New Delhi: Cowishield The vaccine “does not currently have a marketing authorization” in Europe and will be considered when an application for the same is received, European Medicines Agency (EMA) said on Monday.
“The only COVID-19 vaccine astraZeneca a marketing for authority “The application was submitted and evaluated by the EMA, leading to its authorization in the European Union, Vaxjeveria,” said Alessandro Faya, a spokesman for EMA.
“In the European Union, the vaccine, called Covishield, currently does not have marketing authorization. Even though it may use a production technology analogous to Vaxjeveria (the Covid-19 AstraZeneca vaccine authorized in the EU), Covishield is not currently approved under EU regulations,” the official said.
Giving reasons, the official said: “This is because vaccines are biological products. Even small differences in manufacturing conditions can result in differences in the final product, and EU law requires evaluation and approval of manufacturing sites and production processes as part of the authorization process.
“Should we receive a marketing authorization application for Covishield or any changes to approved construction sites for Vaxzeveria, we will communicate that.”
“The only COVID-19 vaccine astraZeneca a marketing for authority “The application was submitted and evaluated by the EMA, leading to its authorization in the European Union, Vaxjeveria,” said Alessandro Faya, a spokesman for EMA.
“In the European Union, the vaccine, called Covishield, currently does not have marketing authorization. Even though it may use a production technology analogous to Vaxjeveria (the Covid-19 AstraZeneca vaccine authorized in the EU), Covishield is not currently approved under EU regulations,” the official said.
Giving reasons, the official said: “This is because vaccines are biological products. Even small differences in manufacturing conditions can result in differences in the final product, and EU law requires evaluation and approval of manufacturing sites and production processes as part of the authorization process.
“Should we receive a marketing authorization application for Covishield or any changes to approved construction sites for Vaxzeveria, we will communicate that.”
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