Guillain-Barre syndrome (GBS) occurs when the immune system assaults a portion of the body's peripheral nervous system. Now, according to a WHO expert panel, symptoms of GBS were seen after the administration of Janssen and AstraZeneca COVID-19 vaccines.

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When do the GBS cases arise?

Guillain-Barré Syndrome cases may arise occasionally after Janssen and AstraZeneca vaccinations, according to a WHO panel. Guillain-Barré Syndrome (GBS), a rare immune system disease characterised by muscular weakness, discomfort, or numbness, and in extreme instances, paralysis, and may develop after immunisation with the Janssen and AstraZeneca COVID-19 vaccines, a World Health Organisation expert panel stated.

Although rare instances of GBS have been reported after seasonal influenza vaccinations and shingles vaccines, it is unknown if the immunisations cause GBS. In 2011, a systematic study and meta-analysis estimated the background incidence of GBS in Europe and Northern America to be 0.8-1.9/100,000 people.

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Monitoring GBS

1. On 9th of July, the European Medicines Agency's (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) recommended adding a warning to Vaxzevria (AstraZeneca's COVID-19 vaccine marketed in Europe), but they could not confirm or rule out a connection with the vaccine.
2. By 27th June 2021, the EU/EEA had reported 227 instances of GBS to the EMA, and approximately 51.4 million doses of Vaxzevria had been administered to individuals in the EU/EEA. The US Food and Drug Administration (FDA) notified on the 13th of July that a modification to the vaccine recipient and immunisation provider fact sheets for Johnson & Johnson (Janssen) COVID-19 vaccine to add information about an observed elevated risk of GBS after vaccination.
3. At its meeting on 22nd July, the US Advisory Committee on Immunisation Practices (ACIP) reviewed the information and noted that, as of 30th June, 100 cases of GBS had been reported in the vaccine adverse event reporting system, the US's nationwide passive surveillance system for vaccines, involving approximately 12.2 million doses of Janssen vaccine.

The GACVS subcommittee has examined the comments and actions taken by the US Food and Drug Administration and the European Medicines Agency. Additionally, the subcommittee examined early data from Vigibase, the World Health Organisation's worldwide database of Individual Case Safety Reports (ICSR), which showed 164 unconfirmed cases of GBS in countries outside the European Economic Area (EEA) and the United States.

The GACVS panel determined after a thorough scientific assessment of the available data that rare instances of GBS have been recorded after immunisation with adenovirus vector COVID-19 vaccines.

The WHO panel said,

“No increase in GBS cases has been reported after the administration of mRNA COVID-19 vaccinations. To properly evaluate the importance of these occurrences, further rigorous research using alternative data sources and robust study designs, as well as comparisons of vaccinated and unvaccinated populations, would be required."

The WHO encouraged healthcare providers to monitor for and report any adverse events, including GBS. Countries should continue to compile comprehensive information on individual instances. To get a more complete picture, data should ideally be collected via active monitoring inside hospitals. The World Health Organisation's COVID-19 vaccine safety surveillance handbook offers nations, advice on safety monitoring and adverse occurrences.

Individuals using Janssen or AstraZeneca should be aware of the signs and symptoms of GBS and seek prompt medical care if they experience weakness/tingling and paralysis in the limbs, which may spread to other areas of the body, including the chest and face.

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Symptoms of GBS

The symptoms of GBS may include:

• Trouble walking
• Difficulties with facial motions
• Double vision or the inability to move one's eyes
• Difficulty regulating bladder or bowel function

Healthcare workers should be aware of the symptoms in order to diagnose and treat patients promptly. The WHO said that the majority of individuals completely recover from GBS.

WHO stated:

“While countries should always consider their unique pandemic circumstances and benefit-risk profiles, the subcommittee concludes that the potential benefits of both the Janssen and AstraZeneca COVID-19 vaccines continue to outweigh any potential risk of GBS, particularly in light of the increase in the more transmissible Delta (B.1.617.2) variant."

In Australia, the Therapeutic Goods Administration (TGA) has received 89 cases of Guillain-Barre Syndrome (GBS) after immunisation with Vaxzevria (AstraZeneca). It says that the warning included in the vaccine's Product Information is a 'precautionary step' in response to rare instances of vaccination-related complications in Australia and elsewhere.

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The situation in India

In 2 independent trials, doctors in India and England reported that eleven individuals who got the AstraZeneca-Oxford COVID-19 vaccination experienced a rare neurological disease - Guillain-Barre syndrome. While seven instances were recorded from a medical centre in Kerala, where about 1.2 million individuals got the AstraZeneca COVID-19 vaccination, marketed in India as Covishield, four cases were reported from Nottingham, UK, where roughly 700,000 (7 lakh) people received the shot. All 11 had had the COVID preventative medication between 10 and 22 days before.

The two investigations, which were published on June 10th in the journal Annals of Neurology, reveal an uncommon form of GBR characterised by significant facial weakness. The authors of the two investigations calculated that the incidence of GBS in the regions where cases were recorded was up to tenfold than anticipated.

The frequency of GBS was 1.4 to tenfold than anticipated for a population of this size over this time, they said. According to the researchers, the prevalence of facial paralysis on both sides of the face, which happens in fewer than 20% of GBS cases, indicates a pattern linked with the vaccine.

According to the authors of a UK research from Nottingham University Hospitals NHS Trust, "While SARS-CoV-2 vaccinations are very safe, we describe four instances of bifacial weakness with paraesthesias associated with GBS within three weeks of immunisation with the Oxford-AstraZeneca SARS-CoV-2 vaccine."

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Recommendation

It is recommended, for increased attention of instances of bifacial weakness with paraesthesias variant GBS, after SARS-CoV-2 vaccination and post-vaccination surveillance programmes, a collection of rigorous data on this event to determine the cause may help. Although the advantages of vaccination exceed the risk of this very uncommon adverse event (5.8 per million), the researchers cautioned physicians to be aware of this possibility.

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Disclaimer- The views and opinions expressed in this article are those of the author's and do not necessarily reflect the official policy or position of M3 India.

The author is a practising super specialist from New Delhi.