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ICMR-Bharat Biotech COVID-19 vaccine trial results to be released by Aug 15

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Published : Jul 3, 2020, 9:49 AM IST

Updated : Jul 3, 2020, 5:55 PM IST

In a letter to Bharat Biotech, the ICMR has demanded fast track trial procedure of the COVID-19 vaccine 'Covaxin' so that results can be launched by August 15. Covaxin is the first indigenous vaccine being developed by India and has been derived from a strain of SARS-CoV-2 isolated by ICMR-National Institute of virology.

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New Delhi: In a major development, Government of India aims to launch indigenous COVID19 vaccine (BBV152 COVID vaccine) commemorating forthcoming Independence Day celebrations on August 15.

India's apex medical research institute, Indian Council of Medical Research (ICMR), has partnered with Bharat Biotech International Limited (BBIL) to fast track clinical trials of the vaccine.

Terming the clinical trial as 'top priority projects', ICMR director-general Dr Balram Bhargava has dashed a D.O. letter (D.O.No.ECD/COVID19/Misc./2020) to a few selected institutes tagging them as a clinical trial site.

This is the first indigenous vaccine being developed by India and is one of the top priority projects which is being monitored at the topmost level of the government.

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.

"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," read the letter written by Dr Bhargava.

READ:| 20 ISRO officials to go into isolation as trainee Covid positive

ICMR has selected 12 institutes across the country as a clinical trial site for BBV152 COVID Vaccine.

"Given 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 the initiation of the clinical trial and ensure that the subject enrollment is initiated no later than July 7, 2020," Dr Bhargava said in his letter.

The letter further said that 'non-compliance' will be viewed very seriously.

Dr Bhargava in his letter asked the head of the clinical institutes to treat this project on the highest priority and meet the given timeline without any lapse.

However, experts are of the opinion that delivering the vaccine before August 15 may not be practically possible. In view of the exhaustive trails involved, it would be available in the market only by the year-end.

Visakhapatnam based Ming George Hospital, Rohtak based Pt. BD Sharma PGIMS, University of Health Science, New Delhi based AIIMS, Patna based AIIMS, Belgaum based Jeevan Rekha Hospital, Nagpur based Gillurkar Multispeciality Hospital, Gorakhpur based Rana Hospital, Chengalpattu (Tamil Nadu) based SRM Medical College and Research Centre, Hyderabad (Telangana) based Nizam's Institute of Medical Sciences, Bhubaneswar based Indian Medical Science institute, Kanpur based Prakhar Hospital Pvt. Ltd. and an institute in Goa have been selected as a clinical trial site.

India's coronavirus tally crossed 6 lakh cases yesterday after 19,148 new cases were reported in the last 24 hours.

Speaking to ETV Bharat Dr Amrinder Singh Malhi, former AIIMS RDA President and a senior resident in Cardiovascular Radiology Department said, " Time will only tell whether the clinical trials can be completed within the duration provided or not. But, it is very important to say that the Indian Government is very serious for the development and has kept it as a top priority. I hope that all these procedures get completed by August 15."

New Delhi: In a major development, Government of India aims to launch indigenous COVID19 vaccine (BBV152 COVID vaccine) commemorating forthcoming Independence Day celebrations on August 15.

India's apex medical research institute, Indian Council of Medical Research (ICMR), has partnered with Bharat Biotech International Limited (BBIL) to fast track clinical trials of the vaccine.

Terming the clinical trial as 'top priority projects', ICMR director-general Dr Balram Bhargava has dashed a D.O. letter (D.O.No.ECD/COVID19/Misc./2020) to a few selected institutes tagging them as a clinical trial site.

This is the first indigenous vaccine being developed by India and is one of the top priority projects which is being monitored at the topmost level of the government.

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.

"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," read the letter written by Dr Bhargava.

READ:| 20 ISRO officials to go into isolation as trainee Covid positive

ICMR has selected 12 institutes across the country as a clinical trial site for BBV152 COVID Vaccine.

"Given 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 the initiation of the clinical trial and ensure that the subject enrollment is initiated no later than July 7, 2020," Dr Bhargava said in his letter.

The letter further said that 'non-compliance' will be viewed very seriously.

Dr Bhargava in his letter asked the head of the clinical institutes to treat this project on the highest priority and meet the given timeline without any lapse.

However, experts are of the opinion that delivering the vaccine before August 15 may not be practically possible. In view of the exhaustive trails involved, it would be available in the market only by the year-end.

Visakhapatnam based Ming George Hospital, Rohtak based Pt. BD Sharma PGIMS, University of Health Science, New Delhi based AIIMS, Patna based AIIMS, Belgaum based Jeevan Rekha Hospital, Nagpur based Gillurkar Multispeciality Hospital, Gorakhpur based Rana Hospital, Chengalpattu (Tamil Nadu) based SRM Medical College and Research Centre, Hyderabad (Telangana) based Nizam's Institute of Medical Sciences, Bhubaneswar based Indian Medical Science institute, Kanpur based Prakhar Hospital Pvt. Ltd. and an institute in Goa have been selected as a clinical trial site.

India's coronavirus tally crossed 6 lakh cases yesterday after 19,148 new cases were reported in the last 24 hours.

Speaking to ETV Bharat Dr Amrinder Singh Malhi, former AIIMS RDA President and a senior resident in Cardiovascular Radiology Department said, " Time will only tell whether the clinical trials can be completed within the duration provided or not. But, it is very important to say that the Indian Government is very serious for the development and has kept it as a top priority. I hope that all these procedures get completed by August 15."

Last Updated : Jul 3, 2020, 5:55 PM IST
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