The EUDCC and Covishield

Well, that was unexpected, at least by me.

I figured that discussion of the European Union Digital COVID Certificate (EUDCC) would focus on use of the certificate by residents of the EU.

However, the big debate right now is about how citizens of countries outside of the EU are affected. While the EUDCC is primarily designed for EU citizens, the EU has an interest in getting people from outside of the EU to travel to Europe and spend lots of euros and make everyone happy.

However, some of the regulations that govern the EUDCC and the EU’s COVID response are actually hampering travel from outsiders.

And when words like “equitable” are being bandied about, people are going to take notice.

Let’s start by examining the list of vaccines that are approved in the European Union.

Four vaccines are currently approved for use in the EU: Pfizer/BioNTech, Moderna, AstraZeneca and Johnson & Johnson. Another four are under “rolling review” for possible approval: Russia’s Sputnik, China’s Sinovac, Germany’s CureVac and Novavax of the United States.

So if you received one of the first four vaccines, this can be listed on your EUDCC and you can go about your merry way.

But African governmental entities believe that a fifth vaccine, one that happens to be available in Africa, should be added to the list.

[W]hile the goal is for EU Member States to issue vaccination certificates regardless of the COVID-19 vaccine type used, the granting of a “green pass” applies, only to vaccines that have received EU-wide marketing authorisation. Thus, while the AstraZeneca vaccine (ChAdOx1_nCoV-19) produced and authorized in Europe (Vaxzervria) is included, the same formation of the vaccine (Covishield) produced under license by the Serum Institute of India (SII), is excluded.

The TL;DR version: since Covishield is equivalent to Vaxzervria/AstraZeneca, people who received Covishield should get EU travel privileges.

Why does the same vaccine formulation have two different names? Because a special effort was mounted to provide vaccines to the Third World without endangering First World profits.

Covishield is the Indian counterpart of AstraZeneca-Oxford developed Vaxzervria and is identical to the one made in Europe. It has been widely distributed in many low and middle-income countries through the EU-supported COVAX programme. However the vaccine has not been included on the EUDCC because it is not approved by the European Medicines Agency (EMA). 

The European Medicines Agency counters that Covishield is NOT the same as the European version of AstraZeneca, despite an identical formulation:

“Even though it may use an analogous production technology to Vaxzevria (AstraZeneca’s vaccine), Covishield as such is not currently approved under EU rules,” the European Medicines Agency (EMA) said in a statement to AFP. “This is because vaccines are biological products. Even tiny differences in the manufacturing conditions can result in differences in the final product, and EU law therefore requires the manufacturing sites and production process to be assessed and approved as part of the authorisation process.”

So that’s where things stand as of now. And they may remain this way unless there’s pressure on the EMA to revise its decision.

Now I’m wondering how many Nigerians…and how many Indians…and how many Chinese and Russians (remember that Sputnik and Sinovac aren’t approved either)…are choosing to forgo a European holiday this summer.