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The European Medicines Agency updated safety issues about COVID-19 vaccines.

Janssen vaccine

It's recommended to the 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.

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.

Also, cases of dizziness and tinnitus (ringing or other noises in one or both ears) are linked to the administration of COVID-19 vaccine Janssen, so it's 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.

Vaxzevria vaccine

Committee reviewed the reports of Guillain-Barré syndrome related with Vaxzevria, and continues to do so.

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.

The committee has asked for more data and will keep the discussion open. Also, a warning is included in the product information 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.

Other safety issues

Cases of menstrual disorders occurring after vaccination against COVID-19 were also discussed but so far, no causal association between COVID-19 vaccines and menstrual disorders has been established.

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.

More information can be found here:

The Source: Estonian Agency of Medicines

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