为2026年12月COVID-19疫苗抗原组分审议提供信息所需的数据类型
正文 · 中文译文
世界卫生组织（WHO）COVID-19疫苗成分技术咨询小组（TAG-CO-VAC）继续密切监测SARS-CoV-2变异株的遗传和抗原演化、对SARS-CoV-2感染和COVID-19疫苗接种的免疫应答，以及COVID-19疫苗对流行变异株的性能。基于这些评估，WHO就未来更新COVID-19疫苗抗原组成的意义向疫苗制造商和监管机构提供建议。TAG-CO-VAC的下一次决策会议定于2026年12月举行，之后将在WHO网站上发布关于COVID-19疫苗抗原组成的声明及随附数据附件。这些会议的时机安排旨在平衡最新流行病学、免疫学和病毒学数据的可获得性、疫苗诱导保护的动力学，以及制造商更新已授权COVID-19疫苗抗原组成所需的前置时间。 本声明的目的是指导科学界和疫苗制造商，在2026年12月TAG-CO-VAC审议之前应生成哪些数据。它是对2026年3月.1关于所要求数据类型的先前声明的更新。 为给COVID-19疫苗抗原组成提供决策依据，2-9 TAG-CO-VAC审查了关于SARS-CoV-2遗传演变以及既往和当前流行变异株抗原特性的数据（表1）。这包括对初次感染或疫苗接种后动物抗血清进行单向和双向中和试验的分析，以及使用序贯免疫或感染动物的血清和疫苗接种前后的人血清评估免疫应答广度与持久性（包括中和抗体应答）的免疫原性数据。TAG-CO-VAC还考虑了当前获批COVID-19疫苗的疫苗有效性（VE）估计值，特别是那些控制了接种后时间因素、并提供不同疫苗平台针对任何感染、症状性疾病和重症疾病变异株特异性估计值的研究。TAG-CO-VAC审查并用于为COVID-19疫苗抗原组成决策提供依据的其他已发表数据示例，可在先前各次声明的附件中找到。2-9 此外，TAG-CO-VAC 审查了来自疫苗制造商的可获得数据，包括证明当前已授权疫苗以及任何在研候选疫苗所诱导免疫应答的广度和持久性的动物及人体研究。对于在研候选疫苗，TAG-CO-VAC 强调了非临床和临床免疫原性数据在 COVID-19 疫苗抗原组成决策中的实用性。TAG-CO-VAC 还指出，来自先前疫苗组成（即针对相同变异株）的可比免疫原性数据尤其有用。疫苗制造商还被要求提供观察性流行病学数据，以证明其已授权 COVID-19 疫苗以及任何在研候选疫苗的有效性或实效性。 在此阶段，用于2026年12月决策会议以证明广谱性的关键抗血清和关注抗原包括针对以下毒株的抗血清：LP.8.1、NB.1.8.1、XFG（包括近期亚系ST.1和SW.2.1）、BA.3.2、PQ.16.1.1以及潜在新出现的SARS-CoV-2变异株（包括PJ.2.1）。关注的抗血清为单次或序贯暴露于上述变异株后的动物血清，以及接种单价XFG、LP.8.1、JN.1或KP.2疫苗加强针后的人血清。应包含接种前和接种后的血清，并且对于所有抗血清，应针对至少一种在疫苗抗原之后出现的变异株分析中和抗体滴度，并在可行的情况下在多个时间点进行评估以衡量持久性。针对同一组病毒抗原以及其他新出现的SARS-CoV-2变异株对这些抗血清进行的分析，将有助于了解既往和新兴变异株的抗原特性。新兴变异株包括世界卫生组织网站上维护的“关注变异株”（VOI）和“监测中变异株”（VUM）列表。应计算以下每种疫苗抗原组成的相对疫苗效力（VE）估计值：单价XFG、单价LP.8.1、单价JN.1或单价KP.2。在可用的情况下，还应提供用于推导相对VE估计值的潜在疾病结局发生率。 为筹备2026年12月的会议，TAG-CO-VAC鼓励科学界和疫苗制造商优先生成并分享下表中列出的数据，以确保关于COVID-19疫苗抗原组成的审议基于证据；请联系TAG-CO-VAC秘书处：tagcovac@who.int 表1. 为2026年12月COVID-19疫苗抗原组成审议提供信息所要求的数据类型摘要 数据类型 备注 SARS-CoV-2基因进化 关键变异株包括“关注变异株”（VOI）和“监测中变异株”（VUM）列表。该列表在WHO网站上维护。+ 如可获得，变异株特异性数据应包括关于生长优势、地理分布、疾病严重程度、公共卫生和社会措施的 effectiveness、或其他相关特征的信息，以为病毒进化技术咨询小组进行的风险评估提供信息。 既往和新出现的SARS-CoV-2变异株的抗原特性描述 针对以下每种变异株初次感染或疫苗接种后的动物血清：LP.8.1、NB.1.8.1、XFG、BA.3.2、PQ.16.1.1以及可能的新出现变异株，* 通过单向和双向中和试验（假病毒和活病毒中和测定）进行分析。 关于接种SARS-CoV-2变异株抗原疫苗或感染后免疫应答广度和持久性的初步免疫原性数据。 非未致敏（non-naïve）动物血清（例如，序贯免疫或感染）对多种代表性病毒的中和作用，针对以下每种抗原：LP.8.1、NB.1.8.1、XFG、BA.3.2、PQ.16.1.1及新发变异株；* 接种前和接种后的人血清对多种代表性病毒（LP.8.1、NB.1.8.1、XFG、BA.3.2、PQ.16.1.1及可能的新发变异株*）的中和作用。疫苗接种者血清应按以下优先顺序分析：XFG、LP.8.1、JN.1、KP.2，并在多个时间点进行评估以评价持久性； 来自可代表近期人群免疫状况的队列的血清对变异株（LP.8.1、NB.1.8.1、XFG、BA.3.2、PQ.16.1.1及可能的新发变异株*）的中和作用。 当前已获批疫苗的疫苗有效性（VE）估计值 研究需要估算按疫苗接种后时间划分的相对疫苗效力，或至少提供疫苗接种后时间的度量，如平均值或中位数。研究应提供针对当前流行或近期流行的变异株的变异株特异性估算，以及按疫苗抗原组成分层的单独估算。如果无法提供变异株特异性估算，应描述主要流行变异株。用于估算相对疫苗效力的疾病结局基础发生率也应予以报告。研究应提供除重症疾病之外的一系列结局的相对疫苗效力，包括任何感染或症状性疾病。重症疾病不应使用通用住院数据进行定义，而应使用具体标准，如因呼吸道症状而使用氧气、通气或入住重症监护病房。 来自疫苗制造商的数据 动物和人类数据，证明当前产品组合中的疫苗以及任何在研疫苗候选株针对LP.8.1、NB.1.8.1、XFG、BA.3.2、PQ.16.1.1及潜在新出现变异株所引发的免疫应答的广度和持久性；* 观察性流行病学数据，证明当前产品组合中的任何疫苗以及任何在研疫苗候选株针对LP.8.1、NB.1.8.1、XFG、BA.3.2、PQ.16.1.1及潜在新出现变异株的效力或有效性。* + 世卫组织网站：https://www.who.int/activities/tracking-SARS-CoV-2-variants * 这可能还包括XFG后代谱系ST.1和SW.2.1，以及PJ.2.1。为证明抗体广度而演化并被认为具有相关性的主要新兴变异株包括关注变异株（VOI）和监测中变异株（VUM）列表。该列表维护在WHO网站上：https://www.who.int/activities/tracking-SARS-CoV-2-variants 参考文献 世界卫生组织。