Johnson & Johnson vaccine: the EMA believes that the risk / benefit balance remains "positive"

The European Medicines Agency announced on Tuesday that it had established a "possible link" between the Johnson & Johnson vaccine against Covid-19 and cases of blood clots.

The European regulator nevertheless considers that the benefit / risk balance of this vaccine remains "positive".

The European Medicines Agency (EMA) announced on Tuesday that blood clots should be listed as a "very rare" side effect of the Johnson & Johnson vaccine against Covid-19, while believing that the benefits outweigh the risks .

The European regulator said in a statement to have established a "possible link" between the vaccine of the American laboratory and cases of blood clots, which should "be listed as very rare side effects of the vaccine".

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"The EMA finds a possible link with very rare cases of unusual blood clots associated with low blood platelets," the agency said, adding that this "confirms that the overall benefit-risk balance remains positive."

The EMA pharmacovigilance committee concluded "that a warning about unusual blood clots with low blood platelets should be added to the product information" for the Johnson & Johnson vaccine, the Amsterdam-based European regulator added. .

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Its experts also "concluded that these cases should be listed as very rare side effects of the vaccine," said the European Medicines Agency.

Johnson & Johnson's chief financial officer said on Tuesday that the laboratory remained "fully confident" about its Covid-19 vaccine and hoped to find a solution "very soon" with regulators on its use, which is currently suspended in Europe and the United States. United.