Countries are changing their recommendations for who should receive the AstraZeneca coronavirus jab after the EMA confirmed a "possible link" between the vaccine and a rare form of blood clot.
A number of EU countries and the UK have changed their plan for the rollout of the AstraZeneca coronavirus vaccine, despite calls from EU chiefs to “speak with one voice” to maintain trust in vaccinations.
The changes swiftly followed confirmation from the European Medicines Agency (EMA) that there was a “possible link” between the jab and a rare form of blood clot.
The reported cases of unusual blood clots were mostly observed in women under the age of 60, but the EMA committee did not conclude that age and gender were clear risk factors.
The agency maintained that the benefits of the vaccine outweigh the risks of side effects.
In a statement, AstraZeneca said both UK and EU regulators had requested their vaccine labels be updated to warn of these “extremely rare potential side effect(s).”
“Both of these reviews reaffirmed the vaccine offers a high-level of protection against all severities of COVID-19 and that these benefits continue to far outweigh the risks,” it said.
The EU’s health commissioner Stella Kyriakides called on the EU to “speak with one voice” to improve trust in vaccines.
But following the EMA’s announcement on Wednesday, member states and the UK were quick to react unilaterally.
After the EMA announcement, Italy on Wednesday said it was reserving the use of AstraZeneca's vaccine for people over 60.
It has been decided "to recommend the use in preference to people over 60," Italian government scientific adviser Franco Locatelli told a news conference hours after the EMA proposed listing the risk of blood clots as a rare side effect of the Anglo-Swedish jab.
France's health authority has recommended reserving the vaccine for people aged 55 and over.
The French health authority (HAS) gave the green light for AstraZeneca to resume vaccination "without delay" but has still urged caution.
Belgium also decided on Wednesday to restrict the use of the AstraZeneca vaccine to people over 55.
"On the basis of recent scientific advice, the Belgian health ministers have decided to replace (the AstraZeneca vaccine) with other vaccines for people aged between 18 and 55; for people aged 56 and over, all vaccines will continue to be administered," said a statement from the health authorities.
This measure will be re-evaluated in four weeks' time, according to the press release from the inter-ministerial conference on public health.
This decision is based on the opinions of the Higher Health Council and the country's "Vaccination Task Force", as well as on the conclusions presented on Wednesday by the EMA.
Authorities in the UK recommended on Wednesday, following the EMA statement, that the AstraZeneca jab not be given to adults under 30 where possible.
The UK’s regulator maintained, like EMA, that the benefits of continuing to administer the vaccine outweighed the risk.
However it recommended that those under the age of 30 should be offered a different vaccine.
“We are not advising a stop to any vaccination for any individual in any age group,” said Wei Shen Lim, who chairs Britain’s Joint Committee on Vaccination and Immunisation.
“We are advising a preference for one vaccine over another vaccine for a particular age group ... out of the utmost caution rather than because we have any serious safety concerns.”
France and Germany had already decided to stop giving the vaccine to people under a certain age, while the Castilla y León region in northwest Spain has suspended its use altogether, as has Denmark and Norway.
The AstraZeneca vaccine is cheaper and easier to store than many others, and is critical to global immunisation campaigns such as the COVAX scheme that aims to get vaccines to some of the world’s poorest countries.