国际指南丨双语版美国流感疫苗2024-2025版指南全文
2024-2025年流感季使用疫苗预防和控制季节性流感：免疫实践咨询委员会的建议——美国
Prevention and Control of Seasonal Influenza with Vaccines: Recommendations of the Advisory Committee on Immunization Practices — United States, 2024–25 Influenza Season
（人名不翻译了，反正没有David Shao）
Lisa A. Grohskopf, MD；Jill M. Ferdinands, PhD；Lenee H. Blanton, MPH；Karen R. Broder, MD；Jamie Loehr, MD
摘要
Summary
本报告更新了免疫实践咨询委员会（ACIP）关于在美国使用季节性流感疫苗的2023-2024年建议（MMWR Recomm Rep 2022;72[No. RR-2]:1-24）。建议所有年龄在6个月及以上且无禁忌症的人每年进行常规的流感疫苗接种。预计将提供三价灭活流感疫苗（IIV3）、三价重组流感疫苗（RIV3）和三价减毒活流感疫苗（LAIV3）。所有适龄人群应接种对应流感疫苗（即经批准适用于其年龄的疫苗），例外的是，年龄在18至64岁之间的实体器官移植受者正在接受免疫抑制药物治疗时，高剂量灭活流感疫苗（HD-IIV3）或佐剂灭活流感疫苗（aIIV3）是可接受的选择（不优先于其他适龄可选择的IIV3或RIV3）。除≥65岁的成人接种外，当有多种获得批准和被推荐的疫苗可用时，ACIP不对特定疫苗作出优先推荐。ACIP建议，年龄≥65岁的成年人优先接种以下任何一种高剂量或佐剂流感疫苗：三价高剂量灭活流感疫苗（HD-IIV3）、三价重组流感疫苗（RIV3）或三价佐剂灭活流感疫苗（aIIV3）。如果在接种疫苗时这三种疫苗都不可用，那么应使用其他任何适龄流感疫苗。
This report updates the 2023–24 recommendations of the Advisory Committee on Immunization Practices (ACIP) concerning the use of seasonal influenza vaccines in the United States (MMWR Recomm Rep 2022;72[No. RR-2]:1–24). Routine annual influenza vaccination is recommended for all persons aged ≥6 months who do not have contraindications. Trivalent inactivated influenza vaccines (IIV3s), trivalent recombinant influenza vaccine (RIV3), and trivalent live attenuated influenza vaccine (LAIV3) are expected to be available. All persons should receive an age-appropriate influenza vaccine (i.e., one approved for their age), with the exception that solid organ transplant recipients aged 18 through 64 years who are receiving immunosuppressive medication regimens may receive either high-dose inactivated influenza vaccine (HD-IIV3) or adjuvanted inactivated influenza vaccine (aIIV3) as acceptable options (without a preference over other age-appropriate IIV3s or RIV3). Except for vaccination for adults aged ≥65 years, ACIP makes no preferential recommendation for a specific vaccine when more than one licensed and recommended vaccine is available. ACIP recommends that adults aged ≥65 years preferentially receive any one of the following higher dose or adjuvanted influenza vaccines: trivalent high-dose inactivated influenza vaccine (HD-IIV3), trivalent recombinant influenza vaccine (RIV3), or trivalent adjuvanted inactivated influenza vaccine (aIIV3). If none of these three vaccines is available at an opportunity for vaccine administration, then any other age-appropriate influenza vaccine should be used.
