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

Hospital Moinhos de Vento4,574 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

4,574

Conditions

Covid19

Interventions

Pfizer/BioNTech BNT162b2 mRNA COVID-19 vaccineDRUG

Pfizer/BioNTech BNT162b2 mRNA COVID-19 vaccine

Eligibility

Sex: ALLMin age: 12 Years

Medical Language ↔ Plain English

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.

Locations (3)

Pronto Atendimento Municipal de Toledo

Toledo, Paraná, Brazil

Unidade Básica de Saúde Jardim Cosmos

Toledo, Paraná, Brazil

Unidade de Pronto Atendimento Pediátrico Dr. José Ivo Alves da Rocha

Toledo, Paraná, Brazil

Outcomes

Primary Outcomes

Odds of symptomatic SARS-CoV-2 infection

Odds of symptomatic SARS-CoV-2 infection defined by the presence of symptoms suggestive COVID-19 with a positive PCR test for SARS-CoV-2. Symptoms suggestive of COVID-19 are defined as follows: 1) Acute respiratory illness 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).

Time frame: At the moment of enrollment

Secondary Outcomes

Odds of symptomatic SARS-CoV-2 infection due to Gamma variant

Odds of symptomatic SARS-CoV-2 infection due to Gamma variant defined by the presence of symptoms suggestive COVID-19 with a positive PCR test for SARS-CoV-2 Gamma variant

Time frame: At the moment of enrollment

Odds of symptomatic SARS-CoV-2 infection due to other circulating variants of concern

Odds of symptomatic SARS-CoV-2 infection due to other circulating variants of concern defined by the presence of symptoms suggestive COVID-19 with a positive PCR test for SARS-CoV-2 Alfa, Beta, or Delta variant

Time frame: At the moment of enrollment

Duration of COVID-19 symptoms

Length of COVID-19-related symptoms

Time frame: within 180 days from enrollment

Incidence of hospitalization due to COVID-19

Incidence of hospital admission due to COVID-19

Time frame: Within 30 days from enrollment

Incidence of ICU admission

Time frame: Within 30 days from enrollment

Incidence of mechanical ventilation

Incidence of invasive mechanical ventilation

Time frame: Within 30 days from enrollment

Mortality due to COVID-19

Incidence of COVID-19-related mortality

Time frame: Within 90 days from enrollment

Utility score of health-related quality of life at 3 months

Utility score of health-related quality of life assessed with the EuroQol- 5 dimensions 3-level questionnaire. The utility score derived from the descriptive system for the Brazilian population ranges from -0.176 (indicating the worst health status \[serious problems in all domains\]) to 1.0 (indicating the best health status \[no problems at all\])

Time frame: 90 days after enrollment

Prevalence of long COVID-19 symptoms at 6 months

Incidence of long COVID-19-related symptoms (fatigue, muscular weakness, dyspnea, cough, loss of taste or smell, concentration or memory difficulties, sleep disorders, headache, anxiety, and depression)

Time frame: 180 days after enrollment

Incidence of new symptomatic COVID-19 infection

Incidence of new symptomatic COVID-19 infection defined as recurrence of COVID-19-related symptoms with a positive PCR test for SARS-CoV-2 90 days after the index infection

Time frame: 365 days from enrollment

Incidence of any vaccine-related adverse event

Incidence of any vaccine-related adverse event including local pain, hyperemia or necrosis; fever; fatigue; headache; myalgia; arthralgia; vomiting; diarrhea; and other symptoms

Time frame: 365 days from enrollment

Incidence of vaccine-related severe adverse event

Incidence of any adverse event that result in death, hospitalization or prolongation of hospitalization, and persistent or significant disability

Time frame: 365 days from enrollment