First trials of Sputnik Light vaccine to be held in Kolkata
Probably the most talked about COVID-19 vaccine right now is the Sputnik Light, the Russian vaccine whose trials are about to begin in India. And Kolkata has been chosen as the place to begin with.
The country’s first trials of this single-dose vaccine will be held at the School of Tropical Medicine and two private hospitals located along EM Bypass.
Sputnik Light is actually the first dose of the two-dose vaccine, Sputnik V. Sputnik V is a heterogeneous vaccine where the first and second doses are different and use two different vectors, Ad26 and Ad5; hence, the first dose has been found to be suitable as a standalone vaccine.
The trials of Sputnik Light (or first dose of Sputnik V) would technically be the third phase of the trials of Sputnik V. Since the first two phases have already been completed in other countries, they would not be held in India. This third phase is therefore being called the ‘bridge’ phase.
Initially, the doses of Sputnik were being imported, with Dr Reddy’s Laboratories being the licensed importer. Now, Indian companies have started manufacturing the vaccine. This would reduce the cost of the vaccine.
Hetero Biopharma and Dr Reddy’s Laboratories (DRL) are the two companies which would be conducting the trials of Sputnik Light. Several other companies are also expected to be given the license by the Russian manufacturer to manufacture the Sputnik vaccines.
The trial subjects would be divided into two groups, with one group receiving the Russian-manufactured vaccine and another group the Indian-manufactured vaccine. Unlike the trials of other vaccines, there would be no placebo group.
Thirty volunteers would be selected from each centre across the country for the trialling of Sputnik Light. While Hetero Biopharma would need the participation of, and positive results from, at least 213 subjects, for DRL, it needs to be 179 subjects. Only then would Sputnik Light be approved by the Indian regulator.
According to hospital sources, DRL’s trials are likely to begin in the first week of October and Hetero’s in the second week. The results are expected after a gap of about a month.
The efficacy of the vaccine in Russia has been recorded to be 79.4 per cent. If Sputnik Light is approved, India’s COVID-19 inoculation drive would gather pace, which is much needed, given that it is massively behind schedule.
