The Spanish Agency for Medicines and Health Products (AEMPS), dependent on the Ministry of Health, has reported that the Guillain-Barré syndrome (GBS) as a very rare possible adverse reaction associated with vaccination with ‘Vaxzevria’, AstraZeneca’s Covid-19 vaccine.
As of July 31, 833 cases of GBS have been reported worldwide after the administration of this vaccine, in the context of more than 592 million doses administered until July 25. In Spain They have registered 32 cases SGB confirmed Until the 8 of August, with about 9.6 million doses administered to this same date.
This alert comes after the Committee for the Evaluation of Risks in Pharmacovigilance (PRAC) of the European Medicines Agency (EMA) has evaluated the most recent data on the risk of appearance of GBS after the administration of the vaccine ‘Vaxzevria ‘, including cases reported worldwide in vaccination campaigns, information from clinical trials and scientific literature.
This risk has not been identified for mRNA vaccines., ‘Comirnaty’ (BioNTech / Pfizer) and ‘Spikevax’ (Moderna). 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.
Thus, it is recommended that healthcare professionals pay attention to the possible appearance of signs or symptoms of GBS in order to establish a diagnosis and treatment as early as possible, and explain to those vaccinated that they should seek immediate medical attention in case such symptoms People who after receiving this vaccine have weakness in their limbs or face; coordination difficulties in movement, walking or standing; pain and tingling in extremities; difficulty speaking, chewing, or swallowing; Double vision or difficulty moving the eyes, among other symptoms, should seek immediate medical assistance.
The PRAC has concluded that there may be a causal relationship between the administration of this vaccine and the appearance of GBS, so it will be included in the technical data sheet and in the package leaflet of this vaccine as a possible adverse reaction with a very rare frequency of appearance. Last July, a warning on this matter was included in the technical sheet.