The European Medicines Agency (EMA) said on Wednesday that it expects to issue a recommendation on Janssen “next week” and stressed that, although his investigation of unusual cases of blood clotting is ongoing, he “maintains the view” that the benefits of the vaccine outweigh its risks.
The European regulator “has accelerated” its evaluation of the six cases of rare thromboembolism registered after vaccination with Janssen in the United States, an investigation that began last week, before the US health authorities recommended temporarily suspending the use of this vaccine.
The EMA, which will decide next week “if regulatory action is necessary” Regarding the use of this vaccine in the European Union (EU), remember that the United States has administered more than 6.8 million doses of Janssen.
The cases being investigated by the PRAC, the committee responsible for evaluating the safety problems of medicines for human use, affect six people who received the Janssen vaccine and developed symptoms of venous brain thrombi between six and thirteen days later (CVST), in combination with low levels of blood platelets (thrombocytopenia).
The United States Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) have recommended yesterday that the use of Janssen be suspended until these six cases of a “rare and serious” type of blood clot are investigated and to determine if there is a causal relationship with the preparation against covid-19 developed by the pharmaceutical subsidiary American Johnson & Johnson.
The EMA added that Janssen has already announced that it is proactively delaying the delivery of doses to the EU while the PRAC investigations continue, which “It is working closely with the US FDA and other international regulators.”, before making the “necessary recommendations to minimize risks and protect people’s health.”
“The vaccine was licensed in the EU on March 11, 2021, but its widespread use within the EU has yet to begin. The company is in contact with the national authorities, recommending storing the doses already received until the PRAC issues an expedited recommendation, “the agency underlines.
The European regulator recalls that its scientific opinions “provide EU member states with the information they need to make decisions about the use of vaccines in their national vaccination campaigns” and notes that the most common side effects of the Janssen vaccine tend to to be “mild or moderate, and they improve a day or two after “the injection.”
This research occurs in the context of what is known as a “safety signal”, information about a new or previously 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 establish whether there is a causal relationship.
Eddie is an Australian news reporter with over 9 years in the industry and has published on Forbes and tech crunch.