12:02 GMT08 March 2021
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    This is the well-respected medical journal's second publication about Sputnik V since September 2020. It's dedicated to Stage III of the vaccine's clinical trials.

    Sputnik V is safe, efficient, and provides full protection against severe cases of COVID-19 - this is the key takeaway from a publication in The Lancet. It took months of research for Russian immunologists, and for 19,866 volunteers to complete Phase III of the clinical trials, which have confirmed a 91.6 percent efficacy.

    The other important finding is the immunogenicity of the Russian jabs. The 14,964 volunteers, who received actual shots of Sputnik V developed 1.3-1.5 times more antibodies against the novel coronavirus than those who recovered from COVID-19. During the study, the remaining 4,902 participants received a placebo - as was required by the rules of regular large-scale clinical trials. 

    The trial included a group of volunteers aged 60 to 87, showing impressive results for this particular age strata. Surprisingly, Sputnik V's efficacy among the elderly was comparable to the 18-60 age group (91.8%).

    When it comes to safety, the Independent Data Monitoring committee has confirmed 94% of all adverse effects were mild. No serious adverse effects or allergies connected with the product were detected, and most mild complications were limited to flu-like symptoms or headaches.

    The Russian Direct Investment Fund (RDIF) – the country's sovereign wealth fund, established to make equity co-investments, primarily in Russia, alongside international strategic and financial investors, is currently tasked with ramping up Sputnik V's production and international distribution.

    RDIF CEO Kirill Dmitriev has hailed The Lancet publication, saying "this is a great day in the fight against the COVID-19 pandemic": 

    "The data published by The Lancet proves that not only Sputnik V is the world's first registered vaccine, but also one of the best. It fully protects against severe COVID-19, according to data which has been independently compiled and reviewed by peers and then published in The Lancet. Sputnik V is one of only three vaccines in the world with an efficacy of over 90% but outperforms them in terms of safety, ease of transportation due to storage requirements of +2 to +8 degrees, and a more affordable price. Sputnik V is a vaccine for all mankind".

    Globally only four vaccine developers, including the Gamaleya Institute, have published their Phase III clinical trial results in leading peer-reviewed medical journals. Sputnik V is one of only three vaccines in the world with a proven efficacy of over 90%. Other vaccines show lower efficacy rates, such as 62.1% for AstraZeneca, 50.4% for Sinovac, and 79.3% for Sinopharm

    Russian Gam-COVID-VAK (trademark Sputnik V) coronavirus vaccine
    © Sputnik / Abzal Kaliyev
    Russian Gam-COVID-VAK (trademark "Sputnik V") coronavirus vaccine

    However, it beats the other vaccines with an efficacy of over 90%, providing easier logistics, lower price, and a longer lasting immune response achieved through so-called "heterogeneous boosting", and the use of two different vectors in two separate shots  

    The RDIF has repeatedly said that Sputnik V is ready to help increase the efficacy of other vaccines with an efficacy rate below 90% by providing one of Sputnik V's shots. It is already cooperating with AstraZeneca to increase its efficacy from 62.1% to a higher level by adding a Sputnik V shot to AstraZeneca. 

    'Easy to Produce and Convenient to Deploy'

    With criticism of only several months ago gradually waning in the face of solid data, many Western scientists have also welcomed the new publication.

    "The development of the Sputnik V vaccine has been criticised for unseemly haste, corner cutting, and an absence of transparency. But the outcome reported here is clear and the scientific principle of vaccination demonstrated, which means another vaccine can now join the fight to reduce the incidence of COVID-19", according to Dr Ian Jones from the University of Reading and Dr Polly Roy from the London School of Hygiene & Tropical Medicine, who were not involved in the peer review of the article in The Lancet.

    Research Director at France's National Institute of Health and Medical research Cecil Czerkinsky emphasises Sputnik V's definite advantages when it comes to logistics, as well as its formulation: "The interim results of the Phase 3 clinical trials of the Sputnik V COVID adenovirus vector vaccine are fairly impressive. This vaccine appears to be highly efficacious and immunogenic across age groups. This is clearly good news as this dual formulation vaccine is comparatively easy to manufacture and to deploy amid the anticipated global shortage of vaccines and logistical problems in vaccination rollout of temperature-sensitive vaccines recently authorised for emergency use".