本报告的主要更新包括以下两个方面：2024-2025年美国季节性流感疫苗组分以及成人实体器官移植受者的接种建议更新。首先，自2020年3月以来，全球监测中没有发现B/Yamagata谱系流感病毒野毒株引发的确诊病例，因此2024-2025年美国流感疫苗将不再包括B/Yamagata组分。在2024-2025年流感季，美国提供的所有流感疫苗将是三价疫苗，包含以下血凝素组分：1）基于鸡胚制备的疫苗中为A/Victoria/4897/2022 (H1N1)pdm09-类似株，或基于细胞制备或重组疫苗中的A/Wisconsin/67/2022 (H1N1)pdm09-类似株；2）基于鸡胚制备的疫苗中为A/Thailand/8/2022 (H3N2)-类似株，或基于细胞制备或重组疫苗中的A/Massachusetts/18/2022 (H3N2)-类似株；3）B/Austria/1359417/2021 (Victoria谱系)-类似株。其次，成人实体器官移植受者的接种建议已更新，包括HD-IIV3和aIIV3作为正在接受免疫抑制药物治疗的18至64岁实体器官移植受者的可接受选择（不优先于其他适龄接种的IIV3或RIV3）。
Primary updates to this report include the following two topics: the composition of 2024–25 U.S. seasonal influenza vaccines and updated recommendations for vaccination of adult solid organ transplant recipients. First, following a period of no confirmed detections of wild-type influenza B/Yamagata lineage viruses in global surveillance since March 2020, 2024–25 U.S. influenza vaccines will not include an influenza B/Yamagata component. All influenza vaccines available in the United States during the 2024–25 season will be trivalent vaccines containing hemagglutinin derived from 1) an influenza A/Victoria/4897/2022 (H1N1)pdm09-like virus (for egg-based vaccines) or an influenza A/Wisconsin/67/2022 (H1N1)pdm09-like virus (for cell culture-based and recombinant vaccines); 2) an influenza A/Thailand/8/2022 (H3N2)-like virus (for egg-based vaccines) or an influenza A/Massachusetts/18/2022 (H3N2)-like virus (for cell culture-based and recombinant vaccines); and 3) an influenza B/Austria/1359417/2021 (Victoria lineage)-like virus. Second, recommendations for vaccination of adult solid organ transplant recipients have been updated to include HD-IIV3 and aIIV3 as acceptable options for solid organ transplant recipients aged 18 through 64 years who are receiving immunosuppressive medication regimens (without a preference over other age-appropriate IIV3s or RIV3).
引言
Introduction
流感病毒通常每年都会在美国传播，最常见的时间是从晚秋到初春。大多数感染流感病毒的人在没有严重并发症或后遗症的情况下康复。然而，流感可能与重症、住院治疗和死亡相关，特别是在老年人、非常年幼的儿童、孕妇以及所有年龄段患有某些慢性疾病的人群中（1-7）。此外，流感也是缺勤和缺课的重要原因（8-10）。
Influenza viruses typically circulate annually in the United States, most commonly from the late fall through the early spring. Most persons who become ill after influenza virus infection recover without serious complications or sequelae. However, influenza can be associated with serious illnesses, hospitalizations, and deaths, particularly among older adults, very young children, pregnant persons, and persons of all ages with certain chronic medical conditions (1–7). Influenza also is an important cause of missed work and school (8–10).
自2010年以来，CDC和免疫实践咨询委员会（ACIP）推荐所有≥6月龄且没有禁忌症的人进行年度常规流感疫苗接种（11）。疫苗接种能有效保护免受流感及其潜在并发症的影响。流感疫苗的有效性受多个因素影响，如接种者的年龄和健康状况、疫苗类型、社区中流感病毒的型别和亚型以及流行病毒与疫苗中毒株的相似度（12）。在2010-2011至2015-2016的六个流感季中，流感疫苗每季预防了约160万到670万例流感病例、79万到310万次门诊就医、39000到87000次住院以及3000到10000例呼吸道和循环系统相关死亡（13）。在2017-2018年严重的流感季中，虽然整体疫苗保护效果为38%（对流感A[H1N1]pdm09为62%，对流感A[H3N2]为22%，对B型为50%）（14），但疫苗仍预防了约710万例流感病例、370万次医疗就诊、10.9万次住院以及8000例死亡（14），当时美国流感活动范围广泛且持续时间异常长，与近期流感季相比，门诊就医和住院率也较高。
Routine annual influenza vaccination for all persons aged ≥6 months who do not have contraindications has been recommended by CDC and the Advisory Committee on Immunization Practices (ACIP) since 2010 (11). Vaccination provides important protection from influenza illness and its potential complications. The effectiveness of influenza vaccination varies depending on multiple factors such as the age and health of the recipient, the type of vaccine administered, the types and subtypes of influenza viruses circulating in the community, and the degree of similarity between circulating viruses and those included in the vaccine (12). During each of the six influenza seasons from 2010–11 through 2015–16, influenza vaccination prevented an estimated 1.6–6.7 million illnesses, 790,000–3.1 million outpatient medical visits, 39,000–87,000 hospitalizations, and 3,000–10,000 respiratory and circulatory deaths each season in the United States (13). During the severe 2017–18 season, notable for an unusually long duration of widespread high influenza activity throughout the United States and higher rates of outpatient visits and hospitalizations compared with recent seasons, vaccination prevented an estimated 7.1 million illnesses, 3.7 million medical visits, 109,000 hospitalizations, and 8,000 deaths (14), despite an overall estimated vaccine effectiveness of 38% (62% against influenza A[H1N1]pdm09 viruses, 22% against influenza A[H3N2] viruses, and 50% against influenza B viruses) (14).
