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The Russian ‘Sputnik V’ vaccine, administered in 2 doses 21 days apart, has a ‘91.6% effective against Covid-19. The protective effect is not statistically different for those older than 60 years compared to the age group 18 to 60 years and the the safety profile is high, with the majority (94%) of adverse effects occurring mildly. These are the preliminary results of a phase 3 study published in ‘The Lancet’, as announced by the Gamaleya National Research Center for Epidemiology and Microbiology of the Ministry of Health of the Russian Federation and by the sovereign wealth fund Rdif (Fondo Direct Investment of Russia).
The study reports preliminary results of Efficacy and Safety of the Phase 3 Trial Interim Analysis about the Russian vaccine against Covid. Analysis that included data on almost 20,000 participants. The calculation of the effectiveness of the regimen 2 doses of the adenovirus-based protective product was performed in the examination of 78 confirmed cases of Covid-19, 62 identified in the placebo group and 16 in the vaccine group. “Among the cases analyzed, more than 98% of the volunteers developed a humoral immune response and 100% a cellular immune response,” the experts report.
From the analyzes performed, the level of neutralizing antibodies in volunteers vaccinated with Sputnik V was “1.3-1.5 times higher than the level of antibodies in patients who recovered from Covid,” the authors explained. Serious adverse events, ie requiring hospitalization, were “rare in the placebo and vaccine groups (0.2%)” and “none were found to be associated with vaccination”. Most of the adverse events reported were “Mild, including flu-like symptoms, pain and weakness at the injection site”. Four deaths were reported in the study, none of which were considered vaccine-related. The data on those older than 60 years are obtained from a sub-analysis of 2,144 people (maximum age 87 years), according to which the efficacy in the elderly was 91.8%.
The experimentation is still ongoing and aims to include a total of 40,000 participants, the authors add. Monitoring of safety and efficacy continues. “The vaccine is 100% effective in preventing serious illness or death, which is the most crucial parameter,” stresses Hildegund CJ Ertl, professor at the Wistar Institute (USA) in a statement quoted on the website dedicated to the vaccine Sputnik V. Even after a single dose, the protection against the disease was 87.6% ”. Gam-COVID-Vac is a 2-part vaccine that includes 2 adenovirus vectors (rAd26-S and rAd5-S), modified to express the Spike Sars-CoV-2 protein. According to the authors, using a different adenovirus vector as a booster can help create a more powerful immune response, as it minimizes any risk of resistance.
“Our interim analysis showed high efficacy, immunogenicity, and a good tolerability profile in participants older than 18 years,” says Inna V Dolzhikova, co-lead author of the study, from the Gamaleya National Research Center for Epidemiology and Microbiology in Russia. “Stopping the pandemic requires the introduction of more vaccines based on different mechanisms of action to meet different global health needs. Our vaccine, along with others, helps to diversify the global pipeline, ”says Denis Logunov, the other co-lead author from the Gamaleya National Research Center for Epidemiology and Microbiology. There are currently 64 vaccines in the clinical evaluation phase (13 in phase 3) and 173 in preclinical analysis. Vaccines based on a variety of platforms, in fact.
The Russian vaccine study was conducted in 25 Moscow hospitals and polyclinics. The participants, between September 7 and November 24, 2020, were randomly assigned to the 2 groups, one destined to receive the vaccine and the other placebo. The authors note that more research is needed to understand the efficacy of the vaccine in asymptomatic transmission of Covid and viruses. “The publication of internationally peer-reviewed data on Sputnik V clinical trial results is a great success in the global battle against the pandemic,” says Alexander Gintsburg, director of the Gamaleya Research Institute.
“The world needs all the good vaccines it can get against Covid – reflects David Livermore, University of East Anglia (UK) – And Sputnik V is the first adenovirus vector vaccine to achieve 90% efficacy observed with two vaccines of MRNA “. The storage temperature of the product is, among other things, “between 2 and 8 ° C, which allows an easier distribution throughout the world”, finally point out the Russian experts.
Burioni: “Excellent news, the Russian vaccine is exceptionally effective”
“Good news, the ‘Russian’ vaccine is more than 90% effective. Another exceptionally effective vaccine with a mechanism similar to AstraZeneca, but with a fundamental difference that we are going to comment on ”. This was underlined in a tweet by the virologist from the San Raffaele University Roberto Burioni commenting on the news.
Galli: “” I was surprised “
Even Sack of Milan infectious disease specialist Massimo Galli enthusiastically welcomed the news from Moscow: “Sputnik with data beyond expectations. I was impressed with the result. An even cleaner result than the others because they excluded those who had already had the disease from the trials. It is clear that the Sputnik results are superior to those obtained by Astrazeneca ”continues Professor Galli.
Politics
And who knows that now, with Europe’s known difficulties with supplies from Western pharmaceutical companies, Sputkìnik will not become a precious ally also for the thawing of relations between the EU and Russia. In response to a question about the Russian vaccine against coronavirus, Angela Merkel said a few weeks ago: “If the vaccine is approved by the EMA, we will be able to talk about agreements on production and even use”, these are the words of the Chancellor, highlighting that it has offered that through the Paul Ehrlich Institute Russia has “development support” of the vaccine. “Beyond the wide political differences, we can certainly work together in a pandemic, in a humanitarian sector.”
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