The European Medicines Agency has excluded Serum Institute of India manufactured Covishield (COVID-19 vaccine) from the list of approved vaccines for ‘Green Pass’. According to Medicines Agency, Covishield was excluded from list because it does not have marketing authorisation in European Union.
- The Covishield does not have a marketing authorisation even though it may use an analogous production technology to Vaxzevria.
- Vaczevria is the only Covid-19 vaccine from AstraZeneca for which marketing authorisation application was submitted to and evaluated by European Medicines Agency. It was given authorisation.
- European Medicines Agency highlights, small differences in manufacturing conditions can result in differences among final produce because vaccines are biological products.
How EU give clearance to vaccines?
European Union law requires manufacturing sites and production process to be assessed, before giving clearance to vaccines.
How it will impact Indians?
Indian travellers vaccinated with Covishield may not be eligible to get European Union ‘Green Pass’.
European Union member countries have started issuing digital ‘vaccine passport’ to enable easy travel into and between member countries for the purpose of work and tourism. European Union ‘Green Pass’ is also a kind of digital vaccine passport recognising EMA approved Vaxzevria version of AstraZeneca vaccine which are produced in UK and Europe, even though WHO has endorsed SII’s Covishield for emergency use across the globe. Green pass will be launched on 1st July 2021. It will display bearer’s vaccination status.
Which vaccines are approved by EMA?
European Medicines Agency, which is responsible for evaluation and supervision of medicinal products, has approved four Covid-19 vaccines namely, Comirnaty, Moderna, Vaxzevria and Janssen, as of now. But Covishield, which is the Indian version of AstraZeneca and University of Oxford’s Covid vaccine, is yet to be recognised for European market by European Medicines Agency.
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