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European Medicines Agency to rule ‘next week’ on use of Janssen vaccine

Publication: Wednesday April 14, 2021 4:40 PM

The European Medicines Agency (EMA) has assured that it intends to issue a recommendation on Janssen “next week” and stressed that although its investigation into unusual cases of blood clotting is still ongoing, it “maintains the ‘opinion’ that the benefits of the vaccine outweigh its risks.

The European regulator “accelerated” its assessment of the six cases of rare thromboembolism recorded after vaccination with Janssen in the United States, an investigation that the EMA’s safety committee (PRAC) began last week, before US health authorities do not recommend temporarily stopping the use of this vaccine.

The EMA, which will decide next week “if regulatory action is necessary” in relation to the use of this vaccine in the European Union, recalls that the United States has administered more than 6.8 million doses of Janssen . The cases studied by the PRAC, the committee responsible for assessing safety concerns for medicines for human use, involve six people who received the Janssen vaccine and developed symptoms of cerebral venous thrombus (CVST, between six and thirteen days later). ). In association with low levels of blood platelets (thrombocytopenia).

The Centers for Disease Control and Prevention of the United States (CDC) and the Administration of Drugs and Food (FDA) yesterday recommended that the use of Janssen be suspended until these six cases of a type of blood clot are studied “rare and serious” and to determine if there is a causal link with the preparation against the covid-19 developed by the subsidiary of the American pharmaceutical company Johnson & Johnson.

The EMA added that Janssen had previously announced that it was proactively delaying delivery of doses to the EU while continuing investigations by the PRAC, which “works closely with the US FDA and other international regulators.” , before making the “recommendations necessary to minimize risks and protect people’s health”.

The most common side effects of Janssen vaccine are usually mild or moderate and get better a day or two later. “

“The vaccine was authorized in the EU on March 11, 2021, but its widespread use in the EU has not yet started. The company is in contact with national authorities, recommending that doses already received be kept until ‘that the PRAC issues an accelerated recommendation, “the agency said.

The European regulator recalls that its scientific opinions “provide EU member states with the information they need to make decisions on the use of vaccines in their national vaccination campaigns” and notes that the most common side effects of Janssen vaccine tend to be “mild or moderate, and get better a day or two after injection.

This research takes place in the context of what is known as a ‘safety signal’, information about a new or undocumented adverse event, which could be caused by a drug, but this signal ‘does not necessarily mean that’ a drug caused the adverse event ”and the evaluation seeks to determine if there is a cause and effect relationship.

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