While approving the AstraZeneca’s other vaccine Vaxzevria, the European Medicines Agency has excluded Covishield from the list of approved vaccines for the 'Green Pass“. The move is highly discriminatory as there is no place for either nationalism or brand discrimination for the vaccines in the Covid-19 battle.
At a time when nations across the world are fighting out the Covid-19 pandemic, the move by the European Medicines Agency (EMA) to exclude the Covishield vaccine, manufactured by Serum Institute of India (SII) with licence from AstraZeneca, from the list of approved vaccines for the 'Green Pass' for travel to European Union countries has been termed “discriminatory” by scientists and experts in India.
Europe’s new ‘vaccine passport’ programme, which recognises a few vaccines whose recipients will be able to travel in and out of Europe with fewer roadblocks than others, includes the AstraZeneca vaccine, called Vaxzevria outside India but not India’s Covishield.
The Covid19 vaccine by Oxford University-AstraZeneca is produced mainly by three companies, SII, SK Biosciences in South Korea and AstraZeneca’s four manufacturing units. When the EMA recognises the other vaccine manufactured by AstraZeneca vaccine outside India, the EMA’s denial to include Covishield in the “green pass” category is highly discriminatory as there is no place for either nationalism or brand discrimination for the vaccines in the Covid-19 battle.
Indian scientists and medical experts have pointed out while the components, as well as the manufacturing process are exactly the same in the case of both Covishield and Vaxzevria and there is practically no difference between the two vaccines, the EMA’s decision is clearly unpalatable. The question why the same vaccine produced in two different countries is being treated differently without any plausible explanation paves the way for vaccine racism and demands greater scrutiny.
What is the “Green Pass”?
“Green Pass” is the unofficial name for EU’s Digital Covid Certificate that is to be issued in all its 27 member countries from July 1 to “facilitate safe free movement of citizens in the EU during the Covid-19 pandemic. Only those inoculated with EMA-recognised vaccines will be able to claim this "digital passport”. The certificate essentially details a traveller’s Covid-19 status. It is a “digital proof" that a person has either been vaccinated, tested negative within a stipulated timeframe, or recovered from a bout of Covid-19.
By the third week of June close to 20 EU countries had started issuing vaccine passports for restriction-free travel. As it becomes available in all EU countries from July 1, travellers will have to check the regulations for their destination country to see which vaccine is being accepted for a vaccine passport.
Both Germany and France only considers EMA-approved vaccines. And since none of the vaccines approved for use in India – Covaxin, Covishield and Sputnik V – have the EMA’s approval, even vaccinated Indians will be considered to be “unvaccinated”. In fact, with the ‘Green Pass’ programme, scheduled to launch from July 1, this will be the case in all European Union nations.
The European Medicines Agency (EMA) clarified the exclusion of Serum Institute of India (SII) manufactured Covishield from the list of approved vaccines for the 'Green Pass', stating that the vaccine does not currently have a marketing authorisation in the European Union (EU). The EMA said tiny differences in manufacturing conditions can result in differences in the final product. "This is because vaccines are biological products," it said.
The EU law requires the manufacturing sites and production process to be assessed. This is mandatory for clearance. "The only Covid-19 vaccine from AstraZeneca for which a marketing authorisation application was submitted to and evaluated by EMA, leading to its authorisation in the EU, is Vaxzevria (previously COVID-19 Vaccine AstraZeneca)," the EMA said.
So far, EMA has permitted Green Pass for four vaccines -- Comirnaty (Pfizer), Covid-19 Vaccine Janssen, Spikevax (previously Covid-19 Vaccine Moderna), and AstraZeneca's Vaxzevria. However, Serum Institute, which makes Covishield in India with a license from AstraZeneca, didn’t apply to have the vaccine approved by the European Medicines Agency (EMA).
The EMA regulates drugs and medical products in European nations. The nations’ ‘vaccine passport’ programme, formally called the ‘Green Pass’, has approved only four vaccines - Vaxzevria (Oxford-AstraZeneca), Comirnaty (Pfizer-BioNTech), Spikevax (Moderna) and Janssen-Johnson & Johnson. WHO has given an emergency nod to eight COVID-19 vaccines so far, including AstraZeneca’s Vaxzevria and the corresponding ‘versions’ of Serum Institute and S.K. Biosciences.
Covishield is an important part of the international COVAX alliance. Vaccines in this initiative need to have the WHO’s approval. On the other hand, the ‘Green Pass’ initiative is based on the EMA’s approval. India’s other major COVID-19 vaccine, Covaxin, has been approved neither by the WHO nor the EMA.
How the exclusion will impact Indians
It is estimated that in 2019, 1.8 million Indians visited central/eastern Europe and 1.1 The European Commission says 16 countries (out of 27) have begun using the EU's Digital COVID Certificate (EUDCC) to enable international travellers to easily travel across the bloc. Indians who got Covishield will be considered unvaccinated and could be barred from getting travel visas by many EU member countries. Nearly three million Indians are expected to travel to European countries and require the Green Pass, from July 1 to ensure hassle free travel.
Accordingly Indians who got Covishield will be considered unvaccinated and could be barred from getting travel visas by many EU member countries. The rules imply that Indians or other nationals who have been vaccinated with Covishield will not be eligible for restriction-free travel within European countries. They will hence be subject to strict rules concerning quarantine and testing as enforced by each country they travel to. However, EU member states are free to amend the rules to allow entry to travellers vaccinated with other jabs. Though EU has made it clear that the “green pass” will not be compulsory, but the ‘vaccine passport’ issue has given rise to larger concerns over intrusion, privacy and a curb on the right to free movement.
Adar Poonawala, CEO, Serum Institute of India, said, "I realise 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" . Indian government has taken up the issue of approval of the Serum Institute of India’s Covishield vaccine by the European Medicines Agency (EMA) with the European Union. At the recent meeting of G7 countries, Union Health Minister Harsh Vardhan said that India was “strongly opposed to a ‘vaccine passport’ at this juncture”. “Expressed India’s concern & strong opposition to ‘Vaccine Passport’ at this juncture of the pandemic. With vaccine coverage as a % of population in developing countries still low compared to developed countries, such an initiative could prove to be highly discriminatory,” he later tweeted.