Kolkata: Two versions of the Sputnik V vaccine — one the Russian made and the other Indian made — will undergo an equivalent trial at Peerless Hospital. If the Indian made vaccine proves to be equal or close to the efficacy of the original vaccine, this will open the doors for the local company to manufacture the doses. This, health experts believe, will allow more local manufacturers to come into the play by helping the country with more vaccine options at a time when India is facing an acute shortage of vials.
“During an equivalent study the two vaccines will be pitted against each other to see how the India version by Hyderabad-based Hetero Healthcare fairs in its efficacy vis-à-vis the original Russian vaccine. We have been chosen as one of the sites for the study,” said Subhrojyoti Bhowmick, director clinical research & academics at Peerless Hospital. Earlier, Peerless was part of the concluded phase III trial of the Russian made vaccine. Dr Reddy’s Laboratories has already started importing Sputnik V after getting the nod from the Drug Control General of India (DCGI), Hetero Healthcare while another Hyderabad based pharma company has tied up with Russian Direct Investment Fund (RDIF) for manufacturing the vaccine locally.
Before the roll out of the Indian version of the vaccine its efficacy has to be studied against the original vaccine. The formulation of the two vaccines is the same.
“This will be a head on comparison study of the two vaccines. Unlike other vaccine trials that are placebo controlled, in this trial, all will be given the actual vaccine. While half of the participants will be administered the Russian made doses the rest will get a shot of the Indian made vaccine of Sputnik V. We will be enrolling 100 volunteers and if all goes well, the trail should kick off in about two weeks,” added Bhowmick, who will play the role of a principal investigator.
The Russian made vials have already arrived in Hyderabad. With the price of the vaccine being fixed as Rs 995 per dose it is expected to be rolled out in about a week. This will be the third vaccine to be introduced in India after Covishield and Covaxin in the inoculation drive against Covid-19. Sputnik V has an efficacy of 92%.
Apart from Peerless, some more institutes are also expected to conduct the equivalent study on the two versions of the vaccine.
“Such equivalent trials are to analyse how close the local made version of the vaccine is to the original version in terms of efficacy or to assess that the locally made one is not inferior. This happens when the technology is transferred. When the country needs more vaccine to inoculate its population, this will allow more local players to manufacture it,” said senior clinical trial expert, Santanu Tripathi.
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