Rare nerve disorder listed as possible side effect of AZ’s COVID vaccine in EU
pharmafile | September 9, 2021 | News story | |
An extremely rare nerve-damaging disorder, Guillain-Barré syndrome (GBS), has been listed by EU regulators as a possible side effect from AstraZeneca’s COVID-19 vaccine.
The EMA 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 side effect was categorised as “very rare” – the lowest frequency a side effect can be listed as –and the EMA continued to stress that the benefits of the vaccine continue to outweigh the risks.
He FDA has already listed GBS as a possible side effect for Johnson & Johnson’s COVID vaccine, with both vaccines using viral vector technology. Both vaccines have also been linked to cases of rare blood clotting.
The EMA also tagged some other less severe side-effects to vaccines from Johnson & Johnson and Moderna, as well as AstraZeneca’s shot.
GBS is a rare disorder where the body’s immune system damages nerves. The damage to the nerves causes muscle weakness and sometimes paralysis. While its cause is not fully understood, the syndrome often follows infection with a virus or bacteria. Each year in the United States, an estimated 3,000 to 6,000 people develop GBS. Most people fully recover from GBS, but some have permanent nerve damage.