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

被引：0

作者：

Rodrigues, Cristina de Oliveira ^{[1
]}

Spinardi, Julia ^{[2
]}

Rosa, Regis Goulart ^{[3
,4
,5
]}

Falavigna, Maicon ^{[5
,6
]}

de Souza, Emanuel Maltempi ^{[7
]}

Manfio, Joselia Larger ^{[5
]}

Souza, Ana Paula de ^{[5
]}

de Araujo, Cintia Laura Pereira ^{[5
]}

Cohen, Mirian ^{[5
,8
]}

Barbosa, Gynara Rezende Gonzalez do Valle ^{[5
]}

Silva, Fernanda Kelly Romeiro ^{[5
]}

Sganzerla, Daniel ^{[5
]}

da Silva, Mariana Motta Dias ^{[5
]}

Ferreira, Diogo ^{[9
]}

Kunkel, Nicolas Taciano ^{[5
]}

Camargo, Nathan Iori ^{[5
]}

Sarturi, Jean Carlos ^{[5
]}

Guilhem, Marcia Cristina ^{[5
]}

de Oliveira, Jaqueline Carvalho ^{[7
]}

Lopes, Caroline Cardoso ^{[5
]}

Widmar, Fernanda ^{[5
]}

Barufi, Leticia Killes ^{[5
]}

da Silva, Gabrielle Nunes ^{[5
]}

Gradia, Daniela Fiori ^{[7
]}

Brandalize, Ana Paula Carneiro ^{[1
]}

Royer, Carla Adriane ^{[7
]}

Luiz, Rafael Messias ^{[1
]}

Baura, Valter Antonio ^{[7
]}

Abreu, Hellen ^{[7
]}

Poitevin, Carolina Gracia ^{[7
]}

Kucharski, Gabriela Almeida ^{[10
]}

Pedrotti, Fernando ^{[10
]}

Valluri, Srinivas Rao ^{[2
]}

Srivastava, Amit ^{[2
,11
]}

Juliao, Viviane Wal ^{[2
]}

Melone, Olga Chameh ^{[2
]}

Allen, Kristen E. ^{[2
]}

Kyaw, Moe H. ^{[2
]}

Castillo, Graciela del Carmen Morales ^{[2
]}

Mclaughlin, John ^{[2
]}

机构：

[1] Fed Univ Parana UFPR, Fac Med, Campus Toledo, Toledo, Brazil

[2] Pfizer, Vaccines Med & Sci Affairs, Emerging Markets, Collegeville, PA USA

[3] Hosp Moinhosde Vento HMV, Internal Med Dept, Porto Alegre, RS, Brazil

[4] Inova Med, Res Unit, Porto Alegre, RS, Brazil

[5] HMV, Res Inst, Porto Alegre, RS, Brazil

[6] McMaster Univ, Dept Hlth Res Methods Evidence & Impact, Hamilton, ON, Canada

[7] UFPR, Dept Biochem & Mol Biol, Dept Genet, Curitiba, Brazil

[8] Fed Univ Rio Grandedo Sul UFRGS, Porto Alegre, Brazil

[9] Otus Solut, Porto Alegre, RS, Brazil

[10] Dept Hlth Toledo, Toledo, PR, Brazil

[11] Orbital Therapeut, Cambridge, MA USA

来源：

IMMUNOLOGY LETTERS | 2024年 / 269卷

关键词：

COVID-19; Vaccines; BNT162b2; vaccine; SARS-CoV-2; variants; Treatment outcome; Child; VACCINATION;

D O I：

10.1016/j.imlet.2024.106903

中图分类号：

R392 [医学免疫学]; Q939.91 [免疫学];

学科分类号：

100102 ;

摘要：

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. Trial registration number: ClinicalTrials.gov number, NCT05403307 (https://classic.clinicaltrials.gov/ct2/sh ow/NCT05403307)

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