India set for pivotal role in Covid-19 vaccine production: ICMR
Balram Bhargava, the head of ICMR, said two India-made Covid-19 vaccines are now being trialled with 1,000 volunteers each, and the focus will be on easing regulatory clearances for the process without compromising on scientific or ethical parameters.
India will play a crucial role in scaling up production of any Covid-19 vaccine that is developed anywhere in the world, the head of India’s top medical research body said on Tuesday, citing the size of the domestic pharma industry and expressing hope that the country will be well poised for the production of successful candidates.
The comments come weeks after the Indian Council of Medical Research (ICMR) appeared to rush the trial process of one of the two Indian vaccines by setting an August 15 launch deadline, before widespread criticism forced officials to clarify that a letter mentioning that date was meant to speed up the regulatory approvals process rather than lay down a hard timeline.
“India is well-known as the pharmacy of the world... It also supplies 60% of the world’s vaccines, whether it be Africa, Europe, south east Asia or anywhere. So, any vaccine candidate that’s produced or developed in any part of the world will ultimately have to be scaled-up in India or by China because these are the two major vaccine producers of the world,” said Balram Bhargava, the head of ICMR, while adding that several developed nations are in touch with Indian entities for vaccine distribution.
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Bhargava said two India-made vaccines are now being trialled with 1,000 volunteers each, and the focus will be on easing regulatory clearances for the process without compromising on scientific or ethical parameters. “The two indigenous vaccine candidates have undergone successful toxicity studies in rates, mice and rabbits and their data was submitted to the drugs controller general of India, following which both these candidate vaccines got clearance to start the early phase human trials early this month,” he said.
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Among the two is Bharat Biotech’s Covaxin, which received drugs controller general of India’s nod for human trials on June 29 . On July 2, a letter sent by Bhargava to hospitals where vaccine trials were to be done said, “it is envisaged to launch the vaccine for public health use latest by 15th August 2020 after completion of all clinical trials”. Criticised for setting an unrealistic timeline that would compromise vaccine safety, the ICMR later backtracked and said international trial protocols will be followed.
Another vaccine candidate is from Zydus Cadila called ZyCov-D, which received the drug controller’s approval for human trials on July 2. It was developed indigenously at the company’s Vaccine Technology Centre in Ahmedabad, Gujarat.
“They have got their sites ready and they are doing their clinical studies on approximately a 1,000 human volunteers each at different sites, some have six and some 12. They are trying to do the early clinical testing for these two indigenous candidate vaccines. Over and above there are pre-clinical experiments for other vaccine being done at National Institute of Virology in Pune, which is trying to work day and night to do these experiments because it is our moral duty to develop these vaccines as fast as possible,” said Bhargava.
The world over, vaccine candidates that have been put on a fast-track are from Russia, China, United States of America and the United Kingdom. “We are making all efforts to fast-track developing the vaccine and it is the moral duty that there should not be a delay even by a day for the regulatory clearances for these vaccines so that we can break the transmission of the virus as soon as possible,” said Bhargava.
Dr VK Paul, member, Niti Ayog, in an earlier interview to HT, also had said that India will take the lead in manufacturing the Covid-19 vaccine when it is developed.
Experts also say that eventually it is the vaccine that will provide the key to break the transmission cycle.“The vaccine will be ultimate to check the disease spread but we don’t know when will an effective vaccine be available for use even though all our efforts are being directed towards making it happen as soon as possible. A good vaccine is the most cost-effective way of preventing a disease,” said Dr Amita Jain, head, microbiology department, KGMU, Lucknow.
Bhargava was speaking at briefing organised by the Union government on Tuesday.