Covishield approval to be considered on receiving marketing authorisation application: EMA

The Covishield vaccine “does not currently have a marketing authorisation” in Europe and the matter would be considered when an application is received for it, the European Medicines Agency (EMA) said.

People vaccinated with Covishield, manufactured by the Serum Institute of India (SII), are unlikely to be eligible to travel to the European Union member states under the ”Green Pass” scheme as the vaccine is yet to be cleared by the EMA.

The EU Digital COVID certificate or ”Green Pass” will be mandatory to travel to European countries and the document is likely to serve as proof that a person is vaccinated against COVID-19.

Travel under ”Green Pass” to non-EU citizens may be rolled out in a phased manner from July 1.

However, individual European Union member countries may have separate rules and norms for travellers.

The EMA has already approved four COVID-19 vaccines which included Vaxzevria, the AstraZeneca vaccine manufactured in the UK and EU-member countries.

The SII makes Covishield in India with a licence from AstraZeneca.

“The only COVID-19 vaccine from AstraZeneca for which a marketing authorisation application was submitted to and evaluated by EMA, leading to its authorisation in the EU, is Vaxzevria,” said Alessandro Faia, a spokesperson of the EMA.

“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 COVID-19 AstraZeneca vaccine authorised in the EU), Covishield as such is not currently approved under EU rules,” the official said.

Explaining the reason, the official said even tiny differences in the manufacturing conditions can result in differences in the final product.

“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,” the spokesperson said.

“Should we receive a marketing authorisation application for Covishield or should any change to the approved manufacturing sites for Vaxzevria be approved, we would communicate about it,” he said.

The official clarified that the EMA is not responsible for any decision regarding travelling into the EU and the travelling conditions associated with COVID-19 vaccination, such as the EU Digital COVID certificate.

“This is a matter for the European Commission and for individual member states,” the official added.