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。

IF 4.3 3区材料科学 Q1 ENGINEERING, ELECTRICAL & ELECTRONIC ACS Applied Electronic Materials Pub Date : 2024-07-26 DOI:10.1016/j.imlet.2024.106903

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

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引用次数: 0

摘要

目的估计原始野生型 BNT162b2 对 5-11 岁儿童感染无症状奥米克龙病毒的有效性：这项前瞻性试验阴性病例对照研究于 2022 年 6 月至 2023 年 7 月在巴西南部托莱多市进行。研究对象包括 5-11 岁、因急性呼吸道症状到公共卫生系统就诊并通过反转录聚合酶链反应检测出 SARS-CoV-2 的患者。在主要分析中，我们确定了两剂原始野生型 BNT162b2 对无症状 COVID-19 的有效性。参考暴露组为未接种疫苗的儿童：共有 757 名儿童参与了研究，其中 461 人（25 例病例；436 例对照）被纳入主要分析。平均年龄为 7.4 岁，49.7% 为女性，34.6% 为肥胖，14.1% 患有慢性肺病。在所有已确定的 SARS-CoV-2 变体中，Omicron 占 100%，BA.5、BQ.1 和 XBB.1 分别占 35.7%、21.4% 和 21.4%。从接种第二剂疫苗到开始出现 COVID-19 症状的中位时间为 192.5 天（四分位间范围为 99 天至 242 天），调整后的估计值为 3.1%（95% CI，-133.7% 至 61.8%）：在这项以5-11岁儿童为对象的研究中，从第二次服药到开始出现COVID-19症状的中位时间为192天，两次服用原始野生型BNT162b2并不能显著预防无症状的奥米克龙感染，尽管该研究可能未达到检测临床重要差异的水平：ClinicalTrials.gov 编号：NCT05403307 (https://classic.Clinicaltrials: gov/ct2/show/NCT05403307)。

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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.