Evidence map›Paper›PMID 36264905›Full record

ArticlePloS one2022

BNT162b2 against COVID-19 in Brazil using a test-negative design: Study protocol and statistical analysis plan.

Regis Goulart Rosa, Julia Spinardi, Kristen E Allen, Josélia Manfio, Cintia Laura Pereira de Araujo, Mírian Cohen, Caroline Cabral Robinson, Daniel Sganzerla, Diogo Ferreira, Emanuel Maltempi de Souza and 11 more

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in PloS one, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05052307 (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), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.3field-weighted citation impact, top 43% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05052307 completednot on this map

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

TypeobservationalSponsorHospital Moinhos de VentoRan2021 to 2023Enrolled4,574ConditionsCovid19ArmsPfizer/BioNTech BNT162b2 mRNA COVID-19 vaccine, CoronaVac COVID-19 vaccine, ChAdOx1 nCoV-19 Covid-19 Vaccine, Ad26.COV2.S COVID-19 Vaccine
3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 3 citations in OpenAlex.

  1. Observational
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

21 authors at 4 institutions in 3 countries.

Regis Goulart RosaSocial Responsibility Unit, Hospital Moinhos de Vento (HMV), Porto Alegre, RS, Brazil.ORCID 0000-0001-7881-9866
Julia SpinardiPfizer, Vaccines Medical and Scientific Affairs-Emerging Markets, Collegeville, PA, United States of America.
Kristen E AllenPfizer, Vaccines Medical and Scientific Affairs-Emerging Markets, Collegeville, PA, United States of America.
Josélia ManfioResearch Institute, HMV, Porto Alegre, RS, Brazil.
Cintia Laura Pereira de AraujoResearch Institute, HMV, Porto Alegre, RS, Brazil.
Mírian CohenResearch Institute, HMV, Porto Alegre, RS, Brazil.
Caroline Cabral RobinsonResearch Unit, Inova Medical, Porto Alegre, RS, Brazil.
Daniel SganzerlaUnimed, Porto Alegre, RS, Brazil.
Diogo FerreiraOtus Solutions, Porto Alegre, RS, Brazil.
Emanuel Maltempi de SouzaUniversidade Federal do Paraná (UFPR), Curitiba, PR, Brazil.
Jaqueline Carvalho de OliveiraUniversidade Federal do Paraná (UFPR), Curitiba, PR, Brazil.
Daniela Fiori GradiaUniversidade Federal do Paraná (UFPR), Curitiba, PR, Brazil.
Ana Paula Carneiro BrandalizeUniversidade Federal do Paraná (UFPR), Curitiba, PR, Brazil.
Gabriela Almeida KucharskiSecretaria Municipal de Saúde de Toledo, Toledo, PR, Brazil.
Fernando PedrottiSecretaria Municipal de Saúde de Toledo, Toledo, PR, Brazil.
Cristina de Oliveira RodriguesUniversidade Federal do Paraná (UFPR), Curitiba, PR, Brazil.ORCID 0000-0003-0845-0738
Moe H KyawPfizer, Vaccines Medical and Scientific Affairs-Emerging Markets, Collegeville, PA, United States of America.
Graciela Del Carmen Morales CastilloPfizer, Vaccines Medical and Scientific Affairs-Emerging Markets, Collegeville, PA, United States of America.
Amit SrivastavaPfizer, Vaccines Medical and Scientific Affairs-Emerging Markets, Collegeville, PA, United States of America.
John M McLaughlinPfizer, Vaccines Medical and Scientific Affairs-Emerging Markets, Collegeville, PA, United States of America.
Maicon FalavignaSocial Responsibility Unit, Hospital Moinhos de Vento (HMV), Porto Alegre, RS, Brazil.
Pfizer (United States) · USUniversidade Federal do Paraná · BRHospital Moinhos de Vento · BRSecretaria Municipal de Saúde · BR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionReal-world data on COVID-19 vaccine effectiveness are needed to validate evidence from randomized clinical trials. Accordingly, this study aims to evaluate, in a real-world setting in Brazil, the effectiveness of Pfizer-BioNTech BNT162b2 against symptomatic COVID-19 and COVID-19-related complications across diverse populations. MATERIALS AND

methodsA test-negative case-control study with follow-up of cases is currently being conducted in Toledo, a city in southern Brazil, following a mass COVID-19 vaccination campaign with BNT162b2. The study is being conducted among patients aged 12 years or older seeking care in the public health system with acute respiratory symptoms and tested for SARS-CoV-2 on reverse transcription polymerase chain reaction (RT-PCR). Cases are RT-PCR positive and controls RT-PCR negative. Test-positive cases are prospectively followed through structured telephone interviews performed at 15 days post-enrollment, and at 1, 3, 6, 9 and 12 months. Baseline demographic, clinical, and vaccination data are being collected by means of structured interviews and medical registry records reviews at the time of enrollment. All RT-PCR-positive samples are screened for mutations to identify SARS-CoV-2 variants. ETHICS AND DISSEMINATION: The study protocol has been approved by the research ethics committee of all participant sites. Study findings will be disseminated through peer-reviewed publications and conference presentations. TRAIL REGISTRATION: Clinicatrials.gov: NCT05052307.

Indexed as

COVID-19SARS-CoV-2BNT162 VaccineBrazilCase-Control StudiesCOVID-19 VaccinesHumansRandomized Controlled Trials as TopicBNT162 VaccineCOVID-19 Vaccines

Identifiers

PMID36264905
PMCPMC9584383
OpenAlexW4306898524

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.