Hetero to manufacture 100 mn doses of Sputnik V for India

A view of a vial of Russia's experimental Sputnik V coronavirus vaccine. (Photo: AP)

Hyderabad-based drugmaker Hetero Drugs, through its biologics arm, will be producing “over” 100 million doses of Sputnik V starting 2021, said the Russian Direct Investment Fund (RDIF) Friday. The agreement makes it easier for India to get access to the Russian Covid-19 vaccine as, so far, the Russian sovereign wealth fund was going to export batches of the vaccine to India for use.

The firm, through subsidiary Hetero Biopharma, is expected to produce these doses over the course of the year, according to RDIF. It is unclear whether the vaccines produced here will also be used to fulfill demand from other countries. When asked, RDIF’s spokesperson declined to comment on this.

Sputnik V is also expected to be tested in mid- to late-stage clinical trials in India by Dr Reddy’s Laboratories, another Hyderabad-headquartered drugmaker.

These tests — a phase 2/3 clinical trial — are yet to start, The Indian Express has learnt. The second phase in India will enroll 100 volunteers and, if the data collected from this trial is satisfactory, the vaccine will progress to phase 3 trials testing around 1,500 volunteers.

Going by the country’s drug regulations, it is likely that, once Hetero manufactures batches of Sputnik V here, the firm may have to conduct separate trials in order for it to market its version of the vaccine in India.

Meanwhile, if Sputnik V is approved in India after Dr Reddy’s phase 2/3 trials, RDIF plans to supply at least 100 million doses of the vaccine to the firm for distribution. This means the vaccine would be supplied for at least 100 million people, as one “dose” is considered to be two shots of the vaccine, according to RDIF’s spokesperson.

Serum Institute of India, which has a similar agreement with The University of Oxford and AstraZeneca for their Covid-19 vaccine, is currently conducting phase 2/3 trials on around 1,600 participants. This is to show that its version of the vaccine — Covishield — is just as safe and has the ability to elicit the same immune response as the Oxford-AstraZeneca vaccine, AZD1222.

According to the latest interim analysis of data collected from participants undergoing Sputnik V trials in Russia, the vaccine seems to have demonstrated an efficacy of 91.4 per cent.

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