India caught asleep at the wheel with Green Pass for Covishield

The definitive steps taken by the EU in issuing digital vaccination certificates since January this year was well known. Yet, it was only on June 29, two days before the Green Pass became effective in the European Union that India woke to reality. External Affairs Minister S. Jaishankar tweeted saying he had taken up the issue of Covishield authorisation for travel to Europe with his EU counterpart.

India has once again been caught napping. With the European Union’s Digital COVID Certificate coming into force throughout the Union from July 1, over 290 million people in India vaccinated with Covishield manufactured by the Pune-based Serum Institute will not be eligible for a Green Pass. The green pass allows for free movement across 27 member States of the European Union for business and tourism without the need for quarantining.

However, people vaccinated with AstraZeneca’s Vaxzevria, which is the vaccine developed by Oxford University much like Covishield, will be eligible for the green pass. People vaccinated with Pfizer, Moderna and Johnson & Johnson vaccines will also be eligible for a green pass. The reason: the four vaccines, including AstraZeneca’s, have received marketing authorisation from the European Medicines Agency (EMA) and the current green pass only lists vaccines approved by the EMA. Thus people vaccinated with AstraZeneca’s Vaxzevria will automatically be eligible for the green pass while Covishield has neither been approved by the EMA for marketing nor has India got the EU to approve Covishield to enable travel to EU member States without any restriction.

Getting EMA’s marketing authorisation in the EU for Covishield will not only take time but will also be uncertain as such approvals are based on clinical trial data and inspection of vaccine manufacturing sites, if such facilities manufacturing Covishield are already not approved by the European regulator.

An alternative and easier route that might make people vaccinated with Covishield to become eligible for the green pass is when the EU recognises all vaccines approved by the WHO. According to Murali Neelakantan, Principal Lawyer at amicus, Mumbai, there is an ongoing discussion between the EU and the WHO about whether WHO-approved vaccines could be the basis for the green pass.

Not only Indians

It is not only Indians who will be impacted by the current EU decision not to approve Covishield but millions of people in other countries who have been immunised with the Serum vaccine. Over 660 million doses of Covishield have so far been distributed to over 90 countries either as grant, commercial sales or through the COVAX facility. Therefore, if the EU recognises Covishield based on the WHO approval, everyone who has been vaccinated with the Indian vaccine too can travel to the EU member States without any restriction.

On June 29, the External Affairs Minister S. Jaishankar tweeted saying he had taken up the issue of Covishield authorisation for travel to Europe with his EU counterpart High Representative Josep Borrell Fontelles.

WHO-listed vaccines

Even if the EU does not include the WHO-listed vaccines, individual member States can on their own add other vaccines recognised by the global health body. The member States’ freedom to independently recognise vaccines that have been included in the WHO’s emergency use list becomes particularly relevant as Hungary has used Russia’s Sputnik V and China’s Sinopharm’s COVID vaccine, neither of which has been currently approved by the EMA.  However, Covaxin is yet to be approved by the WHO to be included in its emergency use list.

Already, 16 member States have included Covishield in the basket of vaccines for the green pass.

The member States can also include other public health criteria such as the disease prevalence and rate of vaccination in a specific country to decide a restriction-free entry into the EU. Member States can also decide whether to allow entry after a single dose or after full vaccination.

Missing the early signs

Incidentally, issuing vaccination passports to people who have been immunised has been hotly debated since last year. The definitive steps taken by the EU in issuing digital vaccination certificates since January this year was well known and so does not come as a surprise. There were major steps taken by the EU towards meeting this objective. For instance, in the third week of May the European Parliament and the Council agreed on the EU Digital COVID Certificate, and on June 1, the EU gateway went live. But India woke up to reality only a week before the system goes live on July 1.

All these could have been avoided if at the time AstraZeneca got its approval, Serum’s facility was also mentioned as one of the vaccine manufacturing sites, like the ones producing the vaccine outside the EU in China, South Korea and the U.S.

Reacting to CEO of Serum Adar Poonawalla’s tweet about him taking up the issue at the highest level and hoping to resolve the matter both with regulators and at a diplomatic level with countries, Mr. Neelakantan feels that it has been made to appear as if the lapse was only on Serum’s part and not also the Indian government.

While EMA’s approval of Covishield or EU’s recognition of the vaccine will make every recipient of Covishield across countries eligible for unrestricted entry into the EU, any bilateral agreement between India and the EU will only serve the interests of people vaccinated here. With a planned supply of millions of doses of Covishield to COVAX for distribution to numerous low- and middle-income countries, India exclusively resolving the issue with the EU will potentially put millions of people in other countries with little bargaining power at a great disadvantage.

The bigger issue in achieving a seamless interoperability is by ensuring that a robust IT system is in place in India to issue credible and authentic digital certificates. These certificates should be verifiable with a digital signature and compatible with the EU gateway for hassle-free entry into any of the European Union member States without the need for quarantining.

With numerous cases of fraudulent vaccination and people receiving vaccination certificates despite not having been immunised, including a 13-year-old boy in Bhopal, does not inspire confidence in the vaccination certificates issued through the CoWIN portal. Yet, India wants the EU to accept such certificates issued through the CoWIN portal.  

In comparison, besides issuing digital certificates, the main focus of the European Union was to have in place the EU digital COVID certificate gateway which will facilitate the authentication of certificates of vaccination, recovery, and negative test. The second area that member States actively participated was in developing and testing the IT system, the backbone of the gateway, in May-June in time for the roll-out on July 1. The third critical area of focus was in ensuring data safety and security.