New Delhi: Covishield Vaccine “currently does not have marketing authorization” in Europe and this problem will be considered when the application is accepted for it, the European Medicine Agency (EMA) said on Monday.
“The only Covid-19 vaccine from AstraZeneca where the marketing authorization application was handed over to and evaluated by EMA, which led to authorization in the EU, was Vaxzevria,” Alessandro Faia, an ema spokesman said.
“In the EU, the vaccine called Covishield currently has no marketing authorization.
Even though it can use analog production technology with Vaxzevria (AstraZeneca Covid-19 vaccine which is approved in the EU), Covishield as it is currently not approved based on the European Union rules,” the official said that.
Explain the reason, the official said: “This is because vaccines are biological products.
Even small differences in manufacturing conditions can lead to differences in end products, and UE laws, therefore, requires manufacturing sites and production processes to be assessed and approved as part From the authorization process.
“Should we accept the marketing authorization application for Covishield or must be any change to the approved manufacturing site for Vaxzevria approved, we will communicate about it.”