Covishield exclusion from EU's green pass inequitable, activists warn

People who have received Covishield, the COVID-19 vaccine produced by the Serum Institute of India that has been central to immunization efforts across the global south, may not immediately be eligible for the digital travel pass the European Union is launching today.

Covishield is the linchpin of COVAX, the global facility to ensure equitable vaccine access, but it has not received approval from Europe’s regional regulatory authority, the European Medicines Agency.

Serum Institute of India officials have indicated they are now scrambling to secure emergency approval from EMA. While observers said they are almost certain to receive the approval, activists warn that Covishield’s exclusion from the EU’s digital COVID certificate will extend inequities that have overshadowed the rollout of COVID-19 vaccines to how and where people are allowed to travel.

Jaume Vidal, a senior policy adviser at the Amsterdam-based Health Action International, called the situation “a clear example of lack of coordination between EU institutions with far-reaching consequences at the global level.”

The digital COVID certificate, or green pass, is central to the EU’s efforts to reopen Europe and facilitate free movement across the continent. The certificate will record whether a user has been vaccinated, recovered from COVID-19, or received a negative test within 72 hours of travel. If they meet any of those criteria, the user will be able to move without restrictions, including quarantining and testing, in most cases.

Except that users who have received a vaccine that has not been approved by the EMA may not qualify for a green pass. So far the EMA has only approved four vaccines, including the AstraZeneca shot, Vaxzevria.

Covishield is the Serum Institute of India-produced version of that jab. That does not mean Covishield automatically receives regulatory approval, though.

“The safety of the vaccine is critical,” Benjamin Kagina, a vaccine specialist at the University of Cape Town, told Devex. “Even changing one small thing, let alone changing the manufacturing site, certainly requires the full review of the regulatory process.”

The Serum Institute of India, the world’s largest vaccine manufacturer, has been focusing on distributing its vaccine domestically, as well as in countries across the global south through COVAX, and not in Europe. It had not sought approval from EMA, according to the regulatory agency.

That appears to be changing. Serum’s CEO Adar Poonawalla issued a Tweet on Monday saying he has “taken this issue up at the highest levels” and hopes “to resolve this matter soon, both with regulators and at a diplomatic level.”

Under the terms of the green pass, individual EU member states do still have the option to decide whether they will include vaccines that have received regulatory approval from other bodies. That includes Covishield, which was approved for emergency use by the World Health Organization in February. On Wednesday, the Indian government informed the EU member states that it will follow a policy of reciprocity if both the Indian vaccines  — Covishield and Bharat Biotech’s Covaxin — are not accepted.

The fact that Covishield was not automatically included, though, raised concerns that the system could create a vaccine hierarchy at a time when access to other jabs in the global south remains limited.

The Africa Centres for Disease Control and Prevention issued a statement this week describing the situation as “concerning given that the Covishield vaccine has been the backbone of the EU-supported COVAX contributions to the [African Union] member states’ vaccination programs.”

Its use stretches far beyond Africa and across the global south. Through COVAX, Covishield has been distributed in at least 35 countries across all six WHO regions. The jab has also been central to India’s vaccination response.

With at least 16 European countries already using the green pass and the rest of the EU scheduled to come on board today, Vidal said the inequities created by Covishield’s exclusion from the certificate should have been anticipated well before it reached this point.

It is an “episode that highlights most of the weaknesses that some voices have been denouncing for some time,” he wrote in an email. That includes that “COVAX, which the EC and some EU member states like Germany and France, have continuously identified as the solution to the global pandemic is in fact perpetuating the inequalities that it was deemed to counter.”

The immediate impact of Covishield’s exclusion may be difficult to gauge, with the green pass limited only to EU citizens and residents. But the European Commission has indicated the certificate could play a broader role in facilitating access for people traveling from outside the EU in the future.

Alongside the equity concerns, observers are worried about the signal the EU may be sending about the vaccine. Especially as it comes on the heels of reports from Kenya that people fully vaccinated with Covishield who otherwise meet EU visa requirements are being denied access because the jab is not approved by EMA.

That is why, Kagina said, it is important to emphasize people who receive Covishield “are not getting a lower quality vaccine that’s not recognized by Europe.” That Covishield “was given an emergency use listing by the WHO together with the regulatory authorities of different countries in Africa should give people confidence.”

The current approval distinctions are largely a reflection of the speed with which regulators have been asked to examine COVID-19 vaccines, he said. The U.S. regulatory authority, the Food and Drug Administration, has not yet approved any version of the AstraZeneca vaccine, for instance, even as it continues to be administered in other places.

“I can say with a fair amount of confidence, it will only take a fair amount of time until Covishield is approved after all of the data is submitted,” he said.

In a statement released today, COVAX called on governments to recognize all fully vaccinated people who received vaccines given emergency authorization by WHO and other stringent regulatory authorities. Recognizing only a few vaccines would further widen the “global vaccine divide,” exacerbate inequities, and negatively impact already suffering economies, the statement said.

Update, July 1, 2021: This article has been updated with a statement from COVAX.