辉瑞-生物科技 BNT162b2 mRNA 疫苗预防非免疫功能低下 5-17 岁儿童和青少年与 COVID-19 相关的急诊和紧急护理就诊及住院的有效性 - VISION 网络，10 个州，2021 年 4 月-2022 年 1 月。
Effectiveness of COVID-19 Pfizer-BioNTech BNT162b2 mRNA Vaccination in Preventing COVID-19-Associated Emergency Department and Urgent Care Encounters and Hospitalizations Among Nonimmunocompromised Children and Adolescents Aged 5-17 Years - VISION Network, 10 States, April 2021-January 2022.
出版信息
MMWR Morb Mortal Wkly Rep. 2022 Mar 4;71(9):352-358. doi: 10.15585/mmwr.mm7109e3.
The efficacy of the BNT162b2 (Pfizer-BioNTech) vaccine against laboratory-confirmed COVID-19 exceeded 90% in clinical trials that included children and adolescents aged 5-11, 12-15, and 16-17 years (1-3). Limited real-world data on 2-dose mRNA vaccine effectiveness (VE) in persons aged 12-17 years (referred to as adolescents in this report) have also indicated high levels of protection against SARS-CoV-2 (the virus that causes COVID-19) infection and COVID-19-associated hospitalization (4-6); however, data on VE against the SARS-CoV-2 B.1.1.529 (Omicron) variant and duration of protection are limited. Pfizer-BioNTech VE data are not available for children aged 5-11 years. In partnership with CDC, the VISION Network* examined 39,217 emergency department (ED) and urgent care (UC) encounters and 1,699 hospitalizations among persons aged 5-17 years with COVID-19-like illness across 10 states during April 9, 2021-January 29, 2022, to estimate VE using a case-control test-negative design. Among children aged 5-11 years, VE against laboratory-confirmed COVID-19-associated ED and UC encounters 14-67 days after dose 2 (the longest interval after dose 2 in this age group) was 46%. Among adolescents aged 12-15 and 16-17 years, VE 14-149 days after dose 2 was 83% and 76%, respectively; VE ≥150 days after dose 2 was 38% and 46%, respectively. Among adolescents aged 16-17 years, VE increased to 86% ≥7 days after dose 3 (booster dose). VE against COVID-19-associated ED and UC encounters was substantially lower during the Omicron predominant period than the B.1.617.2 (Delta) predominant period among adolescents aged 12-17 years, with no significant protection ≥150 days after dose 2 during Omicron predominance. However, in adolescents aged 16-17 years, VE during the Omicron predominant period increased to 81% ≥7 days after a third booster dose. During the full study period, including pre-Delta, Delta, and Omicron predominant periods, VE against laboratory-confirmed COVID-19-associated hospitalization among children aged 5-11 years was 74% 14-67 days after dose 2, with wide CIs that included zero. Among adolescents aged 12-15 and 16-17 years, VE 14-149 days after dose 2 was 92% and 94%, respectively; VE ≥150 days after dose 2 was 73% and 88%, respectively. All eligible children and adolescents should remain up to date with recommended COVID-19 vaccinations, including a booster dose for those aged 12-17 years.
研究目的：
这项研究旨在评估 2 剂 mRNA 疫苗在 12-17 岁青少年（报告中称为青少年）中的有效性（VE），并分析针对 SARS-CoV-2 B.1.1.529（奥密克戎）变异株的有效性和保护持续时间。
研究方法：
研究人员采用病例对照测试阴性设计，对 2021 年 4 月 9 日至 2022 年 1 月 29 日期间，10 个州 5-17 岁因 COVID-19 样疾病就诊于急诊或紧急护理的 39217 例患者和 1699 例住院患者进行分析。
研究结果：
在 5-11 岁儿童中，第 2 剂后 14-67 天（该年龄段第 2 剂后最长时间间隔）针对实验室确诊 COVID-19 相关 ED 和 UC 就诊的 VE 为 46%。
在 12-15 岁和 16-17 岁青少年中，第 2 剂后 14-149 天 VE 分别为 83%和 76%；第 2 剂后 150 天 VE 分别为 38%和 46%。
在 16-17 岁青少年中，第 3 剂后 7 天（加强针）VE 增加至 86%。
在 12-17 岁青少年中，奥密克戎占主导时期与 B.1.617.2（德尔塔）占主导时期相比，ED 和 UC 就诊的 VE 明显降低，第 2 剂后 150 天以上无明显保护作用。然而，在 16-17 岁青少年中，奥密克戎占主导时期 VE 增加至第 3 剂加强针后 7 天的 81%。
结论：
在包括德尔塔和奥密克戎流行之前、期间和之后的整个研究期间，5-11 岁儿童第 2 剂后 14-67 天针对实验室确诊 COVID-19 相关住院的 VE 为 74%，置信区间很宽，包括零。在 12-15 岁和 16-17 岁青少年中，第 2 剂后 14-149 天 VE 分别为 92%和 94%；第 2 剂后 150 天 VE 分别为 73%和 88%。所有符合条件的儿童和青少年都应及时接种推荐的 COVID-19 疫苗，包括 12-17 岁青少年的加强针。
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