Ghana and African countries that have received Indian-produced COVID-19 vaccines may be in danger as there is a report that those are not approved.
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 a vaccine that was donated to many African countries through the COVAX initiative.
The European Union Digital Covid-19 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, the 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 the 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.”
The EU told CNN in a statement Wednesday that the certificate was “not a prerequisite for travel into the European Union” and that “Member States could also allow entry for people vaccinated with vaccines having completed the WHO Emergency Use Listing process,” which includes Covishield. Travelers may also enter the EU by presenting a negative PCR test.
Meanwhile, Ghana and some African countries are halfway done with the general vaccination of their populace with the Indian-produced AstraZeneca vaccines ( which is also known as the COVISHIELD ) through the COVAX facility.
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