为2026年5月COVID-19疫苗抗原组成审议提供信息所需的数据类型。2026年3月30日。可从以下网址获取：https://www.who.int/news/item/30-03-2026-types-of-data-requested-to-inform-may-2026-covid-19-vaccine-antigen-composition-deliberations 世界卫生组织。关于当前COVID-19疫苗组成的临时声明。2022年6月17日。可从以下网址获取：https://www.who.int/news/item/17-06-2022-interim-statement-on--the-composition-of-current-COVID-19-vaccines. 世界卫生组织。关于COVID-19疫苗抗原组成的声明。2023年5月18日。可从以下网址获取：https://www.who.int/news/item/18-05-2023-statement-on-the-antigen-composition-of-covid-19-vaccines. 世界卫生组织。关于COVID-19疫苗抗原组成的声明。2023年12月13日。可从以下网址获取：https://www.who.int/news/item/13-12-2023-statement-on-the-antigen-composition-of-covid-19-vaccines. 世界卫生组织。关于COVID-19疫苗抗原组成的声明。2024年4月26日。可从以下网址获取：https://www.who.int/news/item/26-04-2024-statement-on-the-antigen-composition-of-covid-19-vaccines. 世界卫生组织。关于COVID-19疫苗抗原组成的声明。2024年12月23日。可查阅：https://www.who.int/news/item/23-12-2024-statement-on-the-antigen-composition-of-covid-19-vaccines. 世界卫生组织。关于COVID-19疫苗抗原组成的声明。2025年5月15日。可查阅：https://www.who.int/news/item/15-05-2025-statement-on-the-antigen-composition-of-covid-19-vaccines. 世界卫生组织。关于COVID-19疫苗抗原组成的声明。2025年12月18日。可查阅：https://www.who.int/news/item/18-12-2025-statement-on-the-antigen-composition-of-covid-19-vaccines. 世界卫生组织。关于COVID-19疫苗抗原组成的声明。2026年5月16日。可查阅：https://www.who.int/news/item/16-05-2026-statement-on-the-antigen-composition-of-covid-19-vaccines.
正文 · 英文原文
The WHO Technical Advisory Group on COVID-19 Vaccine Composition (TAG-CO-VAC) continues to closely monitor the genetic and antigenic evolution of SARS-CoV-2 variants, immune responses to SARS-CoV-2 infection and COVID-19 vaccination, and the performance of COVID-19 vaccines against circulating variants. Based on these evaluations, WHO advises vaccine manufacturers and regulatory authorities on the implications for future updates to COVID-19 vaccine antigen composition. The next decision-making meeting of the TAG-CO-VAC is scheduled for December 2026, after which a statement on COVID-19 vaccine antigen composition and an accompanying data annex will be published on the WHO website. These meetings are timed to balance the availability of the latest epidemiological, immunological, and virological data, with the kinetics of vaccine-induced protection and the lead time manufacturers need to update the antigen composition of authorized COVID-19 vaccines. The purpose of this statement is to guide the scientific community and vaccine manufacturers as to which data should be generated ahead of the December 2026 TAG-CO-VAC deliberations. It is an update to the previous statement on the types of data requested in March 2026.1 To inform decisions on COVID-19 vaccine antigen composition,2-9 the TAG-CO-VAC reviews data on the genetic evolution of SARS-CoV-2 and the antigenic characteristics of previously and currently circulating variants (Table 1). This includes the analysis of animal antisera following primary infection or vaccination in one-way and two-way neutralization tests, as well as immunogenicity data that assess the breadth