New Delhi: The European Union’s plan to roll out its vaccine passport programme, called the ‘Green Pass’, to the exclusion of India’s Covishield vaccine has been criticised in India and also Africa.
There seem to be two issues, both related to the fact that only those recipients of vaccines approved by the European Medicines Agency (EMA) will be eligible to hold a ‘Green Pass’, which will essentially allow quarantine-free travel within the EU. The EMA is the regulator of drugs, vaccines and medical devices for the EU bloc of countries.
The first issue, from India’s perspective, is that the EMA has approved the emergency use of Vaxzevria but not Covishield. Both Vaxzevria and Covishield are different names for the same vaccine: developed and licensed by the University of Oxford and AstraZeneca, respectively. As a result, Covishield recipients – which is a majority of vaccinated Indians as well as many beneficiaries of the COVAX initiative worldwide – will be considered to be ‘unvaccinated’ under the ‘Green Pass’ programme, and will have to comply with each country’s regulations for this group.
On this count, experts have said that a part of the licensing process of many major regulatory bodies is an inspection of the manufacturing facilities. As a result, two manufacturers making the same vaccine will have to apply separately for licenses, and a vaccine approved for one manufacturer can’t be automatically extended to other manufacturers. Serum Institute of India, which makes Covishield in India, hadn’t applied for a license with the EMA because it wasn’t planning to sell doses in Europe. As a result, the EMA recognises Vaxzevria but not Covishield.
The second issue is that the EMA has in the past acknowledged the WHO’s approval for vaccines and drugs, but in the present case does not. Covishield has the WHO’s approval, which is necessary for vaccine-makers to participate in the COVAX scheme. However, the EMA hasn’t recognised Covishield in this case, surprising health-policy experts.
One explanation, The Wire has learnt, lies in the realm of politics. Sources at India’s external affairs ministry told The Wire that the EMA approval process was arrived at as part of the EU’s internal decision making, to streamline the vaccine passport’s launch, as all the different member states had approved their own list of vaccines.
Russian, Chinese vaccines
It’s notable that while it’s a drug-regulating agency, the EMA differs from, say, the US Food and Drug Administration (FDA) in some important ways. The FDA has a centralised remit and is a consumer-protection agency. In Europe, on the other hand, each member-state has a national-level drug-regulating body. The EMA works with all of these bodies to develop consensus – and in the case of the ‘Green Pass’, the consensus required the body to accommodate political issues as well.
Hungary is administering Sinopharm vaccines, but Germany, among others, didn’t want people vaccinated with Chinese and Russian vaccines travelling to them, a source at the ministry said.
Politico had reported on March 5 that Hungary, the Czech Republic and Slovakia had pitched for the EMA to quickly approve Sputnik V, while the Baltic states and Poland – formerly part of the Soviet bloc – had warned that Sputnik V could be “a geopolitical weapon deployed to widen political divides within the EU”.
These issues in turn happened against the backdrop of the run-up to elections in Germany. As the most influential EU state continued in its campaign mode in February, according to Politico, German politicians also took aim at the EU’s as well as Germany’s slow pace of vaccinations, forcing members of the EU Commission on the back foot.
So during the deliberations, the source continued, they realised that if they had to use WHO-approved vaccines, then they would have to recognise Russian and Chinese vaccines as well.
The EMA-approved list of vaccines provided a workaround. This list is only four items long: Oxford-AstraZeneca, Pfizer-BioNTech, Moderna and Janssen-Johnson & Johnson.
None of the three vaccines in India’s COVID-19 vaccination drive – Sputnik V, Covaxin and Covishield – have EMA approval at present. Reuters reported on June 16 that the EU’s approval of Sputnik V would also “be delayed because a June 10 deadline to submit data was missed, two people familiar with the matter” said.
Approval for Covishield
The backlash to the EU’s ‘Green Pass’ announcement prompted a comment from Serum Institute CEO Adar Poonawala. He tweeted on June 28 that he would work to have the matter resolved “soon”. One way to do this is for Serum Institute to apply for ’emergency use’ approval with the EMA for Covishield.
Another way, the external affairs ministry source said, is for EU member states to include Covishield in their national framework; some EU member states have already done so. The alternative is also likely to be more onerous – to apply for approval in each of the 27 EU member states.
This ‘alternate’ route wouldn’t be a big leap either, considering, as virologist Shahid Jameel told The Wire Science earlier, both Covishield and Vaxzevria are “biologically similar”. Perhaps more notably, the WHO didn’t approve Covishield without also comparing its data with data from the Vaxzevria trials and finding its safety and efficacy to be favourable.
In addition, Serum Institute’s bridging trial in India for Covishield administered Vaxzevria to a sub-group of 100 participants (out of 1,600) to compare the safety and immunogenicity of the two vaccines (made at different sources).
The EU member-states’ political agendas may explain why the ‘Green Pass’ programme excludes Covishield. However, the repercussions are not limited to each of these countries but are global. Covishield is a big part of India’s vaccination drive – 87% of all doses administered (as of 1 pm, June 29, 2021) – as well as of the COVAX initiative.
Despite criticism that the initiative has failed to live up to its potential, its continued operation is important for countries that haven’t been able to purchase enough doses of COVID-19 vaccines, even as they need to be vaccinated pronto to bring an end to the pandemic. Many of these countries are in Africa. And although many companies have announced plans to set up vaccine-manufacturing units on the continent, there is a big problem: competition from India.
After the EU’s ‘Green Pass’ announcement, the Africa CDC, of the African Union, published a statement on June 28 expressing “concerns” over the initiative’s approval for Vaxzevria but not Covishield. The body urged “the EU Commission to consider increasing mandatory access to those vaccines deemed suitable for global rollout through the … COVAX Facility.”
The EU provides a part of the monetary support for COVAX, so the exclusion of Covishield is tantamount from the EU’s point of view to shooting itself in the foot.