Serious adverse events of special interest following mRNA COVID-19 vaccination in randomized trials in adults.

ABSTRACT:

Introduction

In 2020, prior to COVID-19 vaccine rollout, the Brighton Collaboration created a priority list, endorsed by the World Health Organization, of potential adverse events relevant to COVID-19 vaccines. We adapted the Brighton Collaboration list to evaluate serious adverse events of special interest observed in mRNA COVID-19 vaccine trials.

Methods

Secondary analysis of serious adverse events reported in the placebo-controlled, phase III randomized clinical trials of Pfizer and Moderna mRNA COVID-19 vaccines in adults (NCT04368728 and NCT04470427), focusing analysis on Brighton Collaboration adverse events of special interest.

Results

Pfizer and Moderna mRNA COVID-19 vaccines were associated with an excess risk of serious adverse events of special interest of

SUBMITTER: Fraiman J 

PROVIDER: S-EPMC9428332 | biostudies-literature | 2022 Sep

REPOSITORIES: biostudies-literature