The development came in the wake of the UK regulator Medicines and Health Products Regulatory Authority (MHRA) on Wednesday granting emergency use approval to the Oxford-AstraZeneca’s vaccine Covishield – for which SII is a manufacturing partner and also conducting bridging studies in India. The approval in the UK raised hopes in India as it brightened the chances of the vaccine’s approval in India. Expectations were fuelled further after an urgent meeting of the SEC was called to consider the applications for EUA for the Covid-19 vaccines.
“The committee has to go through the data based on which the company has received an approval in the UK. In a situation like this, the regulator will have to ensure that the data submitted in India is co-relatable with the global data,” an official said.
“The additional data and information presented by SII and Bharat Biotech was perused and analysed by the SEC. The analysis of the additional data and information is going on. SEC will convene again on 1st January 2021 (Friday),” the government said.
The government is hopeful of rolling out the vaccination drive in January itself to inoculate around 30 crore people in the first phase by July. SII has stockpiled 40-50 million doses of Covidshield, most of which is likely to initially come to India in the absence of WHO’s pre-qualification required for exporting the vaccine to other countries.
The government is also conducting dry runs to ensure there are no gaps in implementation of its mega vaccine administration plan once the jab is approved and available for use.
Apart from SII and Bharat Biotech, the committee also took up Pfizer’s application for EUA but the company has requested for more time.
The UK on Wednesday approved the Covid-19 vaccine developed by scientists at Oxford University and produced by AstraZeneca for human use, the second coronavirus vaccine to be cleared for rollout in Britain after the Pfizer/BioNTech’s vaccine.