Tuesday, June 15, 2021

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India approves Russia's Sputnik V vaccine for emergency use


India granted emergency use approval to Russia's highly effective Sputnik V coronavirus vaccine, making it the third such shot approved by the nation as it races to contain an escalating health crisis amid a record daily surge in infections.

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Dr. Reddy's Laboratories Ltd., the Indian drugmaker that has partnered with Russia to supply this vaccine, has received the regulatory approval, a person familiar with the matter said, who asked not to be identified as they're not authorized to speak publicly. A spokesperson for Dr. Reddy's did not immediately respond to a query while V. G. Somani, the drug controller general of India, could not be reached for a comment.

The Hyderabad-based company approached the Indian drug regulator seeking emergency regulatory approval in February after it was deemed safe in Phase 2 human trials in January. It proceeded to the larger Phase 3 trials soon after. Dr. Reddy's shares closed almost 5% higher in Mumbai after the news broke on Monday.

India is trying to curb a second wave that has already overwhelmed hospitals and put the Asian nation on track to overtake Brazil as the second worst-hit country. Some parts of India have already imposed partial lockdowns while some states such as Maharashtra -- where financial hub Mumbai is located -- are seeing vaccine shortages. Adding a third vaccine to its arsenal will hopefully ease the shortfall.

Vaccination is also key to fending off further stay-at-home orders and re-opening the economy after a national lockdown in March last year caused a historic recession. India already allows shots made by Astrazeneca Plc's local partner, Serum Institute of India Ltd., and Hyderabad-based Bharat Biotech International Ltd. Sputnik's emergency use approval was earlier reported by CNBC-TV18 and other local news outlets.

With Sputnik V winning international recognition in February, overcoming early skepticism, countries are lining up for supplies after peer-reviewed results published in The Lancet medical journal showed the Russian vaccine -- with 92% efficacy -- protects against the deadly virus just as well as the mRNA shots from Pfizer Inc. and Moderna Inc.

Sputnik V uses a platform based on the adenovirus, which causes the common cold, and has been studied in vaccine development for decades.

Besides Dr. Reddy's, Russia has tied up with a bunch of Indian drugmakers in recent weeks including Gland Pharma Ltd., Panacea Biotech Ltd., Virchow Biotech Private Ltd. and Stelis Biopharma to produce as many as 852 million doses of Sputnik.

Still, the road to approval was slower than initially anticipated. In September, when Dr. Reddy's and the Russian Direct Investment Fund announced their partnership, they said deliveries of the vaccine to India, which has required local bridging trials before approval, could potentially begin in late 2020.

India's inoculation drive, which saw a tepid response in the initial weeks endangering its target of reaching about a quarter of its population by August, is now picking up. Bharat reported 81% efficacy of its Covid vaccine on March 3, days after Prime Minister Narendra Modi got the shot and urged Indians to step forward for inoculation. Sign ups among those willing to be vaccinated has improved in the past month.

India is expanding the campaign to all those over the age of 45 from April 1 and New Delhi has slowed vaccine exports as it seeks to shore up its own immunization drive. So far, more than 104 million vaccination doses have been administered.

Published : April 13, 2021

By : Syndication Washington Post, Bloomberg · Abhijit Roy Chowdhury, Chris Kay