No application for Covishield yet: EU drug regulator

The European Medicines Agency (EMA) hasn’t got any application to authorise Covishield, the vaccine made by the Serum Institute of India (SII). “We have not received any marketing authorisation application for Covishield, nor is this vaccine under rolling review by the EMA,” the European Union (EU) drug regulator said in an email to ET.

The EMA website lists four vaccines as under rolling review — Sputnik V, Covovax, CureVac and Sinovac.

An SII executive who is familiar with the approval process said the company had applied for approval for Covishield through


“We had applied in the last week of May — we have even got confirmation. I can confirm for sure that we had applied through AstraZeneca as they are the licence holders in Europe,” the person told ET.

Serum Institute expected the approval within a month, since AstraZeneca’s vaccine — the same formulation as Covishield — has already been approved by the UK and European Medicines Agency.

As reported by ET last month, EMA has not mandated that Covishield be accepted by countries that issue the Green Pass, intended to ease travel within the European Union.

Country-specific Acceptance

Many countries have independently said they will accept Covishield for their country-specific passes.

The SII executive pointed out that approval by EMA is independent of European Union countries validating certificates of vaccination by Covishield. “Fifteen countries in Europe have already done it. It’s only a few countries like Italy and France that haven’t yet done it,” he said.

India had pressed the EU to include Covishield and Covaxin in the list of vaccines that qualify for the grouping’s Digital Covid Certificate. Recognition of the India-made vaccines would be reciprocated and holders of the EU inoculation pass will be exempted from mandatory quarantine, the ministry of external affairs is said to have conveyed earlier.

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