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AstraZeneca, Guillain-Barré Syndrome Warning / Ema Update the Vaccine Bulletin

L ‘European Medicines Agency (EMA) adjusts indications based on possible but rare side effects of AstraZeneca, as well Pfizer and modern, which involves updating the liar to alert health professionals and recipients, and signing informed consent. The major novelty relates to Syndrome de Guillain Barre (Gbs), which will be included as a warning in the vaccine product information vaxiferia by AstraZeneca. The decision was made by pharmacovigilance committee (Brac) from the European Medicines Agency, even if “At this point, the available data neither confirm nor exclude a possible association»Between Guillain-Barré Syndrome (GBS) and the Covid vaccine.

Experts remember thatAn immune system disorder that causes nerve inflammation and can cause pain, numbness, muscle weakness, and difficulty walkingThis syndrome was already identified during the product marketing authorization process asPotential adverse event requiring specific safety monitoring activities».

ASTRAZENECA, EMA Updating the Vaccine Fool

The Pharmacovigilance Committee (Prac) of the European Medicines Agency Therefore, it is recommended to modify the product information of AstraZeneca It specifies, in this respect, that it has evaluated all available evidence. This also applies to cases reported to the European Database on Suspected Side Effects (EudraVigilance) and data from the scientific literature, but the data currently available do not confirm or exclude a possible association with the vaccine. Due to the seriousness of this rare condition, PRAC recommended adding a warning to Syndrome de Guillain Barre (Gbs) in section 4.4 of the summary of product characteristics and section 4 of the package leaflet for Vaxzevria. Therefore, healthcare professionals and people who will be given the vaccine must be alert to signs and symptoms for early diagnosis, supportive care, and treatment. It is also advised to seek medical attention in case of weakness and paralysis of the extremities that can progress to the chest and face. But the EMA emphasized that the vaccine’s benefit-to-risk ratio had not changed.

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