Guillain-Barre syndrome has been listed by the European Medicines Agency (EMA) as a side effect of the AstraZeneca Covid vaccine. The condition that affects the nerves is considered serious. The feet, hands and limbs are mainly affected, with problems such as numbness, weakness and pain. In some cases, temporary paralysis can occur.
But the side effect has been described as being “very rare”.
The relationship was “considered at least a reasonable possibility,” the EMA said in an update on Wednesday, after a total of 833 cases of the syndrome had been reported worldwide by July 31, from around 592 million doses of the AstraZeneca vaccine administered.
“GBS should therefore be added to the product information as a side effect of Vaxzevria,” it said.
The EMA recommended a warning be added to information on the vaccine that tells people to seek medical attention if they develop weakness and paralysis in the extremities that can progress to the chest and face.
The European drug regulator previously listed Guillain-Barre syndrome as a “very rare” side effect of the Johnson & Johnson vaccine, which uses the same adenovirus technology as the AstraZeneca vaccine.
The US Food and Drug Administration also warned in July of an “increased risk” of developing the condition with Johnson & Johnson’s jab.
But both regulators stressed the vaccine’s benefits outweighed the potential risks.
The UK Government has said: “Since all adults in the UK have been offered a coronavirus (COVID-19) vaccine, a certain number of cases of GBS would be expected following vaccination.”
It’s added: “As of the 11 August 2021, in the UK there have been 383 reports of GBS following AstraZeneca (AZ) vaccination and 23 reports of Miller Fisher syndrome, a variant of GBS which causes abnormal muscle coordination, paralysis of eye muscles and loss of tendon reflexes.
“There were 42 reports of GBS following Pfizer/BioNTech vaccination and 2 following Moderna vaccination.
“Over this time period, 24.8 million first doses and 23.9 million second doses of the AZ vaccine have been administered, 21.0 million first doses and 24.7 second doses of the Pfizer/BioNTech vaccine have been administered, and 1.4 million first doses and 0.6 million second doses of the Moderna vaccine.”
In the UK, all suspected cases of GBS should be reported to the MHRA using the COVID-19 Yellow Card scheme.
The current advice is if someone had GBS after their first COVID-19 vaccine they should have the second dose.
GOV.UK states: “There is no evidence that a previous episode of GBS predisposes an individual to further episodes.
“Hence, in those who develop GBS following COVID-19 vaccination, the balance of risk benefit is still in favour of completing a full COVID-19 vaccination schedule.
“In addition, a causal link between COVID-19 vaccination and GBS has not been proven and cases of GBS that occur following vaccination may occur by chance, with a background rate of GBS of 2 per 100,000 per year.
“The same vaccine should be used to complete the vaccination course, as there is an increased rate of known side-effects if mixed schedules are used.”
If someone has had GBS unrelated to the COVID-19 vaccine they should still get vaccinated.
It adds: “A causal link between COVID-19 vaccination and GBS has not been proven and there is no evidence of a higher rate of reporting of GBS following COVID-19 vaccination in individuals who have previously had GBS.
“Hence, the balance of risk benefit is in favour of having a full COVID-19 vaccination schedule.”