The European Medicines Agency has said that it has not yet received a marketing authorisation application from the Serum Institute of India for its Covishield vaccine. At a press briefing on Thursday, the drug regulator said that the application was needed to evaluate the vaccine before allowing its use in the European Union.
The European Union launched a “vaccine passport” system from July 1. Under the system, those visiting member-states of the bloc will be issued a “green pass”, to allow travel between countries in the EU. So far, four vaccines – those developed by Moderna, Pfizer-BioNTech, Johnson & Johnson and the AstraZeneca shot manufactured and sold in Europe as Vaxzevria – have been given approval under the system by the EU.
Last month, the European Medicines Agency had clarified that even though the 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 laws.
The agency also said that it would assess the manufacturing site of Serum Institute of India before approving the Covishield vaccine. The comment from European Medicines Agency on Thursday indicates that the process is yet to begin as it has not received an application from the Pune-based vaccine maker.
This is despite Serum Institute of India chief Adar Poonawalla’s assurance on June 28 that he had taken up the matter at the “highest levels”. He made the comment while acknowledging that several Indian citizens were facing problems in the process of their scheduled travel to the European Union.
On July 2, India’s foreign ministry said it expects that the European Union will consider those vaccinated in the country will be treated in the same manner as those inoculated by the 27-member bloc. The ministry’s spokesperson Arindam Bagchi said that the Indian government was in touch with countries in the European Union to recognise digital vaccine certificates issued by the CoWin platform on a reciprocal basis.
Meanwhile, nine European countries have separately recognised the Covishield vaccine after the government requested members of the EU to individually consider allowing Indians who have taken Covishield and Covaxin shots. However, among these nine countries, only Estonia has recognised the Covaxin jab.