Why might some fully vaccinated Aussies be banned from Europe when Australia’s borders finally reopen to the world?
- Some EU countries may remain off-limits when Australia’s borders reopen
- AstraZeneca has yet to register its Melbourne CSL facility with the EMA regulator
- The EU’s Covid-19 certificate only recognizes AstraZeneca manufactured in Europe
- AstraZeneca says it is working to get more production sites approved by the EMA
Some of Europe’s most popular tourist destinations may remain off limits to vaccinated Australians when international borders finally reopen.
Australians who roll up their sleeves for the AstraZeneca coronavirus shot could potentially be banned from visiting countries like Italy, Croatia, France and Malta, thanks to a red tape in the European Union’s vaccine approval process.
The European Medicines Agency has confirmed that AstraZeneca has yet to register CSL’s Melbourne facility with the drug regulatory agency, despite the lab producing millions of doses that are also approved for emergency use by the WHO.
The pharmaceutical giant has 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, which allows residents of the 27-nation bloc to travel freely, only recognizes AstraZeneca vaccines manufactured in Europe, which could pose a hurdle for Australians who received the locally produced jab.
Australians receiving the AstraZeneca shot 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 must apply for a ‘variation’ to the vaccine’s marketing authorization in order to register its Australian site.
“An application for a variation contains information about the new site, supported by several test results confirming the quality of the vaccine produced at the new site and comparing it to the currently approved vaccine,” it said. 9 News.
AstraZeneca said it was working hard to get more manufacturing sites approved by the EMA, but declined to 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 exacting quality standards regardless of where they are made, as each batch passes more than 60 quality tests as part of our robust quality assurance process,” it said.
European Medicines Agency has confirmed that AstraZeneca has yet to register CSL’s Melbourne facility with the drug regulatory agency, despite the lab producing millions of doses that are also approved for emergency use by the WHO
Croatia (pictured) is one of the EU countries that only allows travelers who have been vaccinated with shots approved by the EMA
The EU’s Covid-19 certificate, which came into effect this month, allows residents to move freely through the bloc of 27 countries.
Travelers must show that they have been vaccinated with one of the four EMA-approved shots, have a recent negative test or prove that they have recovered from the virus.
Some EU countries accept the Indian version of AstraZeneca, mainly used in the UK and around Africa, but others, such as Croatia and Italy, do not, causing headaches across the continent in the summer.
France has since allowed international travelers who have had AstraZeneca’s Indian-made coronavirus vaccine.
As of Sunday, unvaccinated travelers entering France from Britain, Spain, Portugal, the Netherlands, Greece or Cyprus must present a negative test from the past 24 hours.
Australia has administered 9,970,746 doses since Friday.
AstraZeneca has yet to register its Australian CSL vaccine manufacturing facility with the European Medicines Agency. Pictured is Prime Minister Scott Morrison visiting the Melbourne facility