As part of the pan-India Phase III trial for Covid-19 vaccine, Covaxin vials reached National Institute of Cholera and Enteric Disease (NICED) from Hyderabad today.
According to sources at the NICED, which is under the Indian Council of Medical Research (ICMR), the phase III clinical trial of Covaxin is likely to begin at the institute during the first week of December. Till then, the vials will be preserved in minus four degree temperature at the NICED laboratory.
The Kolkata Municipal Corporation (KMC) has already assured the NICED authorities to cooperate in all aspects for successful trial of Covaxin in the city.
It is learnt that Firhad Hakim, state urban development minister and KMC board chairperson, has also spoken with the NICED director Dr Shanta Dutta. Hakim has reportedly expressed his desire to participate in the clinical trial as a volunteer at NICED if he meets the criteria for the project. Neither Dr Dutta nor
Hakim was available for comment.
It is learnt that around a 1,000 volunteers will participate in the clinical trial at the institute.
Covaxin has been developed indigenously by Bharat Biotech and ICMR jointly. It will be administered among 28,500 volunteers in the third phase trial across the country.
The trial at NICED will be conducted on placebo-controlled method where half the participants will receive inert placebo and rest will be given candidate vaccine.
The volunteers would be followed up over a considerable period of time to look at the efficacy of the vaccine in preventing coronavirus infections.
Elderly people and pregnant women are barred from the trial as volunteers.
Volunteers would be selected after thorough screening of their health condition.
Their personal details would be kept secret. Third phase clinical trial of another vaccine would also be conducted at the state-run School of Tropical Medicine (STM) in the city.
The ethics committee headed by pharmacologist professor Shantanu Tripathi at STM held a meeting with experts to discuss different aspects of the vaccine trial at the STM.