The medical clinics picked by the ICMR to direct human trials of the coronavirus vaccine created by Bharat Biotech — COVAXIN — are looking to reconsider the high priority undertaking now. Reportedly the principal investigators decided to take at least a half year in observing the individuals who will be administered the vaccine.
Hyderabad-based Bharat Biotech got approval from the Central Drugs Standard Control Organization (CDSCO) to start human clinic trials of COVAXIN on June 30. The immunization has been created in a joint effort with the ICMR and National Institute of Virology in Pune.
Following the permit for human trials, ICMR picked 12 sites as ‘clinical trial sites’ to lead the preliminaries of the vaccine for two stages on picked members.
Dr Chandrashekhar Gillurkar, director Gillurkar Multi speciality Hospital in Nagpur, is planning an observation period of at least six months for the volunteers who will be given the vaccine candidate. His hospital is one of the 12 trial sites chosen by ICMR to conduct human trials. Dr Gillurkar says the ICMR’s deadline for vaccine is unscientific and the human trials can’t be fast forwarded.
The doctor depicted about the possible medical timeline of Phase I and Phase II trials, he said that the research team will check in with the ‘participants’ of the trials on day 14, day 28, day 42, day 104, and day 194 post the vaccine administration.
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