A medical worker holds a bottle of AstraZeneca's COVID-19 vaccine at a vaccination centre in Kuala Lumpur, Malaysia May 5, 2021 in this file photo. REUTERS/Lim Huey Teng/File Photo/File Photo
Europe's medicines regulator has added an extremely rare nerve-damaging disorder, Guillain-Barré syndrome, as a possible side-effect of AstraZeneca's (AZN.L) COVID-19 vaccine, regular safety updates from the watchdog showed on Wednesday.
The European Medicines Agency said a causal relationship between GBS and the AstraZeneca shot, known as Vaxzevria, was a "at least a reasonable possibility" after 833 cases of GBS were reported out of 592 million doses of the vaccine given worldwide by July 31.
The EMA categorised the side-effect as "very rare", the lowest frequency of side-effect category it has, and has emphasised that the benefits of the shot outweigh the risks.
The U.S. Food and Drug Administration has added a warning over Guillain-Barré syndrome as a possible side-effect of Johnson & Johnson's (JNJ.N) shot. Both vaccines use viral vector technology, and have also been associated with rare blood clots.
The EMA also tagged some other less severe side-effects to vaccines from Johnson & Johnson (JNJ.N), Moderna as well as AstraZeneca's shot.
Reporting by Pushkala Aripaka in Bengaluru; Editing by Shinjini Ganguli and Mark Heinrich