Covishield marketing authorisation will be considered when application is received: EU agency

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," Alessandro Faia, a spokesperson of the EMA said.

"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.