Janssen vaccine also under EMA scrutiny for four blood clots
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Janssen vaccine also under EMA scrutiny for four blood clots

Janssen Pharmaceutica, based in Beerse east of Antwerp. © Belga

Janssen’s (Johnson & Johnson) Covid-19 vaccine is under scrutiny from the European Medicines Agency (EMA) for thromboembolic cases reported after its administration, the agency announced Friday.

Four serious cases of unusual blood clots associated with low blood platelet levels have been reported. One occurred during a clinical trial and three during vaccination in the US.

One of these cases was fatal.

Currently, the Janssen vaccine is only used in the US under a provisional licence. It was approved for use in the European Union on 11 March, but its roll-out has not yet begun.

Janssen is particularly eagerly awaited by authorities in the coming weeks because it only requires a single dose.

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The current review does not suggest a causal link between the vaccine and the observed thromboembolic cases, the EMA notes. Its Pharmacovigilance Risk Assessment Committee (PRAC) is continuing its reviews and will have to decide whether any restrictions are necessary, including an update of the product information.

In the case of the AstraZeneca vaccine, the EMA on Wednesday acknowledged a link between the administration of the vaccine and very rare cases of unusual blood clots associated with low blood platelets, now listed as “very rare side effects.”

Pending further information from the Agency, Belgium has suspended the administration of AZ for the next four weeks for people under 56 years of age.

The Brussels Times