Why some fully vaccinated Aussies could be locked out of visiting Europe when Australia’s borders finally reopen to the world
- Some EU countries could remain off limits when Australia’s borders reopen
- AstraZeneca yet to register its CSL facility in Melbourne with EMA regulator
- EU´s Covid-19 certificate only recognises AstraZeneca manufactured in Europe
- AstraZeneca says it’s working to get more production sites approved by the EMA
Some of Europe’s most popular tourist destinations could remain off-limits to vaccinated Australians when international borders finally reopen.
Australians who roll up their sleeves for the AstraZeneca coronavirus jab may be banned from visiting countries such as Italy, Croatia, France, and Malta, thanks to a red tape in the European Union’s vaccine approval process.
European Medicines Agency confirmed AstraZeneca is yet to register CSL’s Melbourne facility with the drugs regulator, despite the lab producing millions of doses that are also approved for WHO emergency use.
The pharmaceutical giant is also yet to register its lab in India, throwing the travel plans of at least five million Britons and millions more worldwide vaccinated with the Indian-made doses of the vaccine into chaos.
The European Union´s Covid-19 certificate allowing residents from the 27-nation bloc to freely travel only recognises AstraZeneca vaccines manufactured in Europe, which could be hurdle for Australians who received the jab produced locally.
Australians who get the AstraZeneca jab may not be able to travel to some EU countries such as Italy once our borders finally reopen. Pictured is Venice
The EMA said AstraZeneca needs to apply for a ‘variation’ to the vaccine’s marketing authorisation to register its Australia site.
‘A variation application includes information on the new site supported by various test results confirming the quality of the vaccine manufactured at the new site and comparing it to the currently authorised vaccine,’ it told 9 News.
AstraZeneca said it was working hard to get more production sites approved by the EMA but wouldn’t say whether registering the Australian lab was part of those plans.
‘It should be noted that all AstraZeneca Covid-19 vaccine doses meet the same rigorous quality standards no matter where they are made as each batch passes over 60 quality tests as part of our robust quality assurance process,’ it said.
European Medicines Agency confirmed AstraZeneca is yet to register CSL’s Melbourne facility with the drugs regulator, despite the lab producing millions of doses that are also approved for WHO emergency use
Croatia (pictured) is among the EU countries who only allow travellers vaccinated with jabs approved by the EMA
The EU’s Covid-19 certificate, which came into effect this month, allows residents to move freely around the 27-nation bloc.
Travellers must show they have been vaccinated with one of the four jabs approved by the EMA, have a recent negative test, or provide proof they have recovered from the virus.
Some EU countries accept AstraZeneca’s Indian version notably used in the UK and around Africa, but others such Croatia and Italy don’t, which caused headaches across the continent during the summer.
France has since allowed international travellers who have had AstraZeneca’s Indian-manufactured coronavirus vaccine to enter.
From Sunday, unvaccinated travellers to enter France from Britain, Spain, Portugal, the Netherlands, Greece, or Cyprus must present a negative test from the past 24 hours.
Australia has administrated 9,970,746 doses as of Friday.
AstraZeneca is yet to register its Australian CSL vaccine manufacturing facility with the European Medicines Agency. Pictured is Prime Minister Scott Morrison visiting the Melbourne facility