Russia's Sputnik Light could be the first single-dose vaccine to be used in India and Dr Reddy's will have discussions with the government and the regulator in June for an immediate launch, the company told NDTV today.
"We are working very closely with our Russian partner and the Gamaleya Institute on this. As you may be aware, the Sputnik Light has already been approved in Russia. It demonstrated an efficacy of 79.4 per cent. This is a single-shot vaccine," Deepak Sapra, the CEO of Dr Reddy's, said in an exclusive interview.
"What it essentially is, is that it is the first shot of Sputnik," he explained, adding that a second dose would take the efficacy to up to 91.6 per cent.
"What we are doing here in India is working with our partners in Russia, getting all that data and assessing that data. We are looking at the data on Day 28, on Day 42, both on safety and immunogenicity and we expect to have a dialogue with the Indian regulator on Sputnik Light. Assuming we are able to get this in place and get in approved in India, this would be a very, very significant aspect of India's vaccination drive because it would convert the entire vaccination process into a single vaccine which can give you 79.4% efficacy," Mr Sapra said.
The possibility of Sputnik as India's first single-dose vaccine "depends on approval from the regulator and on the dialogue which we have with them and on the guidance we receive from the regulator," he pointed out.
For now, the two-dose Sputnik V will be rolled out at 35 centres across India. The first lot of Sputnik vaccines will be imported from Russia, fully developed and ready to administer.
The imported vaccine shot will cost Rs 995.40 in India, Dr Reddy's Laboratories, which is manufacturing the vaccine in India, says.
The first dose of the vaccine was administered in Hyderabad today as part of a soft launch by Dr Reddy's. The price will be brought down once the vaccine is manufactured in India.
Sputnik V is the third vaccine to be used in India after Serum Institute of India's Covishield and Bharat Biotech's Covaxin.
At a time when the shortage of vaccine shots has slowed down or halted inoculations in many states, a single-dose vaccine could be a game-changer.
"As a starting point, in a country which is really wanting to vaccinate as many people as possible and give them a meaningful extent of immunity as early as possible, I believe Sputnik Light will be a very, very important step in that direction,'' Mr Sapra said.
Other than the Pfizer and Moderna vaccines, Sputnik V is the only shot to show an effectiveness of over 91 per cent against Covid-19 when taken in two doses, 21 days apart.
Russian scientists have countered allegations that Sputnik's trial data is not transparent.
Writing in medical journal The Lancet, scientists involved in a peer-review of the vaccine have said, ''Notwithstanding the previous issues and lack of transparency, the interim results from the phase 3 trial of the Sputnik V vaccine again raise serious concerns.''
In another piece in The Lancet, Russian scientists said, ''Clear and transparent regulatory standards exist for provision of clinical trial data.''
Mr Sapra said: "We are very satisfied with the response which has been given by the Russian partner to Lancet. It has also been published in the Lancet as a rejoinder and I feel comfortable about Sputnik being a safe and efficacious vaccine which can really make a difference in India from the standpoint of its vaccination drive.''
Why is Sputnik still not approved by the World Health Organisation, he was asked.
''That is a process that is underway. I think this is very likely to get approved in the next few weeks. There were a host of things which the World Health Organisation was asking for. As you also know, the production of Sputnik is also getting ramped up, not only in India but also in Russia. There are multiple production sites that are coming upstream in Russia and I think a lot of that data required - chemistry, manufacturing and control requirements - all of that has been put together and we expect that the WHO should be approving Sputnik soon," Mr Sapra asserted.