A large-scale international study involving researchers from the Drug Safety Research Unit (DSRU), UK, highlights the relationship between SARS-CoV-2 infection, certain COVID-19 vaccines, and Guillain-Barré syndrome (GBS).
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The research, published in Vaccine, reinforces the importance of continuous vaccine safety monitoring and highlights key differences in risk associated with different vaccine types.
GBS is a rare but serious neurological condition that can cause progressive limb weakness and eventual paralysis, with an annual incidence of 1 to 4 cases per 100,000 people worldwide. It has been linked to various infections, including Campylobacter jejuni, Zika virus, influenza, and SARS-CoV-2.
The study used advanced epidemiological methods and healthcare data from over 230 million people across 20 global sites within the Global Vaccine Data Network (GVDN), including the Vaccine monitoring Collaboration for Europe (VAC4EU), of which the DSRU is an active member.
People infected with SARS-CoV-2 were around three times more likely to develop Guillain-Barré syndrome (GBS) within six weeks of infection compared to other times, suggesting that infection with this virus increases the risk of GBS. An increased risk was also observed following adenoviral vector vaccines (AstraZeneca, Janssen/Johnson & Johnson), but not after mRNA vaccines (Pfizer-BioNTech, Moderna) or inactivated vaccines (Coronavac/Sinovac).
Dr Alison Yeomans, senior research fellow at the DSRU, led the UK contribution to the study. Yeomans said: “This comprehensive global vaccine safety study used real-world data from multiple countries to investigate the safety of COVID-19 vaccination and the risk of GBS. Although an increased risk of GBS was observed with adenoviral vector vaccines, this was not seen with mRNA-based vaccines. The understanding of the relative risks of vaccination and infection is critical to enable personalised decisions on vaccination. These findings highlight the need for ongoing safety monitoring and evidence-based guidance. The safety of all COVID-19 vaccines was thoroughly tested before being recommended for use during the COVID-19 pandemic and continues to be monitored in the real-world setting to safeguard public health.”
GVDN collaborates with leading research institutions, policymakers, and vaccine organisations across six continents to create a comprehensive, evidence-based approach to vaccine safety and effectiveness. The study drew data from eight African countries (Ethiopia, Ghana, Kenya, Malawi, Mali, Mozambique, Nigeria, and South Africa), Argentina, Australia (two sites), Canada (two sites), Denmark, Finland, Indonesia, Republic of Korea, Spain (two sites), and the United Kingdom.
Dr. Steve Black, GVDN Co-Director, said: “GVDN has long been committed to rigorous and transparent vaccine safety research. The size and diversity of this study population, attained through multinational collaboration, is a testament to this. Our findings highlight the importance of continuous monitoring and real-world data to guide public health decisions.”