Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 5 August 2021

News 06/08/2021

COVID-19 Vaccine Janssen: update on safety issues

The PRAC recommended updating the product information of COVID-19 Vaccine Janssen 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 PRAC recommended an update to the risk management plan of COVID-19 Vaccine Janssen to re-classify ‘thrombocytopenia’, currently an important potential risk, as an important identified risk.

Immune thrombocytopenia is a condition in which the immune system mistakenly attacks and destroys blood cells called platelets that are needed for normal blood clotting.

The Committee assessed the available evidence, including scientific literature and cases reported to the European database for suspected side effects (EudraVigilance), to the Vaccine Adverse Event Reporting System (VAERS) in the United States and to the marketing authorisation holder's global safety database.

The PRAC concluded that cases of dizziness and tinnitus (ringing or other noises in one or both ears) are linked to the administration of COVID-19 vaccine Janssen.

In reaching this conclusion, the Committee took into consideration all currently available evidence.

This included an analysis of 1,183 cases of dizziness identified as part of spontaneous reports on anxiety-related reactions to immunisation.

Regarding tinnitus, EMA investigated 6 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.

EMA will continue to closely monitor this issue and will communicate further when new information becomes available.

PRAC continues to closely review reports of Guillain-Barré syndrome with Vaxzevria

As part of the review of monthly summary safety reports for Vaxzevria, the PRAC continues to analyse data provided by the marketing authorisation holder on cases of Guillain-Barré syndrome (GBS) reported following vaccination.

GBS is a rare immune system disorder that causes nerve inflammation and can result in pain, numbness, muscle weakness and difficulty walking. In the most severe cases it can progress to paralysis. Most people fully recover from the disorder.

In the context of the next monthly summary safety report, the PRAC has 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 PRAC 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.

Menstrual disorders are very common and can occur without an underlying medical condition. Causes can range from stress and tiredness to underlying medical conditions, such as fibroids and endometriosis. Women experiencing unexpected vaginal bleeding (e.g. in postmenopausal 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.


  • Safety signal assessments. A safety signal is information on a new or known adverse event that is potentially caused by a medicine and that warrants further investigation. Signals are generated from several sources such as spontaneous reports, clinical studies and the scientific literature. More information can be found under Signal management.
  • Periodic safety update reports, abbreviated as PSURs, are reports prepared by the marketing authorisation holder to describe the worldwide safety experience with a medicine in a defined period after its authorisation. PSURs for medicinal products that contain the same active substance or the same combination of active substances, but have different marketing authorisations and are authorised in different EU Member States, are jointly assessed in a single assessment procedure. More information can be found under .
  • Risk management plans, abbreviated as RMPs, are detailed descriptions of the activities and interventions designed to identify, characterise, prevent or minimise risks relating to medicines. Companies are required to submit an RMP to EMA when applying for a marketing authorisation. RMPs are continually updated throughout the lifetime of the medicine as new information becomes available. More information is available under Risk management plans.
  • Post-authorisation safety studies, abbreviated as PASSs, are studies carried out after a medicine has been authorised to obtain further information on its safety, or to measure the effectiveness of risk-management measures. The PRAC assesses the protocols (aspects related to the organisation of a study) and the results of PASSs. More information can be found under Post-authorisation safety studies (PASS).
  • Referrals are procedures used to resolve issues such as concerns over the safety or benefit-risk balance of a medicine or a class of medicines. In a referral related to safety of medicines, the PRAC is requested by a Member State or the European Commission to conduct a scientific assessment of a particular medicine or class of medicines on behalf of the EU. More information can be found under Referral procedures: human medicines.
  • Pandemic summary safety reports have been introduced as part of the enhanced safety monitoring of COVID-19 vaccines. Marketing authorisation holders are required to submit these reports to EMA on a monthly basis. Their submission complements the submission of PSURs. For more information see EMA’s pharmacovigilance plan for COVID-19 vaccines.

Ongoing referrals




Amfepramone-containing medicinal products - Article -31 ReferralUnder evaluationPRAC continued its assessment

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