The announcement from Paul came on the day the US regulator Food and Drug Administration refused Emergency Use Approval to Bharat Biotech and advised the makers to apply for full authorisation of the vaccine.
The third phase clinical data of Coronavirus vaccine developed by Hyderabad-based Bharat Biotech is going to be released in a week’s time, VK Paul who is the head of the country’s Covid task force said. Paul said that the efficacy data of Covaxin vaccine will be published in the peer review journal “go-beyond”, the Indian Express reported. The announcement from Paul came on the day the US regulator Food and Drug Administration refused Emergency Use Approval to Bharat Biotech and advised the makers to apply for full authorisation of the vaccine.
Talking about phase 3 clinical trial data of Covaxin, Paul said that both Bharat Biotech and Indian regulator had ample amount of clinical data which has already been screened. Informing about the publication of the phase 3 data, Paul said that he expects the phase 3 efficacy data to be out in 7-8 days and this set of data will go beyond what had earlier been shared with the Indian regulator by the company at the time of seeking emergency use approval.
Commenting upon the US regulator’s decision on Bharat Biotech vaccine, Paul said that the US decision would not in any manner impact the regulatory decisions taken by the Indian bodies and said that India respects the decision taken by the US regulator. Paul said that every country had a different regulatory system and India respected that. Paul further said that India’s regulator also takes scientific decisions in the same manner but some nuances are based on different context.
In addition to Serum manufactured Covishield, the Indian drug regulator had also given approval to Covaxin and the vaccine accounts for about 12 percent of the total vaccinations in the country. Covaxin had been granted emergency use approval by the Drug Controller General of India (DCGI) without the completion of its phase 3 trials in January this year. Consequently, the Hyderabad-based pharma company had also released phase-3 interim clinical data that had shown vaccine efficacy rate of 78 percent in April this year.