During its August 2021 meeting, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) recommended updating the product information of COVID-19 Vaccine Janssen. Furthermore, the PRAC continues to closely review reports of Guillain-Barré syndrome with Vaxzevria and discussed other safety issues occurring after vaccination against COVID-19.
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.
More information is available on the EMA website