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Uncertainty remains over Covishield vaccine as Serum Institute says European approval could be delayed; Indian Government intervenes to expedite the process

NEW DELHI: European approval for the Indian-made Covishield vaccine could be delayed, said Adar Poonawalla, CEO of vaccine manufacturer Serum Institute of India (SII). He estimated it would take about a month for approval.

The European Medicines Agency (EMA) has not yet specified whether Covishield will be included in the European Union (EU) Digital COVID Certificate.

European Union Ambassador to India, Ugo Astuto, on Tuesday confirmed that there is no ban on India’s Covishield vaccine and that it will be accepted once the EMA receives an approval request. However, the application process may take longer.

Unless there is Government intervention, anyone who has been fully vaccinated with Covishield vaccine will not be able to travel to Europe during the Pandemic until Covishield is approved.

Indian Government intervenes to speed up the process

India immediately responded to the EU Ambassador’s recommendation that in order for the Covishield to be approved, a formal application be made to the European Medical Agency.

India has requested EU member states to include two Indian-made vaccines, Covishield and Covaxin, in the ‘Green Passport,’ which is set to go into effect on July 1.

The Indian Minister of External Affairs, who is currently in Italy to attend the G20 summit, has personally met with representatives of European countries and expressed concern.

African countries that imported and used Indian vaccines are also in trouble. The African Union also called for an immediate end to the crisis.

If Covishield and Covaxin are approved for inclusion in the EU Digital COVID Certificate and the Indian CoWIN vaccination certificates are approved, India proposes that their health authorities will exempt all COVID Certificate holders in EU member states from the mandatory quarantine.

Only those who have received four vaccines approved by the EMA – Pfizer-BioNTech, AstraZeneca, Moderna, Vaxzevria, and Johnson & Johnson – are currently permitted to travel to Europe. The EU stance is that only those who have been vaccinated with these vaccines will be issued vaccination passports and will be allowed to travel within the EU during the Pandemic.

However, this is only likely to change if EU member states directly approve the Covishield, recognising India’s and African countries’ requests, or allowing travellers to continue the current quarantine system.

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