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Serum Institute of India in Process of Seeking Emergency Covid-19 Vaccine Approval, Says CEO Adar Poonawalla

File photo of Serum Institute of India CEO Adar Poonawalla.

File photo of Serum Institute of India CEO Adar Poonawalla.

Poonawalla said that his company, which is manufacturing Covishield, a Covid-19 vaccine made with a master seed from Oxford-AstraZeneca, is in the process of applying for emergency use authorization (EUA) from the country’s drug regulator.

Pune-based Serum Institute of India (SII) and the government of India does not have anything in writing so far on the number of doses it would purchase for immunizing citizens against Covid-19, said Adar Poonawalla, the vaccine manufacturer’s Chief Executive Officer on Saturday.

Poonawalla said that his company, which is manufacturing Covishield, a Covid-19 vaccine made with a master seed from Oxford-AstraZeneca, is in the process of applying for emergency use authorization (EUA) from the country’s drug regulator.

The SII CEO was speaking during a virtual press briefing following Prime Minister Narendra Modi’s visit to Serum’s vaccine manufacturing facility in Manjri, Pune.

“We discussed the implementation plan once we get the EUA licensure, if that is granted based on the data that is submitted by us. We are in the process of submitting that data to the Drug Controller General of India. After they review it we will follow all the processes because we don’t want any shortcuts at all,” said Poonawalla.

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“As of now, we have nothing in writing with the government of India on the production and purchase (of the vaccine). But the indication is 300-400 million by July 2021, which the health ministry has made public in the past,” he added.

Modi visited facilities of three vaccine manufacturers – Zydus Cadila, Bharat Biotech and SII – on Saturday across Ahmedabad, Hyderabad and Pune respectively to review their preparedness and progress on Covid-19 vaccine candidates. Among the three, Bharat Biotech and SII, in partnership with Indian Council of Medical Research, have finished enrolment for Phase-III trials of their respective vaccines. In Phase III trials, the vaccine’s efficacy to prevent the infection from progressing to severe disease is tested.

Meanwhile, Cadila is finishing Phase II trials, which looks at the immunogenicity of the vaccine, or its effectiveness in triggering an immune response against the Coronavirus infection.

The PM’s visit also comes over a week after Oxford-AstraZeneca announced interim results of the Phase III efficacy trials underway in United Kingdom and Brazil. They claimed that the vaccine candidate had achieved 90% efficacy in a one dose regimen among 2,741 people when given as a half dose and following the second dose a month apart, the efficacy was 62%. The combined analysis resulted in an average efficacy of 70%. However, it also came to light later that the half dose administered in the first regimen was a mistake and the result was happenstance. Some quarters from the scientific community have thus sought a more transparent assessment of this vaccine.

When asked if SII will undertake an additional trial in India, Poonawalla said, “At the moment, the trials are more than enough for efficacy. Of course, there was a bit of confusion in the communication which will be explained in the coming days but that is not going to affect the EUA licensure in the UK and not affecting in India at all. We are looking at doing trials for the under-18 age group after a few months.”

Poonawalla also said that India was the first priority for the company, followed by Africa and other developing countries. “It will be distributed in India initially and then COVAX countries in Africa. If they (AstraZeneca) need help in scaling up manufacturing, we are always there to support them. But our priority is going to be India and the developing world,” he said.

‘PM Visit a Special Day for Company’

Vaccine major Serum Institute of India on Saturday said it was a special day for the company with Prime Minister Narendra Modi visiting its facility in Pune to go into details on the manufacturing status of the coronavirus vaccine. Modi visited Serum Institute of India on Saturday and interacted with the team at the Institute, an official release said. They shared details about their progress so far on how they plan to further ramp up vaccine manufacturing, it added.

Addressing a virtual presser, Serum Institute of India CEO Adar Poonawalla said, “Worldwide everybody is now dependent and is looking forward to the vaccines comingout in large volumes and at affordable price from India as everybody already knows that more than 50 to 60 per cent of all vaccines are made in India." “With the Aatmanirbhar Bharat vision in mind we have built the largest pandemic level facility in Pune in our sister campus at Manjri", and that was showcased also to the prime minister, he added.

About the discussion with the prime minister, he said: “We discussed the plan, the implementation plan which will happen only after the emergency use licence, that is granted based on the data that will have to be submitted. We are in the process of submitting that officiallyto the Drug Controller of India …". Serum Institute is conducting clinical trials of AstraZeneca-Oxford’s COVID-19 vaccine candidate in India. Earlier in a tweet, Adar Poonawalla said; “Sri @narendramodi Ji, it was a great honour for you to have spared the time, to visit us here at @SerumInstIndiato discuss in detail, the complex challenges yet to come and review the vaccine production status. @PMOIndia".

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