The European Medicines Agency (EMA) last week added an autoimmune condition known as Guillain-Barré syndrome (GBS) as a possible side effect to the product information on AstraZeneca/Oxford University’s Vaxzevria (or “AZD1222”) experimental adenovirus vectored vaccine. GBS is a neurological disorder that causes pain, numbness, muscle weakness and sometimes paralysis.1 2 3 4
The EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) recommended updating the existing warning on the vaccine package leaflet with the following advice:
Patients are asked to talk to their healthcare professionals before they are given Vaxzevria if they previously had GBS after being given Vaxzevria.
Reminder: People should seek immediate medical attention if they develop weakness and paralysis in the extremities that can progress to the chest and face.1
European Medicines Agency Includes GBS Warning to Vaxzervia Product Insert
The information update follows a recommendation by the EMA’s PRAC on July 9 that the product information for Vaxzevria should include a warning of cases of GBS that have been reported after receiving the vaccine. According to the EMA, “GBS was identified during the marketing authorization process as a possible adverse event requiring specific safety monitoring activities.”4
A total of 227 cases of GBS following vaccination with Vaxzevria had been reported to the EMA from the European Union/European Economic Area as of June 27.5
In view of the “seriousness of this rare condition,” the PRAC recommended the warning be added in Section 4.4 of the Summary of product characteristics and in Section 4 of the patient leaflet for the vaccine to “alert healthcare professionals and people taking the vaccine of this potential risk.”4
GBS Warning Added to Johnson & Johnson’s COVID Vaccine by FDA
In July, the U.S. Food and Drug Administration added a warning label to Johnson & Johnson/Janssen’s experimental adenovirus vector Ad26.COV2.S vaccine linking the product to cases of GBS. The FDA noted that there had been 100 preliminary reports of GBS after Ad26.COV2.S vaccinations and that, of those, 95 were serious and required hospitalization and there was one reported death.6
On July 26, the World Health Organization (WHO) announced that the COVID-19 subcommittee of its Global Advisory Committee on Vaccine Safety (GACVS) met to review the reports of GBS associated with both Vaxzevria and J&J’s Ad26.COV2.S vaccine. The subcommittee determined that “more rigorous studies” needed to be done “using alternative data sources and robust study designs” and that “comparison of vaccinated and unvaccinated populations would be needed, to fully assess the significance of these events.”7
GBS Also Linked to Pfizer’s COVID Shot
Based on a recent analysis of medical records in Israel, GBS has also been linked to Pfizer/BioNTech’s experimental messenger RNA (mRNA) COVID vaccine BNT162b2 (renamed “Comirnaty”). Of 702 GBS cases identified, 579 of the patients had received one dose of Comirnaty and 539 had received two doses.8 9 10
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Click here to view References:
1 European Medicines Agency. COVID-19 vaccine safety update—VAXZEVRIA. Sept. 8, 2021.
2 Reuters. EU lists rare nerve disorder as possible side-effect of AstraZeneca COVID-19 vaccine. Sept. 8, 2021.
3 U.S. Centers for Disease Control and Prevention. Guillain-Barré Syndrome and Vaccines. Aug. 25, 2021.
4 Press release. Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 5-8 July 2021. European Medicines Agency July 9, 2021.
5 EMA. Summary of product characteristics.
6 Weixel N. FDA adds new warning to J&J COVID-19 vaccine. The Hill July 12, 2021.
7 World Health Organization. Statement of the WHO Global Advisory Committee on Vaccine Safety (GACVS) COVID-19 subcommittee on reports of Guillain-Barré Syndrome (GBS) following adenovirus vector COVID-19 vaccines. July 26, 2021.
8 George J. Can Guillain-Barré Syndrome Recur After mRNA COVID Vaccine? Medpage Today Sept. 2, 2021.
9 Shapiro S, David B, Potasman I, Rahamim-Cohen D. Rate of Recurrent Guillain-Barré Syndrome After mRNA COVID-19 Vaccine BNT162b2.
10 Sadia Waheed S, Bayas A, Hindi F, Rizvi Z, Espinosa PS. Neurological Complications of COVID-19: Guillain-Barre Syndrome Following Pfizer COVID-19 Vaccine. Cureus February 2021; 13(2): e13426.