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EMA again states that benefits of AZ vaccine outweigh risks

Drug regulator concludes that unusual blood clots are very rare

Vaccine vial

The European Medicines Agency (EMA) has said that there is no definite causal link between the AstraZeneca (AZ)/Oxford vaccine and blood clots.

The EMA added that unusual blood clots were a very rare side effect of AZ’s COVID-19 vaccine and should be listed as such.

AstraZeneca has also said that no causal link with blood clots has been found in its studies.

The EMA looked at 86 cases of blood clots in the EU and again emphasised that the benefits of the AZ vaccine outweigh the risks.

Cases occurred in men as well as women, although most cases were in women younger than 60.

Over 20 million people have now been vaccinated in the EU.

The EMA said that the blood clots may be connected to an immune response “similar to one seen sometimes in patients treated with heparin". This immune response can lead to heparin-induced thrombocytopenia (HIT). HIT is an adverse reaction driven by the immune system to the blood thinning drug heparin, and can be dangerous.

EU health ministers will investigate these findings further.

Emer Cooke, EMA executive director, said at the press briefing yesterday that there was no available evidence of "specific risk factors such as age, gender, or previous medical history of clotting disorders" and that the combination of blood clots and low blood platelets was very rare but was seen in "all ages, and in men and women".

She went on to say that the safety committee has “confirmed that the benefits of the AstraZeneca vaccine in preventing COVID-19 overall outweigh the risks of side effects”.

Cooke added that the vaccine is highly effective, “prevents severe disease and hospitalisation, and is saving lives".

However, some EU countries are recommending that the use of the AZ vaccine should be restricted to older age groups.

Germany has said that people under the age of 60 who are due to have a second AZ vaccine should be given a different vaccine, even though studies on the effectiveness of using different vaccines for the first and second jabs are still ongoing. Other EU countries like France, Finland and Norway may look at making similar moves.

Article by
Iona Everson

8th April 2021

From: Research, Regulatory

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