With preparations of rolling out the potential vaccine for coronavirus by January, the Drugs Controller General of India (DCGI) may give Serum Institute of India the approval for emergency use authorisation (EUA) of its COVID-19 vaccine ‘Covishield’, which is developed by the Jenner Institute (Oxford University) in association with AstraZeneca.
With this, the Oxford vaccine is likely to become the first to be rolled out in India.
Once the UK drug regulator gives its approval, the subject expert committee (SEC) on COVID-19 at the Central Drugs Standard Control Organisation will hold a meeting to review the safety and immunogenicity data from the clinical evaluations before granting the EUA, LiveMint quoted the sources.
The UK’s approval process may take time, given that the vaccine is still under Phase 3 trials.
Earlier this month, SII, Bharat Biotech and Pfizer had approached the DCGI, seeking EUA for their vaccines. Later, on December 9, the SEC had sought additional information on these potential vaccines’ safety and efficacy.
Last week, the SII submitted additional data required by the DCGI. Reviewing the application, the committee recommended the firm to submit an updated safety and immunogenicity data of Phase 2 and 3 clinical trials in the UK and India, along with the assessment done by the UK Medicines and Healthcare products Regulatory Agency.
The data provided by Pfizer was not taken up, as the company had sought more time for making a presentation. Their potential vaccine had been approved by several countries, including the UK, US, and Bahrain.
As of Bharat Biotech’s ‘Covaxin’, the committee recommended that the firm present the safety and efficacy data from the ongoing Phase 3 clinical trial in the country for further consideration.
Meanwhile, the COVID-19 national task force held a meeting on Saturday, December 26, over the novel coronavirus’s new strain and discussed the surveillance strategies to contain the infection.
As per the latest updates, over 50 samples of people who have recently returned from the UK to India, are being examined at six labs across the country to find out if they have a new strain.
The task force will also conduct routine genomic surveillance to track different strains of the coronavirus. For the same, nearly 5 per cent of the COVID cases from across the states and UTs are being examined.
The genomic surveillance team called INSACOG has been formed under the National Centre for Disease Control (NCDC) leadership for laboratory and epidemiological surveillance of coronavirus, NDTV reported.
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