本报告更新了2023-2024年ACIP关于季节性流感疫苗的建议（15），并提供了针对2024-2025年流感季在美国使用流感疫苗的建议和指导。报告中包含了各种流感疫苗的配方（表1）。流感疫苗的禁忌症和使用注意事项已总结（表2和表3）。报告中使用了缩写来表示各种疫苗类型（下框）。这些建议的总结和包含流感、流感相关疾病及流感疫苗的更多信息的背景文档可在https://www.cdc.gov/acip-recs/hcp/vaccine-specific/flu.html?CDC_AAref_Val=https://www.cdc.gov/vaccines/hcp/acip-recs/vacc-specific/flu.html获得。
This report updates the 2023–24 ACIP recommendations regarding the use of seasonal influenza vaccines (15) and provides recommendations and guidance for vaccination providers regarding the use of influenza vaccines in the United States for the 2024–25 season. Various formulations of influenza vaccines are available (Table 1). Contraindications and precautions for the use of influenza vaccines are summarized (Tables 2 and 3). Abbreviations are used in this report to denote the various types of vaccines (Box). A summary of these recommendations and a Background Document containing additional information on influenza, influenza-associated illness, and influenza vaccines are available at https://www.cdc.gov/acip-recs/hcp/vaccine-specific/flu.html?CDC_AAref_Val=https://www.cdc.gov/vaccines/hcp/acip-recs/vacc-specific/flu.html.
方法
Methods
ACIP每年提供关于在美国预防和控制季节性流感的流感疫苗使用建议。ACIP流感工作组每月通过电话会议沟通一到两次。工作组成员包括ACIP的多个投票成员、ACIP联络组织的代表和顾问。讨论的主题包括流感监测、疫苗效果和安全性、接种覆盖率、程序可行性、成本效益和疫苗供应。邀请专家进行报告，并讨论已发表和未发表的数据。
ACIP provides annual recommendations for the use of influenza vaccines for the prevention and control of seasonal influenza in the United States. The ACIP Influenza Work Group meets by teleconference once to twice per month throughout the year. Work Group membership includes multiple voting members of ACIP, representatives of ACIP liaison organizations, and consultants. Discussions include topics such as influenza surveillance, vaccine effectiveness and safety, vaccination coverage, program feasibility, cost effectiveness, and vaccine supply. Presentations are requested from invited experts and published and unpublished data are discussed.
