A European Medical body has said no application from the Serum Institute of India for Covishield authorisation has been received after the European Union has introduced the digital Covid Certificate that makes travel within the Union possible.
For Covishield, the Covid-19 vaccine to be evaluated for use in the Union, the European Medicines Agency (EMA) has said that the developer needed to submit a formal marketing authorisation application to them. However, to date, it has not received any application from the Serum Institute of India.
As part of the authorisation process, the medical body has said minor differences in manufacturing processes could result in differences in the final product, and the European Union law required assessments.
So far, four vaccines- Moderna’s Spikevax, Comirnaty of Pfizer/BioNTech, Vaxzervria by AstraZeneca-Oxford, and Johnson & Johnson’s Janssen have been approved by the European medical body for restriction-free travel within the EU during the pandemic.
Since only India’s Covishield, developed by AstraZeneca’s formula, has been authorised under EMA, the Indian travellers are facing hurdles travelling to the European Union. However, the Covishield has also been excluded despite being granted emergency use listing from the World Health Organisation in February.
The European Medicines Agency had earlier clarified Covishield’s exclusion from the list of approved vaccines for the ‘Green Pass’, stating that the vaccine does not currently have a marketing authorisation in the European Union (EU).
Currently, the people vaccinated with Covishield will be subjected to quarantine protocols as enforced by individual member countries, and may even be blocked from entering some others.
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Meanwhile, Serum Institute CEO Adar Poonawalla had said that he was taking this up at the highest levels with regulators and diplomats and that he hoped to resolve this matter soon.