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

A Real-world Evidence Study of BNT162b2 mRNA Covid-19 Vaccine Among Children Aged 5 to 11 Years in Brazil

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 among children aged 5 to 11 years in the city of Toledo in Southern Brazil.

Individuals aged 5 to 11 years who seek the public healthcare system with symptoms suggestive COVID-19 will be enrolled. Participants with a positive reverse transcriptase polymerase chain reaction (RT-PCR) test for SARS-CoV-2 will be classified as cases, and those with negative RT-PCR test for SARS-CoV-2 will be classified as controls. Cases will be followed-up for a period of 3 months by means of structured telephone interviews.

Study Overview

• Status: Completed
• Conditions: COVID-19
• Intervention / Treatment: Biological: Pfizer/BioNTech BNT162b2 mRNA COVID-19 vaccine; Biological: CoronaVac COVID-19 vaccine

• Study Type: Observational
• Enrollment (Actual): 757

Contacts and Locations

Study Locations

• Brazil
  • PR
    • Toledo, PR, Brazil
      • Jardim Coopagro
    • Toledo, PR, Brazil
      • Jardim Cosmos primary healthcare unit
    • Toledo, PR, Brazil
      • Jardim Maracanã
    • Toledo, PR, Brazil
      • Jardim Porto Alegre
    • Toledo, PR, Brazil
      • Pediatric Emergency Service

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 11 years (Child)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

The present study population will be composed by individuals aged 5 to 11 years who seek the public healthcare system of Toledo city with symptoms suggestive COVID-19. Participants with a positive RT-PCR test for SARS-CoV-2 will be classified as cases, and those with negative RT-PCR test for SARS-CoV-2 will be classified as controls.

Description

Inclusion Criteria:

• Age between 5 and 11 years;
• 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 or nasopharyngeal sample for SARS-CoV-2 test 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;
• Failure to perform RT-PCR for diagnosis of SARS-CoV-2 infection.

Study Plan

How is the study designed?

Number of groups / cohorts

7

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.
Two doses or more of BNT162b2; Defined as ≥ 2 doses of BNT162b2 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.	Biological: Pfizer/BioNTech BNT162b2 mRNA COVID-19 vaccine; Pfizer/BioNTech BNT162b2 mRNA COVID-19 vaccine
One dose of BNT162b2; Defined as 1 dose (only) of Pfizer/BioNTech BNT162b2 COVID-19 vaccine received with ≥14 days between receipt of the 1st dose and ARI symptom onset.	Biological: Pfizer/BioNTech BNT162b2 mRNA COVID-19 vaccine; Pfizer/BioNTech BNT162b2 mRNA COVID-19 vaccine
One dose or more of BNT162b2; 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.	Biological: Pfizer/BioNTech BNT162b2 mRNA COVID-19 vaccine; Pfizer/BioNTech BNT162b2 mRNA COVID-19 vaccine
Two doses of BNT162b2; Defined as 2 doses of BNT162b2 COVID-19 vaccine received with ≥7 days between receipt of the 2nd dose and acute respiratory illness (ARI) symptom onset.	Biological: Pfizer/BioNTech BNT162b2 mRNA COVID-19 vaccine; Pfizer/BioNTech BNT162b2 mRNA COVID-19 vaccine
Three doses of BNT162b2; Defined as 3 doses of BNT162b2 COVID-19 vaccine received with ≥7 days between receipt of the 3rd dose and acute respiratory illness (ARI) symptom onset.	Biological: Pfizer/BioNTech BNT162b2 mRNA COVID-19 vaccine; Pfizer/BioNTech BNT162b2 mRNA COVID-19 vaccine
Fully vaccinated with other available COVID-19 vaccines; Defined as fully vaccinated with available COVID-19 vaccines according to Brazil National Immunization Program recommendations.	Biological: CoronaVac COVID-19 vaccine; CoronaVac COVID-19 vaccine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 RT-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).	At the moment of enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality due to COVID-19	Incidence of COVID-19-related mortality	Within 90 days from enrollment
Odds of symptomatic SARS-CoV-2 infection due to Omicron variant	Odds of symptomatic SARS-CoV-2 infection due to Omicron variant defined by the presence of symptoms suggestive COVID-19 with a positive RT-PCR test for SARS-CoV-2 Omicron variant	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 RT-PCR test for SARS-CoV-2 variants of concern.	At the moment of enrollment
Duration of COVID-19 symptoms	Length of COVID-19-related symptoms	within 90 days from enrollment
Incidence of hospitalization due to COVID-19	Incidence of hospital admission due to COVID-19	Within 90 days from enrollment
Incidence of PICU admission	Incidence of Pediatric intensive care unit admission	Within 90 days from enrollment
Incidence of invasive mechanical ventilation	Incidence of invasive mechanical ventilation	Within 90 days from enrollment
Incidence of multisystem inflammatory syndrome	Incidence of multisystem inflammatory syndrome	Within 90 days from enrollment
Prevalence of long COVID-19 symptoms at 3 months	Prevalence of long COVID-19-related symptoms (fatigue, muscular weakness, dyspnea, cough, loss of taste or smell, concentration or memory difficulties, sleep disorders, headache)	Within 90 days from enrollment

Collaborators and Investigators

• Sponsor: Hospital Moinhos de Vento
• Collaborators: Pfizer; Universidade Federal do Paraná; Inova Medical
• Investigators: Principal Investigator: Regis G Rosa, MD, PhD, Hospital Moinhos de Vento, INOVA; Principal Investigator: Maicon Falavigna, MD, PhD, Hospital Moinhos de Vento, INOVA

Study record dates

Study Major Dates

• Study Start (Actual): June 8, 2022
• Primary Completion (Actual): April 30, 2023
• Study Completion (Actual): July 17, 2023

Study Registration Dates

• First Submitted: May 27, 2022
• First Submitted That Met QC Criteria: May 27, 2022
• First Posted (Actual): June 3, 2022

Study Record Updates

• Last Update Posted (Actual): November 7, 2023
• Last Update Submitted That Met QC Criteria: November 3, 2023
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: BNT162b2 pediatric Toledo

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes