Russia has already approved two COVID-19 vaccines, including the Sputnik V shot, developed by Moscow's Gamaleya Institute, following a similar approach of granting approval before seeing any late-stage trial results.
"Sputnik has received EUA (emergency use authorisation)," the minister, Faisal Sultan, told Reuters in a WhatsApp text message.
Researchers say based on their trial, which involved about 20,000 people in Russia last fall, the vaccine is about 91 per cent effective and that the shot also appeared to prevent people from becoming severely ill with COVID-19. The study was published online Tuesday in the journal, Lancet.
Iran, which is fighting the Middle East's deadliest outbreak, has said it will only rely on vaccines made by Russia, India or China, while also working to produce a homemade jab.
"Study results have demonstrated the effectiveness of the vaccine in triggering a strong antibody response against the virus, its safety for use, and its compliance with international safety and effectiveness standards," the statement said.
The Sputnik V and EMA teams held a scientific review of the vaccine on Tuesday, the Sputnik V account said, adding the EMA will take a decision on the authorization of the vaccine based on the reviews.
The Russian Direct Investment Fund (RDIF), which has financed the development of the Sputnik V coronavirus vaccine, confirmed the figure to AFP without offering a breakdown of where the jab was distributed.
The human trial, announced in October before the recent rise in cases, is initially seeking up to 500 volunteers to be vaccinated at a hospital in the emirate of Abu Dhabi. Two doses of the vaccine will be given, 20 days apart, to volunteers, the statement said. Participants will have to be 18 years or older, have not previously been infected with COVID-19 or participated in other COVID-19 vaccine trials, it said.
Pharma major Dr. Reddy's Laboratories shut down its production facilities following a data breach in the servers, ET Now reported, citing sources.Data breach prompts Dr Reddy's to shut key plants
In September 2020, Dr. Reddy’s and RDIF entered into a partnership to conduct clinical trials of Sputnik V vaccine and its distribution in India. As part of the partnership, RDIF shall supply 100 million doses of the vaccine to Dr. Reddy’s upon regulatory approval in India.
Russia faced international criticism for approving a vaccine that hasn't completed advanced trials among tens of thousands of people, and experts both at home and abroad warned against its wider use until the studies are completed.
EpiVacCorona, which is being developed by Siberia’s Vector Institute, was authorized this month to carry out trials on 150 volunteers over 60 and 3,000 volunteers over 18, the watchdog has said.
The calculations were based on preliminary data obtained 42 days after the first dose, Russia's health ministry, the state-run Gamaleya research centre and the Russian Direct Investment Fund (RDIF) said in a statement.
Putin also proposed that the creation of a vaccine research centre for BRICS countries - Brazil, Russia, India, China and South Africa - be sped up, TASS reported.
‘ The Russian vaccine is not an approved vaccine and hardly any trials have taken place.’
The vaccine will be ready for wide distribution late this year or early next, officials say. That's roughly the same schedule as shots from rivals in the U.S., U.K. and China. Initial results from final-stage studies won’t be ready until November, with full data expected next year.
The US and other superpowers have laid claim to billions of Covid vaccine doses that are nearing the finish line. That’s sparked worries that poorer countries will be left behind and shots will be slow to reach many of them. Dozens of laboratories, researchers and companies from Thailand to Nigeria are bootstrapping their own work on inoculations.
Sputnik V has been developed by the Gamaleya Research Institute of Epidemiology and Microbiology, along with the RDIF. The vaccine has not been tested in Phase 3 or larger clinical trials.
Sputnik V has been developed by the Gamaleya Research Institute of Epidemiology and Microbiology along with the Russian Direct Investment Fund (RDIF). The vaccine has not been tested in Phase 3 or larger clinical trials.
Russia has named its first approved coronavirus vaccine 'Sputnik V' for the foreign markets. It is a reference to the world's first satellite Sputnik and what Moscow sees as its success at becoming the first country to approve a vaccine, a top official said.Russia names its coronavirus vaccine as 'Sputnik V' in reference to world's first satellite
Russia has approved a coronavirus vaccine but the World Health Organisation is wary of it. "We are in close contact with Russian health authorities and discussions are ongoing with respect to possible WHO prequalification of the vaccine, but again prequalification of any vaccine includes the rigorous review and assessment of all required safety and efficacy data," WHO spokesman Tarik Jasarevic told.WHO in contact with russia on new coronavirus vaccine Sputnik V
RDIF has seen strong global interest in the vaccine and plans to conduct Phase 3 clinical trials in different countries, including Saudi Arabia, UAE, Brazil, India and Philippines, and 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, according to the statement.
Kirill Dmitriev, head of the RDIF sovereign wealth fund, said Russia had already received requests from more than 20 countries for 1 billion doses of its newly-registered COVID-19 vaccine.
Russia has developed the first vaccine offering "sustainable immunity" against the coronavirus, President Vladimir Putin announced Tuesday. "This morning, for the first time in the world, a vaccine against the new coronavirus was registered" in Russia, he said during a televised video conference call with government ministers. "One of my daughters had this vaccine. I think in this sense she took part in the experiment," Putin said.Russia announces World's 'first' Covid-19 vaccine, Putin says daughter inoculated
Speaking at a government meeting on Tuesday, Vladimir Putin said that the vaccine has proven efficient during tests, offering a lasting immunity from the coronavirus.
"The vaccine developed by the Gamaleya centre will be registered on August 12. At the moment, the last, third, stage is underway. The trials are extremely important. We have to understand that the vaccine must be safe. Medical professionals and senior citizens will be the first to get vaccinated," Gridnev told reporters at the opening of a cancer centre building in the city of Ufa.
Putin said Moscow was ready to cooperate with all other countries on coronavirus vaccines, but urged against politicising the process, the day after vaccine developers Pfizer Inc and BioNTech said their experimental COVID-19 vaccine was more than 90% effective.
Last week, Russia became the first country in the world to license a coronavirus vaccine when President Vladimir Putin announced its approval. But the vaccine has not yet passed the advanced trials normally required to prove it works before being licensed, a major breach of scientific protocol.
Lauding Russia for the vaccine, Raut, in his weekly column 'Rokhtokh' in the Shiv Sena mouthpiece 'Saamana', said this was a sign of being a superpower, and added that Indian politicians will not follow Russia's example as a model since "they are in love with America".
The country is pushing ahead with several vaccine prototypes and one trialled by the Gamaleya institute in Moscow has reached advanced stages of development and is about to pass state registration, officials said. "We are very much counting on starting mass production in September," Industry Minister Denis Manturov said.
While the country hopes to start mass-producing the vaccine by October and plans to offer the first doses to essential workers, many in the science community seem unimpressed. The announcement should be taken "with a pinch of salt", said Indian immunologist Vineeta Bal.