Serum Institute of India
The issue of the European Medicines Agency (EMA) refusing to approve Serum Institute of India's coronavirus disease (Covid-19) vaccine Covishield is expected to be raised by Indian officials with European Union (EU) officials on the margins of the G20 foreign ministers' meeting in Italy on June 29, according to people familiar with the situation. Meanwhile, Adar Poonawalla, CEO of the Serum Institute of India, stated on Monday that he had taken up the subject “at the highest level” to guarantee that Indians do not experience any travel limitations.
“I realise that a lot of Indians who have taken Covishield are facing issues with travel to the EU. I assure everyone, I have taken this up at the highest levels and hope to resolve this matter soon, both with regulators and at a diplomatic level with countries,” tweeted Adar Poonawalla, chief executive officer, Serum Institute of India, on Monday.
On the condition of anonymity, those familiar with the situation stated that the Serum Institute of India might apply for accreditation independently to the EMA.
Travelers who have been vaccinated with Covishield, an Oxford-AstraZeneca vaccine manufactured in India by Serum Institute of India, are presently ineligible for the European Union's green pass – an immunity statement designed to make travel within and outside the bloc easier – because the European Medicines Agency (EMA) identifies only four Covid-19 vaccines that have received EU-wide marketing authorization. By July 1, 2021, the green pass is expected to be operational.
According to a senior govt. official, “The position taken by EMA is perplexing because Covishield and Vaxzevria, the AstraZeneca vaccine approved by the European agency, are qualitatively similar in nature,” on the condition of anonymity.
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