A Real-world Evidence Study of BNT162b2 mRNA Covid-19 Vaccine in Brazil

Effectiveness of Pfizer-BioNTech BNT162b2 mRNA COVID-19 Vaccine on Symptomatic SARS-CoV-2 Infection and COVID-19-related Hospitalizations, Mortality, and Long-term Consequences in Brazil: a Real-world Evidence Study

The present test-negative design study aims to estimate the real-world effectiveness of Pfizer-BioNTech BNT162b2 mRNA vaccine on symptomatic SARS-CoV-2 infection and its consequences following a mass vaccination campaign in the city of Toledo in Southern Brazil.

Individuals aged 12 years or older who seek the public healthcare system with symptoms suggestive COVID-19 will be enrolled. Participants with a positive polymerase chain reaction (PCR) test for SARS-CoV-2 will be classified as cases, and those with negative PCR test for SARS-CoV-2 will be classified as controls. Cases will be followed-up for a period of one year by means of structured telephone interviews.

Inclusion Criteria:

• Age ≥ 12 years old;
• Resident of Toledo city;
• Seeking care in the public healthcare system with symptoms suggestive of COVID-19 defined as follows: 1) ARI symptoms (nasal congestion, rhinorrhea, anosmia, sore throat, hoarseness, new or increased-from-baseline cough, sputum production, dyspnea, wheezing, myalgia) OR 2) Admitting diagnosis suggestive of ARI (pneumonia, upper respiratory infection, bronchitis, influenza, cough, asthma, viral respiratory illness, respiratory distress, AND/OR respiratory failure).
• Nasal sample for SARS-CoV-2 diagnosis obtained as standard of care.

Exclusion Criteria:

• SARS-CoV-2-directed antiviral treatment within the past 30 days;
• COVID-19 monoclonal antibody therapy within the past 90 days;
• COVID-19 convalescent serum therapy within the past 90 days;
• Lack of consent to participate.