SARS-CoV-2变种分类的定义

变种分类

The US Department of Health and Human Services (HHS) established a SARS-CoV-2 Interagency Group (SIG) to improve coordination among the Centers for Disease Control and Prevention (CDC), National Institutes of Health (NIH), Food and Drug Administration (FDA), Biomedical Advanced Research and Development Authority (BARDA), and Department of Defense (DoD). This interagency group is focused on the rapid characterization of emerging variants and actively monitors their potential impact on critical SARS-CoV-2 countermeasures, including vaccines, therapeutics, and diagnostics.

In collaboration with the SIG, CDC established a classification scheme that defines three classes of variants of SARS-CoV-2. These classes include definitions and attributes of the variants. Resulting public health actions are also described in the sections below.

Notes: Each classification of variant includes the possible attributes of lower classes (e.g., VOC includes the possible attributes of VOI); variant status might escalate or deescalate based on scientific evidence. This page will be updated as needed to show the variants that belong to each class. The World Health Organizationexternal icon (WHO) also classifies variant viruses as Variants of Concern and Variants of Interest; US classifications may differ from those of WHO since the importance of variants may differ by location.

See Variant Proportions in the U.S.

存疑变种

带有特定遗传标记的变种与受体结合变化、既往感染或免疫接种所产生的抗体中和作用降低、治疗方法效力降低、潜在诊断影响或者传播性或疾病严重程度预计增加相关。

存疑变种的可能属性：

• 特定遗传标记预计会影响传播、诊断、治疗方法或免疫逃逸
• Evidence that it is the cause of an increased proportion of cases or unique outbreak clusters
• 在美国或其他国家流行或扩张有限

A variant of interest might require one or more appropriate public health actions, including enhanced sequence surveillance, enhanced laboratory characterization, or epidemiological investigations to assess how easily the virus spreads to others, the severity of disease, the efficacy of therapeutics and whether currently authorized vaccines offer protection.

美国当前的存疑变种正接受监控和定性，如下表所列。此表将在确认新的存疑变种时更新。

(*) = detected in some sequences but not all

⁺These variants share one specific mutation called D614G. This mutation was one of the first documented in the US in the initial stages of the pandemic, after having initially circulated in Europe^[13]. There is evidence that variants with this mutation spread more quickly than viruses without this mutation ^[12].

a – Phylogenetic Assignment of Named Global Outbreak (PANGO) Lineages is software tool developed by members of the Rambaut Lab. The associated web application was developed by the Centre for Genomic Pathogen Surveillance in South Cambridgeshire and is intended to implement the dynamic nomenclature of SARS-CoV-2 lineages, known as the PANGO nomenclature.

b – Nextstrain, a collaboration between researchers in Seattle, USA and Basel, Switzerland, provides open-source tools for visualizing the genetics of outbreaks. The goal is to support public health surveillance by facilitating understanding of the spread and evolution of pathogens.

c – The Biodefense and Emerging Infections Research Resources (BEI Resources) is a NIAID-funded repository to provide reagents, tools, and information to the research community. The reference viruses proposed here facilitate the harmonization of information among all stakeholders in the COVID-19 pandemic research community. Please note that the reference viruses provided in the tables below are based on what is currently available through the BEI Resources.

关切变种

A variant for which there is evidence of an increase in transmissibility, more severe disease (e.g.,  increased hospitalizations or deaths), significant reduction in neutralization by antibodies generated during previous infection or vaccination, reduced effectiveness of treatments or vaccines, or diagnostic detection failures.

关切变种的可能属性：

除了存疑变种的可能属性以外

• Evidence of impact on diagnostics, treatments, or vaccines
  • 广泛干扰诊断检测靶点
  • Evidence of substantially decreased susceptibility to one or more class of therapies
  • 证据表明既往感染或免疫接种产生的抗体中和作用大幅降低
  • 证据表明疫苗的重病保护效力降低
• 证据表明传播性增加
• 证据表明疾病严重程度增加

关切变种可能要求采取一种或多种相应的公共卫生措施，例如根据《国际卫生条例》通知WHO、报告CDC、地方或区域控制传播工作、增加检测，或研究确定疫苗和治疗方法抗击变种的有效性。根据变种特性，其他注意事项可能包括新诊断法的制定或者改变疫苗或治疗方法。

