Risk of Guillain-Barré Syndrome After Hepatitis B Vaccination
Current evidence indicates that the risk of developing Guillain-Barré Syndrome (GBS) after hepatitis B vaccination is extremely low, with no established causal relationship between modern recombinant hepatitis B vaccines and GBS. 1
Background and Risk Assessment
Early post-licensure surveillance in the 1980s suggested a possible association between GBS and the first dose of plasma-derived hepatitis B vaccine. However, subsequent analysis of GBS cases among approximately 2.5 million adults who received recombinant hepatitis B vaccine during 1986-1990 found that the rate of GBS after vaccination did not exceed the background rate in the unvaccinated population. 1
Key points about the risk:
- The Institute of Medicine concluded that evidence was insufficient to either accept or reject a causal relationship between hepatitis B vaccination and GBS 1
- Hepatitis B vaccines have been demonstrated safe with over 70 million adolescents/adults and 50 million infants/children vaccinated in the US since 1982 1
- Among all vaccines, hepatitis B vaccine was associated with the second highest number of GBS reports (94 cases) in the Vaccine Adverse Event Reporting System between 1990-2005 2
- However, these reports represent temporal associations rather than proven causation
Comparative Risk Context
- The background annual incidence of GBS in the general population is 10-20 cases per 1,000 adults 1
- For comparison, the 1976 swine influenza vaccine (which had a confirmed association with GBS) showed a risk of <10 cases per 1,000 persons vaccinated 1
- Modern seasonal influenza vaccines are estimated to have a risk of approximately 1 additional GBS case per 1,000 vaccinations 1, 3
Risk Factors and Recurrence
Individuals with a history of GBS have a higher baseline risk of developing GBS again compared to the general population 1, 3. However:
- A 2012 study found that among 550 GBS cases followed for recurrence, none had recurrent GBS after influenza vaccination and none within 6 weeks after any vaccine 4
- A 2020 large retrospective study found no increased risk of GBS or its recurrence within 180 days following any vaccination, including hepatitis B 5
Clinical Considerations
Contraindications and Precautions
- Hepatitis B vaccination is not contraindicated in persons with a history of GBS 1
- The only absolute contraindication to hepatitis B vaccination is a history of hypersensitivity to yeast or any vaccine component 1
Monitoring and Management
- The most common side effects of hepatitis B vaccination are pain at the injection site (3-29%) and fever >99.9°F (1-6%) 1
- Anaphylaxis is a confirmed but extremely rare adverse event, occurring at a rate of approximately 1 case per 1.1 million vaccine doses 1
Bottom Line
The benefits of hepatitis B vaccination in preventing serious illness, hospitalization, and death from hepatitis B infection substantially outweigh the theoretical risk of GBS. While isolated case reports exist 6, population-based studies have not demonstrated a causal relationship between hepatitis B vaccination and GBS 5.
For individuals with a history of GBS, the decision to vaccinate should be based on their risk of hepatitis B infection, as the evidence does not support withholding hepatitis B vaccination from these individuals.