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MHRA Message: Updates to Vaxzevria (formerly known as COVID-19 Vaccine AstraZeneca) product information

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We would like to inform you that we have updated the product information for Vaxzevria (formerly known as COVID-19 Vaccine AstraZeneca).

 

Following a review of the available data, a precautionary warning about Guillain-Barré Syndrome (GBS) has been included in the Summary of Product Characteristics and Patient Information Leaflet for Vaxzevria. This is to help the public and healthcare professionals to identify signs and symptoms of GBS and to enable prompt diagnosis in order to initiate adequate supportive care and treatment, and to rule out other causes.

 

Summary of Product Characteristics

Section 4.4 now includes the following: Neurological events: Guillain-Barré Syndrome (GBS) has been reported very rarely following vaccination with Vaxzevria. Healthcare professionals should be alert of GBS signs and symptoms to ensure correct diagnosis, in order to initiate adequate supportive care and treatment, and to rule out other causes.

 

Patient Information Leaflet

 

A change has been made to Section 2 to include: Neurological events: Seek immediate medical attention if you develop weakness and paralysis in the extremities that are persistent and can affect both sides of the body at the same time and can progress to the chest and face (Guillain-Barré Syndrome). This has been reported very rarely after vaccination with Vaxzevria.

 

Please see the Decision page on our website which has more details about Vaxzevria

 

We would be grateful if you could share this information wider with your contacts and network.

 

Patient, Public and Stakeholder Engagement

Communications Division

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