(AFP)\u2014 India\u2019s version of AstraZeneca\u2019s coronavirus vaccine is not authorised in the EU due to the possibility of \u201cdifferences\u201d with the original, Europe\u2019s drug regulator said Wednesday.<\/p>\n
The African Union has complained that the EU\u2019s non-recognition of the low-cost Indian-made Covishield jab might be detrimental to people in Africa where it is widely used.<\/p>\n
\u201cEven though it may use an analogous production technology to Vaxzevria (AstraZeneca\u2019s vaccine), Covishield as such is not currently approved under EU rules,\u201d the European Medicines Agency (EMA) said in a statement to AFP.<\/p>\n
\u201cThis is because vaccines are biological products. 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.\u201d<\/p>\n
The Amsterdam-based agency added: \u201cShould we receive a marketing authorisation application for Covishield or should any change to the approved manufacturing sites for Vaxzevria be approved, we would communicate about it.\u201d<\/p>\n
Four vaccines are currently approved for use in the EU: Pfizer\/BioNTech, Moderna, AstraZeneca and Johnson & Johnson. Another four are under \u201crolling review\u201d for possible approval: Russia\u2019s Sputnik, China\u2019s Sinovac, Germany\u2019s CureVac and Novavax of the United States.<\/p>\n
The World Health Organization (WHO) has however approved Covishield and lamented the fact that some countries were rejecting Covishield\u2019s use on vaccination passes.<\/p>\n
\u201cThis is a great pity because AstraZeneca-Covishield is exactly the same vaccine as AstraZeneca-Vaxzevria, which is accepted as proof of vaccination,\u201d said Richard Mihigo of the WHO Regional Office for Africa late Tuesday.<\/p>\n
\u201cIt is only that AstraZeneca-Covishield is manufactured and distributed in other parts of the world other than Europe.\u201d<\/p>\n
He urged EU countries to recognise Covishield on vaccine passes.<\/p>\n
The EMA statement said it was \u201cnot responsible for any decision regarding travelling into the EU\u201d, which is the responsibility of the European Commission and EU member states.<\/p>\n
In a joint statement released Monday, the African Union (AU) and the Africa Centres for Disease Control and Prevention said the rules \u201cput at risk the equitable treatment\u201d of people vaccinated in Africa.<\/p>\n
People in some African nations have also complained about the lack of recognition for any of the widely used Chinese vaccines.<\/p>\n","protected":false},"excerpt":{"rendered":"
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