- Friday, April 19, 2024
By: Shubham Ghosh
THE European Medicines Agency (EMA) has said it has not received any application from the Serum Institute of India in Pune, Maharashtra, for the authorisation of Covishield, the Covid-19 vaccine which has been manufactured under technology transfer from Oxford/AstraZeneca. Covishield doesn’t come under the authorised vaccines under the EMA and it is creating hurdles for Indian travellers to the European Union (EU). It has been weeks since the EU introduced the EU Digital Covid Certificate that makes intra-EU travel possible.
“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 said at a press meeting.
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The EMA had earlier said that minor differences in manufacturing processes could result in differences in the final product and the EU law required assessments as part of the authorisation process.
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So far, the EMA has approved only those vaccinated by either of the four vaccines — Comirnaty of Pfizer/BioNTech, Moderna’s Spikevax, Vaxzervria by AstraZeneca-Oxford and Johnson & Johnson’s Janssen – for unrestricted travel within the EU during the coronavirus pandemic.
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Several European countries have accepted Covishield independently. The Serum Institute doesn’t market Covishield in Europe and it was AstraZeneca which expected to deal with the European medical authority.
The India-made vaccine has also been excluded despite holding an emergency use listing or EUL from the World Health Organisation. It was granted in February and it is one of only seven vaccines on the list. It means people who have taken the Covishield jab will be subject to quarantine protocols as enforced by individual member-countries and may even be blocked from entering some others.
Serum Institute CEO Adar Poonawalla said in June that he was “taking this up at the highest levels… with regulators and diplomats” and that he “hoped to resolve this matter soon”.
