NEW DELHI: 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 on Monday.
“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: “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.
“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.”