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Risk of hospitalisation with fever following MenB vaccination: self-controlled case series analysis
Heather Murdoch1, Lynn Wallace2, Jennifer Bishop2
1Immunisation Team, Health Protection Scotland, National Services Scotland, Glasgow, UK.
Objective:
To investigate a possible association between fever admissions and 4 component Meningococcal B (4CMenB).
Design:
4CMenB is given at 8 and 16 weeks in the first year of life. Self-controlled case series using linked routinely collected healthcare data, where the risk period was the 3 days immediately following receipt of a vaccine dose.
Patients:
Children aged under 1 year in Scotland preintroduction and postintroduction of 4CMenB vaccine (pre-September 2014 to August 2015 and post-September 2015 to June 2016).
Main Outcome Measures:
Hospitalisations for fever attributable to 4CMenB vaccine.
Results:
The postintroduction model showed an increased risk in the 3 days after dose 1 (relative incidence (RI), 10.78; 95% CI: 8.31 to 14.00) and dose 3 (RI, 9.80; 95% CI: 7.10 to 13.62), with a smaller increased risk after dose 2 (RI, 2.20; 95% CI: 1.27 to 3.82). The magnitude of these effects was greater than in the preintroduction model. The attributable fractions were 90.7%, 54.8% and 89.7%, equating to 162, 14 and 84 vaccine attributable cases per 100 000 doses, respectively.This is equivalent to 102 extra hospitalisations in Scotland annually, based on a birth cohort of 55 100 and extrapolated to 1430 across the UK based on a birth cohort of 777 165.
Conclusion:
There is an increased risk of hospital admission with fever within 3 days of the routine childhood immunisations at 8 and 16 weeks following introduction of 4CMenB vaccine. The results indicate that further understanding of the current use of prophylactic paracetamol is needed. Communication to parents and health professionals may also need to be re-examined, and guidance on the use of prophylactic paracetamol reinforced.
Insights
The four-component Meningococcal B (4CMenB) vaccine is associated with an increased risk of fever-related hospital admissions in infants. Further research into prophylactic paracetamol use and improved communication are recommended.
Area of Science:
- Pediatric Vaccinology
- Immunology
- Public Health
Background:
- The four-component Meningococcal B (4CMenB) vaccine is a crucial tool for preventing meningococcal disease.
- Routine childhood immunizations are administered at specific ages, with potential for vaccine-associated side effects.
Purpose of the Study:
- To investigate the association between fever hospital admissions and the 4CMenB vaccine.
- To quantify the risk of fever hospitalizations following 4CMenB vaccination in infants.
Main Methods:
- A self-controlled case series study design was employed.
- Routinely collected healthcare data from children under one year in Scotland were analyzed.
- The risk period was defined as the three days immediately following vaccine administration.
Main Results:
- An increased risk of hospital admission for fever was observed within three days of 4CMenB vaccine doses, particularly after dose 1 and dose 3.
- The magnitude of this risk was greater post-introduction of the vaccine.
- Attributable fractions indicated a significant number of vaccine-associated fever hospitalizations, estimated at 102 annually in Scotland.
Conclusions:
- The introduction of the 4CMenB vaccine is linked to a heightened risk of fever hospital admissions in infants.
- Current practices regarding prophylactic paracetamol use require further investigation.
- Communication strategies for parents and healthcare professionals regarding fever management post-vaccination may need revision.