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

Area of Science:

• Epidemiology
• Vaccinology
• Public Health

Background:

• Real-world vaccine effectiveness data are crucial for validating clinical trial findings.
• COVID-19 vaccine effectiveness studies are needed globally, particularly in diverse populations.
• The Pfizer-BioNTech BNT162b2 vaccine has been widely deployed, necessitating real-world effectiveness evaluations.

Purpose of the Study:

• To evaluate the real-world effectiveness of the Pfizer-BioNTech BNT162b2 vaccine against symptomatic COVID-19.
• To assess the vaccine's efficacy in preventing COVID-19-related complications.
• To analyze vaccine effectiveness across diverse demographic groups in Brazil.

Main Methods:

• Test-negative case-control study design with prospective follow-up.
• Participants aged 12+ with acute respiratory symptoms tested for SARS-CoV-2 via RT-PCR.
• Data collection includes baseline demographics, clinical information, vaccination status, and variant screening.

Main Results:

• N/A - Study is ongoing.

Conclusions:

• N/A - Study is ongoing. Findings will inform public health strategies and vaccine recommendations.