NEW DELHI: 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.
“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.