An expert committee of the Drug Controller General of India (DCGI) has kept on hold, pending more evidence, proposals by the Serum Institute of India (SII) and Bharat Biotech requesting emergency use authorisation of their vaccine candidates in India, a person closely connected with the approval process confirmed to The Hindu.
When evaluating their applications on Wednesday, the committee members opined that they needed more data to gauge the vaccines’ efficacy. “Neither company presented data from their ongoing phase 3 trials. We also wanted more information on the reported case of a volunteer in Chennai who allegedly had a severe adverse reaction,” the person cited above told The Hindu on condition of anonymity.
The committee consists of members from multiple disciplines and meets periodically to recommend approval, or rejection, of new drugs and vaccines.
The SII is testing a vaccine candidate developed by Oxford University and AstraZeneca, on 1,600 volunteers in India. This vaccine has yet to be approved by regulators in the United States and the United Kingdom for public use. “Were any of these countries’ regulators to approve, we would consider it favourably for approving in India. But now we have neither this nor convincing India specific data,” the person added.
The Union Health Ministry termed as “fake news” a media report on Wednesday that said that SII and Bharat Biotech ‘s applications were “rejected.” However, a ministry spokesperson didn’t offer additional clarification.
Both SII and Bharat Biotech are relatively ahead of other vaccine companies in India developing potential vaccines for COVID-19, having initiated large human trials, or phase-3 trials.
Officials have said that 30 crore Indians are expected to be inoculated in the first half of 2021.