The Drugs Controller General of India has approved the emergency use of Covid-19 vaccine Sputnik V, the Union health ministry said on Tuesday. The Russian vaccine, being developed in India in partnership with Dr Reddy’s Laboratories in Hyderabad, is the third vaccine to get approved in the country after Serum Institute of India’s Covaxin and Bharat Biotech’s Covishield.
“The approval of the vaccine in Russia along with its conditions/restrictions was also reviewed by the SEC [Subject Expert Committee],” the health ministry said in a statement on Tuesday. The Subject Expert Committee of the Indian drug regulator had approved the vaccine on Monday.
“The SEC noted that the safety & immunogenicity data presented by the firm from the Indian study is comparable with that of the Phase III clinical trial interim data from Russia. After detailed deliberation, the SEC recommended for grant of permission for restricted use in emergency situations subject to various regulatory provisions.”
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 Russian Direct Investment Fund, Russia’s sovereign wealth fund, 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.