Not Received Any Application Seeking Approval For Covishield: European Medicines Agency

Serum Institute of India’s (SII) Covishield Covid-19 vaccine can only be considered for marketing authorisation in the European Union (EU) if we receive an application in this regard, the European Medicines Agency (EMA) said on Monday.

This development comes in the backdrop of reports stating that people vaccinated with Covishield will most likely not be able to travel across the EU as the vaccine is yet to receive clearance by EMA.

"Concerning a possible EMA authorisation for Covishield, as of yesterday, the European Medicine Agency (EMA) stated that it had not received a request for approval. It will examine any such request when received, as per its procedures," NDTV quoted the EU as saying.

Prior to this development, SII had urged the Indian government to take up inclusion of Covishield in the EU Covid-19 Vaccination Passport with the European Union and other countries.

The EU Digital COVID certificate or 'Green Pass' 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.

Travel under 'Green Pass' to non-EU citizens may be rolled out in a phased manner from July 1.

However, individual European Union member countries may have separate rules and norms for travellers.

The EMA has already approved four Covid-19 vaccines which included Vaxzevria, the AstraZeneca vaccine manufactured in the UK and EU-member countries.

The SII makes Covishield in India with a licence from AstraZeneca.

"The only Covid-19 vaccine from AstraZeneca for which a marketing authorisation application was submitted to and evaluated by EMA, leading to its authorisation in the EU, is Vaxzevria," Alessandro Faia, a spokesperson of the EMA said.

"In the EU, the vaccine called Covishield does not currently have a marketing authorisation. Even though it may use an analogous production technology to Vaxzevria (the COVID-19 AstraZeneca vaccine authorised in the EU), Covishield as such is not currently approved under EU rules," the official said.

Explaining the reason, the official said even tiny differences in the manufacturing conditions can result in differences in the final product.

"This is because vaccines are biological products. Even tiny differences in the manufacturing conditions can result in differences in the final product, and EU law, therefore, requires the manufacturing sites and production process to be assessed and approved as part of the authorisation process," the spokesperson said.

"Should we receive a marketing authorisation application for Covishield or should any change to the approved manufacturing sites for Vaxzevria be approved, we would communicate about it," he said.

The official clarified that the EMA is not responsible for any decision regarding travelling into the EU and the travelling conditions associated with Covid-19 vaccination, such as the EU Digital COVID certificate.

"This is a matter for the European Commission and for individual member states," the official added.

(With PTI inputs)