Europe’s medicine regulator has confirmed that “unusual blood clots” should be listed as a “very rare” side-effect of the AstraZeneca jab.
The announcement by the European Medicines Agency (EMA) came as the UK’s regulator indicated that people under 30 would be advised to take the Pfizer or Moderna vaccine instead.
“EMA’s safety committee has concluded today that unusual blood clots with low blood platelets should be listed as very rare side effect,” the EMA said in a statement ahead of a press conference on AstraZeneca’s COVID-19 vaccine.
But it stressed that the benefits of the jab developed by the British-Swedish drugmaker and Oxford University continued to outweigh the risks.
While countries including Canada and Germany have restricted rollout of the vaccine to older populations, the EU’s drug regulator said on Wednesday that no specific risk factors such as age had been identified for blood clots.
“Specific risk factors such as age, gender or medical history have not been able to be confirmed, as the rare events are seen in all ages,” EMA chief Emer Cooke told a news conference.
She said that one “plausible explanation for these rare side effects is an immune response to the vaccine.”
The EMA said that so far, most of the cases reported have occurred in women under 60. It advised healthcare professionals to remain aware of the possibility of very rare cases of blood clots, as well as low levels of blood platelets, occurring within two weeks of vaccination.
COVID-19 continues to cause thousands of deaths in Europe alone and the AstraZeneca vaccine is highly effective.
However, concerns over very rare cases of patients suffering blood clots after receiving the vaccine has seen several countries including Italy suspend their rollout of the jab.
Canada last week suspended its use of the vaccine in people aged under 55 and Germany restricted use to the over-60s.
European Union health ministers have been told that the announcement would have an “immediate impact on vaccination plans” and “vaccine confidence”, according to an EU document seen by Reuters news agency.
Italy in particular has already seen an increase in vaccine hesitancy following the questions around the AstraZeneca jab.
More to come