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.
Immunol Lett
; 269: 106903, 2024 Oct.
Article
en En
| MEDLINE
| ID: mdl-39069096
ABSTRACT
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/show/NCT05403307).Palabras clave
Texto completo:
1
Colección:
01-internacional
Base de datos:
MEDLINE
Asunto principal:
SARS-CoV-2
/
COVID-19
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Eficacia de las Vacunas
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Vacuna BNT162
Límite:
Child
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Child, preschool
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Female
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Humans
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Male
País/Región como asunto:
America do sul
/
Brasil
Idioma:
En
Revista:
Immunol Lett
Año:
2024
Tipo del documento:
Article
País de afiliación:
Brasil
Pais de publicación:
Países Bajos