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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

4574 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-11-03

Study Completion Date

2023-07-20

Brief Summary

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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.

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Detailed Description

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Conditions

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Covid19

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Fully vaccinated with BNT162b2 COVID-19 vaccine

Defined as 2 doses of Pfizer/BioNTech BNT162b2 mRNA COVID-19 vaccine received with ≥7 days between receipt of the 2nd dose and acute respiratory illness (ARI) symptom onset. This group will serve as the 'exposed' group evaluated in the primary objective.

Pfizer/BioNTech BNT162b2 mRNA COVID-19 vaccine

Intervention Type DRUG

Pfizer/BioNTech BNT162b2 mRNA COVID-19 vaccine

Ever vaccinated with BNT162b2 COVID-19 vaccine

defined as ≥1 dose of Pfizer/BioNTech BNT162b2 mRNA COVID-19 vaccine received with ≥14 days between receipt of the 1st dose and ARI symptom onset.

Pfizer/BioNTech BNT162b2 mRNA COVID-19 vaccine

Intervention Type DRUG

Pfizer/BioNTech BNT162b2 mRNA COVID-19 vaccine

Partially vaccinated with BNT162b2 COVID-19 vaccine

Defined as 1 dose (only) of Pfizer/BioNTech BNT162b2 mRNA COVID-19 vaccine received with ≥14 days between receipt of the 1st dose and ARI symptom onset.

Pfizer/BioNTech BNT162b2 mRNA COVID-19 vaccine

Intervention Type DRUG

Pfizer/BioNTech BNT162b2 mRNA COVID-19 vaccine

Fully vaccinated with other available COVID-19 vaccines

Defined as fully vaccinated with available COVID-19 vaccines other than the BNT162b2 according to the manufacturer recommendations.

CoronaVac COVID-19 vaccine

Intervention Type DRUG

CoronaVac COVID-19 vaccine

ChAdOx1 nCoV-19 Covid-19 Vaccine

Intervention Type DRUG

ChAdOx1 nCoV-19 Covid-19 Vaccine

Ad26.COV2.S COVID-19 Vaccine

Intervention Type DRUG

Ad26.COV2.S COVID-19 Vaccine

Never vaccinated

Defined as never received any COVID-19 vaccine. This group will serve as the reference exposure group (i.e., 'unexposed' group) in all vaccine effectiveness analyses.

No interventions assigned to this group

Fully vaccinated plus booster dose of BNT162b2 COVID-19 vaccine

Defined as fully vaccinated with available COVID-19 vaccines according to the manufacturer recommendations plus booster dose of BNT162b2 COVID-19 vaccine received with ≥14 days between receipt of the 1st dose and ARI symptom onset.

Pfizer/BioNTech BNT162b2 mRNA COVID-19 vaccine

Intervention Type DRUG

Pfizer/BioNTech BNT162b2 mRNA COVID-19 vaccine

CoronaVac COVID-19 vaccine

Intervention Type DRUG

CoronaVac COVID-19 vaccine

ChAdOx1 nCoV-19 Covid-19 Vaccine

Intervention Type DRUG

ChAdOx1 nCoV-19 Covid-19 Vaccine

Ad26.COV2.S COVID-19 Vaccine

Intervention Type DRUG

Ad26.COV2.S COVID-19 Vaccine

Interventions

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Pfizer/BioNTech BNT162b2 mRNA COVID-19 vaccine

Intervention Type DRUG

CoronaVac COVID-19 vaccine

Intervention Type DRUG

ChAdOx1 nCoV-19 Covid-19 Vaccine

Intervention Type DRUG

Ad26.COV2.S COVID-19 Vaccine

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No