NEW DELHI: Healthcare workers across India may be just a few days away from getting shots against Covid-19, as an expert panel of the Central Drugs Standards Control Organisation (CDSCO) on Friday granted emergency use authorisation to the vaccine candidate developed by Oxford University-AstraZeneca.The Pune-based Serum Institute of India is its local partner and had already manufactured the vaccine, under the brand name, Covishield.
The official confirmation of the approval, however, is yet to follow. Also, it is not clear under what conditions has the approval been granted or the quantum of vaccines the government will immediately procure from for one of the world’s largest vaccination drives ever.
Sources said data from the vaccine’s late stage clinical trials in the UK and Brazil, safety and immunogenicity data from its bridging trial in India and the approval granted by the UK regulator to the vaccine, were taken into account for making the recommendation.
“The first vaccine against Covid-19 has been approved in India but the first beneficiaries may be about a week away from getting the actual shots as transportation of the vaccines has to be done under specified conditions,” a top official in the Union ministry of health and family welfare told this newspaper.
The subject expert committee of the CDSCO, which also considered Hyderabad-based Bharat Biotech’s candadate, felt the company needs to present at least an interim analysis of its phase 3 clinical trial. “The panel was of the view that the data from phase 1 and 2 are not sufficient to approve it for wider use in the country,” said a source.