本报告的补充背景文档包含与前几季建议相关的文献。背景文档中包含的信息不是系统评价；它旨在提供背景文献的概述，并定期更新，主要通过广泛搜索英语语系的流感和流感疫苗文章来识别文献。总体上，本文件中长期存在的建议反映了专家意见，而非进行系统评价和证据评估。对于现有建议的轻微措辞更改、流感疫苗的FDA推荐病毒抗原组分的变化以及流感疫苗使用指导的轻微更改（例如，接种时间的指导、特定人群的剂型指导、推荐接种的特定人群疫苗选择指导和与FDA批准指示和处方信息一致的变化），没有进行系统评价和证据评估。
The Background Document that supplements this report contains literature related to recommendations made in previous seasons. The information included in the Background Document for such topics is not a systematic review; it is intended to provide an overview of background literature and is periodically updated with literature being identified primarily through a broad search for English-language articles on influenza and influenza vaccines. In general, longstanding recommendations in this document that were made in previous seasons reflect expert opinion, and systematic review and assessment of evidence was not performed. Systematic review and evidence assessment are not performed for minor wording changes to existing recommendations, changes in the Food and Drug Administration (FDA)-recommended viral antigen composition of seasonal influenza vaccines, and minor changes in guidance for the use of influenza vaccines (e.g., guidance for timing of vaccination and other programmatic issues, guidance for dosage in specific populations, guidance for selection of vaccines for specific populations that are already recommended for vaccination, and changes that reflect use that is consistent with FDA-licensed indications and prescribing information).
通常，对于新的建议或现有建议的重大变化（例如，流感疫苗接种建议扩展到以前未推荐接种的新群体或对特定疫苗的潜在优先推荐），会使用推荐等级评估、发展和评价（GRADE）方法进行系统评价和证据评估（16）。
Typically, systematic review and evaluation of evidence using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach (16) are performed for new recommendations or substantial changes in the current recommendations (e.g., expansion of the recommendation for influenza vaccination to new populations not previously recommended for vaccination or potential preferential recommendations for specific vaccines).
ACIP流感工作组审查证据，并将工作组考虑纳入ACIP证据与建议框架（EtR）（17），以帮助制定ACIP发起投票的建议。系统评价、GRADE和ACIP EtR框架用于制定本报告中讨论的针对成人实体器官移植受者的更新建议。
Evidence is reviewed by the ACIP influenza Work Group, and Work Group considerations are included within the ACIP Evidence to Recommendations framework (EtR) (17) to inform the development of recommendations that are proposed for vote by the ACIP. Systematic review, GRADE, and the ACIP EtR framework were used in the development of the updated recommendations for adult solid organ transplant recipients discussed in this report.
Primary Changes and Updates
本报告描述的主要变化和更新包括1）2024-2025年美国季节性流感疫苗的组分和2）针对成人固体器官移植受者的更新接种建议。相关信息包括以下内容：
Primary changes and updates to the recommendations described in this report include 1) the composition of 2024–25 U.S. seasonal influenza vaccines and 2) updated recommendations for vaccination of adult solid organ transplant recipients. Information relevant to these changes includes the following:
2024-2025年美国季节性流感疫苗的组分包括更新的流感A(H3N2)组分。在2024-2025年流感季中，美国批准的流感疫苗将包含以下血凝素（HA）组分：1）基于鸡胚制备的疫苗中为A/Victoria/4897/2022 (H1N1)pdm09类似株，或基于细胞制备或重组疫苗中的A/Wisconsin/67/2022 (H1N1)pdm09类似株；2）基于鸡胚制备的疫苗中为A/Thailand/8/2022 (H3N2)类似株，或基于细胞制备或重组疫苗中的A/Massachusetts/18/2022 (H3N2)类似株；3）B/Austria/1359417/2021 (Victoria系)类似株（适用于基于鸡胚制备、细胞制备和重组疫苗）。北半球流感疫苗的组分建议由世界卫生组织（WHO）提出，该组织通常在每年2月召开咨询会议。审查流感监测数据并讨论候选疫苗病毒。有关2024年2月WHO会议的流感疫苗组分选择信息可在https://www.who.int/publications/m/item/recommended-composition-of-influenza-virus-vaccines-for-use-in-the-2024-2025-northern-hemisphere-influenza-season获取。随后，美国FDA召集其疫苗和相关生物制品咨询委员会（VRBPAC）会议。该委员会考虑WHO的建议，审查和讨论类似数据，并对在美国批准和销售的流感疫苗的组分做出最终决定。有关2024年3月5日VRBPAC讨论材料的信息可在https://www.fda.gov/advisory-committees/advisory-committee-calendar/vaccines-and-related-biological-products-advisory-committee-march-5-2024-meeting-announcement获取。对于2024–25年流感季，FDA建议美国季节性流感疫苗的组分不再包括流感B/Yamagata，因为自2020年3月以来，全球流感监测中未确认发现流感B/Yamagata谱系（18,19）。
