New Delhi, August 22:
At present, two vaccine candidates are at phase I and II clinical human trials in Indis. India’s first COVID-19 vaccine “ Covaxin” has been developed by the Hyderabad-based vaccine maker-“Bharat BioTech”, Indian Council of Medical Research (ICMR) and National Institute of Virology (NIV), has “successfully completed” Phase-I human clinical trials of the vaccine and Phase-II will start soon.
Another vaccine developed by Zydus Cadila, dubbed as “ZyCoV-D”, vaccine commenced phase II clinical trials from August 6 onwards and was found to be safe and well tolerated in the phase I clinical trial.
The promising initial trial results of the vaccine developed by Oxford-Astrazeneca, were published by Oxford a couple of days back. The vaccine is now in the third phase of human clinical trials. It will be manufactured as “Covishield” by the Pune-based Serum Institute of India(SII). The SII plans to manufacture 20-30 lakh doses of “Covishield”.
On Wednesday, the during the presentation before the parliamentary standing committee on home affairs, Indian Council of Medical Research (ICMR) Chief Balram Bhargava, indicated that the authorisation, at first could be granted to locally produced and manufactured vaccines. While admitting that under normal circumstances, vaccine trials could take anywhere between 6-9 months to complete, he said that if the authorities allow for it, vaccines could be used for emergency use.
The ICMR also informed the parliamentary committee that Bharat Biotech’s inactivated vaccine candidate, co-developed with the National Institute of Virology, and Zydus Cadila Ltd’s DNA plasmid vaccine are currently in phase 1 clinical trials. The ICMR is supporting both companies in parallel, pre-clinical studies on safety, immunogenicity and efficacy in non-human primates and lab assays for antibody detection and immunological response assessment.
While this will be the first time a vaccine could be issued emergency authorisation, treatment drugs and methodologies have been given fast approvals. Life-saving drug, “Remdesivir” was given fast track authorisation to be used in severe infection cases, to be administrated under hospital settings
Fast trials and administration won’t really mean that it would be safe to use by all sections. Unless and until a vaccine is found to be safe for all age groups and provides protection for a longer time, it is not considered ideal for use. The same applies for “Covaxin” and “ZyCoV-D”. A lot of extensive studies and researches are needed before we pin our hopes on the indigenous vaccines.
The ICMR is helping the SII in conducting phase II and III clinical trials for two COVID-19 vaccine candidates- developed by the University of Oxford and US-based company Novavax and the vaccine developed by Oxford-Astrazeneca. Besides, the ICMR is also helping “Zydus Cadila” conduct lab tests to detect antibody response.
“ZyCOV-D” (Zydus Cadila) and “Covaxin” (Bharat BioTech), which are currently, in the middle of phase II of trials have also shown promising results in early studies. A third vaccine, is also in critical stages of development, although no other details have been revealed as of yet.