Tuesday, August 9, 2022
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Tuesday, August 9, 2022
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No Application From SII For Authorisation Of Covishield, Says EU

Almost a fortnight after the EU established the EU Digital Covid Certificate, which allows intra-EU travel; the European Medicines Agency (EMA) has not received any application from the Serum Institute of India for authorisation of Covishield, a COVID-19 vaccination.

“For the COVID-19 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.

The EMA had previously stated that slight variations in manufacturing procedures could lead to variances in the final product, and that assessments were required as part of the licencing process under EU law.

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.

India’s Covishield vaccine, based on AstraZeneca’s formula, is not on the EMA’s list of approved vaccines. Covishield’s lack of approval is causing problems for Indian visitors visiting the EU.

Despite having an EUL, or emergency use listing, from the World Health Organization, Covishield has been omitted. The EUL was issued in February, and it is one of just seven vaccines with an EUL.

This means that those who have received the Covishield vaccine will be subject to quarantine rules imposed by individual member countries, and may even be barred from visiting certain countries.

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

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