BLOOD clots should be listed as a ‘very rare’ possible side effect of the AstraZeneca vaccine, said the the European Medicinces Agency (EMA) today.
The group said it had found a possible link between the vaccine and unusual clots with low blood platelets but added that the benefits continue to be ‘much greater’ than the risks.
Head of the EMA Emer Cooke said: “This vaccine has proven to be highly effective, it prevents severe disease and hospitalisation and it is saving lives.
“Prac, after a very in-depth analysis, has concluded that the reported cases of unusual blood clotting following vaccination of the AstraZeneca vaccine should be listed as possible side effects of the vaccine.”
At its briefing the European Medicines Agency (EMA) says it has found a ‘possible link’ between the AstraZeneca coronavirus vaccine and blood clots but said that the benefits of the shot still outweigh risks. They added that ‘specific risk factors’, such as age or gender, had not been confirmed.
Cooke told a Brussels press briefing: “Based on the current available evidence, specific risk factors, such as age, gender or previous medical history of clotting disorders, have not been able to be confirmed, as the rare events are seen in all ages, and in men and women.
“A plausible explanation for these rare side events is an immune response to the vaccine, leading to a condition similar to one seen sometimes in patients treated with heparin.”
A review by the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK today similarly concluded that the benefits of the jab still outweigh the risks for most people.
Dr June Raine, MHRA chief executive, said the risks associated with the AstraZeneca jab are “more finely balanced” for younger people than their elders. She stressed that the blood clots had occurred in an “extremely small” number of vaccinated people.
They also revealed that under 30s in the UK will now be offered Pfizer or Moderna vaccine instead of Astrazeneca due to extremely rare blood clots linked to the vaccine.
The blood clot probes had prompted concerns for the vaccine rollout in the UK, with ministers worried that news from Europe could dissuade younger people from getting the Oxford jab.
Tens of millions of people have now received at least one dose worldwide, and the EMA, MHRA, World Health Organisation and other health authorities have repeatedly stressed that it is safe and effective.
Rare blood clots have been associated with the deaths of seven vaccinated people in Britain and at least 14 across Europe.
The UK’s cases come from more than 20 million jabs, meaning that there is less than one death per million administered.
There is currently a 1 in 250,000 chance of blot clots with the AstraZeneca vaccine, while around one in four coronavirus patients admitted to ICU will develop a pulmonary embolism.
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