The Pune-based Serum Institute would conduct the Phase 3 trial on 1,500 volunteers across 14 locations.
The Union Health Minister Dr Harsh Vardhan said on Friday that nearly 30 COVID-19 candidates are in pre-clinical and clinical stages, developed by the pharmaceutical industry and academia in India.
Vardhan informed the House that the government has extended its support for the development of vaccine-associated research resources, the establishment of clinical trial sites, and notifying enabling regulatory guidelines.
"A high-level expert group is looking into matters related to vaccine distribution and immunisation. The distribution and immunisation of the Coronavirus vaccine are subject to availability. Once available, the Coronavirus vaccine distribution follows the same route as for the current practice of vaccines distribution under," Vardhan apprised the Lok Sabha on Friday through a written reply.
He also informed that the distribution of COVID-19 vaccine, when available, would be done as per the protocols under the Universal Immunization Program (UIP).
Besides, he also said that genome sequencing of 1000 SARS-CoV-2 RNA has been successfully completed. It was led by the National Institute of Biomedical Genomics (NIBMG-Kalyani), an autonomous institute under the department of biotechnology, situated in West Bengal. Five other national clusters, clinical organizations and other hospitals took part in the process as well.
It is imperative to know that two indigenous vaccines developed by ydus Cadila and Bharat Biotech are currently undergoing clinical trials with both successfully completing phase 1 testing.
Meanwhile, the Drugs Controller General of India (DCGI) has allowed the Serum Institute of India (SII) to restart its phase two and three clinical trials for the Oxford-AstraZeneca COVID-19 vaccine.
The Pune-based Serum Institute would conduct the Phase 3 trial on 1,500 volunteers across 14 locations.
Earlier, the Indian Council of Medical Research (ICMR) had announced that three vaccine candidates against Covid-19 are in the clinical stage of trials in India and one of them would soon begin Phase 3 trials after getting clearances.
(With IANS inputs)
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