Hetero to manufacture over 100 million doses of the Sputnik V vaccine in India

Hetero to manufacture over 100 million doses of the Sputnik V vaccine in India

The Indian generic pharmaceutical company Hetero has joined hands with the Russian Direct Investment Fund (RDIF) to produce over 100 million doses of the COVID-19 vaccine Sputnik V in India through the company’s biologics arm Hetero Biopharma.

The production of the vaccine shall begin early 2021. The Gamaleya Centre and RDIF, on November 24, had announced positive results obtained during the second interim data analysis of the largest double-blind, randomized, placebo-controlled phase III clinical trials in Russia’s history involving 40,000 volunteers.

The interim trial results once again confirmed the high efficacy of the human adenoviral vector-based Sputnik V vaccine. Evaluation of efficacy was carried out among 18,794 volunteers 28 days after receiving the first dose and 7 days after the second dose of the vaccine or placebo upon reaching the second control point of the trial in compliance with the clinical trial protocol. The analysis demonstrated a 91.4% efficacy rate for the Sputnik V vaccine.

The vaccine uses two different vectors based on the human adenovirus, which allows for a stronger and longer-term immune response as compared to vaccines using one and the same vector for two doses.

Currently, phase III clinical trials are approved and are ongoing in Belarus, the UAE, Venezuela and other countries, as well as phase II-III in India. Requests for more than 1.2 billion doses of Sputnik V vaccine came from more than 50 countries, revealed RDIF in the press release. The vaccine supplies for the global market will be produced by RDIF’s international partners in India, Brazil, China, South Korea and other countries.