'Snatching' Russia : Solid Foundation or 'Launching Satellites'?

In September, the world is likely to officially usher in the first new coronavirus vaccine. At this time, it was less than 10 months since the first known case of new coronary pneumonia was discovered. This speed far exceeds the 8-10 years required for general vaccine development.

Global developers are racing against time and 170 vaccine candidates flood the track.

Among them, a total of 7 candidate vaccines from China (4), the United States (2), and the United Kingdom (1) are the first to enter the final stage of phase III clinical trials. The sudden emergence of the Russian vaccine 'Sputnik-V' has also attracted attention.

At the same time, global buyers represented by governments of various countries have also preemptively placed orders, and the 'vaccine battle' is about to start.

Surging international launched a series of reports on the 'Global Vaccine Road' to comprehensively analyze the 'racers' on the vaccine development track.

In 1957, the Soviet Union successfully launched the first man-made satellite, triggering global exploration of space. Today, 63 years later, Russia seems to be once again leading the way in vaccine research and development in the face of the new coronary pneumonia that is ravaging the world.

On August 11, Russian President Vladimir Putin announced that the Russian Ministry of Health had granted national registration to a new coronavirus vaccine developed by the country for the first time. Russia became the first country in the world to register a new coronavirus vaccine.

This new coronavirus vaccine was developed by the 'Gamaleya' National Research Center for Epidemiology and Microbiology (hereinafter referred to as the 'Gamaleya' Center) and was named 'Sputnik-V'. According to the 'Sputnik-V' website, this vaccine has a similar leading significance to the artificial earth satellite 63 years ago, hence the name.

It is worth noting that when the vaccine was officially registered in August, this candidate vaccine had just completed phase I/II clinical trials, and the phase III clinical trials that were necessary before the vaccine went on sale had not yet started. The first phase started on June 17 clinical trials are also more than two months later than in countries such as China, Britain and the United States.

The 'Sputnik-V' of the 'heroic paradigm' has been widely disputed. At the same time, Russia’s second new coronavirus vaccine is on the way and is expected to be registered from the end of September to early October.

Suffer Controversy

According to Günzburg, Director of the 'Gamaleya' Center, introduced on the 7th, the 'Sputnik-V' vaccine is an adenovirus vector vaccine. The principle is to introduce the nucleic acid fragment encoding the new coronavirus spike protein into the adenovirus and use the adenovirus as a vector to induce the human body's immune response to the new coronavirus spike protein.

This is the fastest progress among at least 26 new coronavirus vaccines being developed by 17 scientific research institutions in countries. The vaccine's Phase I and Phase II clinical trials ended on July 15 and August 3 respectively, and reached the Russian vaccine safety and effectiveness standards. According to the plan, the 'Gamaleya' center will start a five-month phase III clinical trial this month. The Press of the Russian Ministry of Health said on the 26th that 40,000 volunteers will participate in the post-registration trial of the new coronavirus vaccine, and every volunteer must be observed for half a year after receiving the new coronavirus vaccine.

However, before the results of Phase III clinical trials are released, Russia will start vaccination work ahead of schedule. Alexander Günzburg, Director of the National Research Center of Epidemiology and Microbiology of Russia and Gamaleya, stated that the Russian Federal Health Supervision Service will inspect the mass-produced vaccines on the market. After that, on September 15-20 vaccination work was started between.

'I think this is really scary and really dangerous.' The New York Times quoted Daniel Salmon, director of the Institute of Vaccine Safety at Johns Hopkins University, as saying that Russia jumped on the 13th. Passing the Phase III trial is a dangerous step.

Breaking the routine process of 'snatching' has caused controversy and doubts about this vaccine in Russia. On the other hand, the failure of Russian experts to publish the data of Phase I and Phase II clinical trials of 'Sputnik-V' like their international counterparts has also become the point of greatest concern to the outside world.

In this regard, Vladimir Chekhonin, Deputy Dean of the Russian Academy of Sciences, explained that Russia’s vaccine research and development did not start from scratch. Russia had previously used the same adenovirus vector technology to prepare Ebola virus vaccine. 'The Gamaleya Center has a very strong team of experts, they have rich experience in both bio-engineering and genetic engineering, and they also have their own production equipment.' Chekhonin said, based on SARS  and MERS (Middle East Respiratory Syndrome) virus research experience, the team determined the platform route for vaccine development at the beginning. 'There is no reason to doubt that they can not complete this work with high quality.' He said.

This has also been confirmed by Barry R. Bloom, an academician of the National Academy of Sciences and a professor at the Harvard School of Public Health. Bloom said in a conference call on August 11 that Gamaleya is one of Russia's best research institutions, and Russia has always been at the forefront of bio-terrorism research. However, he also pointed out that it would be better if the Russian test data were more transparent.

An article in 'Science' magazine after the 'Sputnik-V' registration also annotated Russia's 'snatch'. In the United States, the Food and Drug Administration (FDA) can use the so-called emergency use authorization in a drug clinical Approved for use before the trial is completed, the registration of this vaccine in Russia is similar to the emergency use authorization of the FDA. However, the article also pointed out that the FDA has an independent advisory committee composed mainly of academics that regularly reviews vaccine approval applications. And Alexei Chumakov, a researcher at a research institute in Moscow, told 'Science' magazine that the Russian Ministry of Health does not seek the opinions of the Russian scientific community like the FDA.

However, according to the 'New York Times' report on August 23, Russian doctors did not buy 'Sputnik-V'. In an online survey, only 24% of 3,040 doctors said they would inject the new coronavirus vaccine into patients.

