Coronavirus | Serum Institute, Bharat Biotech COVID-19 vaccine applications put on hold
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Members of an professional committee of the Drug Controller General of India opined that they wanted extra information to gauge the vaccines’ efficacy.
An professional committee of the Drug Controller General of India (DCGI) has stored on hold, pending extra proof, proposals by the Serum Institute of India (SII) and Bharat Biotech requesting emergency use authorisation of their vaccine candidates in India, an individual carefully linked with the approval course of confirmed to The Puucho.
When evaluating their applications on Wednesday, the committee members opined that they wanted extra information 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 individual cited above instructed The Puucho on situation of anonymity.
The committee consists of members from a number of disciplines and meets periodically to suggest approval, or rejection, of latest medicine and vaccines.
The SII is testing a vaccine candidate developed by Oxford University and AstraZeneca, on 1,600 volunteers in India. This vaccine has but to be accredited by regulators within 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 individual added.
The Union Health Ministry termed as “fake news” a media report on Wednesday that mentioned that SII and Bharat Biotech ‘s applications were “rejected.” However, a ministry spokesperson didn’t provide further clarification.
Both SII and Bharat Biotech are comparatively forward of different vaccine corporations in India creating potential vaccines for COVID-19, having initiated massive human trials, or phase-3 trials.
Officials have mentioned that 30 crore Indians are anticipated to be inoculated within the first half of 2021.
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