From trial to practice: incidence and severity of COVID-19 vaccine side effects in a medically at-risk and vaccine-hesitant community.

ABSTRACT

BACKGROUND: The rapid authorization and widespread rollout of COVID-19 vaccines in the United States demonstrated a need for additional data on vaccine side effects, both to provide insight into the range and severity of side effects that might be expected in medically-diverse populations as well as to inform decision-making and combat vaccine hesitancy going forward. Here we report the results of a survey of 4825 individuals from southcentral Kentucky who received two doses of either the Pfizer-BioNTech (BNT162b2) or Moderna (mRNA-1273) vaccine between December 14, 2020 and May 1, 2021. As new versions of the vaccine are rolled-out, local initiatives such as this may offer a means to combat vaccine hesitancy in reference to COVID-19, but are also important as we face new viral threats that will necessitate a rapid vaccine rollout, and to combat a growing public distrust of vaccines in general. METHODS: Individuals that received two doses of either BNT162b2 or mRNA-1273 between December 14, 2020 and May 1, 2021 were sent a survey, created by the research team. Respondents were asked to rate the incidence and severity of 15 potential side effects and two related outcomes following each of their two doses of the vaccine. All statistical analyses were carried out using SYSTAT, version 13. The data were analyzed utilizing a range of statistical tests, including chi-square tests of association, Cohen's h, Kruskal-Wallis test one-way nonparametric ANOVA, least-squares regression, and Wilcoxon signed-ranks test. Significance was assessed using Bonferroni-adjusted criteria within families of tests. RESULTS: In general, the pattern and severity in side effects was similar to both clinical trial data as well as other published studies. Responses to the mRNA-1273 vaccine were more severe than to BNT162b2, though all were generally in the mild to moderate category. Individuals who reported having previously tested positive for COVID-19 reported stronger responses following the first dose of either vaccine relative to COVID-naïve individuals. The reported severity to the COVID-19 vaccine was positively correlated with self-reported responses to other vaccines. CONCLUSIONS: Our findings allow broad-scale estimates of the nature and severity of reactions one might expect following vaccination within a clinically-diverse community, and provide a context for addressing vaccine hesitancy in communities such as ours, where locally-generated data and communication may be more influential than national trends and statistics in convincing individuals to become vaccinated. Further, we argue this community-based approach could be important in the future in three key ways 1) as new boosters and modified vaccines re-volatilize vaccine hesitancy, 2) as new vaccines receive similar testing and rapid authorization, and 3) to combat vaccine hesitancy in other arenas (e.g., annual vaccines, childhood vaccines).