Sputnik V Gets Emergency Use Approval In India

New Delhi, 13 April 2021:

The Drug Controller General of India (DCGI) has approved the use of the Sputnik V vaccine for usage, according to the Russian Direct Investment Fund (RDIF).

This paves the way for India to rollout its third vaccine against the coronavirus infections. The country has been administering Covishield -- the Oxford-Astrazeneca vaccine manufactured by the Serum Institute of India -- and home-grown Covaxin.

According to RDIF, India has now become the 60th country to approve Sputnik V.

"India is the most populated country to register the Russian vaccine. Total population of 60 countries where Sputnik V is approved for use is 3 billion people or about 40% of the global population," said RDIF.

"The vaccine has been registered in India under the emergency use authorization procedure based on results of clinical trials in Russia as well as positive data of additional Phase III local clinical trials in India conducted in partnership with Dr. Reddy’s Laboratories," the Russian body added.

According to the medical journal Lancet, Sputnik V is 91.6% effective in protecting against the coronavirus.

Russia registered Sputnik V for public use in August, the first country to do so, though the approval came before the start of the large-scale trial in September.

"We appreciate the decision of India's regulatory bodies to grant authorization for Sputnik V. Approval of the vaccine is a major milestone as Russia and India have been developing an extensive cooperation on clinical trials of Sputnik V in India and its local production," said Kirill Dmitriev, CEO of the RDIF.

An expert panel of DCGI had on Monday recommended the vaccine for usage.

India is currently in the third phase of its mega Covid-19 vaccination drive which commenced on 16 January. As many as 10,45,28,565 vaccine doses have been administered through 15,56,361 sessions, the Union health ministry said on Monday.

On last Friday, DCGI sought additional data from drugmaker Dr. Reddy's Laboratories on its Sputnik V Covid-19 vaccine trial, in its second such request after an initial evaluation in February.

The committee had earlier asked the company to submit a comparative analysis of late-stage immunogenicity data from both its Indian studies and an ongoing Russian study, as well as data on serious adverse events and positive cases reported till date. Livemint