India’s drug regulator has approved the Russian-made coronavirus vaccine Sputnik V as the country grapples with a second wave.
Sputnik V is the third coronavirus vaccine to get emergency use approval after Covishield, developed by Oxford-AstraZeneca and manufactured by the Serum Institute of India, and the Indian firm Bharat Biotech’s Covaxin.
The decision was made by the Drugs Controller General of India after a Subject Expert Committee of the Central Drugs Standard Control Organization “deliberated on various critical areas for consideration including safety, immunogenicity, efficacy data from overseas clinical studies, indication, age group, dosing schedule, precautions, storage, warnings, adverse effects of special interest, risk benefit evaluation…,” the Indian Ministry of Health said in a statement on Tuesday.
Sputnik V, which has been approved for use in 60 countries across the world, is manufactured in India by the company, Dr. Reddy’s Laboratories.
In September, the pharmaceutical firm partnered with the Russian Direct Investment Fund (RDIF) to conduct clinical trials of Sputnik V and distribute the vaccine in India, according to a press release issued by Dr. Reddy’s Laboratories.
“We are very pleased to obtain the emergency use authorization for Sputnik V in India. With the rising cases in India, vaccination is the most effective tool in our battle against COVID-19. This will enable us to contribute to our nation’s effort of vaccinating a significant proportion of our population,” said GV Prasad, co-chairman and managing director of Dr Reddy’s Laboratories.
The bigger picture: India reported 161,736 new cases of coronavirus on Tuesday, a slight dip following six consecutive days of record single-day rises, according to a CNN tally of figures from the Ministry of Health.
The country has recorded a total of 13,689,453 cases, which includes 171,058 deaths and 1,264,698 active cases.
A total of 108,533,085 vaccine doses have been administered and so far, to health and frontline workers and people aged 45 and above.
Several states have announced tighter restrictions to curb the spread of coronavirus. On Monday, the northern state of Haryana announced a nightly curfew to come into immediate effect from 9:00 p.m. till 5:00 a.m. until further notice.
The capital territory of Delhi, which reported 11,491 cases on Monday, is preparing for a surge in cases.
The state government has declared 14 private hospitals in the capital be made into “full COVID-19” hospitals and asked them not to admit patients other than those infected with coronavirus. Nineteen private hospitals have been directed to reserve at least 80% of their ICU beds for Covid patients while a further 82 private hospitals have been asked to reserve 60% of their ICU beds for coronavirus patients, according to an order tweeted by Delhi Health Minister Satyendar Jain.