21 April 2021. PenzaNews. The Gamaleya National Research Center of Epidemiology and Microbiology of the Ministry of Health of the Russian Federation and the Russian Direct Investment Fund (RDIF, Russia’s sovereign wealth fund) announced that the Sputnik V vaccine demonstrated efficacy of 97.6%, based on the analysis of data on the infection rate of coronavirus among those in Russia vaccinated with both components of Sputnik V.

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“The Ministry of Health of Russia maintains a register of persons who have been vaccinated, as well as citizens who have got infected with COVID as part of the Unified State Information System in Healthcare. According to the data from 3.8 million Russians vaccinated with both components of Sputnik V from December 5, 2020 to March 31, 2021 as part of the mass-scale civil vaccination program, the infection rate starting from the 35th day from the date of the first injection was only 0.027%. At the same time, the incidence among the unvaccinated adult population was 1.1% for a comparable period starting from the 35th day after the launch of mass-scale vaccination in Russia,” says the message posted on the official website of the Sputnik V vaccine.

It is expected that the data and calculations of the vaccine’s efficacy will be published in a peer-reviewed medical journal in May.

Sputnik V is approved for use in 60 countries with a total population of 3 billion people. It ranks second among coronavirus vaccines globally in terms of the number of approvals issued by government regulators.

Sputnik V has been approved in Russia, Belarus, Argentina, Bolivia, Serbia, Algeria, Palestine, Venezuela, Paraguay, Turkmenistan, Hungary, UAE, Iran, Republic of Guinea, Tunisia, Armenia, Mexico, Nicaragua, Republika Srpska (entity of Bosnia and Herzegovina), Lebanon, Myanmar, Pakistan, Mongolia, Bahrain, Montenegro, Saint Vincent and the Grenadines, Kazakhstan, Uzbekistan, Gabon, San-Marino, Ghana, Syria, Kyrgyzstan, Guyana, Egypt, Honduras, Guatemala, Moldova, Slovakia, Angola, Republic of the Congo, Djibouti, Sri Lanka, Laos, Iraq, North Macedonia, Kenya, Morocco, Jordan, Namibia, Azerbaijan, Philippines, Cameroon, Seychelles, Mauritius, Vietnam, Antigua and Barbuda, Mali, Panama and India.

As noted by the media, earlier Russian Sputnik V was the third in the list of vaccines with the highest level of effectiveness against coronavirus infection. For Moderna, it is 94.1%, while Pfizer/BioNTech initially had this figure at 95%, but in early April, the developer announced its decrease to 91.3%. Thus, the Russian vaccine now ranks first in terms of effectiveness.

According to Alexander Gintsburg, Director of the Gamaleya Research Institute of Epidemiology and Microbiology, the actual efficacy of the Sputnik V vaccine may be even higher than the results of the analysis demonstrate, since “the data on the case registration system allows a time lag between the collection of the sample (the actual date of the disease) and the diagnosis.”

The Sputnik V vaccine is based on a proven and well-studied platform of human adenoviral vectors. The safety, efficacy and lack of negative long-term effects of adenoviral vaccines have been proven by more than 250 clinical studies over two decades. Moreover, the storage temperature of Sputnik V allows storing it in a conventional refrigerator without any need to invest in additional cold-chain infrastructure. There are no strong allergies caused by Sputnik V. The price of Sputnik V is less than $10 per shot, making it affordable around the world.

Assessing the benefits of the Sputnik V vaccine, Muhammad Munir, Lecturer in Molecular Virology, Lancaster University, noted the presence of two different adenoviral vectors in the Russian vaccine – rAd26 and rAd5.

“One of the unique features of Sputnik V is use of two vectors for the delivery of antigen. The first dose primes the immune system and raise substantial antibodies whereas second dose induce the immune system to produce long lasting antibodies and T-cells without being neutralized by the first dose,” the expert told PenzaNews.

According to him, this feature makes Sputnik V better and different compared to AstraZeneca and Johnson & Johnson (J&J) which uses single vector for both injections.

