WHO GACVS reviews cases of GBS after COVID-19 vaccination

The WHO Global Advisory Committee on Vaccine Safety (GACVS) COVID-19 subcommittee has published recommendations on rare cases of Guillain-Barre Syndrome (GBS) after vaccination with the AstraZeneca COVID-19 vaccine [AZD-1222; Vaxzevria, Covishield] and the Johnson & Johnson (Janssen) COVID-19 vaccine [Ad26.COV2-S], both of which use an adenovirus platform.

The European Medicines Agency (EMA)'s Pharmacovigilance Risk Assessment Committee (PRAC) issued a statement in July 2021 recommending the addition of a warning of GBS following vaccination with Vaxzevria, after 227 cases were reported to EMA following administration of approximately 51.4 million doses. The US FDA announced a revision to vaccine recipient and vaccination provider fact sheets for the Janssen COVID-19 vaccine in July advising of an increased risk of GBS, after 100 cases were reported to the Vaccine Adverse Events Reporting System following administration of approximately 12.2 million doses, and the EMA issued a statement that GBS will be listed as a very rare side effects of the vaccine.

The GACVS sub-committee has reviewed the statements and recommendations from the FDA and EMA, and reviewed preliminary data from Vigibase, the WHO global database of Individual Case Safety Reports (ICSR), on 164 unconfirmed cases of GBS for Vaxzevria and Covishield in countries outside the European Economic Area and the US. It has concluded that rare cases of GBS have been reported following vaccinations with adenovirus vector COVID-19 vaccines, but not following vaccinations with mRNA COVID-19 vaccines, and advises that people receiving Janssen or AstraZeneca COVID-19 vaccines should be made aware of signs and symptoms of GBS and should seek medical attention if they develop weakness/tingling and paralysis, or experience difficulty in walking or with facial movements, double vision, inability to move their eyes, or incontinence.

The subcommittee concludes that the potential benefits of both the Janssen and AstraZeneca COVID-19 vaccines continue to outweigh any potential risk of GBS.