The composition of the 2024–25 U.S. seasonal influenza vaccines includes an update to the influenza A(H3N2) component. For the 2024–25 season, U.S.-licensed influenza vaccines will contain hemagglutinin (HA) derived from 1) an influenza A/Victoria/4897/2022 (H1N1)pdm09-like virus (for egg-based vaccines) or an influenza A/Wisconsin/67/2022 (H1N1)pdm09-like virus (for cell culture-based and recombinant vaccines, 2) an influenza A/Thailand/8/2022 (H3N2)-like virus (for egg-based vaccines) or an influenza A/Massachusetts/18/2022 (H3N2)-like virus (for cell culture-based and recombinant vaccines), and 3) an influenza B/Austria/1359417/2021 (Victoria lineage)-like virus (for egg-based, cell culture-based, and recombinant vaccines). Recommendations for the composition of Northern Hemisphere influenza vaccines are made by the World Health Organization (WHO), which organizes a consultation, usually in February of each year. Surveillance data are reviewed, and candidate vaccine viruses are discussed. Information about the WHO meeting of February 2024 for selection of the 2024–25 Northern Hemisphere influenza vaccine composition is available at https://www.who.int/publications/m/item/recommended-composition-of-influenza-virus-vaccines-for-use-in-the-2024-2025-northern-hemisphere-influenza-season. Subsequently, FDA, which has regulatory authority over vaccines in the United States, convenes a meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC). This committee considers the recommendations of WHO, reviews and discusses similar data, and makes a final decision regarding the composition of influenza vaccines licensed and marketed in the United States. Materials from the VRBPAC discussion on March 5, 2024, during which the composition of the 2024–25 U.S. influenza vaccines was discussed, are available at https://www.fda.gov/advisory-committees/advisory-committee-calendar/vaccines-and-related-biological-products-advisory-committee-march-5-2024-meeting-announcement. For the 2024–25 influenza season, FDA has recommended that the U.S. seasonal influenza vaccine composition no longer include influenza B/Yamagata, as there have been no confirmed detections of influenza B/Yamagata viruses in global influenza surveillance since March 2020 (18,19).
针对成人实体器官移植受者的接种建议已更新，包含HD-IIV3和aIIV3可作为正在接受免疫抑制药物治疗的18至64岁实体器官移植受者的可接受选择（不优先于其他适龄可选择的IIV3或RIV3）。为制定此建议，对HD-IIV3和aIIV3与标准剂量未加佐剂灭活流感疫苗的效果和安全性进行了系统评价和GRADE评估。有关该评估的总结和GRADE证据表格可在https://www.cdc.gov/vaccines/acip/recs/grade/influenza-solid-organ-transplant.html获取。ACIP EtR框架的总结可在https://www.cdc.gov/vaccines/acip/recs/grade/influenza-solid-organ-transplant-etr.html获取。
Recommendations for vaccination of adult solid organ transplant recipients have been updated to include HD-IIV3 and aIIV3 as acceptable options for solid organ transplant recipients aged 18 through 64 years who are receiving immunosuppressive medication regimens (without a preference over other age-appropriate IIVs or RIV3). To inform this recommendation, a systematic review and GRADE of evidence concerning effectiveness and safety of HD-IIV3 and aIIV3 compared with standard-dose unadjuvanted inactivated influenza vaccines was conducted. A summary of this review and the GRADE evidence tables is available at https://www.cdc.gov/vaccines/acip/recs/grade/influenza-solid-organ-transplant.html. A summary of the ACIP EtR framework is available at https://www.cdc.gov/vaccines/acip/recs/grade/influenza-solid-organ-transplant-etr.html.
