After 63 years, Sputnik is back again in public discussion. Russians, then USSR launched Sputnik-1 on 4th October 1957. That 58 cm diameter, small polished metal ball, with four long antennas became first-ever human-made satellite to orbit our planet earth. Sputnik instantly became a global household name and icon of scientific achievement. Then Sputnik changed everything and started the space race. Today we can’t imagine life even for a minute without the mad made satellites. But then Sputnik was first. On 10th August 2020, Russians launched another Sputnik, now on the ground, in the lab. Russians are first again. The Sputnik V is the Vaccine to fight COVID-19. Russians seem to be ahead of another race, this time to fight a tiny virus.
Sputnik V : will it save lives and halt the decline of global economy?
After six decades, humanity is facing unprecedented challenge. Progress in space, progress on earth are not able to contain an invisible tiny virus. The fear, the panic and the havoc, this COVID-19 created has started another race on earth. Race to discover the Vaccine to contain this deadly virus and its unprecedented economic, social and political impact. The battle for the Vaccine for COVID-19, for which everyone on planet earth is waiting, has been won, at least for now, by Moscow. Russian Government surprised the world by announcing the approval of the Vaccine against severe acute respiratory syndrome coronavirus 2, scientifically known as SARS CoV-2. Gamaleya National Research Center of Epidemiology and Microbiology was registered by the Ministry of Health of Russia and became the world’s first registered Vaccine against COVID-19. Every few people, including many western experts believed it. Many western countries, their media dismissed it as Putin’s propaganda. Many others were sceptical about it and its authenticity. Even some experts questioned its validity and some even warned the danger of such announcements.
Will Sputnik-V save lives? Is Sputnik V is beginning of end of COVID-19? Too early to say, but certainly Russians seem to be at least two steps and three months ahead of rest of the 8 players most of them in the western world. Sputnik has already changed the rules of the game of Vaccine.
Publication in British Medical Journal- Lancet.
After three weeks of that approval, Russian scientists published a major paper in the Lancet, the most prestigious British Medical Journal. This is the scientific proof Russians presented to world but mostly to western critics. The data and scientific process was scrutinised, reviewed mostly western scientists before publishing this 11 page paper by 33 Russian scientists. Russians seem to have three objectives a) to demonstrate the scientific vigor of their break through b) to announce the road map for phase 3 trails which have already begun and most importantly c) to convince the major countries like India, Brazil etc to be partners in producing and using their Vaccine. Unlike Sputnik 1, this is not about dominance or being first, but Russians wanted to tell the world that, they are still players and they can do major breakthroughs to protect their population. This is also to establish their market share in potential vaccine market. Russian scientists are serious and they indeed seem to have succeeded in developing the Vaccine. The test results are very impressive. Not that this publication will silence the critics, but it appears, Russians are certainly ahead of the other 8 players in the game.
As expected, some western scientists, policy makers and politicians are still sceptical and even critical of the Russian process. No one questioned the results published, at least not yet. Now, the main western objections seem to the approval process of the Russian Government, not about the scientific merits or otherwise of the Vaccine developed by the Russian scientists. While Russian Government approval, surely might have some national and economic motives, but so far, at least there is no constructive scientific critics of the results of their efforts. Russians, not only published the data but seem to be well prepared to deal with future discourse and the process. In order to facilitate the feedback, discussion and counter the criticism, Russians set up a website (https://sputnikvaccine.com/), which is in English. The website purpose is “provide accurate and up-to-date information about Sputnik V and to combat the misinformation campaign launched against it in the international media”.
Vaccine was developed by The Gamaleya National Centre of Epidemiology and Microbiology which is the world’s leading research institution. Their website states that “The center was founded in 1891 as a private laboratory. Since 1949 it bears the name of Nikolai Gamaleya, a pioneer in Russian microbiology studies”. The Gamaleya center is headed by Alexander Gintsburg, a member of the Russian Academy of Sciences. The Gamaleya centre website states that “Center successfully developed and registered in 2015 two vector-based vaccines against Ebola fever using the adenovirus vector platform. Another Ebola fever vaccine was registered in 2020”.
