The European Medicines Agency on Monday said it would assess the manufacturing site of Serum Institute of India before approving the Covishield vaccine against Covid-19, News18 reported.
Earlier on Monday, Serum Institute of India Chief Executive Officer Adar Poonawalla said that several beneficiaries of the Covishield vaccine were facing problems in planning their travel to the European Union. Poonawalla said he had taken up the matter at the “highest levels”.
The European Union drug regulator told News18 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 to News18 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.
“Even though it [Covishield] may use an analogous production technology to Vaxzevria, Covishield as such is not currently approved under EU rules,” the drug regulator’s Press Officer Violeta Pashova told the News18. “Even tiny differences in the manufacturing conditions can result in differences in the final product, and EU law, therefore, requires the manufacturing sites and production process to be assessed and approved as part of the authorisation process.”
Pashova also said that that the European Medicines Agency has so far approved six manufacturing sites for Vaxzevria – Belgium, United States, United Kingdom, Netherlands, Korea and China.
In response to a question on the “green pass”, the European Medicines Agency said that it had no role to play in decisions related to travel restrictions amid the pandemic.
“This is a matter for the European Commission and for individual member states,” the medicine body said.
The Serum Institute chief’s tweet on Monday came amid reports that 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.
Europe’s new “vaccine passport” programme, which recognises a few Covid-19 vaccines whose beneficiaries will be able to travel in and out of Europe, includes the AstraZeneca vaccine but not Covishield, which is produced in India.