Cristina de Oliveira Rodrigues , Julia Spinardi , Regis Goulart Rosa , Maicon Falavigna , Emanuel Maltempi de Souza , Josélia Larger Manfio , Ana Paula de Souza , Cintia Laura Pereira de Araujo , Mírian Cohen , Gynara Rezende Gonzalez do Valle Barbosa , Fernanda Kelly Romeiro Silva , Daniel Sganzerla , Mariana Motta Dias da Silva , Diogo Ferreira , Nicolas Taciano Kunkel , Nathan Iori Camargo , Jean Carlos Sarturi , Márcia Cristina Guilhem , Jaqueline Carvalho de Oliveira , Caroline Cardoso Lopes , John M McLaughlin
{"title":"原始 BNT162b2 mRNA COVID-19 在巴西 5-11 岁儿童中预防无症状奥米克龙感染的实际效果：一项前瞻性阴性试验设计研究。","authors":"Cristina de Oliveira Rodrigues , Julia Spinardi , Regis Goulart Rosa , Maicon Falavigna , Emanuel Maltempi de Souza , Josélia Larger Manfio , Ana Paula de Souza , Cintia Laura Pereira de Araujo , Mírian Cohen , Gynara Rezende Gonzalez do Valle Barbosa , Fernanda Kelly Romeiro Silva , Daniel Sganzerla , Mariana Motta Dias da Silva , Diogo Ferreira , Nicolas Taciano Kunkel , Nathan Iori Camargo , Jean Carlos Sarturi , Márcia Cristina Guilhem , Jaqueline Carvalho de Oliveira , Caroline Cardoso Lopes , John M McLaughlin","doi":"10.1016/j.imlet.2024.106903","DOIUrl":null,"url":null,"abstract":"<div><h3>Objective</h3><p>To estimate original wild-type BNT162b2 effectiveness against symptomatic Omicron infection among children 5–11 years of age.</p></div><div><h3>Methods</h3><p>This prospective test-negative, case-control study was conducted in Toledo, southern Brazil, from June 2022 to July 2023. Patients were included if they were aged 5–11 years, sought care for acute respiratory symptoms in the public health system, and were tested for SARS-CoV-2 using reverse transcription polymerase chain reaction. In the primary analysis, we determined the effectiveness of two doses of original wild-type BNT162b2 against symptomatic COVID-19. The reference exposure group was the unvaccinated.</p></div><div><h3>Results</h3><p>A total of 757 children were enrolled; of these, 461 (25 cases; 436 controls) were included in the primary analysis. Mean age was 7.4 years, 49.7 % were female, 34.6 % were obese, and 14.1 % had chronic pulmonary disease. Omicron accounted for 100 % of all identified SARS-CoV-2 variants with BA.5, BQ.1, and XBB.1 accounting for 35.7 %, 21.4 % and 21.4 %, respectively. The adjusted estimate of two-dose vaccine effectiveness against symptomatic Omicron was 3.1 % (95 % CI, -133.7 % to 61.8 %) after a median time between the second dose and the beginning of COVID-19 symptoms of 192.5 days (interquartile range, 99 to 242 days).</p></div><div><h3>Conclusion</h3><p>In this study with children 5–11 years of age, a two dose-schedule of original wild-type BNT162b2 was not associated with a significant protection against symptomatic Omicron infection after a median time between the second dose and the beginning of COVID-19 symptoms of 192 days, although the study may have been underpowered to detect a clinically important difference.</p></div><div><h3>Trial registration number</h3><p>ClinicalTrials.gov number, NCT05403307 (<span><span>https://classic.clinicaltrials.gov/ct2/show/NCT05403307</span><svg><path></path></svg></span>)</p></div>","PeriodicalId":13413,"journal":{"name":"Immunology letters","volume":"269 ","pages":"Article 106903"},"PeriodicalIF":3.3000,"publicationDate":"2024-07-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Real-world effectiveness of original BNT162b2 mRNA COVID-19 against symptomatic Omicron infection among children 5–11 years of age in Brazil: A prospective test-negative design study\",\"authors\":\"Cristina de Oliveira Rodrigues , Julia Spinardi , Regis Goulart Rosa , Maicon Falavigna , Emanuel Maltempi de Souza , Josélia Larger Manfio , Ana Paula de Souza , Cintia Laura Pereira de Araujo , Mírian Cohen , Gynara Rezende Gonzalez do Valle Barbosa , Fernanda Kelly Romeiro Silva , Daniel Sganzerla , Mariana Motta Dias da Silva , Diogo Ferreira , Nicolas Taciano Kunkel , Nathan Iori Camargo , Jean Carlos Sarturi , Márcia Cristina Guilhem , Jaqueline Carvalho de Oliveira , Caroline Cardoso Lopes , John M McLaughlin\",\"doi\":\"10.1016/j.imlet.2024.106903\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><h3>Objective</h3><p>To estimate original wild-type BNT162b2 effectiveness against symptomatic Omicron infection among children 5–11 years of age.</p></div><div><h3>Methods</h3><p>This prospective test-negative, case-control study was conducted in Toledo, southern Brazil, from June 2022 to July 2023. Patients were included if they were aged 5–11 years, sought care for acute respiratory symptoms in the public health system, and were tested for SARS-CoV-2 using reverse transcription polymerase chain reaction. In the primary analysis, we determined the effectiveness of two doses of original wild-type BNT162b2 against symptomatic COVID-19. The reference exposure group was the unvaccinated.