The African Union and Africa Centres for Disease Control and Prevention (Africa CDC) have voiced concern after it emerged that Europe's digital "green pass" does not recognize the vaccine that was donated to many African countries through the COVAX initiative.
The European Union Digital Covid Certificate enables people who have received two doses of a Covid-19 vaccine approved by its medicines regulator, the European Medicines Agency (EMA), to travel freely within the bloc.
But the pass only recognizes AstraZeneca doses (branded Vaxzevria) made by EMA-approved manufacturers in Europe, US, South Korea and China -- not those manufactured by the world's largest vaccine manufacturer, the Serum Institute of India (branded Covishield).
The EMA told CNN in a statement on Monday that Vaxzevria is only Covid-19 shot from AstraZeneca for which approval was requested -- leading to its authorization in the EU.
"In the EU, the vaccine called Covishield does not currently have a marketing authorization. Even though it may use an analogous production technology to Vaxzevria, Covishield as such is not currently approved under EU rules," the EMA said.
"This is because vaccines are biological products," the agency stated. "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 authorization process."
The EMA statement added: "Should we receive a marketing authorization application for Covishield or should any change to the approved manufacturing sites for Vaxzevria be approved, we would communicate about it."
