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EMA says Covishield does not have marketing authorisation in the EU

PT Jyothi Datta Mumbai | Updated on June 30, 2021

Serum Institute to seek an emergency-use approval from the European regulator

The European Medicines Agency (EMA) has said that Serum Institute of India’s Covishield vaccine does not have a marketing authorisation in the European Union. This comes even as Indians who have taken Covishield worry about their vaccination not being recognised in Europe.

Explaining why the approval was significant, EMA told BusinessLine: “Even though it may use an analogous production technology to Vaxzevria (the Astra Zeneca vaccine authorised in the EU), Covishield as such is not currently approved under EU rules. 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.”

Scientific evaluation

Nevertheless, the EMA clarified that it was involved with the scientific evaluation of medicines and vaccines in view of their marketing authorisation in the EU.

“However, EMA is not responsible for any decision regarding travelling into the EU and travelling conditions associated with Covid-19 vaccination, such as the EU Digital Covid Certificate. This is a matter for the European Commission and for individual Member States,” said the EMA spokesperson.

The only Covid-19 vaccine from AstraZeneca for which a marketing authorisation application was submitted to and evaluated by EMA leading to its authorisation in the EU is Vaxzevria.

“Should 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,” the regulator added.

A person familiar with the development told BusinessLine that Serum Institute will seek an emergency-use approval from the EMA. Industry-watchers point out that since Europe and Britain had a mutual recognition agreement, Covishield should not have had to take a separate approval. Serum’s Covishield (essentially the AstraZeneca-OxfordUniversity vaccine) is accepted in the UK. Covishield is also listed for emergency use by the WHO.

Published on June 29, 2021

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