The European Union on Monday said that its drug regulator has not received a request for approval of Covishield for the bloc’s Covid-19 “vaccination passport” programme, reported NDTV.
The programme recognises a few coronavirus vaccines whose beneficiaries can travel in and out of Europe. It includes the AstraZeneca vaccine but not Covishield, which is produced in India by the Serum Institute of India. Earlier on Monday, Serum Institute of India’s Chief Executive Officer Adar Poonawalla had said that he has taken up the matter at the “highest levels” and was hoping for its early resolution.
“Concerning a possible EMA authorisation for Covishield, as of yesterday [Monday], the European Medicine Agency (EMA) stated that it had not received a request for approval,” the EU said in a statement. It added that it will examine the request when received while following the due procedures.
A European Union official clarified that the European Medicines Agency does not investigate new drugs on its own, unless relevant companies ask for it, reported ANI. “As to travel to the EU from India, temporary restrictions on non-essential travel to EU are currently in place from many non-EU countries, including India, due to Covid-19,” the official added.
Travellers vaccinated with Covishield may not be eligible for the European Union’s “green pass”, a document that is meant for easy travel within and to the group of countries. Many member-states of the European Union have begun issuing the digital vaccine passport to facilitate movement for work and tourism.
So far, four vaccines – BioNTech-Pfizer, Moderna, AstraZeneca-Oxford and Janssen Pharmaceutica NV – have been approved, according to the European Commission.
Meanwhile, the European Medicines Agency on Monday said it would assess the manufacturing site of Serum Institute of India before approving the Covishield vaccine. The European Union drug regulator said that the agency’s approval for the Vaxzveria vaccine does not mean the same for Covishield. Vaxzveria is a version of the AstraZeneca shot developed in Europe. The European Medicines Agency added that it has not received a marketing authorisation application for Covishield yet.
The European Medicine Agency clarified that even though Vaxzevria and Covishield vaccines use the same technology, the shots developed by Serum Institute of India would require a separate approval for use, according to the European Union’s laws.
In June, India’s Covid-19 Working Group of the National Technical Advisory Group on Immunisation said that a single shot of the Covishield vaccine has an efficacy of 61% against the Delta variant of coronavirus, while two doses provide 65% protection. Cases of the Delta variant of Covid-19 have forced multiple countries to reimpose curbs.