BNT162b2 against COVID-19 in Brazil using a test-negative design: Study protocol and statistical analysis plan.

ABSTRACT:

Introduction

Real-world data on COVID-19 vaccine effectiveness are needed to validate evidence from randomized clinical trials. Accordingly, this study aims to evaluate, in a real-world setting in Brazil, the effectiveness of Pfizer-BioNTech BNT162b2 against symptomatic COVID-19 and COVID-19-related complications across diverse populations.

Materials and methods

A test-negative case-control study with follow-up of cases is currently being conducted in Toledo, a city in southern Brazil, following a mass COVID-19 vaccination campaign with BNT162b2. The study is being conducted among patients aged 12 years or older seeking care in the public health system with acute respiratory symptoms and tested for SARS-CoV-2 on reverse transcription polymerase chain reaction (RT-PCR). Cases

SUBMITTER: Goulart Rosa R 

PROVIDER: S-EPMC9584383 | biostudies-literature | 2022

REPOSITORIES: biostudies-literature