Dr. Reddy’s reports success in Sputnik V phase 2 trial, paving the way for phase 3 in India

Dr. Reddy’s Laboratories has announced a major milestone in the development of Sputnik V, the Russian Covid-19 vaccine, following its successful phase 2 clinical trial in India. The trial, which met the primary endpoint of safety, saw the vaccine administered to 100 volunteers under a randomized, double-blind, parallel-group, placebo-controlled study. Based on the findings, an independent data and safety monitoring board (DSMB) has recommended that the vaccine progress to phase 3 trials without any modifications. This endorsement paves the way for further clinical studies and, potentially, the vaccine’s wider deployment in India.

The Sputnik V vaccine, developed by the Gamaleya National Research Institute of Epidemiology and Microbiology in Russia, is based on a human adenoviral vector platform. Notably, the DSMB’s report confirmed that no safety concerns were raised during the trial, further bolstering confidence in the vaccine’s safety profile. Dr. Reddy’s has submitted the safety data to India’s Drugs Controller General (DCGI) for review, and it has also requested approval to move forward with phase 3 trials.

The successful phase 2 trial marks a significant step for Dr. Reddy’s Laboratories, which has partnered with the Russian Direct Investment Fund (RDIF) since September 2020 to bring the vaccine to India. RDIF is set to supply up to 100 million doses of Sputnik V, contingent upon regulatory approval in the country.

G V Prasad, Co-chairman and Managing Director of Dr. Reddy’s Laboratories, emphasized that the Indian clinical trial is an adaptive design phase 2/3 trial, which serves as a bridging study to a larger global phase 3 study involving 31,000 subjects. He expressed optimism over the vaccine’s safety, noting that over 1 million people in Russia and more than 300,000 in Argentina have already received Sputnik V without major concerns. Prasad added that the results from the Indian phase 2 trial further support the vaccine’s safety, reinforcing their commitment to expediting its launch in India.

Sputnik V’s impressive efficacy rate of 91.4% based on the final control point of clinical trials in Russia has garnered international attention. According to Kirill Dmitriev, CEO of RDIF, the safety and efficacy data from the phase 2 trial in India aligns with the vaccine’s performance in other international markets. Dmitriev noted that the vaccine consistently demonstrates both safety and high efficacy, thanks to its use of a human adenoviral vector platform.

As Dr. Reddy’s moves forward with regulatory approvals and plans for phase 3 trials, the success of the phase 2 trial is expected to accelerate the availability of Sputnik V in India. With growing international evidence of its effectiveness and safety, the vaccine could play a significant role in India’s fight against the Covid-19 pandemic.