Nearly 30 COVID-19 vaccine candidates in pre-clinical and clinical stages are under development by the pharmaceutical industry and academia in India. While three of them are in the advanced stage of Phase I/II/III trials and 4 are in the advanced pre-clinical development stage, the union health minister, Dr Harsh Vardhan, told the Parliament on Friday.
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.
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). "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.
Besides, he also said that genome sequencing of 1000 SARS-CoV-2 RNA has been successfully completed. It was led by 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.
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.
Covid-19 vaccine candidates being manufactured by Cadila Healthcare and Bharat Biotech have completed the first phase of the trial while the Serum Institute of India (SII) will begin with Phase 3 trial after getting the nod, Balram Bhargava, ICMR director-general, had informed during the health ministry's briefing, on Tuesday.
On Monday, the minister of state for health, Ashwini Choubey, had informed the Lok Sabha that Phase II clinical trials of Bharat Biotech and Cadila Healthcare are underway.
He also informed the House that discussions on collaborations on the recombinant vaccine developed by Russia are ongoing. However, no formal studies have been initiated.
The Pune-based Serum Institute would conduct the Phase 3 trial on 1,500 volunteers across 14 locations.
