The EU is facing questions from India and Africa after it emerged that a version of the AstraZeneca vaccine offered to developing countries may not allow travellers to enter Europe.
Millions of doses of the vaccine, made and marketed in India under the name Covishield, have been exported around the world under the Covax scheme.
But the doses made by the Serum Institute of India are not automatically valid in Europe because they are not produced at one of the EU’s approved manufacturing sites.
The European Medicines Agency, which approved the Oxford-AstraZeneca vaccine in January, said it would need a separate application to authorise Covishield.
It means that EU members, which are expected to admit travellers who have had two doses of an approved vaccine, do not have to accept Covishield.
Adar Poonawalla, chief executive of the Serum Institute, said many Indians were facing issues with travel to the EU.
“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,” he said.
The African Union said the rules “put at risk the equitable treatment” of people who were vaccinated through the Covax scheme.
The EU is a leading donor to Covax, which aims to vaccinate at least 20 per cent of every country’s population by the end of this year.
“Persons who received Covishield, despite being able to demonstrate proof of vaccination, would continue to be subject to public health restrictions,” the African Union said.
“These developments are concerning given that the Covishield vaccine has been the backbone of the EU-supported Covax contributions.”
Covishield was listed for emergency use by the World Health Organisation in February.
The WHO said it had a “tremendous potential to prevent infections and reduce deaths across the world”.
But the EMA said it could only endorse a vaccine if the manufacturing site sought approval from EU inspectors.
“Even tiny differences in the manufacturing conditions can result in differences in the final product,” the agency said.
The list of approved sites for AstraZeneca vaccines includes factories in the UK, Belgium and the Netherlands.
EU nations decide
Asked if developing countries were being treated unfairly, European Commission spokesman Adalbert Jahnz said EU members were free to accept Covishield vaccines should they choose to.
“They explicitly have the option to do so for people who have been vaccinated with a vaccine that received the WHO emergency authorisation,” he said.
Health ministries in Italy and Denmark are among those insisting on vaccines approved by the EMA.
The agency has approved the Pfizer-BioNTech, Moderna and Johnson & Johnson vaccines as well as the selected AstraZeneca shots.
Germany's Health Ministry told The National it would not distinguish between Covishield and other AstraZeneca shots.
However, India is regarded as a high-risk destination because of the spread of the Delta variant and travel to Germany is heavily restricted.
In addition to Covishield, countries can choose to accept other vaccines such as Russia’s Sputnik V.
Doses of Covishield will make up about 550 million of the vaccines made available to Covax in 2021.
They account for 88 per cent of the doses handed out so far in India, which is the world’s largest manufacturer of vaccines.
Another Indian-made vaccine, Covaxin, has yet to be approved by the WHO.
Wealthy countries are under pressure to address an imbalance in vaccination rates between the developed world and poorer nations.
Critics say the Covax scheme faces a shortfall in donations and will not be enough to take developing countries to herd immunity.
The EU last month unveiled separate plans to donate 100 million doses directly to poorer countries by the end of the year.