Russian Covid vaccine set for India launch

Dr Reddy's Labs signs pact with RDIF for 100 mn doses

Russia's vaccine candidate, Sputnik V, which is based on the human adenovirus platform, will soon be available in India if the regulator gives its approval.

The 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 ~4,631 apiece, up 4.2 per cent, 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, the 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.