Misc 09/04/2021

EMA examines possible link between four cases of severe thrombosis and Janssen vaccine

One case detected in a clinical trial and three more in the United States, one of them fatal

2 min
One vial of Janssen's vaccine

BrusselsThe European Medicines Agency (EMA) is investigating a possible link between four cases of severe thrombosis and the Janssen vaccine. The regulator informed of this action on Friday as part of the conclusions of this week's expert committee meeting, which was primarily aimed at looking into rare cases of thrombosis that have occurred after receiving AstraZeneca's vaccine. "At the moment it is not clear that there is a causal association between the Janssen vaccine and these cases," the statement said.

The EMA explains that one of the cases occurred during clinical trials, while the other three are from the United States, one of which was fatal. The drug from Johnson&Johnson (Janssen is its European subsidiary) was approved in the US on an emergency basis in February. In the European Union, on the other hand, no state has yet started using it after the EU regulator gave it the green light on March 11 . However, the first doses are expected to start arriving in mid-April. In its statement, the EMA reiterates that the vaccine is safe but explains that it is investigating these four cases to decide whether to update the information on the vaccine and consider thrombosis as a possible rare side effect, as from this week happens with the drug developed by Oxford University.

The Johsnon&Johnson solution is one of the most awaited in the European Union because it has a single-dose schedule, which means that it can immunise twice as many people with the same number of doses. It comes at a time when Europe needs to accelerate the vaccination campaign after the several failures of the pharmaceutical company AstraZeneca, which has failed to deliver even a third of the committed doses. AstraZeneca was also meant to be the main pillar of the European vaccination strategy.

The European Medicines Agency gives the Johnson & Johnson vaccine an efficacy of 67%, slightly higher than the AstraZeneca vaccine, which is 60% effective. The efficacy attributed to those of Moderna (90%) and Pfizer/BioNtech (85%) is much higher.

It is foreseen that Catalonia will receive 800,000 doses of the Janssen vaccine, of the 5.5 million that correspond to Spain. It is precisely in Catalonia, in Sant Joan Despí, where the pharmaceutical company will produce doses of this vaccine in the Reig Jofre factory from June onwards.