The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) has concluded that there may be a causal relationship between the administration of AstraZeneca and the appearance of Guillain-Barré Syndrome (GBS). will be included in the technical data sheet and in the package insert of this vaccine as a possible adverse reaction with a very rare frequency of appearance.
GBS is a very rare immune system disorder that causes inflammation of the peripheral nerves and can result in pain and/or numbness, initially in the extremities, muscle weakness, and difficulty walking. In very severe cases it can progress to paralysis. Most patients recover from symptoms.
As of July 31, 833 cases of GBS have been reported worldwide after administration of this vaccine, in the context of more than 592 million doses administered as of July 25. In Spain, 32 cases of confirmed GBS have been registered until August 8, with about 9.6 million doses administered on this same date.
Although the frequency of cases reported after the administration of this vaccine is very low, health professionals are recommended to be alert to the possible appearance of symptoms or signs related to GBS, given the seriousness of this entity, in order to obtain a diagnosis. and treatment as quickly as possible.
Despite this confirmation, the EMA maintains the benefit-risk balance of the vaccine favorably, considering its efficacy and the low frequency of appearance of these conditions. This risk has not been identified for the mRNA vaccines, Comirnaty (BioNTech/Pfizer) and Spikevax (Moderna).
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