The trial in India would be a bridge trial as a phase 3 trial on 40,000 volunteers is already on Russia
candidate, Sputnik V, which is based on human adenovirus platform, will soon be available in India if the regulator gives its approval.
Russian Direct Investment Fund (RDIF), a sovereign wealth fund, has signed a pact with Hyderabad-based Dr Reddy's Laboratories (DRL) for clinical trials and distribution of 100 million doses of Sputnik V in the country. Besides, talks are on with five major Indian manufacturers to produce the vaccine, not only for India but for the world.
Adenoviruses most commonly cause respiratory illnesses.
The cost of clinical trials would be shared equally between the two partners, DRL said on Wednesday. Shares of DRL soared after the announcement and ended at Rs 4,631 apiece, up 4.2 percent, on the BSE.
The trial in India would be a bridge trial as a phase 3 trial on 40,000 volunteers is already on Russia. Speaking to a television channel, Kirill Dmitriev, CEO, RDIF, clarified that the total volunteer count for the phase 3 trials would be 45,000 and that would include countries like Saudi Arabia, UAE, Brazil and India, apart from Russia.
RDIF and DRL have submitted necessary data to the country's drug regulator and are awaiting its approval to start clinical trials. DRL said deliveries could potentially begin in late 2020, subject to the completion of successful trials and registration of the vaccine
by regulatory authorities in India. Dmitriev, however, expected the vaccine
to be available by November here as preliminary results from Russia were expected in October. DRL did not wish to comment on the timeline for the vaccine's launch.
Sputnik V would not be made by DRL. It does not yet have a vaccine manufacturing facility. The 100 million doses will be supplied to DRL by RDIF, informed the company. However, in future, DRL was open to considering the manufacturing of the candidate. As of now, the collaboration was limited to clinical trials and distribution in India and countries where DRL had a strong presence. Separate agreements would be forged for countries other than India.
Russia had reached out to India to help it scale up the manufacturing of Sputnik V. The government had then reached out to vaccine makers if they wished to collaborate with Russia on their candidate.
Industry sources revealed that RDIF was currently in talks with Indian Immunologicals, Serum Institute of India, and Cadila Healthcare, among others. "We are discussing with the Russian counterparts on Sputnik V. However, the data is not yet ready and that is why we are yet to take a call on whether we want to partner them for manufacturing," said a senior official of a vaccine maker here. He added that Russian representatives were quite active and meeting the regulator on a regular basis.
Dmitriev has said India is a 'strategic partner' for manufacturing the Russian vaccine as the country has large-scale vaccine manufacturing capacities. India accounts for 60 per cent of the global vaccine supplies. RDIF is also in talks with COVAX- Covid-19 Vaccine Global Access,
On August 11, the Sputnik V vaccine developed by the Gamaleya National Research Institute of Epidemiology and Microbiology was registered by the Ministry of Health of Russia and became the world’s first registered vaccine against COVID-19 based on the human adenoviral vectors platform. RDIF plans to start manufacturing the vaccine in India even before the approvals come in. Vaccine makers, however, seemed skeptical.