11-07-2021 | 15:03 PM
European Union’s Green Pass
Context: European Medicines Agency (EMA) has excluded Serum Institute of India (SII) manufactured Covishield from the list of approved vaccines for ‘Green Pass’. As per EMA, the vaccine was excluded from the list because it does not have marketing authorisation in European Union (EU).
Key Points
• 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 the marketing authorisation application was submitted to and evaluated by EMA. It was given authorisation.
• EMA highlights small differences in manufacturing conditions can result in differences among final products because vaccines are biological products.
• EU law requires manufacturing sites and production processes to be assessed, before giving clearance to vaccines.
About Green Pass
• EU member states have started issuing digital ‘vaccine passport’ to enable easy travel into and between EU countries for the purpose of work and tourism.
• EU ‘Green Pass’ is also a kind of digital vaccine passport recognising EMA approved Vaxzevria version of AstraZeneca vaccine which are produced in the UK and Europe, even though the World Health Organisation (WHO) has endorsed SII’s Covishield for emergency use across the globe. Green pass will be launched on July 1, 2021. It will display the bearer's vaccination status.
NOTE: EMA, which is responsible for the 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 EMA.
