Bharat Biotech international Limited (BBIL) began developing Covid-19 vaccine from preclinical to last stage of clinical trial in partnership with ICMR, the apex medical research body.
The director general of Indian Council of Medical Research (ICMR), Dr. Balaram Bhargava, has set a launch date of ‘Covaxin’ by August 15th for the public use by compelling all the clinical sites to get fast track clinical trial approval. The news was also doing the rounds in social media and many Whatsapp forwards, where ICMR itself confirmed the news.
The director general also strictly warned all the clinical sites to follow the covid-19 vaccine development protocol and warned serious action against any non-compliance.
Some of the 12 clinical trial sites associated for the development include some of India’s renowned public institutions such as All India Institute of Medical Sciences (AIIMS-New Delhi), AIIMS-Patna, Nizam Institute of Medical Sciences (NIMS) – Hyderabad, Post Graduate Institute of Medical Sciences (PGIMS) – Rohtak, King George Hospital (KGH) – Visakhapatnam, among others.
It’s reported that the vaccine candidate completed animal trials and is all set to begin it’s Human clinical trials, which would start this month from July 7th. However ICMR also instructed 12 selected clinical sites to enrol the participants before 7th. The aftereffects of the pre-clinical preliminaries, the organization had submitted were promising and shown effective reactions.
Why Bharat Biotech was chosen by ICMR?
Bharat Biotech built up the inactivated immunization at its high bio-safety-level-3 containment zone situated in Genome Valley. Prior to that, the NIV had isolated the SARS-CoV-2 strain and sent it to the organization. It is the producer of the world’s least expensive Hepatitis immunization. Additionally, it was likewise apparently became the main firm in the world to discover a Zika infection vaccine. Hence, ICMR selected Bharat Biotech to develop the Covid-19 vaccine.
Is the deadline realistic?
In general, it isn’t possible. The pre-clinical studies alone take a minimum of six months. Nonetheless, by considering the public health emergency due to COVID-19 pandemic, the DCGI(Drug Controller General of India) is giving fast-tracking approvals for accelerating the trials.
Experts proclaim that vaccines are time consuming process to develop due to the strict compliance to stringent safety guidelines. Condensing the timelines for testing and trials severely effects the safety assurance.
Dr. Davinder Gill, vaccine expert and former CEO of Hilleman Labs, claimed that producing a safe and effective vaccine in market by August 15, 2020, was scientifically impossible. “ICMR should admit it was a typo. (The date) should be 2021…that will take away the hysteria and make people focus on real work.”
Among the 12 institutions, four private hospitals got green signal from Institutional ethics committee on June 30. Nevertheless, another seven institutions’ approval is due from ethics committee. The members rubbished saying, it’s a trial on humans but not animals. Vasantha Muthuswamy, chairperson of the ethics advisory committee of the ICMR’s bioethics cell told, the timelines provided by ICMR’s director general Bhargava were too short and unrealistic. “By general experience, a month to decide whether to launch a vaccine is a very short time,” even if you get fast track review, it will take a minimum of one year.
How long will it take for clinical trials?
Clinical trials for any new discovery or vaccine comprises four stages that can last from 10 to 15 years until its completion. Where in first two stages, the safety profile assessment of the vaccine candidate is tested in very less individuals and then after getting approval from DCGI and FDA (Food Drug Administration) it proceeds to second stage with small groups. In the third stage, a larger sample size and 1000’s of healthy participants are enrolled to determine the adverse drug reaction of the sample drug. The principal investigators(who conduct research) of clinical sites should constantly report the safety reports of every individual. Once it gets 100% promising results, FDA gives permission to progress to the last stage i.e, post marketing surveillance, in which the medicine will be available in the market. However, FDA has every right to collect reports of any adverse drug reaction and possible side effects from people and determine whether the medicine can be continued or not. But if the firm gets fast track approval and accelerated FDA review, the trial stages can compress to 2-3 years.
As per the reports, In the current scenario, BBIL has just completed animal trials with good efficacy. But Bharat Biotech has enrolled only till the second stage of human clinical trials for Covaxin that too in an improper sequence, which is scheduled to begin from July 7th. Hence, the medical experts slammed the decision of ICMR and claims it to be scientifically impossible to review the safety in all stages within one month and launch the vaccine by August 15 2020.