EMA had not received Covishield approval request for 'Green Pass', says EU official
The European Medicines Agency (EMA) has not received an authorisation request for the Covidshield vaccine, a version of the AstraZeneca vaccine being manufactured by Pune-based Serum Institute of India (SII), according to an EU official, reported news agency ANI. The EMA doesn't investigate new drugs on its own, unless asked by relevant companies, the official added.
While many EU member states have started issuing the digital “vaccine passport” that will enable travellers to move freely for work or tourism purposes, those vaccinated with Covishield may not be eligible for the ‘Green Pass’ that will be available to use from July 1.
"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 EU said in a statement.
The official clarified that the EU Digital Covid Certificate is meant to facilitate restriction-free movement within the member states and is not a pre-condition to travel. The certificate will serve as proof that the person was either vaccinated against the virus, received a negative test result or recovered from it.
Currently, individuals vaccinated with any of the four EMA-approved vaccines are eligible for the "vaccine passport". The four vaccines are Comirnaty (Pfizer/BioNTech), Moderna, Vaxzervria (AstraZeneca), Janssen (Johnson & Johnson).
But, for the purpose of the Digital Covid Certificate, individual member states will have the option to accept vaccinations that have been authorised by the World Health Organization (WHO).
SII's Adar Poonawalla on Monday said that he has taken the matter up at the highest levels, both with regulators and at a diplomatic level with countries, assuring that it will get resolved soon. "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," Adar Poonawalla tweeted.
(With ANI inputs)