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

Hospital Moinhos de Vento

Status: Completed

Conditions: Covid19

Treatments: Drug: ChAdOx1 nCoV-19 Covid-19 Vaccine; Drug: CoronaVac COVID-19 vaccine; Drug: Pfizer/BioNTech BNT162b2 mRNA COVID-19 vaccine; Drug: Ad26.COV2.S COVID-19 Vaccine

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT05052307

BNT162b2 in Toledo, Brazil

Details and patient eligibility

About

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.

Enrollment: 4,574 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

4,574 participants in 6 patient groups

Fully vaccinated with BNT162b2 COVID-19 vaccine

Description:

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.

Treatment:

Drug: Pfizer/BioNTech BNT162b2 mRNA COVID-19 vaccine

Ever vaccinated with BNT162b2 COVID-19 vaccine

Description:

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.

Treatment:

Drug: Pfizer/BioNTech BNT162b2 mRNA COVID-19 vaccine

Partially vaccinated with BNT162b2 COVID-19 vaccine

Description:

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.

Treatment:

Drug: Pfizer/BioNTech BNT162b2 mRNA COVID-19 vaccine

Fully vaccinated with other available COVID-19 vaccines

Description:

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

Treatment:

Drug: CoronaVac COVID-19 vaccine

Drug: ChAdOx1 nCoV-19 Covid-19 Vaccine

Drug: Ad26.COV2.S COVID-19 Vaccine

Never vaccinated

Description:

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.

Fully vaccinated plus booster dose of BNT162b2 COVID-19 vaccine

Description:

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.

Treatment:

Drug: CoronaVac COVID-19 vaccine

Drug: ChAdOx1 nCoV-19 Covid-19 Vaccine

Drug: Pfizer/BioNTech BNT162b2 mRNA COVID-19 vaccine

Drug: Ad26.COV2.S COVID-19 Vaccine