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

The EMA’s drug safety committee (PRAC) recommends updating risks of Janssen COVID-19 Vaccine, though the benefit-risk balance remains unchanged.

Janssen vaccine, as reviewed by PRAC

In its August meeting, the European Medicine Agency (EMA)’s Pharmacovigilance Risk Assessment Committee (PRAC) recommended including immune thrombocytopenia as an adverse reaction, among others, to Janssen COVID-19 Vaccine, among other decisions.

PRAC recommends inclusion of immune thrombocytopenia as an adverse reaction to Janssen COVID-19 Vaccine

The PRAC recommended updating the product information of the Janssen COVID-19 Vaccine to include immune thrombocytopenia as an adverse reaction, as well as a warning to alert healthcare professionals and people taking the vaccine of this possible side effect.

In addition, the committee recommended an update to the risk management plan of Janssen COVID-19 Vaccine to reclassify ‘thrombocytopenia’, currently an important potential risk, as an important identified risk.

PRAC link dizziness and tinnitus to Janssen COVID-19 Vaccine

The committee concluded that dizziness and tinnitus are linked to the administration of Janssen COVID-19 Vaccine. In reaching this conclusion, the PRAC took into consideration all currently available evidence, including an analysis of 1, 183 cases of dizziness identified as part of spontaneous reports on anxiety-related reactions to immunisation.

Regarding tinnitus, the EMA investigated six cases observed in clinical trials and 108 cases identified by the company during monitoring spontaneous reports. In light of this, the PRAC has recommended amending the product information to add dizziness and tinnitus as adverse reactions to alert healthcare professionals and people taking the vaccine of these potential side effects.

The benefit-risk balance of the vaccine remains unchanged. The EMA will continue to closely monitor the issue and communicate further when new information becomes available.

Guillain-Barré syndrome continues to be closely reviewed with Vaxzevria

The PRAC will continue to analyse data provided by AstraZeneca, the marketing authorisation holder, of Guillain-Barré syndrome (GBS) reported following vaccination with Vaxzevria. PRAC has also requested the marketing authorisation holder to provide additional data to clarify whether further updates to the product information and the risk management plan are necessary.

This follows a PRAC recommendation to include a warning in the product information of Vaxzevria to raise awareness among healthcare professionals and people taking the vaccine of cases of GBS reported following vaccination.

People taking the vaccine are advised to seek immediate medical attention if they develop weakness and paralysis in the extremities that can progress to the chest and face.

These side effects are very rare, and the benefit-risk balance of the vaccine remains unchanged. EMA will continue to monitor the vaccine’s safety and effectiveness and communicate with the latest information.

Other safety issues

The committee discussed reported cases of menstrual disorders occurring after vaccination against COVID-19. No causal association between COVID-19 vaccines and menstrual disorders has been established so far.

Women experiencing unexpected vaginal bleeding (such as in post-menopausal women) or who are concerned about prolonged or severe menstrual disturbances may want to seek medical advice.

The marketing authorisation holders for all COVID-19 vaccines approved in the EU have been asked to provide further data as part of the monthly summary safety reports. The PRAC will review all available evidence, including reports of suspected adverse events and scientific literature and will continue monitoring the issue.

PRAC’s report can be found here.

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