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Effectiveness of BNT162b2 vaccine against SARS-CoV-2 infection and severe COVID-19 in children aged 5–11 years in Italy: a retrospective analysis of January–April, 2022
The Lancet ( IF 168.9 ) Pub Date : 2022-07-01 , DOI: 10.1016/s0140-6736(22)01185-0
Chiara Sacco 1 , Martina Del Manso 1 , Alberto Mateo-Urdiales 1 , Maria Cristina Rota 1 , Daniele Petrone 1 , Flavia Riccardo 1 , Antonino Bella 1 , Andrea Siddu 2 , Serena Battilomo 3 , Valeria Proietti 3 , Patrizia Popoli 4 , Francesca Menniti Ippolito 4 , Anna Teresa Palamara 1 , Silvio Brusaferro 5 , Giovanni Rezza 2 , Patrizio Pezzotti 1 , Massimo Fabiani 1 ,
Affiliation  

Background

By April 13, 2022, more than 4 months after the approval of BNT162b2 (Pfizer–BioNTech) for children, less than 40% of 5–11-year-olds in Italy had been vaccinated against COVID-19. Estimating how effective vaccination is in 5–11-year-olds in the current epidemiological context dominated by the omicron variant (B.1.1.529) is important to inform public health bodies in defining vaccination policies and strategies.

Methods

In this retrospective population analysis, we assessed vaccine effectiveness against SARS-CoV-2 infection and severe COVID-19, defined as an infection leading to hospitalisation or death, by linking the national COVID-19 surveillance system and the national vaccination registry. All Italian children aged 5–11 years without a previous diagnosis of infection were eligible for inclusion and were followed up from Jan 17 to April 13, 2022. All children with inconsistent vaccination data, diagnosed with SARS-CoV-2 infection before the start date of the study or without information on the municipality of residence were excluded from the analysis. With unvaccinated children as the reference group, we estimated vaccine effectiveness in those who were partly vaccinated (one dose) and those who were fully vaccinated (two doses).

Findings

By April 13, 2022, 1 063 035 (35·8%) of the 2 965 918 children aged 5–11 years included in the study had received two doses of the vaccine, 134 386 (4·5%) children had received one dose only, and 1 768 497 (59·6%) were unvaccinated. During the study period, 766 756 cases of SARS-CoV-2 infection and 644 cases of severe COVID-19 (627 hospitalisations, 15 admissions to intensive care units, and two deaths) were notified. Overall, vaccine effectiveness in the fully vaccinated group was 29·4% (95% CI 28·5–30·2) against SARS-CoV-2 infection and 41·1% (22·2–55·4) against severe COVID-19, whereas vaccine effectiveness in the partly vaccinated group was 27·4% (26·4–28·4) against SARS-CoV-2 infection and 38·1% (20·9–51·5) against severe COVID-19. Vaccine effectiveness against infection peaked at 38·7% (37·7–39·7) at 0–14 days after full vaccination and decreased to 21·2% (19·7–22·7) at 43–84 days after full vaccination.

Interpretation

Vaccination against COVID-19 in children aged 5–11 years in Italy showed a lower effectiveness in preventing SARS-CoV-2 infection and severe COVID-19 than in individuals aged 12 years and older. Effectiveness against infection appears to decrease after completion of the current primary vaccination cycle.

Funding

None.

Translation

For the Italian translation of the summary see Supplementary Materials section.



中文翻译:

BNT162b2 疫苗在意大利 5-11 岁儿童中对抗 SARS-CoV-2 感染和重症 COVID-19 的有效性:2022 年 1-4 月的回顾性分析

背景

到 2022 年 4 月 13 日,即 BNT162b2(辉瑞-BioNTech)获批用于儿童的 4 个多月后,意大利只有不到 40% 的 5-11 岁儿童接种了 COVID-19 疫苗。在当前由 omicron 变体 (B.1.1.529) 主导的流行病学背景下,估计 5-11 岁儿童的疫苗接种效果如何,对于告知公共卫生机构制定疫苗接种政策和策略非常重要。

方法

在这项回顾性人群分析中,我们通过将国家 COVID-19 监测系统和国家疫苗接种登记系统联系起来,评估了针对 SARS-CoV-2 感染和严重 COVID-19(定义为导致住院或死亡的感染)的疫苗有效性。所有先前未诊断出感染的 5-11 岁意大利儿童都有资格纳入,并在 2022 年 1 月 17 日至 4 月 13 日期间接受了随访。所有疫苗接种数据不一致、在开始日期之前被诊断患有 SARS-CoV-2 感染的儿童研究或没有居住城市信息的人被排除在分析之外。我们以未接种疫苗的儿童为参照组,评估了部分接种疫苗(一剂)和完全接种疫苗(两剂)的儿童的疫苗有效性。

发现

截至2022年4月13日,纳入研究的2 965 918名5-11岁儿童中有1 063 035名(35·8%)接种了两剂疫苗,134 386名(4·5%)儿童接种了一剂仅剂量,1 768 497 (59·6%) 未接种疫苗。在研究期间,共报告了 766 756 例 SARS-CoV-2 感染病例和 644 例重症 COVID-19 病例(627 例住院,15 例进入重症监护室,2 例死亡)。总体而言,完全接种组的疫苗针对 SARS-CoV-2 感染的有效性为 29·4%(95% CI 28·5–30·2),针对严重 COVID 的有效性为 41·1%(22·2–55·4) -19,而部分接种组的疫苗针对 SARS-CoV-2 感染的有效性为 27·4% (26·4–28·4),针对严重 COVID-19 的有效性为 38·1% (20·9–51·5) 19.

解释

在意大利,与 12 岁及以上的人相比,在意大利 5-11 岁的儿童中接种 COVID-19 疫苗在预防 SARS-CoV-2 感染和严重 COVID-19 方面的有效性较低。在完成当前的初级疫苗接种周期后,抗感染的有效性似乎会降低。

资金

没有任何。

翻译

有关摘要的意大利语翻译,请参阅补充材料部分。

更新日期:2022-07-01
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