UK May Okay Oxford Vaccine By Early Jan, India Next: Serum Institute Head

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Stating that the delay in approval for Oxford-AstraZeneca COVID-19 vaccine – being mass produced by his company – was not worrying, Serum Institute of India’s (SII) Adar Poonawalla said the inoculant is likely to get a go-ahead in the United Kingdom “by end of this December or by early January”.

“Then we may get an approval in India too. We are not concerned about the delay,” the SII Chief Executive Officer said at the unveiling of India’s first indigenously developed pneumonia vaccine on Monday.

“All trial data on Covishield has been submitted for India and UK. We must respect the learned evaluators. Nobody wants to risk safety. We must give a few more days,” the Chief Executive Officer of SII – world’s largest drug maker by volume – said a week after he urged the government in India to “indemnify manufacturers against lawsuits”.

Mr Poonawalla was answering a question on whether he is concerned about the delay in approval from UK regulator for Covishield, which had run into controversy last month over its data.

“Earlier, we were hearing questions on vaccines being rushed, and now we are hearing questions on why is there no approval yet. You will hear good news from UK soon. You heard the Astra Zeneca CEO say the efficacy would be up to 95 per cent,” he said.

The Oxford coronavirus vaccine will “protect 95 per cent of patients” and is “as effective as the Pfizer and Moderna” alternatives, Pascal Soriot, chief executive of AstraZeneca, recently told British daily The Sunday Times, adding scientists had figured out a “winning formula to get efficacy up there with everybody else”.

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However, AstraZeneca is yet to release data confirming these claims. Interim results of Phase 3 trials released last month showed a 70 per cent efficacy rate as the average of two dosing regimens. One of these regimens – a half dose followed by a full dose – showed 90 per cent efficacy, while Pfizer’s data showed 95 per cent and Moderna’s 94.5 per cent.

The Oxford vaccine is one of three being considered for emergency use in India besides Bharat Biotech and Pfizer. While Bharat Biotech is still conducting phase 3 trials, Pfizer is yet to submit its data. Sources have said India is waiting for the UK to approve Covishield first.