Even as the European regulatory authority said that it had not received an application for the marketing authorisation of Covishield, efforts are underway to recognise Serum Institute of India’s (SII) production facility as an alternative site of the AstraZeneca vaccine, Vaxzevria, it is reliably learnt.
On the issue, the European Medicines Agency (EMA) had said on Thursday: “For Covishield to be evaluated for use in the EU, the developer needs to submit a formal marketing authorisation application to EMA, which to date has not been received.”
Setback for travellers
SII makes and markets the AZ-OxfordUniversity vaccine (Vaxzevria) under the Covishield brandname. And though the AZ vaccine is recognised in Europe, travellers who had taken Covishield ran into trouble as their vaccine was not recognised in some of these countries.
This is even as the WHO has said that countries not discriminate based on vaccines.
While AZ and SII have not made a statement on the issue, a source told BusinessLine that in May AZ had applied to the EMA to recognise SII’s India site as an alternative production location of the AZ vaccine that already has EU approvals. Ever since this concern emerged for travellers and students who have taken Covishield, several individual member states of the EU have recognised Covishield.
Explaining why the marketing authorisation was important, EMA had told BusinessLine in an earlier communication: “Even though it may use an analogous production technology to Vaxzevria (the Covid-19 Astra Zeneca vaccine authorised in the EU), Covishield as such is not currently approved under EU rules.
“This is because vaccines are biological products. 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 process to be assessed and approved as part of the authorisation process.”