Is the AstraZeneca vaccine safe? EMA makes major ruling on AstraZeneca jab

AstraZeneca: Blood clots are an 'unusual side effect'

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The European Medicines Agency (EMA) has made a major ruling on Wednesday about the efficacy and safety of the jab. Regulators both in the UK (MHRA) and Europe have been carrying out a review into reports that a small number of recently-vaccinated patients suffered an extremely rare form of blood clot called a cerebral sinus vein thrombosis (CSVT). In the UK, 30 people have developed the clots, with seven of those having died as a result of the rare event. This number is out of 18million people who have received the vaccine. As a result of CSVT cases recorded in the country, Germany has suspended the use of the AstraZeneca vaccine in people under 60.

Is the AstraZeneca vaccine safe?

A review by the EMA’s safety committee concluded on Wednesday that “unusual blood clots with low blood platelets should be listed as very rare side effects” of the AstraZeneca vaccine.

However, the EMA also insisted the benefits of the vaccine in protecting against COVID-19 far outweighs the risks associated with the jab.

Executive director of the medicines agency, Emer Cooke, said its review “confirmed that the benefits of the AstraZeneca vaccine in preventing COVID-19 overall outweighs the risk of side effects”.

Ms Cooke added: “Vaccination is extremely important in helping us in the fight against COVID-19.”

In terms of what’s causing the blood clots, the EMA said: “One plausible explanation for the combination of blood clots and low blood platelets is an immune response, leading to a condition similar to one seen sometimes in patients treated with heparin.”

The reports investigated by the EMA centred around CVST cases.

In the cases of concern, which appear to be more prevalent in women under the age of 60, the CVST has been combined with a condition called thrombocytopenia, in which a patient already presents abnormally low levels of platelets.

The EMA said clotting in the abdomen, called splanchnic vein thrombosis, has also been detected.

As of March 22, a total of 62 CVST and 24 cases of splanchnic vein thrombosis were identified among 25million recipients of the AstraZeneca vaccine.

Eighteen of these cases resulted in the patient dying after having the vaccine.

In the UK, the MHRA said there were still huge benefits of the vaccine in preventing COVID-19 and serious disease.

However, due to a very small number of blood clots detected in younger people, those under the age of 30 will receive the Pfizer/BioNTech or Moderna vaccine instead.

Up to March 31, the MHRA received 79 reports of blood clots accompanied by low platelet count, all in people who had their first dose.

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The MHRA concluded the balance of risk for the vaccine is “very favourable for older people”, but more finely balanced for younger groups.

Prime Minister Boris Johnson said the Government still believes the AstraZeneca vaccine is “safe”.

Mr Johnson told reporters on a visit to Cornwall: “But the crucial thing for everybody is to listen to what the scientists, the medical experts have to say later on today.”

On the vaccine programme, the Prime Minister added: “You can really start to see some of the benefits of that – it’s pretty clear that the decline in the number of deaths, the decline in the number of hospitalisations, is being fuelled, is being assisted.

“The steepness of that decline is being helped by the rollout of the vaccines, so it’s very important for everybody to continue to get your second jab when you’re asked to come forward for your turn.”

More than 20million doses of the AstraZeneca vaccine have now been administered in the UK.

The findings are undoubtedly a blow to AstraZeneca, which was a frontrunner in the race for making an effective vaccine against the virus ever since it partnered up with the University of Oxford.

The EMA’s safety committee has requested for more studies and alterations to the recent one in an effort to gather more information.

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