流感疫苗使用建议，2024-2025年
Recommendations for the Use of Influenza Vaccines, 2024–25
推荐接种的群体
Groups Recommended for Vaccination
常规推荐所有≥6月龄、没有禁忌症的人进行常规年度流感疫苗接种。所有人应接种适合其年龄的流感疫苗（即批准用于其年龄段的疫苗），但18至64岁接受免疫抑制药物治疗的实体器官移植接受者可以选择HD-IIV3或aIIV3（不优先于其他适龄接种的IIV3或RIV3）（见“免疫抑制者”部分）。2024-2025年流感季预计提供的流感疫苗、其年龄适用范围和呈现形式描述在表1中。ACIP在多种获批和推荐的疫苗可用时，不对任何一种流感疫苗优于另一种做出优先推荐，除非是对65岁及以上老年人的疫苗选择（见“老年人”部分）。接种时间、特定人群的考虑、特定疫苗的使用及禁忌症和注意事项总结如下。
Routine annual influenza vaccination of all persons aged ≥6 months who do not have contraindications continues to be recommended. All persons should receive an age-appropriate influenza vaccine (one that is approved for their age), with the exception that solid organ transplant recipients aged 18 through 64 years who are receiving immunosuppressive medication regimens may receive either HD-IIV3 or aIIV3 as acceptable options (without a preference over other age-appropriate IIV3s or RIV3) (see Immunocompromised Persons). Influenza vaccines expected to be available for the 2024–25 season, their age indications, and their presentations are described (Table 1). ACIP makes no preferential recommendation for the use of any one influenza vaccine over another when more than one licensed and recommended vaccine is available, except for selection of influenza vaccines for persons aged ≥65 years (see Older Adults). Recommendations regarding timing of vaccination, considerations for specific populations, the use of specific vaccines, and contraindications and precautions are summarized in the sections that follow.
接种时间
Timing of Vaccination
流感活跃的开始、峰值和下降时间各流行季有所不同（20）。接种决策需要考虑流感季的不可预测性、疫苗诱导的免疫可能会随流感季变化而减退以及实际情况。对于大多数需要1剂流感疫苗的个人而言，理想的接种时间是9月或10月。然而，接种应在10月后和整个流感季内继续进行，只要流感病毒仍在传播且未过期的疫苗仍可用。为了避免错失接种机会，提供者应在常规健康检查和住院期间提供疫苗接种。对于那些已经在本流感季接种了完整免疫程序的人，不推荐重新接种（即提供加强剂次），无论当前流感季的疫苗何时接种。
Timing of the onset, peak, and decline of influenza activity varies from season to season (20). Decisions about timing need to consider the unpredictability of the influenza season, possible waning of vaccine-induced immunity over the course of a season, and practical considerations. For most persons who need only 1 dose of influenza vaccine for the season, vaccination should ideally be offered during September or October. However, vaccination should continue after October and throughout the influenza season as long as influenza viruses are circulating and unexpired vaccine is available. To avoid missed opportunities for vaccination, providers should offer vaccination during routine health care visits and hospitalizations. Revaccination (i.e., providing a booster dose) to persons who have been fully vaccinated for the season is not recommended, regardless of when the current season vaccine was received.
流感疫苗可能早在7月或8月就会提供；然而，由于免疫力可能在流感季中减退（21–40），特别是在老年人群体中（21,22,24,31,34,40），大多数人群不推荐在7月和8月接种。然而，对于任何担心未来无法接种的受种者，可以考虑在7月或8月接种。接种时间的考虑因素包括：
Influenza vaccines might be available as early as July or August; however, vaccination during July and August is not recommended for most groups because of potential waning of immunity over the course of the influenza season (21–40), particularly among older adults (21,22,24,31,34,40). However, vaccination during July or August can be considered for any recipient for whom there is concern that they will not be vaccinated at a later date. Considerations for timing of vaccination include the following:
·对于大多数成人（特别是65岁及以上成人）和怀孕的孕早期（孕1~3月）或孕中期（孕4~6月）妇女：应避免在7月和8月接种，除非担心流感季后期无法接种。
·For most adults (particularly adults aged ≥65 years) and for pregnant persons in the first or second trimester: Vaccination during July and August should be avoided unless there is concern that vaccination later in the season might not be possible.
