The Agency’s Pharmacovigilance Risk Assessment Committee recommends raising awareness of a possible link between the vaccine and VTE
The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) has concluded that there is a possible link to rare cases of venous thromboembolism (VTE) with Janssen’s COVID-19 vaccine.
This safety issue is distinct from vaccine-related thrombosis with thrombocytopenia syndrome.
VTE was included in the risk management plan for the vaccine as a safety concern to be investigated, based on a higher proportion of cases of VTE observed within the vaccinated group versus the placebo group in the large clinical study that was used to authorise this vaccine.
The PRAC has now reviewed new evidence from the study, as well as new evidence from another large clinical study. In this second study, there was no increase in VTE among individuals who received the vaccine. The PRAC also reviewed evidence from post-marketing. When taking all evidence into account, the committee concluded that there is a reasonable possibility that rare cases of VTE are linked to vaccination with the Janssen COVID-19 vaccine.
The committee is therefore recommending listing VTE as a rare side effect in the product information, together with a warning to raise awareness among healthcare professionals and people taking the vaccine, especially those who may have an increased risk of VTE.
This article originally appeared on Univadis, part of the Medscape Professional Network.
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