The European Medicines Agency (EMA) has not received any application from the Serum Institute of India for authorisation of Covishield, a COVID-19 vaccine, almost a fortnight after 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.
For the #COVID19vaccine 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. #EMAPresser
— EU Medicines Agency (@EMA_News) July 15, 2021
The EMA had earlier said 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.
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 restriction-free travel within the EU during the pandemic.
Covishield vaccine, manufactured under technology transfer from Oxford/AstraZeneca, is not among the authorised vaccines under the EMA. The lack of authorisation for Covishield is creating hurdles for Indian travellers to the EU.
However, several European countries have independently accepted Covishield – so the impact of this has also been reduced. The SII doesn’t market Covishield in Europe and it was AstraZeneca which expected to deal with the European medical authority.
Covishield has also been excluded despite holding 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 people vaccinated with Covishield 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 had said last month that he was “taking this up at the highest levels… with regulators and diplomats” and that he “hoped to resolve this matter soon”.