No nod but, Covid vaccine companies advised to offer further information


Aditi Tandon

Tribune News Service

New Delhi, December 9

The national drug regulatory authority today reviewed the emergency use applications of Serum Institute of India and Bharat Biotech for their Covid vaccines and asked them to furnish additional data.

Sources in the Central Drug Standards Control Organisation said both companies had been told to present vaccine efficacy data from phase-3 trials to enable the subject expert committee to take a comprehensive call on safety, effectiveness and immunogenicity of the vaccines.

Serum Institute’s Covishield is being developed by Oxford University and AstraZeneca. In recently published data from trials in the UK, South Africa and Brazil, Oxford University said the vaccine was more than 90 per cent effective when administered as half a dose followed by a standard dose after 28 days and 62 per cent effective when administered as two full doses 28 days apart.

Covishield’s phase-2 and phase-3 trials are underway in India and the results are awaited. Even in the UK, the regulators are yet to allow emergency use authorisation for the Oxford vaccine.

Bharat Biotech-ICMR’s Covaxin is also in phase-3 trials in India. Pfizer India’s application for emergency use was not taken up today. Its vaccine has already been approved for emergency use in the UK.

The Indian regulators have to be cautious while reviewing Covishield for granting nod for emergency use considering no other world regulator has so far approved it.

The sources said safety would be top consideration before any approvals were granted. Health Secretary Rajesh Bhushan had yesterday said some vaccines would get licence for use in India in the next few weeks.

Meanwhile, a team of 70 ambassadors and high commissioners visited Bharat Biotech’s Genome Valley facility in Hyderabad today. They were briefed about the vaccine development programme.


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