JOIN USICMR aims to launch indigenous Covid-19 vaccine by August 15
The Indian Council of Medical Research (ICMR) has asked 12 hospitals chosen to carry out clinical trials of the Covid-19 vaccine candidate developed by Bharat Biotech to accord “highest priority” to the project and fast track approvals to enable launch of the vaccine by August 15.
The apex health research body has asked the medical institutions and principal investigators to ensure that the subject enrolment is initiated no later than July 7.
The coronavirus vaccine candidate Covaxin, developed by the Hyderabad-based Bharat Biotech in collaboration with the ICMR and the National Institute of Virology (NIV), had recently got the nod for human clinical trials from the DCGI.
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According to the Clinical Trials Registry-India, the Phase-I and Phase-II clinical trials of the Covaxin will be carried out on 1,125 participants across 12 hospitals that include AIIMS in Delhi and Patna, and Nizam’s Institute of Medical Sciences in Hyderabad.
The letter to the hospitals, sent by ICMR Director General Balram Bhargava, asked them to enroll volunteers for the trials “no later than” July 7 and warned them that any non-compliance will be viewed very seriously.
“It is envisaged to launch the vaccine for public health use latest by 15th August 2020 after completion of all clinical trials,” Bhargava said in the letter dated July 2.
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Hyderabad-based Bharat Biotech is developing the vaccine based on the strain of the SARS-Cov-2 virus isolated by ICMR-National Institute of Virology, Pune. ICMR and Bharat Biotech are jointly working for the pre-clinical as well as clinical development of the 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 no later than 7th July 2020,” the letter added.
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Bharat Biotech Chairman and Managing Director Krishna Ella, however, was non committal on any launch date for the vaccine.
“I cannot commit now on when the trial would start and when we would receive the results,” Ella told DH.
“For a vaccine for which pre-clinical development is still ongoing, as per the letter itself, how can clinical trial recruitment be starting on 07th July? And that the vaccine will be launched on 15th August? A vaccine trial completed in little over a month, efficacy pre-decided,” Anant Bhan, former President of the International Association of Bioethics said.
According to the submission to the CTRI, the study is designed to evaluate the safety, reactogenicity, tolerability, and immunogenicity of three groups of 125 healthy volunteers each who receive two doses of the vaccine formulations in Phase-I.