and durability of immune responses, including neutralizing antibody responses, using sera from sequentially immunized or infected animals and pre-and post-vaccination human sera. The TAG-CO-VAC also considers vaccine effectiveness (VE) estimates of currently approved COVID-19 vaccines, particularly those that control for time since vaccination and that provide variant-specific estimates across different vaccine platforms for protection against any infection, symptomatic disease, and severe disease. Further examples of published data reviewed by TAG-CO-VAC and used to inform decisions on COVID-19 vaccine antigen composition can be found in the annexes accompanying each of the previous statements.2-9 In addition, the TAG-CO-VAC reviews available data from vaccine manufacturers, including animal and human studies demonstrating the breadth and durability of immune responses elicited by currently authorized vaccines, as well as any vaccine candidates in development. For vaccine candidates in development, the TAG-CO-VAC highlights the utility of both non-clinical and clinical immunogenicity data for decision-making on COVID-19 vaccine antigen composition. The TAG-CO-VAC also notes that comparable immunogenicity data (i.e. to the same variants) from previous vaccine compositions are especially useful. Vaccine manufacturers are also asked to provide observational epidemiological data that demonstrate the efficacy or effectiveness of their authorized COVID-19 vaccines, as well as any vaccine candidates in development. At this stage, the key antisera and antigens of interest for the December 2026 decision-making meeting for demonstrating breadth include antisera to: LP.8.1, NB.1.8.1, XFG (including recent sublineages ST.1 and SW.2.1), BA.3.2, PQ.16.1.1 and potentially emerging SARS-CoV-2 variants (including PJ.2.1). Antisera of interest are animal sera after single or sequential exposure to the above variants and human sera after a boost with monovalent XFG, LP.8.1, JN.1 or KP.2 vaccines. Both pre- and post-vaccination sera should be included and, for all antisera, neutralizing antibody titers should be analyzed against at least one variant that emerged after the vaccine antigen, and at multiple timepoints to assess durability, where feasible. Analysis of these antisera against the same panel of virus antigens as well as other new emerging SARS-CoV-2 variants will provide insight into antigenic characteristics of previous and emerging variants. Emerging variants include the list of SARS-CoV-2 Variants of Interest (VOI) and Variants Under Monitoring (VUM) maintained on the WHO website. Relative VE estimates should be calculated for each of the following vaccine antigen compositions: monovalent XFG, monovalent LP.8.1, monovalent JN.1 or monovalent KP.2. Where available, the underlying rates of disease outcomes used to derive the relative VE estimates should also be provided. In preparation for the December 2026 meeting, the TAG-CO-VAC encourages the scientific community and