India's Serum Institute seeks approval to make Russia's Sputnik V vaccine – sources

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FILE PHOTO: A medical specialist holds a vial of Sputnik V vaccine against the coronavirus in a department store in Moscow, Russia, January 18, 2021 REUTERS/Shamil Zhumatov/File Photo

NEW DELHI (Reuters) -The Serum Institute of India (SII) has sought regulatory approval to make Russia’s Sputnik V COVID-19 vaccine, two sources said on Thursday, joining a clutch of drugmakers in the country that are already expected to make around 1 billion doses annually. SII, the world’s biggest vaccine producer, is already making the AstraZeneca PLC and Novavax vaccines in India. The company has now sought preliminary approval from the federal drug regulator for making Sputnik V, the sources said, declining to be identified as details of the application have not been made public. The drug regulator and SII did not immediately respond to a Reuters e-mail seeking comment.

Six Indian companies have already signed deals to produce around 1 billion doses of Sputnik V annually.

The Indian government expects 156 million doses of Sputnik V between August and December.

Serum is currently ramping up production of the AstraZeneca shot, branded as Covishield, as the Indian government scrambles to boost supplies after a huge surge in infections since April. Indian drugmaker Dr. Reddy’s is already in talks with the government and the private sector to supply Sputnik V vaccine, which the company expects to commercially launch in the country by mid-June. The company has signed a deal with Russian Direct Investment Fund for 250 million doses, of which the initial 15%-20% is expected through imports, it said last month. After a devastating second wave of infections that killed tens of thousands in April-May, the Indian government is under fire to ramp up inoculations of its vast adult population to curb infections. India had given emergency authorisation to Russia’s Sputnik V vaccine in mid-April, as vaccinations slowed and infections surged. Sputnik V is a two-dose shot which has been found to be 91.6% effective in preventing people from developing COVID-19, a higher efficacy rate than the two vaccines currently approved in India. The Indian government is also in talks with Dr. Reddy’s to bring the single-dose Sputnik Light COVID-19 vaccine, a spokesperson for the company told Reuters on Monday.

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