Explained: Why the Russian vaccine is a long way from being available in India, if at all
Russia Coronavirus (Covid-19) Vaccine: 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.
Written by Amitabh Sinha | Pune | Updated: August 15, 2020 1:34:28 pm
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There are two ways in which the Russian vaccine can be made available in 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. This is the usual requirement for all vaccines developed outside of India.
Late-phase human trials are important because the vaccine’s efficacy can differ on different population groups. This is the route being taken by vaccine candidate being developed by Oxford University, for example. The CDSCO recently gave its go-ahead to late-phase trials on Indian volunteers. The Oxford vaccine trials are expected to begin this week...
Russia Coronavirus (Covid-19) Vaccine: 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.
Written by Amitabh Sinha | Pune | Updated: August 15, 2020 1:34:28 pm
...
There are two ways in which the Russian vaccine can be made available in 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. This is the usual requirement for all vaccines developed outside of India.
Late-phase human trials are important because the vaccine’s efficacy can differ on different population groups. This is the route being taken by vaccine candidate being developed by Oxford University, for example. The CDSCO recently gave its go-ahead to late-phase trials on Indian volunteers. The Oxford vaccine trials are expected to begin this week...