“Realizing this advantage, AstraZeneca partnered with Sputnik V to conduct mutual trial which could enhance the performance of AstraZeneca. Based on the published data, Sputnik V outperformed many of the vaccines of similar kind,” Muhammad Munir stressed.

Jacob Koshy, Deputy Science Editor, The Hindu, expressed the opinion that the main advantage of Sputnik V for India is the already established cooperation of vaccine manufacturers with at least five Indian pharmaceutical companies.

“So the hope is that anywhere between 300–600 million doses will be quickly available to India within months. Sputnik V has tied up with Dr. Reddy’s Labs and conducted a phase 2/3 adaptive study. The results of this aren’t in public domain but one hopes that this information is with India’s regulators and they have made a good judgement,” Jacob Koshy said.

He also drew attention to the fact that there is no prejudice in Indian society about Sputnik V, but there are general fears about vaccines.

“Like in Russia, there is significant hesitancy on vaccines in general. The ongoing second wave in India has caused tremendous panic and many – even though initially hesitant – are now seeking vaccines,” the expert said.

According to him, the main issue for India today is the details of the agreements concluded for the production of Sputnik V.

“RDIF has been on a major, global publicity blitz for several months in marketing Sputnik V to the world. However it must be more transparent on how many of the doses it plans for manufacture in India will actually be available to Indians and how many will be sent for export,” Jacob Koshy explained.

Moreover, in his opinion, Russia should conduct and publish more detailed studies of the vaccine, in particular, its effectiveness against new variants of coronavirus and possible side effects associated with vaccination.

In turn, Shankaran Nambiar, Head of Research, Malaysian Institute of Economic Research in Kuala Lumpur, reminded that the Russian vaccine Sputnik V has been highly rated by international agencies and is reported to be both efficient and safe.

“The vaccine is currently under assessment by the local regulatory body and a firm decision has not been announced yet. The minister for science, technology and innovation, Khairy Jamaluddin, who is supervising the vaccination campaign, had warned that if the regulatory approval process takes too long, Malaysia might lose out on the offer that has been made by the Russian authorities. The Russian authorities have offered 6.4 million doses,” the analyst said.

In his opinion, the advantage that comes with accepting Sputnik V is beneficial for Malaysia not only within the framework of the vaccination program but also but also because it will allow the country to obtain technologies for its production.

“Gamaleya National Research Institute of Epidemiology is willing to share its expertise with Malaysia and that will help Malaysia make inroads into the pharmaceutical industry. This will enable Malaysia to be the regional base for the production and distribution of the vaccine. There are tremendous advantages that Malaysia can gain by accepting Sputnik V and working with Gamaleya,” Shankaran Nambiar explained.

Meanwhile, Hildegund Ertl, Professor, Vaccine & Immunotherapy Center, The Wistar Institute, called Sputnik V an excellent vaccine with high efficacy.

“It was shown by the phase III trial results published in Lancet [one of the most famous and respected general medical journals, founded in 1823] [...] and it has complete protection against hospitalisations and deaths and mild to moderate side effects,” the expert said.

However, in her opinion, short terms of application of vaccines against coronavirus in the world do not yet allow making unambiguous conclusions.

“The AstraZeneca vaccine has thus far shown lower efficacy in preventing mild to moderate disease than Sputnik V and there have been claims of rare but serious side effects in women under 50 receiving the AstraZeneca vaccine, which may or may not be related to the vaccine. But the AstraZeneca vaccine also completely protects against severe disease and death,” Hildegund Ertl said and added that we cannot claim that one vaccine is better than another till we know more about duration of protection and protection against circulating and future variants of the coronavirus.

According to her, today, one of the main priorities should be the united struggle of the world community against the pandemic.

“Right now it is crucial that we get the world vaccinated – not just the wealthy countries but every person in every country and for that we need every vaccine that has shown efficacy and will thereby prevent human suffering and death. [...] All the approved vaccines will be a valuable tool to end this pandemic,” the expert concluded.