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Covid-19: the European Medicines Agency investigates cases of thrombosis with the Janssen vaccine

2021-04-09T12:49:31.690Z


"Four severe cases of unusual blood clots" have been reported after vaccination with Janssen laboratory serum, announces this


An investigation must determine, as in the case of AstraZeneca, whether a link can be made between the vaccine and these serious side effects.

Rare cases of thrombosis, that is to say the formation of blood clots in the veins, have been detected in people who have been vaccinated against Covid-19 with the Janssen vaccine from the Johnson & Johnson laboratory, announced this Friday l European Medicines Agency (EMA).

Its pharmacovigilance risk assessment committee (PRAC) "investigates thromboembolic events after vaccination with the Covid-19 vaccine from Janssen," the agency said on its website.

However, she is cautious: “It has not yet been determined that there is a causal link between the vaccination with the Janssen vaccine and these facts.

"

A fatal case

She specifies that "four severe cases of unusual blood clots, with low blood platelet count, have been reported after vaccination."

One of them occurred during a clinical trial and the other three, during the vaccination campaign in the United States.

"One of them was fatal," said the EMA, which assures us that it will communicate in more detail "once the evaluation is complete".

For now the PRAC is continuing its investigations and "will decide whether regulatory action may be necessary".

The latter, specifies the EMA, "generally consists of an update of the information on the product".

To date, the Janssen vaccine is only used in the United States, with an emergency use authorization, but it was authorized by the European Union on March 11, as well as by the High Authority of Health, in France.

He will therefore soon have to join the list of three vaccines against the coronavirus already used in France.

Source: leparis

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