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Safety of LAIV Vaccination in Asthma or Wheeze: A Systematic Review and GRADE Assessment
Allyn Bandell1, Lucia Giles2, Penélope Cervelo Bouzo3
1US Medical Affairs, AstraZeneca, Gaithersburg, Maryland.
Insights
Live attenuated influenza vaccine (LAIV) and inactivated influenza vaccine (IIV) show similar safety profiles in individuals with asthma or recurrent wheeze. This review found comparable outcomes, supporting informed vaccination decisions for this population.
Area of Science:
- Immunology
- Pediatric Pulmonology
- Vaccinology
Background:
- Current US guidelines recommend contraindications and precautions for live attenuated influenza vaccine (LAIV) in children with asthma or recurrent wheeze.
- These recommendations highlight the need for evidence-based safety assessments of influenza vaccines in asthmatic populations.
Purpose of the Study:
- To evaluate the certainty of evidence regarding the safety of LAIV compared to inactivated influenza vaccine (IIV) or no vaccine in individuals with asthma or wheeze.
- To assess safety differences before and after LAIV administration in eligible populations.
Main Methods:
- Comprehensive literature search of Embase, MEDLINE, CCTR, and CDSR databases up to August 27, 2024.
- Screening and data extraction performed by one reviewer, with 10% independent verification.
- Risk of bias and evidence certainty assessed using ROB2, ROBINS-I, and GRADE frameworks.
Main Results:
- Twenty-four studies were identified, with 15 included in the GRADE assessment.
- No significant differences in patient-reported safety outcomes were found between LAIV and IIV in 86.7% of studies (very low to moderate certainty evidence).
- LAIV was associated with higher rhinitis incidence but lower inpatient/emergency visits and wheezing compared to IIV.
Conclusions:
- Despite heterogeneity precluding meta-analysis, findings suggest comparable safety between LAIV and IIV in individuals with asthma and/or recurrent wheeze.
- The safety profile appears consistent across different disease severities.
Context:
The US Advisory Committee on Immunization Practices states a contraindication for live attenuated influenza vaccine (LAIV) use in children aged 2 to 4 years with asthma or recurrent wheeze plus a precaution, defined as defer vaccine use, in those aged >5 years with asthma.
Objective:
We assessed the certainty of evidence on the safety of LAIV vs inactivated influenza vaccine (IIV) or no vaccine, or before vs after LAIV, in eligible individuals with asthma and/or wheeze.
Data Sources:
Embase, MEDLINE, CCTR, and CDSR were searched for eligible studies (database inception to August 27, 2024) via Ovid/Elsevier.
Study Selection:
Screening (title/abstract and full text) and data extraction were performed by a single reviewer; an independent reviewer screened 10%. Risk of bias (ROB) was assessed using ROB2 and ROBINS-I. Evidence certainty was assessed using the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) framework.
Results:
Searches yielded 24 eligible studies (28 publications); 15 comparative studies were included in the GRADE assessment. No difference in patient-reported safety outcomes was reported in 86.7% of studies comparing LAIV and IIV (all ages and disease severities; "very low" to "moderate" certainty evidence). A higher instance of rhinitis and a lower incidence of inpatient/emergency department visits and wheezing were reported after LAIV vs IIV. Evidence was mostly downgraded for ROB, imprecision, and indirectness. Similar results were observed for all comparisons.
Limitations:
The heterogeneity of identified outcomes precluded a meta-analysis.
Conclusions:
This suggests comparable safety outcomes with LAIV vs IIV in persons with asthma and/or recurrent wheeze, irrespective of disease severity.
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