Saturday, September 18, 2021

Russia’s Sputnik V vaccine to seek India approval by March – ET HealthWorld

India’s Dr. Reddy’s Laboratories Ltd will seek emergency-use authorisation for Russia’s Sputnik V coronavirus vaccine by next month, a company official said on Wednesday, after peer-reviewed trial data confirmed its effectiveness.

A source close to the drug regulator said the application could come within days and when approved, bolster India’s 18-day-old immunisation campaign which has covered more than 4 million people with two other shots.

Dr. Reddy’s has been working with the Russian Direct Investment Fund (RDIF) to hold small clinical trials of Sputnik V in India. On Tuesday, RDIF told Indian news agency ANI that it expected to get approval for the vaccine this month or the next.

“We will be applying for emergency-use authorisation (EUA) by March 2021,” a Dr. Reddy’s spokeswoman told Reuters in an email, adding that the company had partnered with RDIF to distribute 250 million doses.

Indian regulator the Central Drugs Standard Control Organization (CDSCO) had no immediate comment on a potential application.

The vaccine has proved 91.6% effective against Covid-19, based on late-stage trials in Russia, results published in the Lancet medical journal showed on Tuesday.

More than a million people in Russia have received Sputnik V, which is marketed abroad by the RDIF and has been approved for emergency use in Algeria, Argentina, Bolivia, Mexico and Serbia.

RDIF expects India, the world’s biggest vaccine maker, to produce about 300 million doses of Sputnik V this year. Hetero Biopharma is making more than 100 million doses.

India’s regulator has approved for emergency use the AstraZeneca vaccine and another developed at home by Bharat Biotech and the state-run Indian Council of Medical Research.

A similar request from Pfizer and partner BioNTech for their vaccine is pending with the regulator.

India says it is the nation fastest to reach the milestone of 4 million vaccinations, with the United States taking 18 days and Israel and Britain 39 days each. Reuters could not find comparable data for China.

Except for the United States, India has the most virus infections, reporting 11,039 new cases on Wednesday, taking its tally to 10.78 million. Deaths rose 110 to stand at 154,596.

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