At the same time, the regulator stressed that the benefits of using the drug continue to outweigh the risks.
The European Medicines Agency (EMA) has concluded that the formation of blood clots should be included in the list of rare side effects of the Janssen vaccine, a division of the American Johnson & Johnson. This is stated in a statement issued on Tuesday by the European Union regulator.
“The agency’s Pharmacovigilance Risk Assessment Committee has concluded that a warning about unusual blood clots should be added to the product information for the COVID-19 Janssen vaccine,” the statement said. At the same time, the European regulator stressed that the benefits of using the vaccine continue to outweigh the risks.
According to the regulator, most cases of complications were detected in women under the age of 60. However,” based on the available data, it is not possible to identify specific risk factors,” the press release states.
At a press conference, the head of the EMA, Emer Cooke, said that no cases of thrombosis had been recorded in the EU after the use of the Janssen vaccine. “I must emphasize that we are not aware of any cases [of blood clots] in the EU; this drug is not widely used in the EU at the moment,” she said. Cook added that the regulator would continue to investigate cases of thrombosis after the use of this drug.
The head of the European Commission, Ursula von der Leyen, called the statement of the EMA “good news for the deployment of the vaccination campaign in the EU.”
Last week, US regulators recommended suspending the Johnson & Johnson vaccine campaign. Johnson & Johnson later announced the suspension of the planned second-quarter supply of 55 million doses of the vaccine to the EU due to the risks of thrombosis.