The news of Covishield not being recognised by the European Medicines Agency (EMA) has worried Indians who have taken the vaccine manufactured by the Pune-based Serum Institute of India.

While confusion prevails about travel to European Union (EU) countries, the EMA, which is responsible for evaluation and supervision of medicinal products, stated on June 28 that the Covishield vaccine’s manufacturer has not yet applied for approval. 

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“In the EU, the vaccine called Covishield does not currently have a marketing authorisation. Even though it may use an analogous production technology to Vaxzevria (the COVID19 AstraZeneca vaccine authorised in the EU),” Zala Grudnik, press officer EMA , was quoted as saying.

The EMA stated that even tiny deviations in manufacturing conditions can result in differences in the final product. “This is because vaccines are biological products,” it added.

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The ‘Green Pass’, which comes into effect tomorrow (July 1) seeks to facilitate hassle-free travel to and amongst EU countries. However, only the ones vaccinated  with EMA-recognised vaccines will be able to claim the benefits of this ‘digital passport’.

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Meanwhile, Ambassador of the European Union to India, Ugo Astuto, clarified on June 29 that there is no ban as such on India’s Covishield vaccine. 

“It is to clarify there is no banning on Covishield, we have set up in place a new system of Digital Covid Certificate which is meant to facilitate travel within the European Union,” Astuto stated.

Serum Institute of India’s response

Meanwhile, Adar Poonawalla, owner and the chief executive officer of the Pune-based Serum Institute of India, said the matter would be resolved. 

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“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,” he stated on Twitter.