The vaccine development has been financed by Russian Direct Investment Fund (RDIF),
the country’s sovereign wealth fund. It is not known how much money has been spent on this effort. But CEO of the fund, Kirill Dmitriev, seem to be confident and strongly critical of the western motives and states “instead of looking into the science behind the proven adenoviral vector-based vaccine platform Russia has developed, some international politicians and media chose to focus on politics and attempts to undermine the credibility of the Russian vaccine”. The RDIF established in 2011 “portfolio companies employ more than 800,000 people and generate revenues which equate to more than 6% of Russia’s GDP. RDIF has established joint strategic partnerships with leading international co-investors from more than 18 countries that total more than $40 bn”. So clearly, Russia by developing this Vaccine, not only focusing on its national interests and national pride but also targeting commercial gains as well.
Sputnik V vaccine.
So Russians not only developed Vaccine but also putting in place to fund the process of producing it. Gamaleya national research centre itself has vaccine production facility, but that is too small, it appears, Russians are looking for global market and global production.
According to Russian website press release (https://sputnikvaccine.com) the Vaccine is “world’s first registered coronavirus vaccine” and completed phase 1 and 2 trails. The Vaccine is going for phase 3 “First results of the ongoing post-registration clinical trials involving 40,000 volunteers are expected to be published in October-November”
The Vaccine has been created with process “a gene with the code of a coronavirus S (spike) protein is inserted into an adenoviral vector”. This inserted component is helps the immune system to react and produce antibodies. This process is called “vaccine vectors” which contains only genetic material of the virus, not the virus itself. Since Vaccine does not contain the coronavirus “which means that it is impossible to get sick or to infect others. A vaccinated person does not become a virus carrier”, says the website. The Vaccine is designed to produce protective antibodies and cells in response to the genetic material present within the Vaccine.
Is it safe?
This is the debate and some extent the western criticism. The main contention of the critics is that the approval process has been rushed without waiting for the positive data of phase 3 trails involving large number of human trails on volunteers. This criticism is technically right. During the normal process, the phase 3 trails are required. But this is not a normal situation. That might be the reason for Russians cutting short a little bit and advancing the approval process. Probable reason for Russians rushing the approval, three months or so in advance, is western world pushing their own Vaccine in commercial way. Trump administration has pre-ordered 100 million doses of Moderna’s mRNA vaccine, and 300 million doses of Astrazeneca’s Advenovirus vector vaccine. Australia recently ordered 85 million doses from Oxford/Astrazeneca and entering commercial agreement with more than $1.5 billion. These commercial agreements before phase 3 trails and not yet completed the process or published any data that their safety . USA already pre-paid close to billion dollars on these purchases. Russians by approving their Vaccine and publishing the data in Lancet, have effectively stopped the pre-orders for Vaccine from many other countries particularly developing countries where the global market is large. The major countries such as India, Brazil might choose to be part of the Russian effort and invest in mass production of Vaccine. Certainly Russian decision to approve is based on commercial and national interests, so as the western criticism on Russian approval process.
Some western scientists such as Peter Openshaw, of Imperial college London who has been quoted in Lancet that “Immune response might not be directly proportional to the degree of protection—you can only find this out in large-scale trials”. The Russian understand this criticism and have a response from Kirill Dimitrov, CEO of RDIF “The publication in The Lancet shows Russia’s openness and readiness for dialogue, and is also a powerful response to sceptics who unreasonably criticized the Russian Vaccine. During a pandemic, it is especially important to use a vaccine platform with proven safety, as Sputnik V does, so as not to leave the world without an effective protection from coronavirus, but also not to risk people’s lives using untested experimental technologies. We are now witnessing a change in the global approach towards the registration of vaccines with the USA, UK, China and other countries following Russia’s path in fast-tracking registration”
The criticism of the west also need to be seen in commercial context than scientific. But Russia seem to be moving systematically both at scientific and commercial front, by publishing the articles in the western journals like Lancet and moving to forge partnerships with large countries for mass production.
