India will take a call on giving approval to the three Covid-19 vaccines developed in the country on January 1.
A high-level DCGI panel met on Wednesday to discuss the approval issue even as the UK became the first country to give nod to the Covishield shot from the stable of drug firm AstraZeneca and the University of Oxford.
In India, Serum Institute of India is developing the vaccine in collaboration with Oxford University and pharmaceutical company AstraZeneca.
The Union Health Ministry in a statement here said the Subject Expert Committee (SEC) in the Central Drugs Standard Control Organisation (CDSCO) had met on Wednesday to consider the Emergency Use Authorisation (EUA) request of Pfizer, Serum Institute of India (SII) and Bharat Biotech Pvt Ltd.
“While further time was requested on behalf of Pfizer, the additional data and information presented by SII and Bharat Biotech Pvt Ltd was perused and analysed by the SEC,” said the Ministry.
The analysis of the additional data and information is going on. SEC will convene again on January 1, 2021, said the statement.
However, sources said the approval by the UK is likely to pave the way for authorisation of the vaccine in several countries. India successfully completed two-day dry run of the Covid immunisation.
India is hoping to launch the immunisation drive soon once vaccines are approved.
Earlier this month, the SEC had sought more data on the safety and efficacy of Covid-19 vaccine candidates after deliberating on the company’s application that sought emergency use authorisation.
While considering the application submitted by Serum Institute of India, the committee had recommended that the firm should provide safety data of phases 2 and 3 clinical trials in the updated applications.
The committed had also sought immunogenicity data from the clinical trial in India as well as in the UK along with the outcome of the assessments made by the MHRA.
Thursday, 31 December 2020 | PNS | New Delhi
