EMA: Causal link of incidents with AstraZeneca’s vaccine not proven, but possible

EU drugs regulator’s safety committee will issue an updated recommendation next week

Photo: EU Emer Cooke.

EMA’s safety committee (PRAC) met Wednesday in the context of its ongoing review of very rare cases of unusual blood clots associated with low numbers of platelets, in people vaccinated with AstraZeneca’s COVID-19 vaccine. Last week several countries, including Germany and France again limited use of the jab to certain populations due to new cases reported. 

EMA convened an ad hoc expert group meeting last Monday to provide further input into the ongoing assessment. Independent external experts with a range of medical specialities, including haematologists, neurologists and epidemiologists, discussed specific aspects such as possible mechanisms, whether underlying risk factors could be identified and what additional data are needed to further characterise the observed events and the potential risk. The outcome of this meeting will be discussed by the PRAC and feed into its ongoing evaluation.

Emer Cooke, Executive Director of the European Medicines Agency (EMA), specified at a news conference on Wednesday afternoon, that at present the review of 62 cases has not identified any specific risk factors, such as age, gender or a previous medical history of clotting disorders, for these very rare events.

A causal link with the vaccine is not proven, but is possible and further analysis is still ongoing, Emer Cooke said adding that “according to the current scientific knowledge there is no evidence that will support restricting the use of this vaccine in any population”.

As it was already said on18 March, EMA is of the view that the benefits of the AstraZeneca vaccine in preventing COVID-19, with its associated risk of hospitalisation and death, outweigh the risks of side effects.

More information and advice for healthcare professionals and the public is available in the vaccine’s product information and the associated direct healthcare professional communication. Vaccinated people should be aware of the remote possibility of these very rare types of blood clots occurring. If they have symptoms suggestive of clotting problems as described in the product information, they should seek immediate medical attention and inform healthcare professionals of their recent vaccination.

EMA continues to work with the national authorities in the EU Member States to ensure that suspected cases of unusual blood clots are reported; these cases are being analysed in PRAC’s ongoing assessment.

Based on all the currently available data, PRAC is expected to issue an updated recommendation during its April plenary meeting on 6–9 April.

 

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