India’s premier medical research body has defended fast tracking of clinical trials of the Covid-19 vaccine candidate being developed by Indian company Bharat Biotech International Ltd and said it was in line with the current global trend to accelerate efforts to procure a medical response to contain the spread of deadly coronavirus disease, that has taken over half a million lives worldwide so far.
ICMR’s clarification comes amid criticism by experts questioning the rationale behind the council’s decision to fast-track clinical trials of Covaxin to time its launch with the Independence Day on August 15.
“In the larger public health interest, it is important for ICMR to expedite clinical trials with a promising indigenous vaccine. Faced with the unprecedented nature of the Covid 19 pandemic, all other vaccine candidates across the globe have been similarly fast-tracked,” ICMR said in an official press release on Saturday.
The controversy erupted after ICMR wrote to the 12 institutes selected for conducting human trials for Covaxin, ordering them to secure necessary approvals from internal committees by July 7 and disclosed that it aimed to launch Covaxin on August 15, potentially making it the world’s first Covid-19 vaccine. The body had also warned institutes that non-compliance with its instructions will be viewed very seriously.
ICMR sets August 15 deadline for world’s 1st Covid-19 vaccine
The letter was followed by criticism, with experts questioning the safety of such expedited trials that generally require months to complete and opposition political parties, including the Congress, attributing a political motive to ICMR’s bid to fast-track the vaccine candidate’s launch.
On Saturday, senior Congress leader Prithviraj Chavan alleged that the launch of a coronavirus vaccine by August 15 was aimed only at enabling Prime Minister Narendra Modi to make a big announcement from the Red Fort.
The ICMR has rejected the allegations of rushing through the process and said its programme was in accordance with globally accepted norms to fast track the vaccine development.
“ICMR’s process is exactly in accordance with globally accepted norms to fast-track the vaccine development for diseases of pandemic potential wherein human and animal trials can continue in parallel,” the council stated in its official release
Bharat Biotech International Ltd and Zydus Cadila are two Indian companies that have already won approvals from the drugs controller general of India (DCGI) for conducting human clinical trials of their vaccine candidates developed indigenously to check the spread of Sars-Cov-2, the virus which causes the coronavirus disease.
The Hdyerabad based company claims the results from pre-clinical studies, done in two months time, have been promising and the vaccine shows extensive safety and effective immune response. The human clinical trials of its vaccine will start sometime in July. The vaccine is being developed in collaboration with ICMR and National Institute of Virology (NIV).
Bharat Biotech is among seven Indian firms working on Covid-19 vaccines. It was the first to get the regulatory nod to begin phase 1 and phase 2 human trials.
More than a dozen Covid-19 vaccines from over 100 candidates globally are currently being tested in humans, and some have shown potential in early-stage trials. However, no vaccine has yet been approved for commercial use.
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