Ruby General Hospital (RGH) in the city is all set to conduct a trial of the single-dose Covid19 vaccine Sputnik Lite among volunteers above 18 years during the first week of October.
The Drugs Controller General of India (DCGI), the country’s drug regulator, has approved the trial of the Russian-manufactured vaccine in many hospitals across states at a time when experts have already pressed an alarm button on Covid-19 third wave by September-end.
The trial run will be conducted among 179 volunteers across the country. Around 18 volunteers will undergo the vaccine experiment in RGH. Six Covid-19 vaccinesCovishield, Covaxin, Sputnik V, Moderna, Zydus Cadila and Johnson and Johnson have been approved for emergency use in the country.
Earlier, in July-end DCGI had refused to grant emergency-use authorisation to single-dose Covid vaccine Sputnik Lite, while ruling out the need for the conduct of the phase-3 trial of the Russian vaccine in the country.
According to the recommendations of the Subject Expert Committee (SEC) meeting held on 30 July, which has been approved by DCGI. Sputnik Lite is the same as the component-1 of Sputnik V and as its safety and immunogenicity data in the Indian population has already been generated in a trial here, there seems to be inadequate data and justification for conducting a separate, similar trial.