vaccine manufacturers to prioritize generating and sharing the data outlined in the Table below to ensure evidence-informed deliberations on COVID-19 vaccine antigen composition; please contact the TAG-CO-VAC Secretariat: tagcovac@who.int Table 1. Summary of the types of data requested to inform December 2026 COVID-19 vaccine antigen composition deliberations Type of data Comments SARS-CoV-2 genetic evolution Key variants include the list of Variants of Interest (VOI) and Variants Under Monitoring (VUM). This list is maintained on the WHO website.+ Where available, variant-specific data should include information on growth advantage, geographic distribution, disease severity, effectiveness of public health and social measures, or other relevant characteristics, to inform risk assessments performed by the Technical Advisory Group on Virus Evolution. Antigenic characterization of previous and emerging SARS-CoV-2 variants Animal sera following primary infection or vaccination against each of the following variants: LP.8.1, NB.1.8.1, XFG, BA.3.2, PQ.16.1.1 and potentially emerging variants,* analyzed in one-way and two-way neutralization tests (pseudotype and live virus neutralization assays). Preliminary immunogenicity data on breadth and durability of immune responses following vaccination or infection with SARS-CoV-2 variant antigens. Neutralization of various representative viruses by non-naïve animal sera (e.g., sequentially immunized or infected), for each of the following antigens: LP.8.1, NB.1.8.1, XFG, BA.3.2, PQ.16.1.1 and emerging variants;* Neutralization of various representative viruses (LP.8.1, NB.1.8.1, XFG, BA.3.2, PQ.16.1.1 and potentially emerging variants*) by both pre- and post-vaccination human sera. Vaccinee sera should be analyzed in priority order: XFG, LP.8.1, JN.1, KP.2, and assessed at multiple timepoints to assess durability; Neutralization of variants (LP.8.1, NB.1.8.1, XFG, BA.3.2, PQ.16.1.1 and potentially emerging variants*) by sera from cohorts that are representative of recent population immunity. Vaccine effectiveness (VE) estimates of currently approved vaccines Studies need to estimate relative VE by time since vaccination or at least provide a measure of time since vaccination, such as the mean or median. They should provide variant-specific estimates for variants that are currently circulating or were recently circulating, as well as separate estimates stratified by vaccine antigen composition. If variant-specific estimates are not feasible, the predominant circulating variant(s) should be described. The underlying rates of disease outcomes used to estimate relative VE should also be reported. Studies should provide relative VE for a range of outcomes beyond severe disease, including any infection or symptomatic disease. Severe disease should not be defined using generic hospital admission data, but rather with specific criteria such as oxygen use, ventilation, or admission to intensive care due to respiratory symptoms. Data from