No request received yet for EU authorisation of Covishield: official

A European Union (EU) official on Tuesday said that the European Medicines Agency (EMA) has not received any request for approval of authorisation of the COVID-19 vaccine, Covishield.

Speaking to ANI, the EU official said: "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."

"The EMA does not investigate new drugs on its own, unless it is asked by the relevant companies," he said.

Meanwhile, the official said the member states of the bloc will gradually lift temporary travel restrictions for people from India at their external borders, based on the developments of the health situation pertaining to the COVID-19 pandemic.

"As to travel to the EU from India, temporary restrictions on non-essential travel to the EU are currently in place from many non-EU countries, including India, due to COVID. EU Member States shall gradually lift these temporary travel restrictions at the external borders, based on developments of the health situation," the EU official told ANI.

Meanwhile, the 27-member European bloc is now introducing the EU Digital COVID Certificate, which is meant to facilitate safe free movement during the COVID-19 pandemic within the EU.

The certificate will serve as evidence that a person was vaccinated against COVID-19, received a negative test result or recovered from COVID-19. The aim of the EU Digital COVID Certificate is to facilitate free movement inside the EU. It is not a pre-condition to travel.

For this purpose, member states of the EU will have the option to accept also vaccinations that have been authorised by the World Health Organization (WHO), including Covishield, confirmed the EU official.

On Monday, Adar Poonawalla, Chief Executive Officer (CEO) and owner of the Serum Institute of India (SII) assured Indians who have taken Covishield doses and are now facing issues while travelling to European Union countries that the matter had been escalated to the 'highest level'.

"I realise that a lot of Indians who have taken COVISHIELD are facing issues with travel to the E.U., I assure everyone, I have taken this up at the highest levels and hope to resolve this matter soon, both with regulators and at a diplomatic level with countries," he tweeted.

This comes after reports that travellers vaccinated with Covishield, the AstraZeneca-Oxford vaccine manufactured in India by the SII, may not be eligible for the European Union's 'Green Pass'.

Europe's vaccine passport programme, which allowed recipients to travel to and from Europe with fewer roadblocks, may not recognise recipients of the Covishield vaccine.

Covishield is one of the three COVID-19 vaccines approved for use in India.