# COVID-19 pediatric vaccine authorization, FDA authority, and individual misperception of risk

**Authors:** Joanna K Sax, Neal Doran

PMC · DOI: 10.1093/jlb/lsae006 · 2024-04-19

## TL;DR

This study examines public comments on a proposed pediatric COVID-19 vaccine authorization and finds that many comments opposed it due to misperceived risks.

## Contribution

The study introduces a novel approach to using public comments as an intervention to correct risk misperceptions related to vaccines.

## Key findings

- Most public comments opposed the EUA for the pediatric vaccine.
- Comments often reflected misperceptions of the vaccine's risks.
- Public participation processes could be modified to improve risk perception alignment with evidence.

## Abstract

Vaccines are one component to the public health strategies to alleviate the COVID-19 pandemic. Hesitancy regarding COVID-19 vaccines in the United States has been problematic, which is not surprising given increasing overall vaccine hesitancy in recent decades. Most vaccines are administered during childhood years. Consequently, understanding hesitancy toward administration of vaccines in this age group may provide insight into possible interventions to reduce vaccine hesitancy. The present study analyzed a subset of over 130,000 public comments posted in response to a notice of meeting of the vaccine advisory group to the Food and Drug Administration. The meeting addressed whether to recommend Emergency Use Authorization (‘EUA’) of the COVID-19 vaccine for children ages 5–11. The results of the study demonstrate that most comments opposed EUA and these comments were associated with statements that indicated misperceptions of risk. Findings provide interesting insights regarding the role of public comments generally but also suggest that the public participation process in notice and comment can be modified to serve as an intervention to align individual perceptions of risk more closely with evidence-based assessment of risk. In addition, the findings provide opportunities to consider strategies for public health messaging.

## Linked entities

- **Diseases:** COVID-19 (MONDO:0100096)

## Full-text entities

- **Diseases:** COVID-19 (MESH:D000086382)

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Source: https://tomesphere.com/paper/PMC11034974