The Russian vaccine is being developed in partnership with Hyderabad-based Dr Reddy’s Laboratories.
he Drugs Controller General of India has approved the emergency use of Covid-19 vaccine Sputnik V, the Russian Direct Investment Fund said on Tuesday. The Russian vaccine, being developed in India in partnership with Dr Reddy’s Laboratories in Hyderabad, will be the third vaccine to get approved in the country after Serum Institute of India’s Covaxin and Bharat Biotech’s Covishield.
The announcement came hours after the Subject Expert Committee of the Indian drug regulator approved Sputnik-V. However, there has so far been no official confirmation on the approval of the vaccine from India’s drug regulator.
“The Russian Direct Investment Fund (RDIF, Russia’s sovereign wealth fund) announces that Drug Controller General of India (DCGI) has approved the use of the Russian Sputnik V vaccine against coronavirus in the country,” the RDIF said. “India has become the 60th country to approve Sputnik V.”
Sputnik V had shown a 91.6% efficacy in late-stage trials, according to results published in February. No serious adverse events were found to be linked with the vaccination. The trial did not include efficacy data of the vaccine for new variants of the coronavirus though.
The vaccine is administered in two doses separated by 21 days, and requires a minus 18-20 degree Celsius cold chain to remain stable. Efforts are underway to develop a freeze dried version of the shot, which will stay stable in the 2 to 8 degrees Celsius temperature range.
“The vaccine has been registered in India under the emergency use authorisation 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 Direct Investment Fund’s statement read.
The RDIF has said that more than 850 million, or 85 crore, doses of the Sputnik V vaccine will be produced annually in India, reported PTI. RDIF Chief Executive Officer Kirill Dmitriev said that the vaccine produced in India will be used for both vaccinating the country’s population as well as its global distribution. The vaccine will be manufactured by several companies in India, including Hetero, Gland Pharma, Stelis Pharma, and the Virchow Group.
Last week, Dr Reddy’s Laboratories had sought the central government’s approval for the vaccine to be used in India.
The development comes at a time when multiple Indian states are grappling with Covid-19 vaccine shortages. Kerala Chief Minister Pinarayi Vijayan on Monday wrote to Union Health Minister Harsh Vardhan seeking 50 lakh coronavirus vaccine doses as the stocks in the state would last only three more days.
At least nine other states – Rajasthan, Andhra Pradesh, Chhattisgarh, Haryana, Maharashtra, Odisha, Telangana, Punjab and Delhi – are experiencing similar shortages. Over 10.47 crore shots have been administered so far in India, while more than 1.22 crore people have received both doses of the vaccine, according to government data.
Sputnik V’s clearance by the Subject Expert Committee on Monday came amid a huge surge in coronavirus cases in the country, which has seen the daily count cross the 1 lakh-mark in seven of the last eight days. On Tuesday, India reported 1.61 lakh new cases, taking the overall tally of infections since the pandemic broke out in March 2020 to 1,36,89,453. Cases in the second wave have risen much faster than last year, with experts also worrying that this wave could potentially be more dangerous than the first wave too.