'Applying For Emergency Use Of Covid Vaccine In 2 Weeks', Says Serum Institute's Adar Poonawalla After PM Modi's Visit

After meeting with PM Modi on Saturday in Pune, SII CEO Adar Poonawalla said that it is in the process of seeking emergency Covid 19 vaccine approval.

Image Courtesy : PIB/ AFP

Coronavirus Vaccine: Pune Based Serum Institute will apply within two weeks for an emergency use license of the coronavirus vaccine being developed by the University of Oxford and pharma giant AstraZeneca, the vaccine maker's chief Adar Poonawalla said on Saturday after a meeting with Prime Minister Narendra Modi.

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.

“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.

PM's visit to vaccine centres

PM Modi on Saturday visited India's three vaccine manufacturers – Zydus Cadila, Bharat Biotech, and SII 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 the 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.

Giving the vaccine candidate a major vote of confidence after some experts raised questions around its trial data, Poonawalla said, "At the moment the trials were more than enough for the efficacy. We might look at doing trials on group less than 18 years of age later on." "This vaccine is a very good one. What we found with Covishield in its global trial is there were zero hospitalisations, which means even if you do get infected you're not going to have a severe attack and secondly even those who got the disease were not infecting others," he said. 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.