    In Argentina – a country that has already received a shipment of the Russian vaccine and launched a successful immunisation campaign, health professionals praised the product's efficacy: "The paper, published in The Lancet, confirms successful results and provides additional information about the efficacy and the safety of this vaccine in different subgroups", says Omar Sued, the President of Argentina's Society of Infectologists.

    "From the public health point of view, the efficacy of the vaccine was very high. The safety profile was very good. The dissemination of this information is vital for informing the scaling up and rollout of this vaccine worldwide".
    Argentine Vice-President Cristina Fernandez de Kirchner gets vaccinated with the Sputnik V (Gam-COVID-Vac) vaccine at the Hospital Presidente Peron, in Avellaneda, on the outskirts of Buenos Aires, Argentina January 24, 2021
    © REUTERS / ARGENTINE VICE-PRESIDENCY
    Argentine Vice-President Cristina Fernandez de Kirchner gets vaccinated with the Sputnik V (Gam-COVID-Vac) vaccine at the Hospital Presidente Peron, in Avellaneda, on the outskirts of Buenos Aires, Argentina January 24, 2021
    "Presently, the world needs all the good vaccines that it can get against COVID-19", says David Livermore, a Professor of Medical Microbiology at the UK's University of East Anglia. "And these are impressive results: Sputnik V is the first adenovirus vector vaccine to achieve the 90% efficacy seen with the two mRNA vaccines".

    In the meantime, as the number of people getting their shots of vaccines against coronavirus grows, US scientist Hildegund C.J. Ertl from the Wistar Institute's Vaccine & Immunotherapy Centre, highlights that Sputnik V "is 100% effective in preventing serious disease or death, which in the end is the most crucial parameter; we can all deal with the sniffles as long as we stay out of the hospital or the graveyard".

    "Even after a single dose of this prime-boost regimen protection against disease was at 87.6%. Sputnik V is thus more effective than the AZ or J&J. Sputnik V, which, unlike the equally efficacious RNA vaccines of Pfizer and Moderna, can be stored in the fridge, will be of tremendous value to combat the global COVID19 pandemic".

    Expanding Reach

    Sputnik V was developed in May of 2020 by the Russian Health Ministry's Gamaleya National Research Centre for Epidemiology and Microbiology. The vaccine was designed using a well-known and reliable human adenoviral platform, and it's also one of the least expensive in the world, with a price of $10 per shot. At the end of last year, the product received approval for use in a full-scale domestic vaccination campaign in Russia that began in December 2020 and is completely free for Russian citizens.

    A health worker holds the Russian coronavirus vaccine Gam-COVID-Vac, trade-named Sputnik V, developed by the Gamaleya Scientific Research Institute of Epidemiology and Microbiology during the vaccination of medical workers, in Sestroretsk, Leningrad region, Russia
    © Sputnik / Alexei Danichev
    A health worker holds the Russian coronavirus vaccine Gam-COVID-Vac, trade-named Sputnik V, developed by the Gamaleya Scientific Research Institute of Epidemiology and Microbiology during the vaccination of medical workers, in Sestroretsk, Leningrad region, Russia

    According to the RDIF, Sputnik V has been registered in 16 countries. It's expected that within the next few days shots of the Russian vaccine will be administered to people in:  

    Bolivia, Kazakhstan, Turkmenistan, Palestinian Authority, UAE, Paraguay, Hungary, Armenia, Algeria, Bosnian Serb Republic, Venezuela, and Iran. 

    ​More than 50 nations have requested 1.2 billion doses of Sputnik V, with the RDIF's partners in India, Brazil, China, South Korea, and other countries preparing to produce the vaccine for the global market.

    Tags:
    vaccination, AstraZeneca, Pfizer, Russian Direct Investment Fund (RDIF), Sputnik V, Vaccine, COVID-19, Russia
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