Dr Reddy’s seeks emergency use approval for Sputnik V

SPUTNIK V HAS SHOWN AN EFFICACY OF 91.6% IN PREVENTING COVID-19 IN PHASE 3 TRIALS

NEW DELHI: : Dr Reddy’s on Friday applied for the emergency use approval of the Sputnik V coronavirus vaccine developed by Russia’s Gamaleya Institute, setting the ball rolling in what could lead to India getting access to a third shot to fight the pandemic.

Sputnik V has shown an efficacy rate of 91.6% in preventing Covid-19 in Phase 3 trials. The vaccine uses a similar adenovirus vector as the Oxford-AstraZeneca vaccine, whose Indian variant is Covishield. Apart from Covishield, India uses the domestically developed Covaxin, and has inoculated over 10 million people since kicking off the drive on January 16.

“The efficacy of Sputnik V was reported to be 91.6% by The Lancet, which is an impressive development in the fight against Covid-19. The initiation of the EUA process will be a critical step forward for us in ensuring speedy access to the Sputnik V vaccine in India,” Dr Reddy’s laboratories co-chairman and managing director GV Prasad said.

As part of the review process for emergency authorisation, the company will submit safety data from the Indian Phase 2 trial and interim data from Phase 3 – a regulatory filing process similar to the one adopted by the Serum Institute of India (SII).

Vaccines developed outside of the country will need to also undergo a bridging trial. Dr Reddy’s is conducting a Phase 3 bridging trial to establish immunogenicity of the vaccine in about 1,500 participants. The Phase 2 trial in India on 100 participants showed “no safety concerns,” according to the company.

In the global trials, the vaccine also maintained a consistent efficacy at 91.8% among group of 2,144 volunteers over 60 years, the company said. The company said that it was one of the three vaccines that had shown such high efficacy; the other two being Moderna and Pfizer. The efficacy rate of the Oxford-AstraZeneca vaccine (whose data was used for Covshield’s approval) was 62%.

In the case of Covaxin, efficacy data is awaited since Phase III trials have not progressed far enough. The vaccine had been approve by the Drug Controller General of India (DCGI) in a “clinical trial mode”, where all those who are vaccinated will be followed-up on.

The vaccine has been administered to more than two million people worldwide, the company said, listing Russia, Bolivia, Kazakhstan, Turkmenistan, Palestine, UAE, Paraguay, Hungary, Armenia, Algeria, Bosnian Serb Republic, Venezuela and Iran as countries where it is in use.