COVID- 19: ICMR'S AUGUST 15 DEADLINE TO VACCINE MAKES STIRS A ROW
NEW DELHI: An Indian council of medical research letter which sought fast-tracking of approvals relating to clinical trials and spoke of the launch of a vaccine by August 15 stirred the medical and scientific community on Friday, with questions being asked on how such deadlines could be adhered to given the complexity and time required for trials on humans. After trials of this vaccine it will be preferred for the covid-19 patients treatment for fast and high rates of recovery.
A vaccine candidate BHARAT BIOTECH received approval to enter initial phases of human clinical trials only earlier this week. In a letter to Bharat Biotech and chosen hospital for trials, ICMR director general Balram Bhargava advised "to fast-track all approvals related to initiation of the clinical trial and ensure that the subject enrolment is initiated no later than July 7" in view of the public health emergency and "urgency to launch the vaccine.
ICMR has partnered with Bharat Biotech to develop a vaccine called COVAXIN. Official sources said the health ministry had asked ICMR about the letter and was informed that the objective was to speed up the processes relating to vaccine development rather than set any hard deadlines. "we need the vaccine as the earliest and that was What ICMR wanted to convey," a source said. ICMR official also told TOI that no deadlines were being set.
How ever the tones of letters, suggesting that noncompliance will be treated seriously, generated concern over whether processes were being rushed. "Its is very envisaged to launch the vaccine for public health use latest by August 15 after completion of call clinical trials. BBIL is working expeditiously to meet the target however final outcome will depend on the cooperation of all the trial sites involved in this project," Bhargava said.
while calling the vaccine a "top priority" project which was "being monitored at the topmost level of the government", Bhargava said "non-compliance will be viewed seriouly.
CORONAVIRUS VACCINE: Bharat biotech announces India's first COVID-19 vaccine Candidate 'COVAXIN' with DCGI Approval for human clinical trials.
Hyderabad-based BHARAT BIOTECH announced that it has successfully developed Covaxin, India's
first vaccine candidate for Covid-19, in collaboration with the Indian council of Medical Research (ICMR) and national Institute of virology (NIV).
The drug controller General of India-CDSCO, Ministry of health & family welfare granted permission
to initiate phase I & II Human clinical trials after the company submitted results generated from preclinical studies, demonstrating safety and immune response. Human clinical trials are scheduled to start across India in July 2020.
The SARS-CoV-2 strain was isolated in NIV, pune and transferred to Bharat Biotech.
The indigenous, inactivated vaccine developed and manufactured in the company's Bio-safety Level 3 (BSL-3) High containment facility located in Genome valley, Hyderabad.
Announcing the vaccine development milestone, DR Krishna Ella, Chairman and Managing Director said:" We are proud to announce COVAXIN, India's first indigenous vaccine against COVID-19.
The collaboration with ICMR and NIV was instrumental in the development of this vaccine."
DR Ella added," The proactive support and guidelines from CDSCO has enabled approvals to this project. Our R&D and Manufacturing teams worked tirelessly to deploy our proprietary technologies
towards this platforms."
Expedited through national regulatory protocols, the company accelerated its objective in completing the comprehensive pre-clinical studies. Results from these studies have been promising and show extensive safety and effective immune responses.
Bharat Biotech's track record in developing vero cell culture platforms technologies has been proven in several vaccines for polio, Rabies, Rotavirus, Japanese Encephalitis, Chikungunya and Zika.(ANI)
we all are hoping that in upcoming time our Doctors and researchers will get success against the Corona virus.
Read More
Post a Comment
Have any queries let me know