AstraZeneca Vaccine and trails in India
The Oxford/AstraZeneca Vaccine is the one many western countries were hoping to save the situation. The AstraZeneca also got wide publicity and financial backing with commitments to buy if the phase-3 trails are success as and when production starts. On 9th September, one week after Russians published The Lancet paper, BBC reported that final clinical trials “have been put on hold after a participant had a suspected adverse reaction in the UK”. The New York times reported that the the UK participant developed a “Transverse myelitis” and inflammatory syndrome which effects spinal cord. Anyway this is serious roadblock and will benefit Russians provided their Phase-3 trails are completely free of any side effects and their reporting is credible enough to the rest of the world. That is challenge. In the meantime, there is call for halt of Phase 3 trails in India by the AstraZeeca which are reported to be continuing ever after Oxford announced. A “pause” on their UK trails. This new situation certainly help many countries to closely monitor the Sputnik-V phase 3 trails, which Russians reported already underway.
What is next?
Russian scientists are already doing The phase 3 clinical trials. In addition to that they want to do clinical trials “in different countries, including Saudi Arabia, UAE, Brazil and the Philippines”. After that they want to “start mass production in other countries in partnership with local sovereign wealth funds, including India, South Korea and Brazil, as well as, in Saudi Arabia, Turkey and Cuba”
Mass production of the Vaccine is expected to start in September 2020. It is planning to start mass production with financial backing of RDIF in September with their own companies R-Pharm and Binnopharm which are part of the Alium Group. Then “The plan is to ramp up the vaccine production to 200 million doses by the end of 2020 including 30 million doses in Russia.
At least 20 countries had expressed interest in obtaining the Sputnik V, including UAE, Saudi Arabia, Indonesia, the Philippines, Brazil, Mexico and India.
So, as per the website information, India is going to play major role, both in using the Vaccine and participating and funding in mass production.
What is this means to India and developing countries?
Russian approval is certainly very good development for countries like India. In such situation, more than one player, particularly from Russia will create more options for countries like India. Time is also essence. If Russia completes phase 3 trails and starts production early, this could be major advantage for countries like India. This means the production could start as early as November. India by partnering could benefit a lot from Russian success. India needs Vaccine soon.
Infections in India are raising at alarming rate. On 9th September, India reported a record number of new cases close to 96,000. This could be simply more tests are being done across the country. Still on per-capita basis India is much low in testing. For example, USA which has – cases, tested 279,000 per one million population, where as that number for India is just 38,000. That means, India conducts tests … times than today, probably, India would report more cases than USA. This is what concern outside of India. However, there is silver line in India. The death rates are very low. India reported less than 76,000 deaths so far, this is remarkable, even if someone considers reporting of deaths are lower than actual. So, it appears, the virus either different in India or our immune systems are helping to recover large number of people. Either way, India has still not peaked in terms of infections or deaths. Therefore, a vaccine, which is working and safe could be timely in order to prevent further spread and open the economy. The Vaccine is even more important, since the much hyped plasma therapy in India seem to have not shown promising results.
The race to produce Vaccine is really started with Russian approval. India needs to take advantage of this process and move fast in proper policy to work both with Russians and Western companies. Probably it is time to collaborate with Russians in their phase 3 trials while working with other companies.. India’s ability to mass-produce vaccine could be a great advantage. Apart from the commercial dimension, India needs this Vaccine in order to save lives and livelihoods. Our economy can only re-bounce once this COVID is under control.
Dr. Biksham Gujja is Scientist, worked with WWF-International as a Policy advisor and based in Gland, Switzerland, Gmail:email@example.com