Journal Scan / Research · August 02, 2022 Risk Factors for Granulomas in Children Following Immunization With Aluminium-Adsorbed Vaccines Contact Dermatitis

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• A Danish nationwide cohort study involving more than 500,000 children vaccinated from 2009 to 2018 found a 0.34% absolute risk for developing a vaccination granuloma. The risk factors for vaccination granulomas were investigated at the vaccine, child, and maternal levels. The factors associated with increased risk of vaccination granuloma development included vaccines with a hydroxide adjuvant, increased aluminium dosage, female sex, and term birth (vs premature birth). The timing of vaccination appointments did not alter the risk of vaccination granulomas.

• With rising vaccine hesitancy, parents should be reassured that the overall risk for the development of vaccination granulomas due to aluminium-adsorbed vaccines is quite low.

–  Ruth McTighe, MD

Abstract

BACKGROUND

Aluminium-adsorbed vaccines may in some children cause severely itching nodules at the injection site, known as vaccination granulomas.

OBJECTIVE

To investigate vaccine-, child- and maternal-level risk factors for the development of vaccination granulomas following immunization with aluminium-adsorbed vaccines.

METHODS

A Danish population-based cohort study with 553 932 children born in Denmark from 1 January 2009 to 31 December 2018, vaccinated with an aluminium-adsorbed vaccine during the first year of life, followed until 31 December 2020. Poisson regression was used to estimate granuloma rate ratios according to the type of adjuvant, accumulated dose of aluminium, timing of vaccination appointments, sex, gestational age, having siblings with granulomas, maternal age and maternal ethnicity.

RESULTS

We identified 1901 vaccination granuloma cases (absolute risk, 0.34%). Among vaccine level factors, revaccination (third vs. first vaccination appointment, adjusted rate ratio [RR] 1.26, 95% confidence interval [CI] 1.03-1.55), the specific adjuvant used (aluminium phosphate vs. hydroxide, RR 0.58, 95% CI 0.48-0.70) and dosage (≥1.0 mg vs. <1.0 mg, RR 1.34, 95% CI 1.19-1.52) were associated with risk of granulomas; the timing of vaccination appointments was not. Among child-level factors, female sex (vs. males, RR 1.12, 95% CI, 1.02-1.22), prematurity (vs. term birth, RR 0.71, 95% CI, 0.54-0.93) and having sibling(s) with granulomas (vs. no siblings with granulomas, RR 46.15, 95% CI, 33.67-63.26) were associated with risk of granulomas. Among maternal-level factors, non-Danish ethnicity (vs. Danish, RR 0.51, 95% CI, 0.42-0.63) and young maternal age (<20 years vs. 20-39 years, RR 0.46, 95% CI 0.25-0.83) were associated with risk of granulomas.

CONCLUSIONS

Several risk factors for vaccination granulomas at the vaccine, child and maternal levels, were identified. Reducing the dose of aluminium or replacing aluminium hydroxide with aluminium phosphate could reduce the risk of granulomas. However, this must be balanced against the potential for reduced immunogenicity.

Contact Dermatitis

Risk factors for granulomas in children following immunization with aluminium-adsorbed vaccines: A Danish population-based cohort study

Contact Derm 2022 Jul 02;[EPub Ahead of Print], SS Hoffmann, EM Thiesson, JD Johansen, A Hviid 

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Benjamin Hidalgo-Matlock
Skin Care Physicians of Costa Rica

Clinica Victoria en San Pedro: 4000-1054
Momentum Escazu: 2101-9574

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