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两剂 BNT162b2 疫苗对巴西和苏格兰青少年中 COVID-19 症状性和重症的有效性:时间依赖性的病例对照研究。

Vaccine effectiveness of two-dose BNT162b2 against symptomatic and severe COVID-19 among adolescents in Brazil and Scotland over time: a test-negative case-control study.

机构信息

Centre of Data and Knowledge Integration for Health (CIDACS), Gonçalo Moniz Institute, Oswaldo Cruz Foundation, Salvador, Brazil; Biomedical Science Institute, University of São Paulo, São Paulo, Brazil.

Usher Institute, University of Edinburgh, Edinburgh, UK.

出版信息

Lancet Infect Dis. 2022 Nov;22(11):1577-1586. doi: 10.1016/S1473-3099(22)00451-0. Epub 2022 Aug 8.

DOI:10.1016/S1473-3099(22)00451-0
PMID:35952702
原文链接:
https://pmc.ncbi.nlm.nih.gov/articles/PMC9359673/
Abstract

BACKGROUND

Little is known about vaccine effectiveness over time among adolescents, especially against the SARS-CoV-2 omicron (B.1.1.529) variant. This study assessed the associations between time since two-dose vaccination with BNT162b2 and the occurrence of symptomatic SARS-CoV-2 infection and severe COVID-19 among adolescents in Brazil and Scotland.

METHODS

We did test-negative, case-control studies in adolescents aged 12-17 years with COVID-19-related symptoms in Brazil and Scotland. We linked records of SARS-CoV-2 RT-PCR and antigen tests to national vaccination and clinical records. We excluded tests from individuals who did not have symptoms, were vaccinated before the start of the national vaccination programme, received vaccines other than BNT162b2 or a SARS-CoV-2 booster dose of any kind, or had an interval between their first and second dose of fewer than 21 days. Additionally, we excluded negative SARS-CoV-2 tests recorded within 14 days of a previous negative test, negative tests recorded within 7 days after a positive test, any test done within 90 days after a positive test, and tests with missing sex and location information. Cases (SARS-CoV-2 test-positive adolescents) and controls (test-negative adolescents) were drawn from a sample of individuals in whom tests were collected within 10 days of symptom onset. We estimated the adjusted odds ratio and vaccine effectiveness against symptomatic COVID-19 for both countries and against severe COVID-19 (hospitalisation or death) for Brazil across fortnightly periods.

FINDINGS

We analysed 503 776 tests from 2 948 538 adolescents in Brazil between Sept 2, 2021, and April 19, 2022, and 127 168 tests from 404 673 adolescents in Scotland between Aug 6, 2021, and April 19, 2022. Vaccine effectiveness peaked at 14-27 days after the second dose in both countries during both waves, and was significantly lower against symptomatic infection during the omicron-dominant period in Brazil (64·7% [95% CI 63·0-66·3]) and in Scotland (82·6% [80·6-84·5]), than it was in the delta-dominant period (80·7% [95% CI 77·8-83·3] in Brazil and 92·8% [85·7-96·4] in Scotland). Vaccine efficacy started to decline from 27 days after the second dose for both countries, reducing to 5·9% (95% CI 2·2-9·4) in Brazil and 50·6% (42·7-57·4) in Scotland at 98 days or more during the omicron-dominant period. In Brazil, protection against severe disease remained above 80% from 28 days after the second dose and was 82·7% (95% CI 68·8-90·4) at 98 days or more after receiving the second dose.

INTERPRETATION

We found waning vaccine protection of BNT162b2 against symptomatic COVID-19 infection among adolescents in Brazil and Scotland from 27 days after the second dose. However, protection against severe COVID-19 outcomes remained high at 98 days or more after the second dose in the omicron-dominant period. Booster doses for adolescents need to be considered.

FUNDING

UK Research and Innovation (Medical Research Council), Scottish Government, Health Data Research UK BREATHE Hub, Fiocruz, Fazer o Bem Faz Bem programme, Brazilian National Research Council, and Wellcome Trust.

TRANSLATION

For the Portuguese translation of the abstract see Supplementary Materials section.

摘要

背景

关于青少年接种两剂 BNT162b2 疫苗后,其针对 SARS-CoV-2 奥密克戎(B.1.1.529)变异株的疫苗有效性能持续多久,目前知之甚少。本研究评估了巴西和苏格兰青少年中,自接种两剂 BNT162b2 疫苗后,时间与出现有症状的 SARS-CoV-2 感染和严重 COVID-19 之间的关联。

方法

我们在巴西和苏格兰开展了青少年有 COVID-19 相关症状的检测阴性、病例对照研究。我们将 SARS-CoV-2 RT-PCR 和抗原检测的记录与国家疫苗接种和临床记录相联系。我们排除了无症状个体、在国家疫苗接种计划开始前接种疫苗、接种其他疫苗或任何类型的 SARS-CoV-2 加强剂、或第一剂和第二剂之间间隔少于 21 天的个体的检测。此外,我们还排除了在之前阴性检测后 14 天内记录的 SARS-CoV-2 阴性检测、在阳性检测后 7 天内记录的阴性检测、阳性检测后 90 天内记录的任何检测以及缺少性别和位置信息的检测。病例(SARS-CoV-2 检测阳性的青少年)和对照(SARS-CoV-2 检测阴性的青少年)均来自症状发作后 10 天内进行检测的个体样本。我们估计了两国的调整后比值比和针对有症状 COVID-19 的疫苗有效性,以及巴西针对严重 COVID-19(住院或死亡)的疫苗有效性,横跨每两周的时间段。

结果

我们分析了 2021 年 9 月 2 日至 2022 年 4 月 19 日期间巴西 2948538 名青少年和 2021 年 8 月 6 日至 2022 年 4 月 19 日期间苏格兰 404673 名青少年的 503776 次检测。在两波疫情中,疫苗有效性在第二剂后 14-27 天达到峰值,在巴西奥密克戎主导期间(64.7%[95%CI 63.0-66.3%])和苏格兰(82.6%[80.6-84.5%]),均显著低于针对有症状感染的德尔塔主导期间(80.7%[95%CI 77.8-83.3%])。在巴西,疫苗效力从第二剂后 27 天开始下降,在奥密克戎主导期间,98 天或更长时间后降至 5.9%(95%CI 2.2-9.4%),在苏格兰降至 50.6%(42.7-57.4%)。在巴西,从第二剂后 28 天开始,对严重疾病的保护仍保持在 80%以上,在接种第二剂后 98 天或更长时间,保护率为 82.7%(95%CI 68.8-90.4%)。

解释

我们发现,在巴西和苏格兰,青少年接种两剂 BNT162b2 疫苗后,针对有症状 COVID-19 感染的疫苗保护作用从第二剂后 27 天开始减弱。然而,在奥密克戎主导期间,98 天或更长时间后,对严重 COVID-19 结局的保护仍然很高。需要考虑为青少年接种加强剂。

资助

英国研究与创新署(医学研究理事会)、苏格兰政府、英国健康数据研究 UK BREATHE 中心、Fiocruz、Fazer o Bem Faz Bem 计划、巴西国家研究理事会和惠康信托基金会。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b3eb/9605873/9e336a5d1c87/gr2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b3eb/9605873/22b461facefd/gr1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b3eb/9605873/9e336a5d1c87/gr2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b3eb/9605873/22b461facefd/gr1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b3eb/9605873/9e336a5d1c87/gr2.jpg

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