor of the United States. Russia is also an example of "vaccine nationalism," according to The Wall Street Journal: it seeks to be the first to vaccinate its population and is developing with minimal cooperation with other countries. In May, President Vladimir Putin said that he was very much counting on the registration of the vaccine in September, and demanded that the country's intellectual property rights for development be issued in advance.
WHO recognizes 9 Russian coronavirus vaccines as promising, but none of them has yet reached the stage of clinical trials. In general, only 10 of the 136 vaccines currently being developed have been tested on volunteers around the world.
Whose vaccines are already undergoing clinical trials
The first human trials of coronavirus vaccines began in March. Clinical trials include several phases. During Phase 1, the vaccine is tested on a small group of people, its safety and dosage are checked. At the stage of Phase 2, extended trials are already being conducted on hundreds of people, among whom target age groups are singled out (for example, children or the elderly). Thousands of people are being tested in Phase 3. After its successful completion, the vaccine must be approved by regulatory authorities. To speed up the development of a vaccine, the phases can be combined: for example, a number of vaccines, according to WHO, are currently undergoing phase 1/2, that is, both the first and second phases of the study.
Oxford University + AstraZeneca. To date, developers from Oxford and the British-Swedish company AstraZeneca are the only ones who have announced the transition to the third, final phase of testing of their vaccine. To be precise – to phase 2b/3. A phase of clinical trials involving more than 10,000 volunteers, including people aged 56-69, over 70 and children aged 5-12, is now starting in the UK. This month, trials also begin in Brazil, one of the countries most affected by the coronavirus. There are 2,000 volunteers participating in this study. Later in the summer, large-scale testing of the vaccine is planned for 30,000 adult US citizens.
Scientists from Oxford have embedded fragments of the genetic code of the coronavirus in a neutralized virus-the causative agent of the common cold (adenovirus) of a chimpanzee. The developers are so confident in the successful outcome of the tests that they began production of the vaccine even before the end of the tests and the approval of the supervisory authorities. It is planned to start vaccination by October.
The Oxford vaccine is one of five receiving funding from the US government under the Operation Warp Speed program (Operation Supernatural Speed). The program aims to accelerate the development of a COVID-19 vaccine and allocates billions of dollars to promising developers.
CanSino Biologics and the Academy of Military Medical Sciences of China. In March, China's CanSino Biologics was the first in the world to begin clinical trials of a coronavirus vaccine based on the adenovirus Ad5, which causes a person to catch a cold. She was also the first to publish the results of the first phase in the scientific journal (Lancet). 108 people took part in the first phase of the research, each was injected with one of three possible doses of the vaccine – high, medium or low. The immune response was achieved, however, few neutralizing antibodies were formed in most of the subjects, and those who had a cold due to Ad5 had antibodies to the adenovirus vector itself and did not show a strong immune response to the vaccine. Also, 81% of the participants had side effects. The second phase of the CanSino vaccine trials started at the end of April, 500 people are taking part in it.
Moderna. The company is developing a vaccine based on matrix RNA (for more information, see Forbes). She was the first in the USA to start clinical trials. Back on March 16, Moderna, together with the National Institute of Allergy and Infectious Diseases, began testing 45 volunteers aged 19 to 55 years. The subjects were given two doses of the vaccine with an interval of 28 days. Already on May 18, the company announced the success of the first phase of trials based on data on only eight volunteers. The company's quotations on the Nasdaq stock exchange that day soared by 20%, to $80 per paper, but the next day fell by more than 10% – after reports that the data provided was not enough to evaluate the experiment.
Moderna is another member of the Warp Speed program. She plans to conduct phase three trials in July, and prepare the vaccine by early 2021, writes The New York Times.
Sinopharm. The Chinese state-owned company Sinopharm has started phase 1/2 clinical trials of two inactivated vaccines (based on weakened viruses). One drug is being developed jointly with the Wuhan Institute of Biologics, the other is being developed jointly with the Beijing Institute of Biologics. Several thousand people have been tested. The company has built a vaccine manufacturing plant in Beijing capable of producing 100 million doses per year, and expects that after the completion of the second plant in Wuhan this month, it will be able to produce 200 million doses of vaccines annually, writes The Wall Street Journal. Although China is quite capable of developing a vaccine before the United States and other countries, it may not receive approval in other states, as was the case with the Ebola vaccine, the publication points out.
Sinovac. The private Chinese company Sinovac Biotech is conducting the second phase of testing of the inactivated CoronaVac vaccine. The company is building a plant that will produce up to 100 million doses of this vaccine per year.
Novavax. At the end of May, the American biotech company Novavax began phase 1/2 trials of its protein vaccine. The first phase started in Australia on May 26, and if the preliminary results, which will be known in July, are positive, the company will start the second phase in several countries. Novavax has received an unprecedented grant of $384 million from the Global Coalition for Epidemic Preparedness Innovations (CEPI) for the first and second phases of clinical trials of the vaccine and the start of work on scaling up its production.
She also signed a $60 million contract with the US Department of Defense to supply her vaccine to the army.
BioNTech + Pfizer + Fosun Pharma. The German company BioNTech is developing a vaccine based on matrix RNA in cooperation with the American Pfizer and the Chinese Fosun Pharma (for more information, see Forbes). In May, Pfizer announced the start of human trials of the vaccine. If they are successful, the company expects to release several million doses for emergency vaccination in the fall. The development is also funded under the Warp Speed program.
The Institute of Medical Biology of the Chinese Academy of Medical Sciences, whose scientists invented vaccines against polio and hepatitis A, has also started the first phase of testing an inactivated vaccine against COVID-19.
Inovio. In May, the American company announced successful trials of a prototype of the INO-4800 vaccine based on DNA on guinea pigs and mice. She began testing the drug on volunteers in the United States in April, the results are planned to be received by the end of June, writes The Montley Fool. Also at the end of June, the vaccine will be tested in South Korea – first on 40, and then on 120 more volunteers.
Currently, Russia is testing about a dozen vaccines in the preclinical phase, according to WHO data. Only the USA, China and Canada presented more "candidates". It is important for the country to develop its own vaccine: it is among the top 3 countries with the highest incidence of coronavirus, the economy has been seriously affected by quarantine measures introduced due to the pandemic. Vaccines are being developed by several groups of Russian scientists, including the Novosibirsk State Scientific Center "Vector" of Rospotrebnadzor, the company "Biocard", the St. Petersburg Research Institute of Vaccines and Serums.
A vaccine developed by the Gamalei National Research Center for Epidemiology and Microbiology of the Ministry of Health of the Russian Federation together with the 48th Central Research Institute of the Radiation, Chemical and Biological Defense Forces of the Ministry of Defense is being prepared for the start of clinical trials. The researchers selected two groups of volunteers: from among the military and from among the civilians, and placed them on 14-day isolation. Defense Minister Sergei Shoigu said at the end of May that clinical trials of the vaccine will be completed by the end of July. "The estimated period for submitting the registration dossier and state registration is August. Accordingly, the industrial production that they assume for themselves is September," Deputy Prime Minister Tatyana Golikova said on Saturday, June 13. In case of successful trials, the vaccine will be produced at the facilities of R-Pharma in Yaroslavl, and the Russian Direct Investment Fund will act as a co-investor in the expansion of the enterprise's capacity.
The Vector Virology Research Center plans to start clinical trials of a coronavirus vaccine at the end of June, said its CEO Rinat Maksyutov. The Center is developing six variants of the COVID-19 vaccine.
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