Jahnavi Sarma
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Written By: Jahnavi Sarma | Published : September 16, 2020 9:30 PM IST
Russia was the first country to license a novel coronavirus vaccine before large-scale Phase III trials were complete, stirring concern among scientists and doctors about the safety and efficacy of the shot.
As the COVID-19 pandemic rages on, many vaccines candidates are now in the final stages of development. Scientists across the world expects mass vaccinations to start as early as January next year. But overtaking all competitors, Sputnik V, the world' first COVID-19 vaccine from Russia, was approved for distribution earlier in August. It raised some safety concerns because this was done well before Phase III clinical trial started. At the time of approval, this vaccine was in Phase I clinical trial, says the World Health Organisation. But the Russian government always maintained that Phase I and Phase II of clinical trials were completed before the vaccine any approval was given. In late August, phase III trials, involving at least 40,000 people, were launched in Russia. But these trials are yet to be completed.
Against this background, Russia's sovereign wealth fund has agreed to supply 100 million doses of Sputnik-V to the Indian drug company Dr Reddy's Laboratories. This news comes even as Moscow speeds up plans to distribute its shot abroad. The deal comes after the Russian Direct Investment Fund (RDIF) reached agreements with Indian manufacturers to produce 300 million doses of the vaccine in India, which is a major consumer of Russian oil and arms. The RDIF has already reached vaccine supply deals with Kazakhstan, Brazil and Mexico. It has also signed a memorandum with the Saudi Chemical company.
The agreement comes as India's coronavirus cases surged past 5 million on Wednesday, piling pressure on hospitals grappling with unreliable supplies of oxygen that they need to treat tens of thousands of critical patients. India is only the second country in the world to cross the grim milestone and said this week it is considering granting an emergency authorisation for a vaccine, particularly for the elderly and people in high-risk workplaces.
Dr Reddy's, one of India's top pharmaceutical companies, will carry out Phase III clinical trials of the vaccine in India, pending regulatory approval, RDIF said in a statement. Deliveries to India could begin in late 2020, it said, adding this was subject to the completion of trials and the vaccine's registration by regulatory authorities in India. Russia was the first country to license a novel coronavirus vaccine before large-scale Phase III trials were complete, stirring concern among scientists and doctors about the safety and efficacy of the shot. The Phase I and II results had shown promise, G V Prasad, co-chairman of Dr Reddy's, was cited in the RDIF statement as saying. "Sputnik V vaccine could provide a credible option in our fight against COVID-19 in India," he said.
There was no detail about the price of the vaccine in the Indian market yet. But RDIF has said previously it was not aiming at making a profit, just covering costs.
(With inputs from Agencies)
