Categories: INDIA NEWS

Phase 3 trials almost over, Dr Reddy’s seeks emergency use nod for Sputnik V


Dr Reddy’s Laboratories (DRL) said Friday it has approached the apex drug regulatory body for emergency approval of Sputnik V.

If cleared by an expert body under the Central Drugs Standard Control Organisation (CDSCO), it would not only become the third Covid-19 vaccine to be approved, but also a potentially more promising vaccine in terms of its ability to prevent symptomatic Covid-19 cases in those vaccinated.

As part of the review process, DRL said it will present the safety profile of the phase 2 study conducted on Sputnik V as well as interim data of its ongoing phase 3 study, which it is expected to complete by February 21. Once the application to the CDSCO is submitted, it will be studied by a Subject Expert Committee, which will make recommendations on whether a restricted approval should be given to Sputnik V on an emergency basis.

The Hyderabad-headquartered firm began testing the vaccine, developed by Moscow’s Gamaleya National Research Institute of Epidemiology and Microbiology, in India on around 1,500 participants last December. In January, DRL said that it had received the green light to progress from phase 2 trials to phase 3 testing. The trials here aim to prove Sputnik V’s ability to provide protection in the Indian population.

The recruitment of the 1,500 participants of this trial was over late last month. In Mumbai, Saint George Hospital recruited 144 participants by January 30 for phase 3, 108 of whom were given the vaccine and 36 a placebo in a 3:1 ratio. “We have given 113 participants their second dose. In the next two days, we will finish the second dose for all participants,” said site investigator Dr Akash Khobragade. In Aurangabad’s MGM Medical College and Hospital, another phase 3 site, Dr Sunil Chaudhary said he is slated to complete the second dosing of vaccination in a week’s time.

Across India, 21 hospitals are a part of the phase 3 trial. At Noble Hospital, Pune, Dr Sidram Raut said over 80 participants have been recruited. “Just like the present Covid vaccines, we are seeing mild reactions in participants. Most have fever that subsides in 24 hours,” he added.

Interim results published in The Lancet from ongoing phase 3 trials of Sputnik V in Russia showed that it demonstrated an efficacy rate of 91.6 per cent. The efficacy of a vaccine shows its ability to prevent symptomatic cases of Covid-19 in the population being inoculated. While this two-dose vaccine seems to be slightly less efficacious than the vaccines developed by Pfizer-BioNTech and Moderna-NIAID, it is so far the only candidate in India with a higher known efficacy than the vaccines currently in use.

GV Prasad, MD, DRL, said, “The efficacy of Sputnik V was reported to be 91.6 per cent 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.”



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