EU Green Pass issue National

Hope to resolve Covishield-EU issue soon, says Adar Poonawalla

Adar Poonawalla. File Photo.  

Amid concerns that Indian travellers who have taken the Covishield vaccine may not be eligible for the European Union’s (EU) ‘Green Pass’, Serum Institute of India (SII) Chief Executive Officer Adar Poonawalla on Monday said he had taken up the matter “at the highest levels” and hoped of an early resolution of the issue.

Reassuring travellers from India to the EU countries, he said in a tweet: “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.”

The SII manufactures the Oxford-AstraZeneca vaccine (with licence from AstraZeneca) under the brand name Covishield in India.

While the EU’s drug regulator, the European Medicines Agency (EMA), has approved Vaxzevria — as AstraZeneca’s shot is known outside India — Covishield has not yet figured in its approval list as yet bespite being approved by the World Health Organisation.

In an e-mail response to media outlets, the EMA’s press officer said it had received a submission for marketing authorisation only for Vaxzevria. This was evaluated by the EMA, which lead to its authorisation in the EU.

Stating that vaccines were biological products, the EMA’s statement further said: “Even tiny differences in the manufacturing conditions can result in differences in the final product, and EU law, therefore, requires the manufacturing sites and production processes to be assessed and approved as part of the authorisation process.”

Along with Vaxzevria, three other vaccines have been approved by the EMA that can be used in the EU member-states: Comirnaty (manufactured by Pfizer-BioNTech), Moderna and Janssen (by Johnson & Johnson).

‘Vaccine passport’ programme

The EU’s digital ‘vaccine passport’ programme, known formally as the ‘Green Pass’, is to serve as proof that a person has been vaccinated against COVID-19, or has recently been tested negative for the virus, or has the natural immunity built up from earlier infection. Many EU member-states have started issuing the digital vaccine passport that is to facilitate movement for work and tourism within the EU.

Despite the EU’s earlier pronouncements of its member-states having the option to accept other vaccination certificates in case the travellers had received COVID-19 vaccines not approved by the EMA, technical specifications of the ‘Green Pass’ seem to indicate that the obligation to issue it is to be limited to only vaccines that have received EU-wide marketing authorisation.

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Printable version | Sep 28, 2021 3:33:31 PM |

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