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".
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.
"Majority of the first 50 million doses will go to India. At least for the first month, most of our doses will go to India. We have a deal with other COVAX countries, but for exporting we will need approvals from World Health Organisation and licenses. So, India will receive first," Adar Poonawalla said.
He added that the vaccine shortage would ease by middle of 2021 "because there will be so many manufacturers by then".
Covishield, which will be sold to the government for Rs 250 per dose, scores over its counterparts in terms of price and storage, both key factors for India.
The Indian government has started prepping for a nationwide rollout of whichever vaccine will be cleared first.
As of Monday, the country reported 2.77 lakh active Covid cases. The total number of cases since the pandemic began in December last year is around 1.02 crore.
Globally, 8.1 crore people have contracted COVID-19 since the outbreak in China's Wuhan late last year with 17 lakh deaths.