Why Was Covishield Denied 'Green Pass' by European Medicine Agency

New Delhi: A controversy erupted in 2021 after the AstraZeneca-Oxford vaccine, Covishield, manufactured by India’s Serum Institute of India (SII), was denied a 'Green Pass' by the European Medicines Agency (EMA). According to the official statement, individuals vaccinated with Covishield, AstraZeneca's version of the vaccine, were not eligible for the EU Digital Covid certificate or "green pass." However, the European Medicine Agency (EMA) recognized its innovative vaccine Vaxzevria among others for the green pass.

What is a Green Pass?

A green pass is an EU Digital COVID-19 certificate introduced by the European Union for safe and hassle-free travel. According to the European Union's official website, almost 2.3 billion certificates have been issued.

The certificate covers vaccination, tests, and recovery facilitated for safe and hassle-free travel for travellers.

In July 2023, the World Health Organization (WHO) took up the digital COVID-19 certification to establish a global system to help protect citizens across the world from global pandemics and health threats.

The digital certificate has helped medical organizations in setting a global standard for international travel.

Why was Covishield Denied a Green Pass?

The European Medicines Agency (EMA) clarified why Covishield was excluded from the list of approved vaccines for the 'Green Pass', stating that the vaccine does not currently have marketing authorization in the European Union (EU) as these vaccines are biological products.

A spokesperson for EMA stated that for any vaccine to be granted the green pass, the law requires the manufacturing sites and production process to be assessed for clearance.

The representative added that the only vaccine approved by AstraZeneca was Vaxzevria after it was evaluated by the EMA.

The European organization permitted Green Pass vaccines like Comirnaty (Pfizer), Covid-19 Vaccine Janssen, Spikevax (previously Covid-19 Vaccine Moderna), and AstraZeneca's Vaxzevria.

Furthermore, in India, following the denial by EMA, Serum Institute of India’s CEO Adar Poonawalla said that he has taken up the matter "at the highest level" to ensure that Indians don’t face any travel restrictions. He tweeted, "I realize that a lot of Indians who have taken Covishield are facing issues with travel to the EU. I assure everyone, I have taken this up at the highest levels and hope to resolve this matter soon, both with regulators and at a diplomatic level with countries."