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.
People who are vaccinated with the Covishield, produced by Pune-based Indian Serum Institute (SII), will not be eligible to travel to European Union member countries with the ‘Green Pass’ scheme because the vaccine has not been cleaned by EMA.
COVID Digital UE or ‘Green Pass’ certificates will be mandatory to travel to European countries and the document is likely to function as evidence that someone is vaccinated against Covid-19.
The journey under the ‘Green Pass’ to non-EU citizens can be launched gradually from July 1.
However, each European Union member country may have separate rules and norms for travelers.
EMA has approved four Covid-19 vaccines including Vaxzevria, AstraZeneca vaccine produced in English and EU member countries.
SII makes a covishield in India with a license from Astrazeneca.
“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 authorized in the EU), Covishield is currently not approved under the EU.
Rules,” said the official that.
Explain the reason, the official said even small differences in manufacturing conditions could lead to differences in the final product.
“This is because vaccines are biological products.
Even small differences in manufacturing conditions can lead to differences in the final product, and the UE law, therefore, requires manufacturing sites and production processes to be assessed and approved as part of the authorization process,” said a repemer Speak it.
“Should we accept the marketing authorization application for covishield or must be every change to the approved manufacturing site for Vaxzevria approved, we will communicate about it,” he said.
The official clarified that EMA was not responsible for any decision on traveling to the EU and travel conditions related to Covid-19 vaccination, such as Covid Digital EU certificates.
“This is a problem for the European Commission and individual member countries,” officially added.
Approval to Covishield will be considered if we receive the Marketing Authorization Application: EU Bodies
