European Drug Regulator Says ‘No Application Received Yet’ For Covishield Authorisation

Covid Vaccine Update: Almost a fortnight after the EU introduced the EU Digital Covid Certificate, which allows intra-EU travel, the European Medicines Agency (EMA) has received no application from the Serum Institute of India for approval of Covishield, a COVID-19 vaccine.

“For the COVID19-vaccine Covishield to be evaluated for use in the EU, the developer needs to submit a formal marketing authorisation application to EMA, which to date has not been received,” the EMA announced at a press meeting.

Minor differences in manufacturing processes, according to the EMA, could result in differences in the final product, and EU law required assessments as part of the authorisation process.

So far, the EMA has approved only those who have received either of the four vaccines – Comirnaty from Pfizer/BioNTech, Spikevax from Moderna, Vaxzervria from AstraZeneca-Oxford, and Janssen from Johnson & Johnson – for restriction-free travel within the EU during the pandemic.

The Covishield vaccine, developed through a technology transfer from Oxford/AstraZeneca, is not one of the EMA-approved vaccines. The lack of authorization for Covishield is causing difficulties for Indian visitors to the EU.

However, because several European countries have independently accepted Covishield, the impact of this has been mitigated. The SII does not market Covishield in Europe, and AstraZeneca anticipated dealing with the European medical authority.

Covishield has also been excluded, despite the fact that it has an EUL, or emergency use listing, from the World Health Organization; the EUL was granted in February, and it is one of only seven vaccines on that list.

This means that people who have been vaccinated with Covishield will be subject to quarantine protocols imposed by individual member countries, and may even be barred from entering some others.

Adar Poonawalla, CEO of the Serum Institute, stated last month that “taking this up at the highest levels… with regulators and diplomats” and that he “hoped to resolve this matter soon”.

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