Union Health Ministry officials on Thursday clarified that the intent of the ICMR Director General's letter envisaging the launch of COVID-19 vaccine by August 15 was "only to expedite duly approved clinical trials without compromising on safety and security concerns".
The Drugs Controller General of India (DCGI) has permitted two vaccines -- one developed by the Bharat Biotech International Limited in collaboration with ICMR and another by Zydus Cadila Healthcare Ltd -- to go in for phase 1 and 2 human clinical trials, said Rajesh Bhushan, Officer on Special Duty in the health ministry.
The sites for phase 1 and phase 2 clinical trials have been finalised and the trials are yet to begin, he said during a press briefing.
"Please don't read something which is not there in DG, ICMR's letter. The intent of the letter is only to expedite duly approved clinical trials without compromising on security and safety concerns," Bhushan said.
Indian Council of Medical Research (ICMR) scientist Nivedita Gupta said indigenous vaccine candidates have been developed for a new disease in record time.
"We want the vaccine to be developed as fast as possible. "The aim of the letter was to ask sites to fast track it. We have the candidate and it should not happen that we miss the bus," she said.
"We need the vaccine today. If we go into conventional methods to develop the vaccine and bring it out after two years then there is no use of it. So the entire restlessness in the government and ICMR is to fastrack the vaccine development to make it available as soon as possible for citizens. The spirit behind the letter was this only," Gupta said.
Speaking on vaccine development for COVID-19, Bhushan said more than 100 vaccine candidates globally are at different stages of trial.
"It is a matter of satisfaction for India that there are two such vaccine candidates which are entirely indigenous," he said. Bhushan added that one has been developed by the Bharat Biotech International Limited in collaboration with ICMR and another one by Zydus Cadila Healthcare Ltd.
Both these vaccine candidates have completed animal toxicity studies after proper approvals. The animal toxicity studies take place on rats, guinea pigs, rabbits and the toxicity data with respect to both these vaccines has been shared with the DGCI.
Thereafter, the DGCI has permitted these two vaccines to go in for phase 1 and 2 of clinical trials. The sites of phase 1 and 2 clinical trials have been finalised and now the trials have to start.
"Whenever the results of these trials come, we will put the results in front of you," he said.
The ICMR in a statement on July 4 had said the letter by Director General of ICMR Dr Balram Bhargava to principal investigators of the clinical trial sites was meant to cut unnecessary red tape, without bypassing any necessary process, and speed up recruitment of participants.
Bhargava had on July 2 written to principal investigators of select medical institutions and hospitals to fast-track human clinical trial approvals for the vaccine candidate 'Covaxin' being developed in collaboration with Bharat Biotech.
"It is envisaged to launch the vaccine for public health use latest by August 15 after completion of all clinical trials.... You have been chosen as a 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 enrolment is initiated no later than July 7," the letter had stated.
The letter further warned that any non-compliance will be viewed very seriously.
"Kindly note non-compliance will be viewed very seriously. Therefore, you are advised to treat this project on highest priority and meet the given timelines without any lapse," the letter had said.
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