EU Agency Clarifies on Covishield Approval Status

The Covishield vaccine “does not presently have a marketing authorization” in Europe, according to the European Medicines Agency (EMA), and the subject will be addressed once an application is received.

According to the EU, Vaxzevria is the only Covid-19 vaccine from AstraZeneca for which a marketing authorization application was submitted to and examined by EMA, resulting in its approval in the EU. they further stated that, Covishield, a vaccination, presently lacks a marketing authorization in the European Union. Covishield is not currently approved under EU laws, despite the fact that it may use a similar production method to Vaxzevria (the Covid-19 AstraZeneca vaccine approved in the EU).

The official explained the reason, saying, “This is because vaccines are biological products.” Because even little discrepancies in manufacturing circumstances might result in significant disparities in the end product, EU law requires that the manufacturing sites and production method be evaluated and authorized as part of the authorisation procedure.

The EU stated that if a marketing authorization application for Covishield is received, or if any changes to the permitted manufacturing sites for Vaxzevria are approved, the EU will communicate.

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