The Subject Expert Committee of The Central Drugs Standard Control Organisation(CDSCO) has not granted the Emergency use authorization of the COVID-19 vaccines in India. It has turned down the request of Hyderabad-based Bharat Biotech and Pune-based Serum Institute of India, for the need for more data.
On the other side, Pfizer which also applied for the emergency use authorization did not attend before the committee. The Pharma major has asked for more time to present its data. That means all hopes of the immediate availability of the vaccines are dashed now.
The major reason for the rejection is that none of these has yet generated data about the effectiveness of their vaccine from phase-III trials conducted in India, which is a mandatory requirement in the normal process of approval.
Meanwhile, a few countries have started immunizing their frontline workers and risk groups with the Pfizer vaccine already. The UK has started administering to the people while Canada has just approved emergency use. The United States is also in the final process of approving the vaccine.
