Up to five million Britons face being locked out of European holidays because their vaccines are not recognised by the EU's passport scheme, the Telegraph has learned.
Millions of vaccines administered here do not qualify for the European Union’s vaccine passport scheme, because the shots were manufactured in India and are not yet authorised by the European Medicines Agency (EMA)
The hitch could leave thousands of Britons turned away at EU border crossings when the batch numbers on their vaccines are checked digitally.
The EU Digital Covid Certificate, which launched on Thursday, is designed to allow Covid-secure travel across the continent but does not recognise a version of the AstraZeneca vaccine called Covishield, produced by the Serum Institute of India (SII), because it is yet to receive approval in Europe.
Up to five million doses of this version of the vaccine have been administered in the UK and are identifiable by the vaccine batch numbers (4120Z001, 4120Z002, 4120Z003) included on recipients’ vaccine cards and in the Covid travel pass available via the NHS app.
The EU ruling has already sparked outrage in Asia and Africa, where the Indian manufactured shot – which forms the backbone of the Covax distribution scheme – has been widely used. Now, some British holiday makers may find themselves similarly excluded.
The Telegraph has traced three Britons affected, none of whom were told in advance they were to receive the Indian version of the AstraZeneca vaccine. All received their shots of the SII vaccine in March.
“Quite frankly [I feel] discriminated against, for lack of a better word,” said 21-year-old Hannah Smith, who found that her first dose of the AstraZeneca vaccine was produced in India when she checked the batch numbers. She added that, until the situation was clarified, she would jettison plans for a European holiday and “settle for Scotland”.
Another individual, whose first shot was also produced in India but who asked not to be identified, added: “That vaccine passports would be a thing is entirely predictable, so our Government should have made sure any they purchased would be recognised for travel everywhere.”
The EU Digital Covid Certificate allows those who are fully vaccinated, recently tested or recovered from Covid-19 to move across borders within the EU without having to quarantine or undergo extra coronavirus tests upon arrival.
But only vaccines approved by the EMA are included, though individual member states are free to accept other vaccines if they choose.
The EMA approved vaccines are Pfizer-BioNTech, Moderna, Johnson & Johnson, and the version of the Oxford-AstraZeneca vaccine manufactured in the UK or Europe, which is sold under the brand name Vaxzevria.
“Entry into the EU should be allowed to people fully vaccinated with one of the vaccines authorised in the EU,” a spokesperson from the European Commission said. “Member States are… not required to issue certificates for a vaccine that is not authorised on their territory.”
The UK authorities have used the brand name Vaxzevria on all UK medical records where the AstraZeneca vaccine has been used, but up to five million doses are actually the Indian-made Covishield version. The doses remain identifiable by their batch numbers.
“For these purposes, the batch numbers; 4120Z001, 4120Z002, 4120Z003 of the SIIPL COVID‑19 Vaccine (ChAdOx1‑S [recombinant]) manufactured by Serum Institute India… were assessed and are treated as Covid-19 Vaccine AstraZeneca,” says an amendment made to the agreement between AstraZeneca and the UK regulator, the Medicines and Healthcare products Regulatory Authority (MHRA), on 23 February.
The EU vaccine passport will soon integrate with the Covid travel pass on the NHS app. By scanning a QR code, the EU system pulls up information including the traveller's name, date of birth and vaccine details, including batch numbers.
“The authorisation via the centralised procedure provides the confidence that all member states can rely on the data on efficacy and safety and on the consistency of the batches being used for vaccination,” says the relevant EU legislation.
The Department of Health refused to say this week how many of the Indian manufactured shots had been administered in the UK, citing commercial sensitivities. However it was widely reported that five million doses from the SII were imported from India earlier this year.
“As we continue to cautiously reopen international travel, NHS Covid Pass will be a key service that allows people to demonstrate their Covid-19 vaccination status,” a spokesman for the Department of Health said.
He added that all AstraZeneca doses used in the UK appeared under the name Vaxzevria in medical records and on the NHS app, even if they had come from India. Only the batch numbers, also included in the NHS Covid pass, identify them.
“All AstraZeneca vaccines given in the UK are the same product and appear on the NHS Covid Pass as Vaxzevria,” said the spokesman.
A travel industry specialist noted many EU countries allowed entry without proof of vaccine status as long as travellers had taken a PCR test within 72 hours of arrival and the result was negative.
There is no suggestion that the Indian manufactured doses are in any way substandard. The EMA has not authorised the vaccine only because the Indian manufacturers have not yet sought a licence for the product in Europe, as the SII intend to predominantly supply low and middle income countries.
British travellers face a similar issue in the United States where no version of the AstraZeneca shot has yet been licensed.
For example, vaccine certificates were a requirement for entry to a Bruce Springsteen show on Broadway in New York last month – but only shots approved by the US Food and Drug Administration (FDA) were accepted.
The EU’s failure to recognise the Indian manufactured Covishield has been met with widespread anger in Asia and Africa, with some accusing it of a “colonial” mindset.
They point out that the shot has been authorised by the World Health Organization (WHO), while the SII is one of the world’s largest vaccine manufacturers.
“It is outrageous,” Dr Ayoade Alakija, co-chair of the Africa Union Vaccine Delivery Alliance, told The Telegraph. “I’ve no doubt it will eventually be rectified but it speaks to the non inclusive nature of the entire scheme… how do you exclude the majority of the world’s population from Europe on the basis of where their vaccine was manufactured?”
She added that the move reinforces the view that poorer countries are getting a “worse” vaccine. Across much of Africa, in particular, hesitancy has risen since rollout began – especially after western countries temporarily suspended use of the AstraZeneca vaccine amid concerns of very rare blood clots.
“What the world is saying to us with actions like this is: we have superior vaccines that provide better protection, because essentially your lives and health status don’t matter as much as ours,” Dr Alakija said. “That’s the message it sends... a two-tier vaccine system for a two-tier world.”
For Britons looking for “green” countries to travel to, the vaccine passport issue is currently only a theoretical problem as there are so few European countries on the list.
However, it is legal to travel to “amber” rated countries, including favourites including France, Spain and Portugal, and many UK citizens had hoped vaccine passports would make things easier.
An analysis by former BA strategy chief Robert Boyle suggests that more than 20 amber countries including France, Italy and Austria are on track to join the UK’s green list and open to British holidaymakers this month.
The 22 nations – primarily in Europe – all meet the threshold for inclusion on the Government’s quarantine-free green list, according to the analysis. All have infection rates below 20 cases per 100,000 of the population, far lower than current rates in Britain.
In India, both the foreign minister and the chief executive of the SII said they had raised the vaccine passport issue with the EU, while the organisations behind Covax have urged Europe to accept all WHO-approved shots.
On Friday, the Prime Minister Boris Johnson will meet German Chancellor Angela Merkel at Downing Street, where travel and vaccines are understood to be on the agenda.
Experts say the issue is only likely to be resolved if and when the EMA formally authorises the Indian-made version of the AstraZeneca jab in Europe.
