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Pharmacovigilance Risk Assessment Committee (PRAC) meeting highlights, September 2021

The EMA’s drug safety committee (PRAC) assessed risks of thrombocytopenia and venous thromboembolism with the Janssen COVID-19 Vaccine.

COVID-19 Vaccine Janssen

In its September meeting, the European Medicines Agency (EMA)’s Pharmacovigilance Risk Assessment Committee (PRAC) concluded that there is a possible risk of venous thromboembolism (VTE) with the Janssen COVID-19 Vaccine and reviews meningioma risk with nomegestrol.

EMA reviews meningioma risk with nomegestrol and chlormadinone-containing medicines

EMA has started a review of medicines containing the active substance nomegestrol or chlormadinone. These medicines can be used, alone or in combination with other active substances, to treat gynaecological disorders such as amenorrhea and other menstrual disorders, uterine bleeding, endometriosis, breast tenderness, as hormone replacement therapy or as contraceptives.

The review was requested by the French medicines agency (ANSM) following new data from two epidemiological studies carried out in France in women taking these medicines to investigate the risk of meningioma, a tumour of the membranes covering the brain and spinal cord. This tumour is usually non-malignant and is not considered to be a cancer, however due to their location in and around the brain and spinal cord, meningiomas can, in rare cases, cause serious problems.

In light of the new data concerning the risk of meningioma, PRAC will now examine the available evidence and make recommendations as to whether the marketing authorisation for nomegestrol- and chlormadinone-containing medicines should be amended across the EU.

PRAC concludes possible risk of venous thromboembolism with Janssen COVID-19 Vaccine

The PRAC has concluded that there is a possible link to rare cases of venous thromboembolism (VTE) with the Janssen COVID-19 Vaccine.

VTE was included in the risk management plan for the Janssen COVID-19 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 which was used to authorise this vaccine. The issue has been kept under close monitoring.

The committee has 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 venous thromboembolic events among individuals who received the Janssen COVID-19 Vaccine.

The PRAC also reviewed post marketing evidence. 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 Janssen COVID-19 Vaccine.

The committee is therefore recommending listing VTE as a rare side effect of the Janssen COVID-19 Vaccine 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.

PRAC reviews cases of immune thrombocytopenia with Vaxzevria and Janssen COVID-19 Vaccine

The committee assessed cases of immune thrombocytopenia (ITP) reported following vaccination with Vaxzevria (formerly COVID-19 Vaccine AstraZeneca) as well as Janssen COVID-19 Vaccine .

The committee assessed all the available data and recommended updating the product information of both vaccines to include ITP as an adverse reaction with an unknown frequency.

Furthermore, a warning statement has been agreed to highlight that cases of very low levels of blood platelets have been reported very rarely, usually within the first four weeks following vaccination with Janssen COVID-19 Vaccine or Vaxzevria.

If an individual has a history of ITP, the risk of developing low platelet levels should be considered before vaccination, and platelet monitoring is recommended after vaccination with either of these vaccines.

As part of its advice on safety-related aspects, the PRAC agreed on direct healthcare professional communications (DHPCs) containing important safety information for the Janssen COVID-19 Vaccine and Vaxzevria.

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