No Central nod, Phase 3 trials of Covaxin delayed by month
Karam Prakash
Tribune News Service
Patiala, October 20
The Phase 3 trials of Covaxin involving clinical testing on humans at the three government medical colleges (GMCs) in Punjab have been delayed by at least a month.
The trials were supposed to commence from October 15, but the state government couldn’t get the mandatory nod from Bharat Biotech. It has been learnt that the government had not received the permission and approval from the Central Government, a process which Bharat Biotech has to complete.
Phase 2 findings not submitted
Bharat Biotech has not submitted the Centre’s approval to the state government to carry out the human trials. We have also not received any documents of the results of Phase 2 trials which had been carried out by Bharat Biotech
Officials of the Medical Education and Research Department said Bharat Biotech had already conveyed to the state government that the process of getting the approval to carry out clinical human trials of Covaxin in Punjab was still under process. The Covaxin trials have to be carried out by the Medical Education and Research Department.
DK Tiwari, Principal Secretary, Medical Education, said, “Bharat Biotech has not submitted the Central Government’s approval to the state government to carry out the human trials. Moreover, we have also not received any documents of the results of Phase 2 trials which had been carried out by Bharat Biotech.”
Tiwari said the state government had been informed by Bharat Biotech that it would take two-three weeks to get the required approval. After that, the state government would seek approval from ethical committees at each college before starting the trials. “The trials of Covaxin in the state will take at least a month. We have to make sure strict adherence to all precautions as directed by the Chief Minister,” he added.
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