Oxford's Covid-19 vaccine may be the first to get emergency use approval in India: Report

Emergency use approval for Bharat BioTech's Covaxin is likely to take some time as its Phase 3 trials are underway. Meanwhile, Pfizer is yet to make a presentation in India.?This indicates, Oxford's vaccine Covishield is likely to be the first to be rolled out in India.

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In India, the Serum Institute of India is manufacturing Covishield and it has already made a request for its emergency use. (Photo: AFP)

Covishield, the Covid-19 vaccine developed by the University of Oxford and drug manufacturer AstraZeneca, is likely to be the first Covid-19 vaccine that may get regulatory approval for emergency use in India, a report has claimed.

Quoting unnamed "official sources", news agency PTI said officials are of the view that India may take a decision on whether to provide emergency use approval to the Oxford vaccine once the UK has given a similar nod to the vaccine for its citizens.

"The Indian drug regulator is looking at the UK, which sources believe may give its nod to the Oxford Covid-19 vaccine next week," PTI reported.

In India, the Covishield is being manufactured by the Pune0based Serum Institute of India.

"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 here," PTI said quoting unnamed official sources.

It added that officials believe that emergency use approval for Bharat BioTech's Covaxin is likely to take some time because the Covid-19 vaccine candidate is still in Phase 3 clinical trials.

Meanwhile, Pfizer, which has received emergency use grant in the US and UK, is yet to make a presentation for a similar application in India.

"Going by this, Oxford vaccine 'Covishield' is likely to be the first to be rolled out in India," PTI reported quoting a source.

Last week, the Serum Institute of India submitted some additional data that was required by the Drug Controller General of India (DCGI).

Earlier this month, Bharat Biotech, Serum Institute of India (SII) and Pfizer had applied to the Drugs Controller General of India (DCGI) seeking emergency use authorisation for their Covid-19 vaccines.

The subject expert committee (SEC) on Covid-19 of the Central Drugs Standard Control Organisation (CDSCO) on December 9 had sought additional safety and efficacy data for Covid-19 vaccines of SII and Bharat Biotech after deliberating upon their applications.

Meanwhile, application moved by the Indian arm of US pharmaceutical firm Pfizer was not taken up for deliberation as the company had sought more time for making a presentation before the committee.

(With PTI inputs)

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