In addition, four Russian trade unions representing doctors and teachers have also advised their members not to vaccinate.

'I will definitely not go to Russia for this vaccine./ The Russian girl Marina, who had studied in the UK, told that she did not believe in the government's propaganda of vaccines, her aunt and cousin are all infected with new coronary pneumonia, but they feel that they can only take protective measures by themselves.

It is understood that the Russian 'Sputnik-V' requires two injections, the first injection is the adenovirus vector 26 (rAd26) vaccine, and the second injection is the adenovirus vector 5 (rAd5) vaccine. The former is similar to a new coronavirus vaccine candidate developed in the United States, and the latter is similar to the candidate vaccine that the Chinese Academician Chen Wei team/Kangsino company is cooperating to promote. Both Chinese and American candidate vaccines currently have very good prospects. Even so, these two vaccines are only in Phase III clinical trials to verify their effectiveness and safety.

On August 10, the day before the 'Sputnik-V' vaccine was registered, the Association of Clinical Trial Institutions (ACTO), located in Moscow and representing the world’s top pharmaceutical companies in Russia, submitted an open letter to the Russian Ministry of Health, calling on the Ministry of Health to stop. The practice of pre-approving vaccine registration, the open letter pointed out, is a relic of the so-called 'heroic paradigm' in the pioneer era of vaccination, 'and modern medicine follows the standard to reduce human risks'.

A politician unnamed, also interprets Russian vaccine research and development from a political perspective. He said that Russia is, undoubtedly, acting similar to 'launching satellites' was used as a political resource. 'Vaccines are an extremely important political resource. Whoever controls the vaccine first will control the initiative in the new order in the post-pandemic era.' The politician told that if the vaccine is proven to be really effective, it will not only help the country. Early full recovery of economic activities can also attract countries to purchase vaccines. On the other hand, vaccines are also a kind of 'political weapon' internally. Even if there is a lot of unknown, they can improve the legitimacy of the regime and system in the short term.

Chekhonin also responded to the suspicions of the international community from the political context, saying that foreign negative comments on Russian vaccines are 'related to competition' and that 'they understand that they are too backward and therefore too critical'. Earlier, Gunzburg, also made similar remarks.

Immediately after Russia announced the registration of 'Sputnik-V', WHO spokesperson Tarik Jasarevic said that accelerating the progress of vaccine development cannot be done at the expense of vaccine safety and effectiveness. Jasarevic said that there are currently more than 160 vaccine candidates, and the WHO website is updating the overview of candidate vaccines every week. All standards can be found on the WHO website, and all candidate vaccines need to be thoroughly checked.

As of August 25, in the latest data released by WHO, it has not yet acknowledged that 'Sputnik-V' is among the candidate vaccines for Phase III trials.

Orders are Coming

Although there are many doubts, after Russia announced the world’s first registered vaccine, Dmitriev, President of the Russian Direct Investment Fund (RDIF), which funded vaccine development, said that a total of 1 billion doses have been purchased from more than 20 countries. For the application of the 'Sputnik-V' vaccine, 150 countries have been reviewing Russian vaccine patents. Five countries including Brazil and Saudi Arabia are very interested in technology transfer. They also hope to produce Russian vaccines in their own countries.

On August 15, the Russian Ministry of Health announced that it had begun production of the vaccine.
Russian Minister of Industry and Trade Manturov stated on August 24 that Russia’s monthly output of new coronavirus vaccines will reach 1.5 to 2 million doses before the end of this year, and plans to gradually increase the monthly output to 6 million doses thereafter.

On the same day, the spokesperson of the president of neighboring Belarus stated that the leaders of Russia and Belarus have reached an agreement that Belarus will become the first country to import 'Sputnik-V'. Belarusian citizens will also voluntarily participate in the Phase III trial of the vaccine.
Two days later, Central Asian country Kazakhstan also reached an agreement with Russia on the new coronavirus vaccine. The Kazakhstan government website reported that the Russian Direct Investment Fund and the Kazakhstan SK Pharmaceutical Company signed an understanding agreement, promising to provide a sufficient amount of 'Sputnik-V' supply after the test is over. Kazakhstan is ready to invest in the establishment of a national epidemiology and microbiology research center. Kazakhs can receive free and voluntary vaccination.

According to a report from 'The Tribune' on August 25, the Indian government said that it was communicating with Russia on the 'Sputnik-V' vaccine. The two sides have shared basic information about the vaccine, and the details are still being discussed.

In addition, President Duterte of the Philippines, President Maduro of Venezuela, President Vucic of Serbia, and President Lopez Obrador of Mexico all expressed their intention to become the 'first people' in their country to receive the Russian vaccine.

Regarding the influx of orders, according to TASS news agency, the Russian Direct Investment Fund and partners are formulating a humanitarian assistance plan for some developing countries so that they can receive the new coronavirus vaccine on an equal footing. 'We believe that people all over the world should receive vaccines equally, regardless of their economic status, religious beliefs, place of residence or other factors.' Dmitriev said at a conference.

In addition to 'Sputnik-V', Russian Deputy Prime Minister Golikova also revealed in a video conference held by Russian President Putin and government members on August 26 that the country will register a second new coronavirus vaccine from the end of September to early October.

The Russian Federal Consumer Rights Protection and Public Welfare Supervision Agency stated on the 21st that the second Russian new coronavirus vaccine developed by the Russian National Science Center for 'Vector' Virology and Biotechnology is undergoing Phase II clinical trials and will be vaccinated in Phase II trials with 43 volunteers. At present, the volunteers generally feel good and there are no obvious side effects. The Phase II clinical trial is expected to end in September.