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The COVID-19 vaccine scene in India is gaining momentum. The Indian council of Medical Research (ICMR) plans to launch the indigenous vaccine for COVID-19 by August 15 after the completion of the clinical trials. It has selected 13 institutions across the country for clinical trials and asked them to initiate subject enrollment by July 7. ICMR has partnered with Hyderabad-based Bharat Biotech International Limited (BBIL) to fast-track clinical trials of the BBV152 COVID vaccine. The vaccine is derived from a strain of SARS-CoV-2 isolated by ICMR-National Institute of Virology, Pune. ICMR and BBIL are jointly working for the preclinical as well as clinical development of this vaccine named Covaxin.
Scientists are hopeful that they can launch the vaccine for public health use latest by 15th August 2020 after completion of all clinical trials. The final outcome, of course, will depend on the cooperation of all clinical trial sites involved in this project. Informing the institutions of their selection as clinical trials sites for the vaccine, the IMCR director general strictly advised them to fast track all approvals related to initiation of the clinical trial and ensure that the subject enrollment is initiated no later July 7, 2020. The list of institutions involved in vaccine trials include Nizam's Institute of Medical Sciences (NIMS), Hyderabad, King George Hospital, Visakhapatnam, University of Health Sciences, Rohtak, All India Institute of Medical Sciences (AIIMS), New Delhi and AIIMS Patna.
Covaxin has been expedited through national regulatory protocols and subjected to "comprehensive pre-clinical studies" according to the company, which reports that the results are "promising" and "show extensive safety and effective immune responses". The virus strain was first isolated by the National Institute of Virology, Pune after it was collected by ICMR. This isolated strain was then used to develop a vaccine candidate at Bharat Biotech. Upon receipt of the virus strain from the NIV Pune, Bharat Biotech was able to quickly layout the GMP (good manufacturing practices) protocols for the manufacture of the vaccine candidate. Bharat Biotech took to develop the first set of GMP batches within 40 days and upon completion, the pre-clinical trials commenced.
Covaxin was evaluated in animals on Schedule Y Guidelines (Schedule Y defines the clinical trials as the requirements and guidelines for import and manufacture of new drugs for sale or for clinical trials. It describes the details of the application process for conducting clinical trials; responsibilities of the sponsor, investigators and the guidelines of India's Independent Ethics Committee) and the World Health Organisation. Scientists working on it saw that it is safe and immunogenic in all animals. This is an inactivated vaccine developed on a Vero-cell platform. Inactivated vaccines have a well-proven and accepted track record.
Conventionally, inactivated vaccines have been around for decades. Numerous vaccines such as seasonal influenza, polio, pertussis, rabies, and Japanese Encephalitis use the same technology to develop inactivated vaccines. Once the vaccine is injected into a human, it has no potential to infect or replicate, since it is a killed virus. It just serves the immune system as a dead virus and mounts an antibody response towards the virus.
(With inputs from IANS)
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