MOSCOW-Russia’s homegrown Sputnik V vaccine showed a high level of efficacy and safety in a peer-reviewed study released on Tuesday, a potential for the Kremlin’s purpose to promote the Kovid-19 shot abroad and to curb the epidemic at home encouragement.
The findings, from a preliminary analysis of a large-scale clinical trial published in the British Medical Journal Lancet, showed that the two-shot vaccine was 91.6% effective against symptomatic Kovid-19 and provided complete protection against severe cases. . There were no serious side effects, the paper said. The vaccine was also found to be equally safe and effective in elderly people.
The study could be an important milestone for Moscow in the global vaccination race, potentially providing a chance to tap into the geopolitical dominance of President Vladimir Putin’s government in the developing world and the lucrative global vaccine market. Russia – the world’s fourth-worst country with nearly four million cases – is also on Sputnik V to avoid new costly lockdowns, as officials plan to vaccinate 60% of the domestic population by the end of the year.
The shot was approved by Russian authorities in August before undergoing large-scale clinical trials, leading to questions over its rapid development and lack of published test data. So far, Sputnik V has been administered to more than two million people worldwide, including Argentina, Serbia and Algeria, according to Russian authorities.
Sputnik V Commentary
Type: Two-dose viral vaccine
Efficacy: 91.6% (91.8% among people over the age of 60)
Price: Under $ 10 a shot
Storage and Transport Temperature: 36-46ºF
Approved for use in: Russia, Belarus, Serbia, Argentina, Bolivia, Algeria, Palestine, Venezuela, Paraguay, Turkmenistan, Hungary, UAE, Iran, Guinea, Tunisia and Armenia
Administered in: Russia, Argentina, Bolivia, Belarus, Serbia, Algeria, Kazakhstan
Source: Lancet, Russian Direct Investment Fund
Tuesday’s results may help clear suspicions surrounding the Russian shot.
Ian Jones, Professor of Vereology at the London School of Hygiene and Tropical Medicine at Britain’s University of Reading and Poly Roy, wrote, “The development of the Spatnik V vaccine has been criticized for unintentional haste, corner harvesting and absence of transparency . ” Lancet. “But the results reported here are clear and the scientific theory of vaccination has been demonstrated, meaning that another vaccine may now be involved in the fight to reduce the incidence of Kovid-19.”
Alexander Gainsbourg, head of vaccine developer at Moscow-based Gamalaya Institute, said the data demonstrate Sputnik V’s safety and high efficacy against viruses.
It is “a major breakthrough in the global fight against the Kovid-19 epidemic,” he said.
The efficacy rate of Sputnik V compares to vaccines developed by modernity Inc.
And Pfizer Inc.
And its German partner BioNTech SE,
Which are about 95% effective.
The Lancet study did not address the usefulness of the shot against new variants of the virus, which, according to some initial evidence, may prove resistant to current vaccines. Russian officials have said that they expect the shot to work against other variants and the study is ongoing.
The results published on Tuesday were based on an interim analysis of a phase 3 trial of approximately 20,000 participants, three-quarters of whom received the vaccine while the rest received a placebo. The analysis was based on a total of 78 confirmed Kovid-19 cases, of which 62 were identified in the placebo group and 16 in the vaccine group. A clinical trial of a total of 40,000 volunteers is underway.
Researchers found that the Kovid-19 vaccine did not cause serious adverse reactions, the Lancet paper said. Most of the side effects included fluike symptoms, pain at the injection site, and headaches.
The newspaper stated that among the elderly, the vaccine was well tolerated and demonstrated efficacy of 91.8%, based on a group of 2,144 volunteers over 60 years of age.
Like other Kovid-19 vaccines developed by Johnson & Johnson and AstraZeneca PLC and the University of Oxford, Sputnik V uses a so-called viral vector approach. It introduces a genetically altered form of a harmless virus, known as adenovirus, to serve as a vehicle or vector for a piece of genetic material from coronoviruses.
Each of the two shots of the vaccine is based on a different adenovirus vector, which Russian scientists say elicits a strong immune response. Sputnik V has comparable logistics requirements with some of its peers, with storage and transportation temperatures between 36 and 46 degrees Fahrenheit. Pfizer’s vaccine should be kept at minus 94 degrees Fahrenheit before thawing.
The Soviet Union launched into orbit ahead of the US in the Cold War space race in the context of the Cold War V-1 satellite – Russia could gain a confrontation with some countries, analysts say, as well as a global coronavirus vaccine market. Which is estimated by Russian officials of $ 100 billion annually.
According to Russian officials, competing on price, Russia is selling the vaccine at a dose of less than $ 10, less than Pfizer and Moderna, and is targeting up to 30% market share among Covid-19 shots.
AstraZeneca has stated that it will test whether its combination of Kovid-19 vaccine, which is effective between 62% and 90% depending on the dose, and may promote Sputnik V efficacy. Clinical trials for the joint shot are expected to begin soon in Azerbaijan, United Arab Emirates and other countries.
Some 15 countries outside Russia have already authorized Sputnik V, and Moscow has received orders of interest or expression for 2.4 billion doses, including Brazil, Mexico and India. To accelerate the global rollout, Russia will also give a dose vaccine, dubbed Sputnik Light, which Russian officials say will be effective between 73% and 85%.
To produce its vaccines, Russia relies on a global supply chain, which includes manufacturing centers in Brazil, South Korea, India and China. Russia has also mounted an aggressive public relations campaign abroad, including posting weekly video updates in English and maintaining a Twitter account for Sputnik V.
Sputnik V has not been approved by Western health authorities or received authorization from the World Health Organization, which many developing countries rely on for vaccines. Russia is in talks with the European Medicine Agency about approving the shot in the European Union and has applied for WHO authorization.
In Iran, health care professionals and lawmakers criticized the government’s announcement that it would import Sputnik V, saying the vaccine was not approved by international bodies and that the purchase was politically motivated. Government officials said on Tuesday that Tehran would buy 1.5 million doses, with the first batch arriving as early as Saturday.
Domestic rollouts have also faced challenges, including production delays and a skeptical population.
Officials recently said that manufacturing is now picking up after problems with initial equipment. They now expect to produce seven million to 11 million doses in January this month.
About 46% of Russians said they would get a vaccine in a January poll by British polling firm Ipsos Mori, up 5 percentage points over December. Nevertheless, Russians were the most reluctant to vaccinate globally, compared to 55% in France, 63% in the US and 86% in the UK.
Russia does not publish daily vaccination rates, but regional data suggests that at least 1.3 million Russians have received one dose so far.
Irina Levashova, a kindergarten teacher in Romodanovo, a small town 400 miles south-east of Moscow, got her second shot last month with her husband.
Ms. Levashova, 58, said, “I have many acquaintances who are ill or have died of the disease, so I wanted to save myself and my family.” “As soon as he started talking about vaccination, I immediately told myself that I and my family would do it.”
-Valentina Ochirova contributed to this article
write to Georgi Kantchev at [email protected]
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