"Applied For Clearance": Serum Sources On Covishield Issue In EU

The European Union has not yet recognised the India-made version of the AstraZeneca-Oxford University vaccine, Covishield.

'Applied For Clearance': Serum Sources On Covishield Issue In EU
New Delhi:

The Serum Institute (SII) has applied through AstraZeneca for the European Medicines Agency's nod to get the Covishield vaccine approved for the European Union's 'vaccination passport', company sources have told NDTV.

The remark comes on a day the European Union said the agency had not received any request for approval from the India-based company.

"We have applied through AstraZeneca, our partners in Europe, for clearance/recognition of Covishield from the European Medicines Agency. This has been done to ease the procedure to get the necessary approvals for Covishield. It is the right and option of every EU country to use a WHO-approved vaccine in their approved list. The approval process should hopefully be concluded in a month," the SII sources said.

The European Union has not yet recognised the India-made version of the AstraZeneca-Oxford University vaccine, Covishield. However, Vaxzervria, the same vaccine manufactured in Europe by AstraZeneca, is on the list of four vaccines approved for the vaccination passport that will enable people to travel within the European Union relatively free of Covid-induced restrictions.

So far, only those vaccinated with either of the four vaccines - Comirnaty of Pfizer/BioNTech, Moderna, Vaxzervria by AstraZeneca-Oxford and Johnson & Johnson's Janssen - will be given vaccination passports.

"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 Pune-based company had requested the government to take up the issue of the vaccine's inclusion in the 'vaccination passport', sources said.

"India has a large population. However, not including Covishield into the EU COVID-19 Vaccination Passport will not allow Covishield vaccinated people to travel to European countries and this will affect students, business travellers back and forth, and cause severe disruptions to our economy and to the global economy," news agency PTI, attributing to sources, quoted Serum Institute CEO Adar Poonawalla as having written to Foreign Minister Dr S Jaishankar.

On Monday, Mr Poonawalla tweeted that he had "taken this up at the highest levels... with regulators and diplomatic" and that he hoped the matter would be resolved soon.