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Guillain-Barré Syndrome deaths ‘likely linked’ to COVID vaccine

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Two people in Australia have died after developing Guillain-Barré Syndrome (GBS) in cases that may be related to COVID vaccination, the Therapeutic Goods Administration (TGA) has revealed.
 
The women – one aged 77 from Victorian and the other 81 from New South Wales – reportedly developed symptoms of the rare immune disorder after receiving AstraZeneca’s COVID-19 vaccine.
 
The deaths were confirmed in the regulator’s latest weekly safety report, after the Vaccine Safety Investigation Group (VSIG) reviewed the cases on 7 December and confirmed that they appeared ‘consistent with being related to vaccination with AstraZeneca’.
 
‘This was based on the time period between vaccination and GBS developing; the absence of other identifiable causes; and evidence from international investigations of a possible link between GBS and AstraZeneca,’ the report said.
 
University of Sydney vaccine expert Professor Robert Booy said the news of the deaths is ‘very distressing’.
 
‘The whole point of vaccination is prevention and the maintenance of good health,’ he told newsGP.
 
‘Unfortunately with COVID infection, we do have to do a cost–benefit analysis, and the cost of COVID internationally has been over five million lives, [with] the true number [likely] over 15 million.
 
‘In Australia, the cost measured in deaths is about 2000 and there are a handful of mainly older people, but some middle-aged people, who have died after vaccination and we all find that very distressing, and we want to do better.’
 
However, while conceding the likely connection between vaccination and the deaths, the TGA also noted there was ‘some uncertainty around this determination’ given that GBS can occur in people who have not received a vaccine, and at times without an obvious trigger.
 
A recent analysis of 32 million adults in England, published in Nature Medicine, also found the risk of developing GBS is ‘substantially higher’ after COVID-19 infection.
 
For every 10 million people diagnosed with COVID-19, there were an estimated 145 extra cases of GBS compared to every 10 million people who received AstraZeneca, which had just 38 excess cases of GBS.
 
Who is at risk of GBS, and what are the signs to look out for?
It was on 26 August that the TGA updated AstraZeneca’s Product Information, warning consumers of the possibility of developing GBS after the regulator received 89 reports of the syndrome post-vaccination.
 
A rare neurological disorder, the immune system mistakenly attacks part of the body’s peripheral nervous system, affecting the nerves, which can result in pain and paralysis.
 
It is thought to occur when the immune system is activated to fight an infection or bacteria, and has been associated with common viral infections, including COVID-19 and some types of gastroenteritis, as well as some vaccines, such as those used to protect against influenza and shingles.
 
Vaccine-related GBS symptoms, which tend to affect both sides of the body, usually occur 2–42 days after vaccination.
 
Symptoms to look out for include:

• muscle weakness
• unusual sensation, ie numbness and/or pins and needles
• unsteadiness when walking
• pain and paralysis in the hands or feet that can progress to the chest and face over a few days or weeks.

Though it is considered rare – GBS is reported in Australia at a rate of about one in every 100,000 people following vaccination with AstraZeneca – and many cases resolve within months, recovery can sometimes take years and, as seen with the two fatalities, can occasionally result in death.
 
Beyond vaccination with AstraZeneca, scientists believe GBS may also arise in some cases 1–3 weeks after an infection in the respiratory or gastrointestinal tract, but there are currently no identified risk factors for GBS.
 
In the general population it occurs at a rate of about 2–8 people per 100,000, and is more common in men and those over the age of 50.
 
Professor Booy said while the vast majority of people who receive AstraZeneca will not suffer any long-term side effects, it is important for GPs advising their patients about vaccination to be aware of any past history of GBS.
 
‘If they’ve got a history of GBS already, I wouldn’t give the AstraZeneca vaccine,’ he said.
 
‘I’d counsel patients just generally to say if you have any symptoms that are untoward, get in touch.
 
‘That will cover things like leg pain, abdominal pain or chest pain with TTS [thrombosis with thrombocytopenia syndrome] and it will cover pins and needles and weakness from GBS.’
 
With Australia’s booster program currently underway, and millions of people set to become eligible by the end of the year, the TGA and Australian Technical Advisory Group on Immunisation have approved and recommend an mRNA vaccine for a booster.  
 
While Professor Booy says this is generally a good idea, particularly pertaining to any risks of GBS, he said for some patients AstraZeneca will be the safer option.
 
‘I can appreciate that the [Federal] Government would prefer to use mRNA vaccines as boosters,’ he said.
 
‘If, however, you’ve had a serious reaction to an mRNA vaccine, like prolonged fever and lymph node enlargement, like anaphylaxis, like myocarditis, then I think it’s more than reasonable to have an AstraZeneca booster.
 
‘Also, we will, within weeks, almost certainly have a protein-based vaccine called Novavax available as a booster and its side effect profile may well be better.’
 
To date, the TGA has received 155 reports of suspected GBS from approximately 13.6 million doses of AstraZeneca administered up to 5 December.
 
Based on current data, the TGA maintains that the benefits of AstraZeneca ‘continue to outweigh the risks’, but that it is monitoring emerging data and that ‘further changes are expected’ to reflect the strengthening evidence of a possible link.
 
‘Health professionals should be aware of the possible signs and symptoms of GBS in people who have been vaccinated to ensure correct diagnosis and so that treatment can be started early,’ the TGA said.
 
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AstraZeneca COVID-19 GBS Guillain-Barre Syndrome TGA vaccination

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