India’s drug regulator has approved Russia-made coronavirus vaccine Sputnik V as the country grapples with a second wave.
Sputnik V is the third coronavirus vaccine to receive emergency approval after Covishield, developed by Oxford-AstraZeneca and manufactured by the Serum Institute of India, and the Indian company 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 ‘discussed several critical areas to consider including safety, immunogenicity, efficacy data from overseas clinical trials, indication, age group, dosing schedule, precautions, storage, warnings, adverse effects of particular concern, benefit-risk analysis… ”the Indian Health Ministry said in a statement on Tuesday.
Sputnik V, which is approved for use in 60 countries around the world, is manufactured in India by the company, Dr. Reddy’s Laboratories.
In September, the pharmaceutical company partnered with the Russian Direct Investment Fund (RDIF) to conduct clinical trials on Sputnik V and distribute the vaccine in India, according to a press release from Dr. Reddy’s Laboratories.
“We are very pleased to obtain the emergency use permit for Sputnik V in India. With the increasing cases in India, vaccination is the most effective tool in our fight against COVID-19. This will enable us to contribute to our country’s efforts to vaccinate a significant portion of our population, ”said GV Prasad, co-chair and general manager of Dr. Reddy’s Laboratories.
The bigger picture: India reported 161,736 new cases of coronavirus on Tuesday, a slight dip after six consecutive days with record one-day increases, according to a CNN count of figures from the Ministry of Health.
The country has a total of 13,689,453 cases, including 171,058 deaths and 1,264,698 active cases.
A total of 108,533,085 vaccine doses have so far been administered to health professionals, primary care workers and people 45 years of age and older.
Several states have announced stricter restrictions to curb the spread of the coronavirus. On Monday, the northern state of Haryana announced a nightly curfew that would take effect from 9 p.m. to 5 a.m. until further notice.
The main area of Delhi, which reported 11,491 cases on Monday, is preparing for an increase in the number of cases.
The state government has stated that 14 private hospitals in the capital are being converted into ‘full COVID-19’ hospitals and has asked them not to take in any patients other than those infected with the coronavirus. Nineteen private hospitals have been ordered to reserve at least 80% of their IC beds for Covid patients, while an additional 82 private hospitals have been asked to reserve 60% of their IC beds for coronavirus patients, according to an order that is tweeted by Delhi’s health minister Satyendar Jain.