Russia claims vaccine will be ready by November, despite questions over testing

Russia plans to begin deliveries of its coronavirus vaccine to partner countries as early as November, officials have revealed. Named Sputnik V, the vaccine is still undergoing large-scale clinical trials but has already secured approval for use from Russian regulators. First results of Phase 3 clinical trials, which have begun in Russia and will involve monitoring as many as 40,000 volunteers over six months, are due to be published by the end of October. Countries that have already signed agreements with Moscow for vaccine supplies could receive deliveries as soon as November, said Kirill Dmitriev, chief executive of the Russian Direct Investment Fund, which is financing the vaccine programme. By the end of December, as many as 300 million doses could be provided to the “countries that have submitted applications earlier”, he said. Other nations could receive supplies from January onwards, Mr Dmitriev said in a Zoom press conference on Tuesday. An effective vaccine is considered vital to combat the pandemic, which has infected more than 31 million people and killed almost one million worldwide. But Russia’s decision in August to approve use of its vaccine has sparked controversy domestically and internationally, given that large Phase 3 clinical trials – which can sometimes highlight rarer side effects and give a better indication of a vaccine’s real-world effectiveness – are incomplete. Some researchers have expressed concerns over what they regard as the politicisation of vaccine development, while the number of people it has been tested on is unknown. Denis Logunov, deputy director of scientific research at Moscow’s Gamaleya Research Institute of Epidemiology and Microbiology, which developed the vaccine, said, however, it was important to fast-track availability. “What else should we do – research the vaccine for many years, for two or three years, or protect the people who may get ill today and may die or get very sick?” he said. Echoing this, Sergei Glagolev, an advisor to the Russian Ministry of Health, said early approval was appropriate given the circumstances. “This tactic is very well balanced, we believe, taking into account the risk of a second wave of the pandemic,” he said Agreements are in place for the supply of a total of more than one billion doses of the vaccine, which is given as two injections. The vaccine is based on a genetically engineered version of a common cold virus, called an adenovirus, altered to produce a surface or spike protein from the Sars-CoV-2 coronavirus. The spike protein should stimulate an immune response that protects against Covid-19, and Russian officials say in early trials there was a 100 per cent response among participants. The vaccine has caused increased temperatures, headaches and pain at the injection site in some who received it, Dr Logunov said, especially in younger people. But he said no “serious adverse effects” had been detected and officials insisted adenovirus-based vaccines were proven technology. Some other vaccines are based on technology that Mr Dmitriev branded “potentially dangerous”. “We’ve seen the criticism expressed targeting the Russian vaccine by competitors. They simply know our vaccine is the safest and most competitive,” Mr Dmitriev said. Currently, trials are being carried out only on people aged 18 to 60, but Dr Logunov said older adults, who are typically among the most vulnerable to Covid-19, would be involved later. There are also plans to conduct trials outside Russia, while manufacturing of the vaccine could be expanded to India, Brazil and South Korea. Russian officials said they were “absolutely open” to forging partnerships with other countries keen to produce the vaccine, but said unless countries already had available suitable bioreactors – large apparatus needed for production – it would be quicker to procure supplies from existing partners. The UAE recently gave emergency approval for the use of a vaccine produced by China’s Sinopharm. Previously trialled in Abu Dhabi, this vaccine has recently been given to several officials, including the Minister of Health and Prevention Abdulrahman Al Owais, and medical and nursing staff at Sharjah’s Al Qassimi Hospital for Women and Children. That vaccine, plus another from Sinopharm, one from CanSino Biologics and a fourth, from Sinovac Biotech, have also received approval for limited use within China. Mr Dmitriev forecast that additional countries would give approval for limited use of coronavirus vaccines even before the completion of clinical trials. Clinical trials of another leading vaccine, from the University of Oxford and AstraZeneca, were recently paused because of concerns over possible side effects among volunteers. US regulators have yet to give approval there for the resumption of trials of the Oxford/AstraZeneca vaccine, but test programmes have restarted in Brazil, India, South Africa and the UK.

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