India has approved the use of Russian Sputnik V Covid-19 vaccine, the Russian Direct Investment Fund (RDIF) said. The RDIF, which is responsible for marketing the vaccine abroad, said the Drug Controller General of India (DCGI) had approved the use of Sputnik V. This paves the way for India to rollout its third vaccine against the coronavirus infections.
The country has been administering Covishield - the Oxford-Astrazeneca vaccine manufactured by the Serum Institute of India - and home-grown Covaxin.
According to RDIF, India has now become the 60th country to approve Sputnik V. "India is the most populated country to register the Russian vaccine. Total population of 60 countries where Sputnik V is approved for use is 3 billion people or about 40% of the global population," said RDIF.
"The vaccine has been registered in India under the emergency use authorization procedure based on results of clinical trials in Russia as well as positive data of additional Phase III local clinical trials in India conducted in partnership with Dr Reddy’s Laboratories," the Russian body added.
According to the medical journal Lancet, Sputnik V is 91.6% effective in protecting against the coronavirus. Russia registered Sputnik V for public use in August, the first country to do so, though the approval came before the start of the large-scale trial in September. "We appreciate the decision of India's regulatory bodies to grant authorization for Sputnik V. Approval of the vaccine is a major milestone as Russia and India have been developing an extensive cooperation on clinical trials of Sputnik V in India and its local production," said Kirill Dmitriev, CEO of the RDIF.
On last Friday, DCGI sought additional data from drugmaker Dr Reddy's Laboratories on its Sputnik V Covid-19 vaccine trial, in its second such request after an initial evaluation in February.
The committee had earlier asked the company to submit a comparative analysis of late-stage immunogenicity data from both its Indian studies and an ongoing Russian study, as well as data on serious adverse events and positive cases reported till date. The RDIF has reached agreements with the leading pharmaceutical companies in the country (Gland Pharma, HeteroBiopharma, Panacea Biotec, Stelis Biopharma, Virchow Biotech) aimed at production of more than 850 million doses per year,” noted the release.
