Dr. Reddy's Laboratories announces DCGI approval to the single-shot Sputnik Light vaccine in India

Dr. Reddy's Laboratories Ltd. today announced that the Drugs Controller General of India (DCGI) has approved the single-shot Sputnik Light vaccine for restricted use in an emergency situation in India.

Sputnik Light is a one-dose vaccine and the same as the first component — recombinant human adenovirus serotype number 26 (rAd26) — of the two-dose Sputnik V vaccine. Following its Phase III clinical trial of the single-shot Sputnik Light vaccine in India, Dr. Reddy's had submitted its application for approval to the DCGI in December 2021, in addition to data from the clinical trial in Russia.

The standalone Sputnik Light vaccine is the latest vaccine to be approved by the DCGI as part of India's national inoculation effort against COVID-19. Sputnik Light is the second COVID-19 vaccine to be made available in India by Dr. Reddy's, reaffirming the company's commitment to exploring every avenue in the fight against the pandemic.

Sputnik Light has been approved in over 30 countries around the world including Argentina, UAE, the Philippines and Russia. Earlier this year, an independent comparative study conducted by the Spallanzani Institute in Italy showed that Sputnik V demonstrates strong protection against the Omicron variant, with over two times higher virus neutralising activity compared to the Pfizer vaccine. The data support the results of the recent laboratory study by the Gamaleya Center demonstrating that Sputnik V induces robust neutralising antibody response to the Omicron variant, further strengthened by Sputnik Light as a booster.

In September 2020, Dr. Reddy's partnered with the Russian Direct Investment Fund (RDIF) to conduct clinical trials of Sputnik V and distribute the vaccine in India. In April 2021, the DCGI approved the two-dose Sputnik V vaccine for restricted use in an emergency situation in India.