India wants a COVID-19 vaccine by August 15 at the risk of rushing trials and approvals
- The Indian Council of Medical Research (
ICMR) is working to launch the first made-in-India coronavirus vaccineby August 15 in partnership with Bharat Biotech International Limited (BBIL).
- The indigenous COVID-19 vaccine ‘Covaxin’ is currently under clinical trials.
- The ICMR has selected 12 institutes, including one from Odisha, for the clinical trial of ‘COVAXIN’.
Even the Oxford COVID-19 vaccine may hit the Indian market only by the end of the year, if successful.
ICMR’s indigenous COVID-19 vaccine (BBV152 COVID vaccine) or ‘Covaxin’ is currently under clinical trials. ICMR is working in partnership with Bharat Biotech International Limited (BBIL) to develop this vaccine. According to reports, this is one of the top priority projects which is being monitored at the topmost level of the government.
If successful, this will be the first indigenous vaccine being developed by India. “The vaccine is being 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,” ICMR Director General Balram Bhargava wrote in a letter to the heads of the selected institutions.
Bharat Biotech’s track record in developing vero cell culture platform technologies has been proven in several vaccines for Polio, Rabies, Rotavirus, Japanese Encephalitis, Chikungunya and Zika.
“It is envisaged to launch the vaccine for public health use latest by August 15, 2020, after completion of all clinical trials. BBIL is working expeditiously to meet the target. However, the final outcome will depend on the cooperation of all clinical trial sites involved in this project,” reads the letter dated July 2.
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 the initiation of the clinical trial and ensure that the subject enrollment is initiated no later July 7, 2020.
ICMR’s COVID-19 vaccine doesn’t sound convincing to experts
However, the letter of ICMR received much criticism from experts on social media for its tone. Some even questioned ICMR for deciding the efficacy of the vaccine even before the clinical trials.
This is a letter which has been sent out by the ICMR DG yesterday. Now that multiple folks have confirmed genuinene… https://t.co/uaj5aMgUyV— Anant Bhan (@AnantBhan) 1593748686000
Earlier in May, Kiran Mazumdar Shaw, founder and executive chairperson at Biocon told Business Insider that vaccine development takes a lot of time because several phases are involved in it.
In the first phase, a dose escalation is done to see what the ideal dose for an optimal immune response is. In the second phase, it is tested if the immune response can be done in all age groups. This is important as the first phase is conducted with young, healthy volunteers who are at minimal risk.
In the third phase, the vaccine is given to a larger population to ensure that the same immune response is given by everyone who is vaccinated.
“One of the most important things of this phase is to check how long the immunity stays. This allows us to determine how often a person will have to get revaccinated,” Shaw further noted.
Speaking about the production capacity, Shaw said that even after the vaccine is approved, India may not be able to produce more than 10-20 million doses in the first year, which is a negligible amount considering India’s population.
ICMR selects 12 institutes for clinical trial
The ICMR has selected 12 institutes, including one from Odisha, for the clinical trial of ‘COVAXIN’.
Bhubaneswar-based Institute of Medical Sciences and SUM Hospital under the SOA Deemed to be University, has been chosen by the Indian Council for Medical Research (ICMR) for undertaking human clinical trials of India’s first coronavirus vaccine.
In view of the public health emergency due to COVID-19 pandemic and urgency to launch the vaccine, the selected institutes are strictly advised to fast track all approvals related to the initiation of the clinical trial and ensure that the subject enrolment is initiated during the first week of July.
Apart from IMS and SUM Hospital, the other institutes selected for the clinical trial are located in Visakhapatnam, Rohtak, New Delhi, Patna, Belgaum (Karnataka), Nagpur, Gorakhpur, Kattankulathur (Tamil Nadu), Hyderabad, Arya Nagar, Kanpur (Uttar Pradesh) and Goa.
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