Context: Russia has approved a novel corona virus vaccine for public use without the final phase of human trials. The Russian vaccine, developed by Moscow-based Gamaleya Institute, has cleared regulatory approvals in record time, less than two months after it got into human trials.

Production & availability

Apart from Gamaleya Institute’s own facility, the vaccine is supposed to be produced at a plant owned by Sistema, one of Russia’s biggest business groups. Its facility had the capacity to produce 1.5 million doses per year, and this capacity was being ramped up.

Will it come to India?

• The Central Drugs Standard Control Organisation (CDSCO) can ask Russia to conduct late-phase human trials, usually both phase-2 and phase-3, on an Indian population.
• Late-phase human trials are important because the vaccine’s efficacy can differ on different population groups.
• The CDSCO recently gave its go-ahead to late-phase trials on Indian volunteers. The Oxford vaccine trials are expected to begin this week.
• Considering the extraordinary situation right now, CDSCO is also empowered to give emergency authorisation without late-phase trials.
• The second issue is that of manufacture of the vaccine in India. More than 50% of vaccines for all kinds of diseases are currently manufactured in India. It is expected that a bulk of vaccines for novel corona virus, wherever they are developed, would also be produced in India.
• Pune-based Serum Institute of India, the world’s largest manufacturer of vaccines by volume, has already entered into tie-ups with developers to mass-produce their vaccines. There is no agreement for production of Russian vaccines in India right now.

Reference:

https://indianexpress.com/article/explained/why-russian-coronavirus-vaccine-is-a-long-way-from-being-available-in-india-if-at-all-6550788/

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