The Indian Council of Medical Research (ICMR), the apex medical research body, has set an ambitious launch date of August 15 for the public use of the Coronavirus vaccine being developed in partnership with Hyderabad-based Bharat Biotech, instructing them to fast-track clinical trials.
ICMR and Bharat Biotech are jointly working on the preclinical as well as clinical development of this vaccine.
Human trials for Covaxin, the vaccine in question, will begin this month itself. The results of the pre-clinical trials the company had carried out were promising and exhibited substantial safety and effective immune responses.
Bharat Biotech developed the inactivated vaccine at its high-containment facility located in Genome Valley. Before that, the NIV had isolated the SARS-CoV-2 strain and passed it to the company.
Bharat Biotech is also the maker of the world’s cheapest Hepatitis vaccine. Besides, it was also reportedly as the first firm in the world to find a Zika virus vaccine.
The Hyderabad-based firm was formed with a total funding of Rs 12.5 crore, of which Rs 5 crore was equity (promoters, Rs 3 crore and IDBI, Rs 2 crore). The balance capital was funded by way of loan from Technology Development Board (Department of Science and Technology) and IDBI Bank, Dr Ella told Rediff.com.
Dr Krishna Ella, chairman and managing director of the company, is a pioneer in molecular research in India. As per an interview conducted by Rediff, Dr Ella, the son of a Tamil Nadu farmer, had advised former Andhra CM Chandrababu Naidu to set up a Biotech Park, which later played a major role in the emergence of over 100 knowledge-based firms.
The company has used Vero cell culture platform technologies to make several vaccines for polio, rabies, rotavirus, Japanese encephalitis and chikungunya.
"You have been chosen as clinical trial site of the BBV152 COVID vaccine. In view of the public health emergency due to COVID-19 pandemic and urgency to launch the vaccine, you are strictly advised to fast track all approvals related to initiation of the clinical trial and ensure that the subject enrollment is initiated not later than July 7, 2020," ICMR Director-General Balram Bhargava said.
Bhargava warned that non-compliance will be viewed very seriously.
"Therefore, you are advised to treat this project on highest priority and meet the given timelines without a lapse," the letter added.
The 12 clinical trial sites include some of India's premier 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.
What exactly will Bharat Biotech do in COVID-19 vaccine development?
Bharat Biotech has grown the virus and inactivated it through a chemical process. The company started testing the vaccine on animals for safety and efficacy as part of pre-clinical studies. The company said it was able to accelerate the whole process of pre-clinical studies through expedited regulatory approvals. According to sources, ICMR had closely monitored the pre-clinical work.
The results from these studies have been promising and showed extensive safety and effective immune responses, the company claims. The data hasn't been published yet.
Bharat Biotech also announced early this week that it got the Drug Controller General of India's approval to test the vaccine on humans on Phase I and II human clinical trials. The clinical trial will be the responsibility of principal investigators appointed by the government and the protocols and data will be audited by independent agencies.
The company's primary role is to supply the vaccine for clinical trials and prepare to roll out billions of doses once the vaccine is approved for public use. The company said it has the capacity to supply enough vaccine doses to meet the country's demand.
Why was Bharat Biotech chosen?
ICMR has been working closely with Bharat Biotech for years. It had earlier partnered with Bharat Biotech for Rotavirus and H1N1 vaccines.
But that's not the only reason; what had prompted ICMR to choose Bharat Biotech could be that the vaccine would be manufactured at the firm's Bio-Safety Level-3 (BSL-3) containment facility located in Genome Valley in Hyderabad, say sources. Bharat Biotech had built India's biggest BSL-3 high-containment facility for manufacturing inactivated polio vaccine, which will now be used for COVID-19 vaccine. BSL-3 is appropriate for work involving microbes that can cause serious and potentially lethal diseases via the inhalation route.
Experts say an inactivated vaccine involving live SARS-CoV-2 should be produced only in a BSL-3 containment facility due to a high risk of contamination or inadvertent release. Other vaccine companies too can approach ICMR for the strain, if they are interested in developing the vaccine.
How realistic is the deadline?
In normal circumstances, it isn't possible. The pre-clinical studies alone take a minimum of six months. But in view of the public health emergency due to COVID-19 pandemic, the government is fast-tracking approvals related to clinical trials. In fact, ICMR's letter says the subject enrollment has to be initiated no later than July 7.
Dr Davinder Gill, vaccine expert and former CEO of Hilleman Labs, told CNBC-TV18 that developing a full-fledged vaccine by August 15, 2020, was scientifically not possible. "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."
Vaccines are complex to develop, largely owing to stringent safety studies needed because it is meant to be given to healthy humans. Compressing the stages of testing and trials severely compromises on the safety assurance, say experts.
Dr Suresh Jadhav, executive director at Serum Institute of India, has also voiced doubts if ICMR will be able to meet the August 15 launch date target.
“In my opinion, vaccine launch is not possible by Aug 15,” he told CNBC-TV18.