The European Medicines Agency (EMA) has maintained that it has not received any application from Serum Institute of India (SII) seeking marketing authorisation for its Covid-19 vaccine, Covishield in the European Union.
While Covishield has an emergency use listing from the WHO, it is yet to receive a similar approval from the European Union.
The European Medicines Agency (EMA) has maintained that it has not received any application from Serum Institute of India (SII) seeking marketing authorisation for its Covid-19 vaccine, Covishield in the European Union.
“For the #COVID19vaccine Covishield to be evaluated for use in the EU, the developer needs to submit a formal marketing authorisation application to EMA, which to date has not been received. #EMAPresser,” the EMA tweeted on Thursday.
Covishield also doesn’t have the EU Digital COVID certificate or 'Green Pass', which will be mandatory to travel to European countries and the document is likely to serve as proof that a person is vaccinated against Covid-19.
The EMA’s statement comes days after SII chief executive officer Adar Poonawalla said that his company has submitted documents to the EMA seeking approval for Covishield.
"We are quite confident that in a month EMA will approve Covishield. There is no reason why not to, because it is based on AstraZeneca data and our product is identical to AstraZeneca more or less and it has been approved by WHO, UK MHRA. So, it's just a matter of time. It is not really going to hinder anything," Poonawalla said on June 30.
The lack of authorisation for Covishield is creating hurdles for Indian travellers to the EU.