Predictors of moderate-to-severe side-effects following COVID-19 mRNA booster vaccination: a prospective cohort study among primary health care providers in Belgium.

Predictors of moderate-to-severe side-effects following COVID-19 mRNA booster vaccination: a prospective cohort study among primary health care providers in Belgium.

Publication date: Oct 10, 2024

COVID-19 vaccine effectiveness declines months after vaccination. Therefore, it is likely that during the next few years, people may be repeatedly offered a booster vaccine to enhance humoral immunity levels. A growing number of people are questioning whether the benefits of a booster vaccine outweigh the side-effects. This study aims (1) to identify the most frequently reported side-effects after different doses of COVID-19 mRNA vaccines, (2) and the longest lasting symptoms; and (3) to predict the likelihood of having moderate-to-severe side-effects after a booster COVID-19 mRNA vaccine given individual- and vaccine-specific characteristics. Secondary analysis of a prospective cohort study in primary health care providers (PHCPs) in Belgium conducted between December 2020 and December 2021, and in February-March 2023. In nine subsequent surveys over a period of 2 years vaccine dose-number and side-effects after COVID-19 vaccines were collected. A Generalized Estimation Equations approach on the data of the first and second booster dose was used to investigate the probability of having moderate-to-severe side-effects after mRNA booster vaccination. Predictive performance of a binary classifier was assessed by looking at discrimination (i. e., quantified in terms of the area under the receiver operating characteristic curve). The final prediction model was validated using data with regard to the third booster by assessing misclassification rate, sensitivity and specificity. In total, 11% of the PHCPs had moderate-to-severe side-effects after their booster COVID-19 mRNA vaccine. The most common side-effects of COVID-19 mRNA doses included fatigue, local pain at the injection site, general pains, and headache. These side-effects typically lasted for a median of 1 to 2 days. The final model included five predictors: sex, alcohol consumption, history of moderate-to-severe side-effects after any previous dose, recent COVID-19 infection, and the booster dose-number (first, second). Having experienced moderate-to-severe side-effects after any previous dose was the strongest predictor of moderate-to-severe side-effects following an mRNA vaccine booster, with an odds ratio (OR) of 3. 64 (95% CI: 2. 80-4. 75). The OR for female sex was 1. 49 (95% CI: 1. 21-1. 84) implying that females have a higher odds of moderate-to-severe side-effects following booster vaccination. The differences in effect for booster dose-number, alcohol consumption and recent COVID-19 infection was not significant. COVID-19 mRNA booster vaccination implies a low prevalence of moderate-to-severe side-effects among PHCPs, with a short median duration of symptoms if any. The strongest predictors are a history of moderate-to-severe side-effects after any previous dose and being female. These reassuring findings can help addressing concerns about booster vaccination and encourage their uptake. NCT04779424 (registration date: 2021-02-22).

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Concepts Keywords
Belgium Adult
Headache Belgium
Nct04779424 COVID-19
Vaccine COVID-19
COVID-19 Vaccines
COVID-19 Vaccines
Female
Health Personnel
Humans
Immunization, Secondary
Male
Middle Aged
Primary Health Care
Prospective Studies
Side-effects
Vaccination

Semantics

Type Source Name
disease MESH COVID-19
disease IDO site
drug DRUGBANK Ethanol
disease IDO history
disease MESH infection
pathway REACTOME Reproduction
disease MESH Infectious Diseases
pathway REACTOME Immune System
disease MESH emergency
disease MESH allergy
disease MESH dyspnea
disease MESH chronic diseases
disease IDO symptom
drug DRUGBANK Sulfasalazine
drug DRUGBANK Coenzyme M

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