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衡量孟加拉国在严重急性呼吸综合征冠状病毒2(SARS-CoV-2)德尔塔变异株激增期间使用的新冠疫苗的有效性:一项检测阴性设计评估。

Measuring the Effectiveness of COVID-19 Vaccines Used during a Surge of the Delta Variant of SARS-CoV-2 in Bangladesh: A Test-Negative Design Evaluation.

作者信息

Khanam Farhana, Islam Md Taufiqul, Ahmmed Faisal, Ahmed Shams Uddin, Hossen Md Ismail, Rajib MdNazmul Hasan, Haque Shahinur, Biswas Prasanta Kumar, Tauheed Imam, Zaman K, Alam Ahmed Nawsher, Billah Mallick Masum, Ashrafi Shah Ali Akbar, Rahman Mohammed Ziaur, Bin Manjur Omar Hamza, Afrad Mokibul Hassan, Shamsuzzaman S M, Saleh Ahmed Abu, Sumon Mostafa Aziz, Rashed Asif, Bhuiyan Md Taufiqur Rahman, Chowdhury Fahima, Khan Ashraful Islam, Flora Meerjady Sabrina, Shirin Tahmina, Clemens John D, Qadri Firdausi

机构信息

International Centre for Diarrhoeal Disease Research, Dhaka 1212, Bangladesh.

Institute for Epidemiology, Disease Control and Research, Dhaka 1212, Bangladesh.

出版信息

Vaccines (Basel). 2022 Dec 2;10(12):2069. doi: 10.3390/vaccines10122069.

Abstract

BACKGROUND

From May to December 2021, Bangladesh experienced a major surge in the Delta variant of SARS-CoV-2. The earlier rollout of several vaccines offered the opportunity to evaluate vaccine effectiveness against this variant.

METHODS

A prospective, test-negative case-control study was conducted in five large hospitals in Dhaka between September and December 2021. The subjects were patients of at least 18 years of age who presented themselves for care, suffering COVID-like symptoms of less than 10 days' duration. The cases had PCR-confirmed infections with SARS-CoV-2, and up to 4 PCR test-negative controls were matched to each case, according to hospital, date of presentation, and age. Vaccine protection was assessed as being the association between the receipt of a complete course of vaccine and the occurrence of SARS-CoV-2 disease, with symptoms beginning at least 14 days after the final vaccine dose.

RESULTS

In total, 313 cases were matched to 1196 controls. The genotyping of case isolates revealed 99.6% to be the Delta variant. Receipt of any vaccine was associated with 12% (95% CI: -21 to 37, = 0.423) protection against all episodes of SARS-CoV-2. Among the three vaccines for which protection was evaluable (Moderna (mRNA-1273); Sinopharm (Vero Cell-Inactivated); Serum Institute of India (ChAdOx1 nCoV-19)), only the Moderna vaccine was associated with significant protection (64%; 95% CI: 10 to 86, = 0.029). Protection by the receipt of any vaccine against severe disease was 85% (95% CI: 27 to 97, = 0.019), with protection estimates of 75% to 100% for the three vaccines.

CONCLUSIONS

Vaccine protection against COVID-19 disease of any severity caused by the Delta variant was modest in magnitude and significant for only one of the three evaluable vaccines. In contrast, protection against severe disease was high in magnitude and consistent for all three vaccines. Because our findings are not in complete accord with evaluations of the same vaccines in more affluent settings, our study underscores the need for country-level COVID-19 vaccine evaluations in developing countries.

摘要

背景

2021年5月至12月,孟加拉国经历了新冠病毒Delta变异株的大规模激增。几种疫苗的早期推出提供了评估针对该变异株疫苗有效性的机会。

方法

2021年9月至12月期间,在达卡的五家大型医院开展了一项前瞻性、检测阴性病例对照研究。研究对象为至少18岁、因出现持续时间少于10天的类似新冠症状前来就医的患者。病例为经PCR确诊感染新冠病毒的患者,根据医院、就诊日期和年龄,为每个病例匹配至多4名PCR检测阴性对照。疫苗保护作用评估为接种完整疗程疫苗与新冠病毒疾病发生之间的关联,症状在最后一剂疫苗接种至少14天后出现。

结果

总共313例病例与1196名对照匹配。病例分离株的基因分型显示99.6%为Delta变异株。接种任何疫苗与预防所有新冠病毒感染事件的12%(95%置信区间:-21至37,P = 0.423)保护作用相关。在三种可评估保护作用的疫苗(Moderna(mRNA-1273);国药集团(Vero细胞灭活疫苗);印度血清研究所(ChAdOx1 nCoV-19))中,只有Moderna疫苗与显著的保护作用相关(64%;95%置信区间:10至86,P = 0.029)。接种任何疫苗预防重症疾病的保护作用为85%(95%置信区间:27至97,P = 0.019),三种疫苗保护作用估计为75%至100%。

结论

疫苗对Delta变异株所致任何严重程度新冠疾病的保护作用程度适中,且仅对三种可评估疫苗中的一种有显著作用。相比之下,对重症疾病的保护作用程度较高,且三种疫苗一致。由于我们的研究结果与在更富裕环境中对相同疫苗的评估不完全一致,我们的研究强调了在发展中国家进行国家层面新冠疫苗评估的必要性。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d996/9780914/38bed06a0683/vaccines-10-02069-g001.jpg

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