India's version of AstraZeneca's coronavirus vaccine is not authorised in the EU due to the possibility of “differences” with the original, Europe's drug regulator has said.

The African Union has complained that the EU's non-recognition of the low-cost Indian-made Covishield jab might be detrimental to people in Africa where it is widely used.

“Even though it may use an analogous production technology to Vaxzevria (AstraZeneca's vaccine), Covishield as such is not currently approved under EU rules,” the European Medicines Agency (EMA) said in a statement to AFP.

“This 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.”