vaccine manufacturers Animal and human data that demonstrate the breadth and durability in immune responses elicited by vaccines in current portfolio, as well as any vaccine candidates in development, against LP.8.1, NB.1.8.1, XFG, BA.3.2, PQ.16.1.1 and potentially emerging variants;* Observational epidemiological data that demonstrate the efficacy or effectiveness of any vaccines in current portfolio, as well as any vaccine candidates in development, against LP.8.1, NB.1.8.1, XFG, BA.3.2, PQ.16.1.1 and potentially emerging variants.* + WHO website: https://www.who.int/activities/tracking-SARS-CoV-2-variants * This may also include XFG-descendant lineages ST.1 and SW.2.1, as well as PJ.2.1. Key emerging variants that evolve and considered relevant for demonstrating breadth include the list of Variants of Interest (VOI) and Variants Under Monitoring (VUM). This list is maintained on the WHO website: https://www.who.int/activities/tracking-SARS-CoV-2-variants References World Health Organization. Types of data requested to inform May 2026 COVID-19 vaccine antigen composition deliberations. 30 March 2026 Available from: https://www.who.int/news/item/30-03-2026-types-of-data-requested-to-inform-may-2026-covid-19-vaccine-antigen-composition-deliberations World Health Organization. Interim statement on the composition of current COVID-19 vaccines. 17 June 2022. Available from: https://www.who.int/news/item/17-06-2022-interim-statement-on--the-composition-of-current-COVID-19-vaccines. World Health Organization. Statement on the antigen composition of COVID-19 vaccines. 18 May 2023. Available from: https://www.who.int/news/item/18-05-2023-statement-on-the-antigen-composition-of-covid-19-vaccines. World Health Organization. Statement on the antigen composition of COVID-19 vaccines. 13 December 2023. Available from: https://www.who.int/news/item/13-12-2023-statement-on-the-antigen-composition-of-covid-19-vaccines. World Health Organization. Statement on the antigen composition of COVID-19 vaccines. 26 April 2024. Available from: https://www.who.int/news/item/26-04-2024-statement-on-the-antigen-composition-of-covid-19-vaccines. World Health Organization. Statement on the antigen composition of COVID-19 vaccines. 23 December 2024. Available from: https://www.who.int/news/item/23-12-2024-statement-on-the-antigen-composition-of-covid-19-vaccines. World Health Organization. Statement on the antigen composition of COVID-19 vaccines.15 May 2025. Available from: https://www.who.int/news/item/15-05-2025-statement-on-the-antigen-composition-of-covid-19-vaccines. World Health Organization. Statement on the antigen composition of COVID-19 vaccines. 18 December 2025. Available from: https://www.who.int/news/item/18-12-2025-statement-on-the-antigen-composition-of-covid-19-vaccines. World Health Organization. Statement on the antigen composition of COVID-19 vaccines. 16 May 2026. Available from: https://www.who.int/news/item/16-05-2026-statement-on-the-antigen-composition-of-covid-19-vaccines