EU regulator noted that Johnson & Johnson’s vaccine has more benefits than risks of causing “rare” clots

The European Medicines Agency has indicated that Johnson & Johnson’s vaccine continues to have a positive benefit / risk ratio, after analyzing the cases of brain thrombi detected in the United States, which motivated the EU regulator recommend adding such boxes to possible side effects.

“COVID-19 is associated with a risk of hospitalization and death. The reported combination of blood clots and low blood platelets is very rare, and the overall benefits of the Janssen COVID-19 vaccine in preventing COVID-19 outweigh the risks of side effects.“The European agency said in a statement.

He also told medical staff and patients that “they should be aware of the possibility” of these conditions occurring within three weeks of vaccination.

The decision a few days ago to postpone the use of Janssen in the EU came after the US Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) recommended suspending its application to Investigate these cases of “type of blood clot and determine if there is a causal relationship with the preparation.

The PRAC, the committee responsible for evaluating the safety problems of medicinal products for human use of the EMA, analyzed the cases of eight people who received Janssen (among seven million doses applied) and developed symptoms of cerebral venous thrombus between 6 and 13 days later (CVST), in association with low levels of blood platelets (thrombocytopenia).

Many European countries have placed their hopes on Janssen because it is the first single-dose vaccine available in the community area. Pfizer / BioNTech, Moderna and AstraZeneca require two injections with an interval of several weeks apart, forcing half of the stored doses to be kept to supplement protection for those who received the first, while the rest of the country waits for more. deliveries.

The American Johnson & Johnson was due to deliver 55 million doses to the EU in the second quarter. The company has advised European governments to hold on to their doses until the EMA issues advice on their use.

This is not the first time that the EMA has faced the decision scenario on the safety of an already authorized vaccine due to the detection of thromboembolism. Two weeks ago, he had to comment on the risk of developing blood clotting with AstraZeneca, and concluded that there was a “possible connection” to these symptoms, but argued that the benefits of the vaccine continue to outweigh on its risks to help fight the pandemic. and save lives.

At the moment, the most common side effects of Janssen tend to be “mild or moderate, and improve within a day or two after the injection,” the EMA points out.

(With information from EFE and AFP)

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