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圣马力诺共和国 COVID-19 疫苗接种计划的影响：重点关注 Gam-Covid-Vac 的有效性。

The impact of COVID-19 vaccination programme in the Republic of San Marino: Focus on effectiveness of Gam-Covid-Vac.

机构信息

Istituto per la Sicurezza Sociale, San Marino.

Istituto Nazionale per le Malattie Infettive "L. Spallanzani", IRCCS, Rome, Italy.

出版信息

Clin Microbiol Infect. 2022 Dec;28(12):1636-1643. doi: 10.1016/j.cmi.2022.06.026. Epub 2022 Jul 4.

DOI:10.1016/j.cmi.2022.06.026
PMID:35798146
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9251905/
Abstract

OBJECTIVE

The adenovirus-based vaccine Gam-COVID-Vac (Sputnik V) showed promising effectiveness in a phase 3 clinical trial; however, data concerning its impact at a population level are scarce. The Republic of San Marino (RSM) conducted a SARS-CoV-2 vaccination programme mainly based (>80%) on Gam-COVID-Vac. Our aims were to investigate the impact of Gam-COVID-Vac vaccination programme and its effectiveness in a retrospective observational study based on the entire RSM population aged ≥12 years.

METHODS

We calculated the incidence rate and the vaccine effectiveness (VE) in the entire RSM population not previously infected, against SARS-CoV-2 infection and COVID-19-related hospitalization, from 25 February to 1 October 2021, considering any vaccine and separately according to the vaccine used. Vaccine effectiveness was calculated using a multivariable negative binomial regression model as 1-Incidence Rate Ratio.

RESULTS

During the study period, 21 568/28 791 (74.9%) not previously infected subjects received at least one dose of the Gam-COVID-Vac (84%) or BNT162b2, vaccines with 98% completing the vaccination schedule. Overall, 1634 SARS-CoV-2 infections and 166 COVID-19-related hospitalizations were observed with 17 COVID-19-related deaths reported. Incidence rates of SARS-CoV-2 infection and COVID-19-related hospitalization were 7.11 and 0.49/100 000 person-days in the fully vaccinated population, respectively. The adjusted overall VE was 67.6% (95% CI: 61.8-72.5) against SARS-CoV-2 infection and 87.9% (95% CI: 77.4-93.5) against COVID-19-related hospitalizations. Gam-COVID-Vac against SARS-CoV-2 infection VE peaked 91.8% (95% CI: 86.3-95.1) in the first bimester from the second dose, declining to 57.8% (95% CI: 42.2-69.2) at 6 months. Protection against hospitalization with COVID-19 was overall 91.6% (95% CI: 81.5-96.2), with no relevant waning trend over time.

DISCUSSION

Our study demonstrated the effectiveness of overall vaccination (Gam-COVID-Vac [84%] and BNT162b2 [16%]) in the prevention SARS-CoV-2 infection (pre-Omicron variant), waning over time but still with sustainable effectiveness against COVID-19-related hospitalization in the Republic of San Marino.

摘要

目的

基于腺病毒的疫苗 Gam-COVID-Vac（卫星 V）在 3 期临床试验中显示出良好的效果；然而，关于其在人群水平上的影响的数据还很缺乏。圣马力诺共和国（RSM）主要基于 Gam-COVID-Vac 开展了一项 SARS-CoV-2 疫苗接种计划（>80%）。我们的目的是通过一项基于整个 RSM 12 岁以上人群的回顾性观察研究，调查 Gam-COVID-Vac 疫苗接种计划及其效果。

方法

我们计算了 2021 年 2 月 25 日至 10 月 1 日期间，未感染 SARS-CoV-2 的 RSM 人群的发病率和疫苗有效性（VE），考虑了任何疫苗，并根据使用的疫苗分别进行了计算。疫苗有效性使用多变量负二项回归模型计算为 1-发病率比。

结果

在研究期间，21568/28791（74.9%）名未感染的受试者至少接种了一剂 Gam-COVID-Vac（84%）或 BNT162b2，98%的人完成了接种计划。共有 1634 例 SARS-CoV-2 感染和 166 例 COVID-19 相关住院治疗，报告了 17 例 COVID-19 相关死亡。完全接种疫苗人群的 SARS-CoV-2 感染和 COVID-19 相关住院治疗的发病率分别为 7.11 和 0.49/100000 人天。总体而言，Gam-COVID-Vac 对 SARS-CoV-2 感染的调整后 VE 为 67.6%（95%CI：61.8-72.5），对 COVID-19 相关住院治疗的 VE 为 87.9%（95%CI：77.4-93.5）。Gam-COVID-Vac 对 SARS-CoV-2 感染的 VE 在第二次剂量后的第一个三个月达到峰值 91.8%（95%CI：86.3-95.1），在 6 个月时下降至 57.8%（95%CI：42.2-69.2）。预防 COVID-19 相关住院治疗的总体保护率为 91.6%（95%CI：81.5-96.2），随着时间的推移，没有明显的减弱趋势。

讨论

我们的研究表明，在预防 SARS-CoV-2 感染（在 Omicron 变异之前）方面，总体疫苗接种（Gam-COVID-Vac[84%]和 BNT162b2[16%]）是有效的，随着时间的推移而减弱，但在圣马力诺共和国，仍对 COVID-19 相关住院治疗具有可持续的效果。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6155/9251905/deaf9fb4c091/gr3_lrg.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6155/9251905/41c5be177978/gr1_lrg.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6155/9251905/92c2a748c0f8/gr2_lrg.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6155/9251905/deaf9fb4c091/gr3_lrg.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6155/9251905/41c5be177978/gr1_lrg.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6155/9251905/92c2a748c0f8/gr2_lrg.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6155/9251905/deaf9fb4c091/gr3_lrg.jpg

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