The Oxford-AstraZeneca coronavirus vaccine could become the candidate approved by the Indian drug regulatory agency as the country prepares for the commencement of mass inoculations. Reports claimed that India will give its emergency authorisation nod to the Oxford candidate after studying the decisions taken by the UK.
Vaccination is expected to start mid-January, going by statements from the Centre.
Once the UK drug regulator gives its approval to the Oxford vaccine, the expert committee on COVID-19 at the CDSCO will hold its meeting and thoroughly review the safety and immunogenicity data from the clinical evaluations conducted abroad and in India before granting any emergency authorisation for the vaccine.
Which are the vaccines in contention in India
Hyderabad-based pharmaceutical firm Bharat Biotech has sought approval for the indigenously developed Covaxin. The vaccine candidate was created in association with ICMR.
The Serum Institute of India on Sunday had sought emergency use authorisation for the Oxford COVID-19 vaccine in the country citing unmet medical needs due to the pandemic and in the interest of the public at large. The third phase clinical trial of the Oxford COVID-19 vaccine, Covishield, is being conducted by the Pune-based Serum Institute of India on Sunday (SII), co-sponsored by Indian Council of Medical Research (ICMR), in various parts of the country in addition to clinical studies being carried out by Oxford-AstraZeneca in the UK and Brazil.
Pfizer India was first pharmaceutical firm to apply for vaccine clearance in India, after its parent company secured such clearance in the UK and Bahrain. The firm, in its application submitted to the drug regulator, has sought permission to import the vaccine for sale and distribution in the country, besides waiver of clinical trials on Indian population in accordance with the special provisions under the New Drugs and Clinical Trials Rules, 2019. Pfizer claims to offer up to 95 per cent protection against COVID-19.
The Oxford vaccine was found to have had an average efficacy of 70.4 per cent—with a double-dose regime generating efficacy of just 62 per cent while those who received a half-dose regime had a 90 per cent efficacy.
The process of granting emergency use approval for Bharat Biotech's COVID-19 vaccine 'Covaxin' may take time as its phase 3 trials are still underway, while Pfizer is yet to make a presentation. "Going by this, Oxford vaccine 'Covishield' is likely to be the first to be rolled out in India," news agency PTI reported.
-Inputs from agencies