美国当前的关切变种正由联邦机构密切监控和定性，如下表所示。此表将在确认新的关切变种时更新。

(*) = detected in some sequences but not all
⁺These variants share one specific mutation called D614G. This mutation was one of the first documented in the US in the initial stages of the pandemic, after having initially circulated in Europe^[13]. There is evidence that variants with this mutation spread more quickly than viruses without this mutation ^[12].

a – Phylogenetic Assignment of Named Global Outbreak (PANGO) Lineages is software tool developed by members of the Rambaut Lab. The associated web application was developed by the Centre for Genomic Pathogen Surveillance in South Cambridgeshire and is intended to implement the dynamic nomenclature of SARS-CoV-2 lineages, known as the PANGO nomenclature.

b – Nextstrain, a collaboration between researchers in Seattle, USA and Basel, Switzerland, provides open-source tools for visualizing the genetics of outbreaks. The goal is to support public health surveillance by facilitating understanding of the spread and evolution of pathogens.

c – The Biodefense and Emerging Infections Research Resources (BEI Resources) is a NIAID-funded repository to provide reagents, tools, and information to the research community. The reference viruses proposed here facilitate the harmonization of information among all stakeholders in the COVID-19 pandemic research community. Please note that the reference viruses provided in the tables below are based on what is currently available through the BEI resources.

d  – Attributes listed are based on data available from pseudoviruses or recombinant viruses containing combinations of substitutions characteristic of specific lineages or from reference virus isolates.

严重后果变种

严重后果变种即有证据清楚表明与此前流通变种相关的预防措施或医疗应对策略（MCM）有效性严重降低。

严重后果变种的可能属性：

除了关切变种的可能属性以外

• 对医疗应对策略（MCM）的影响
  • 证实诊断失效
  • 证据表明疫苗有效性严重降低、不成比例的大量疫苗突破病例，或疫苗对重病程度的保护非常低
  • 对多种应急使用授权（EUA）或批准疗法的易受性严重降低
  • 更多严重临床疾病且住院治疗增加

严重后果变种需要根据《国际卫生条例》向世界卫生组织（WHO）通报，向CDC报告，宣布预防或控制传播的战略，以及提出更新治疗方法和疫苗的建议。

当前没有SARS-CoV-2变种上升到严重后果等级。

Monoclonal antibody treatment considerations for healthcare providers

Substitutions of Concern for SARS-CoV-2 Monoclonal Antibody Therapies

In the United States, there are two anti-SARS-CoV-2 monoclonal antibody treatments with FDA Emergency Use Authorization (EUA) for the treatment of COVID-19: bamlanivimab plus etesevimabexternal icon and casirivimab plus imdevimab.external icon

CDC’s national genomic surveillance program identifies new and emerging SARS-CoV-2 variants to determine implications for COVID-19 diagnostics, treatments, or vaccines authorized for use in the United States. Sequences with similar genetic changes are grouped into lineages, and multiple lineages can have the same substitutions. For example, the E484K substitution is found in lineages B.1.351, P.1, B.1.526, and many others. Genomic surveillance efforts provide the capability to detect viruses that have reduced susceptibility to treatments more quickly.

In laboratory studies, SARS-CoV-2 variants that contain the L452R or E484K substitution in the spike protein cause a marked reduction in susceptibility to bamlanivimab and may have lower sensitivity to etesevimab and casirivimab.

The table below shows the estimated national and regional proportions of SARS-CoV-2 that contain the L452R or E484K substitution. As new data become available, additional substitutions may be added to the table below. The national and regional proportions provided in the table below will be updated every two weeks.

资源

Monoclonal Antibody COVID-19 Infusionexternal icon

Statement on Anti-SARS-CoV-2 Monoclonal Antibodies EUA | COVID-19 Treatment Guidelines (nih.gov)external icon

a – The estimated prevalence of SARS-CoV-2 circulating in the United States that contain the designated substitution, based on >19,000 sequences collected through CDC’s national genomic surveillance during the two-week period ending March 27, 2021.

b – The estimated regional prevalence of SARS-CoV-2 circulating in each HHS region that contain the designated substitution, based on >19,000 sequences collected through CDC’s national genomic surveillance during the two-week period ending March 27, 2021.

c – The lineages listed are the most common lineages within CDC’s national genomic surveillance with these substitutions, but this list is not intended to be a complete list of the lineages that contain the spike protein substitutions.

参考资料

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