</p></div><div><h3>Results</h3><p>A total of 757 children were enrolled; of these, 461 (25 cases; 436 controls) were included in the primary analysis. Mean age was 7.4 years, 49.7 % were female, 34.6 % were obese, and 14.1 % had chronic pulmonary disease. Omicron accounted for 100 % of all identified SARS-CoV-2 variants with BA.5, BQ.1, and XBB.1 accounting for 35.7 %, 21.4 % and 21.4 %, respectively. The adjusted estimate of two-dose vaccine effectiveness against symptomatic Omicron was 3.1 % (95 % CI, -133.7 % to 61.8 %) after a median time between the second dose and the beginning of COVID-19 symptoms of 192.5 days (interquartile range, 99 to 242 days).</p></div><div><h3>Conclusion</h3><p>In this study with children 5–11 years of age, a two dose-schedule of original wild-type BNT162b2 was not associated with a significant protection against symptomatic Omicron infection after a median time between the second dose and the beginning of COVID-19 symptoms of 192 days, although the study may have been underpowered to detect a clinically important difference.</p></div><div><h3>Trial registration number</h3><p>ClinicalTrials.gov number, NCT05403307 (<span><span>https://classic.clinicaltrials.gov/ct2/show/NCT05403307</span><svg><path></path></svg></span>)</p></div>\",\"PeriodicalId\":13413,\"journal\":{\"name\":\"Immunology letters\",\"volume\":\"269 \",\"pages\":\"Article 106903\"},\"PeriodicalIF\":3.3000,\"publicationDate\":\"2024-07-26\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Immunology letters\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://www.sciencedirect.com/science/article/pii/S0165247824000774\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q3\",\"JCRName\":\"IMMUNOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Immunology letters","FirstCategoryId":"3","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S0165247824000774","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"IMMUNOLOGY","Score":null,"Total":0}
Real-world effectiveness of original BNT162b2 mRNA COVID-19 against symptomatic Omicron infection among children 5–11 years of age in Brazil: A prospective test-negative design study
Objective
To estimate original wild-type BNT162b2 effectiveness against symptomatic Omicron infection among children 5–11 years of age.
Methods
This prospective test-negative, case-control study was conducted in Toledo, southern Brazil, from June 2022 to July 2023. Patients were included if they were aged 5–11 years, sought care for acute respiratory symptoms in the public health system, and were tested for SARS-CoV-2 using reverse transcription polymerase chain reaction. In the primary analysis, we determined the effectiveness of two doses of original wild-type BNT162b2 against symptomatic COVID-19. The reference exposure group was the unvaccinated.
Results
A total of 757 children were enrolled; of these, 461 (25 cases; 436 controls) were included in the primary analysis. Mean age was 7.4 years, 49.7 % were female, 34.6 % were obese, and 14.1 % had chronic pulmonary disease. Omicron accounted for 100 % of all identified SARS-CoV-2 variants with BA.5, BQ.1, and XBB.1 accounting for 35.7 %, 21.4 % and 21.4 %, respectively. The adjusted estimate of two-dose vaccine effectiveness against symptomatic Omicron was 3.1 % (95 % CI, -133.7 % to 61.8 %) after a median time between the second dose and the beginning of COVID-19 symptoms of 192.5 days (interquartile range, 99 to 242 days).
Conclusion
In this study with children 5–11 years of age, a two dose-schedule of original wild-type BNT162b2 was not associated with a significant protection against symptomatic Omicron infection after a median time between the second dose and the beginning of COVID-19 symptoms of 192 days, although the study may have been underpowered to detect a clinically important difference.
期刊介绍：
Immunology Letters provides a vehicle for the speedy publication of experimental papers, (mini)Reviews and Letters to the Editor addressing all aspects of molecular and cellular immunology. The essential criteria for publication will be clarity, experimental soundness and novelty. Results contradictory to current accepted thinking or ideas divergent from actual dogmas will be considered for publication provided that they are based on solid experimental findings.
Preference will be given to papers of immediate importance to other investigators, either by their experimental data, new ideas or new methodology. Scientific correspondence to the Editor-in-Chief related to the published papers may also be accepted provided that they are short and scientifically relevant to the papers mentioned, in order to provide a continuing forum for discussion.
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