·需要2剂的儿童：某些6个月至8岁儿童需要接种2剂流感疫苗（见6个月至8岁儿童：流感疫苗剂型）（图）。这些儿童应尽早接种第一剂（包括7月和8月，如果疫苗可用），以便在理想情况下在10月底前接种第二剂（需至少间隔4周）。
·Children who require 2 doses: Certain children aged 6 months through 8 years require 2 doses of influenza vaccine for the season (see Children Aged 6 Months Through 8 Years: Number of Influenza Vaccine Doses) (Figure). These children should receive their first dose as soon as possible (including during July and August, if vaccine is available) to allow the second dose (which must be administered ≥4 weeks later) to be received, ideally, by the end of October.
·仅需1剂的儿童：可以考虑在7月和8月接种所有年龄段仅需1剂流感疫苗的儿童。虽然所有年龄组在流感季内接种后免疫力减退已被观察到（21–40），但有关儿童的研究较少（21,30,32,33,37,39,40）。此外，这些儿童可能在学校开学前的夏末期间访问医疗提供者。可以考虑此时接种，因为这是一个接种触达的机会。
·Children who require only 1 dose: Vaccination during July and August can be considered for children of any age who need only 1 dose of influenza vaccine for the season. Although waning of immunity after vaccination over the course of the season has been observed among all age groups (21–40), there are fewer published studies reporting results specifically among children (21,30,32,33,37,39,40). Moreover, children in this group might visit health care providers during the late summer months for medical examinations before the start of school. Vaccination can be considered at this time because it represents a vaccination opportunity.
·孕晚期（孕7~9月）的妇女：在怀孕7~9个月的女性可以考虑在7月和8月接种流感疫苗，因为多项研究已经证实在此时期接种流感疫苗与降低其婴儿出生后几个月内流感疾病的风险相关（41–44）。对于在7月和8月处于第一或第二三个月的孕妇，除非担心后期无法接种，否则最好等待到9月或10月接种。
·Pregnant persons in the third trimester: Vaccination during July and August can be considered for pregnant persons who are in the third trimester during these months because vaccination has been associated in multiple studies with reduced risk for influenza illness in their infants during the first months after birth, when they are too young to receive influenza vaccine (41–44). For pregnant persons in the first or second trimester during July and August, waiting to vaccinate until September or October is preferable, unless there is concern that later vaccination might not be possible.
越来越多的观察性研究（21–40）报告称，接种疫苗保护效果后随有效性随时间的推移。这些研究观察到的减退率差异很大，并且不同年龄组、流感季和流感病毒类型和亚型间的减退效果不一致；也有一些研究报告称对A(H3N2)型流感病毒的减退速度比对流感A(H1N1)型流感病毒或B型流感病毒更快（25,31,35,40）。一项对14项研究的荟萃分析发现，对A(H3N2)型流感病毒和B型流感病毒的疫苗有效性显著下降，但对A(H1N1)型流感病毒没有显著变化（45）。在该研究中，对A(H3N2)型流感病毒的有效性平均下降了32个百分点，从接种后的前三个月的45%降至第四至第六个月的13%。减退效果的速度可能因年龄而异；在一些研究中，老年人的减退更为明显（21,22,24,31,34,40）。几项最近的多流感季研究发现，在所有年龄段疫苗接种者中，接种后每月流感感染的几率增加了9%至28%，在65岁及以上疫苗接种者中增加了12%至29%（33,39,40）。儿童的相关研究较少，有些报告了有效性减退（21,32,33,37,40），而有些则未发现有效性减退的证据（30,39）。在解读有效性减退的研究报告时，需要注意观察到的保护减少可能至少部分是由于偏倚、未测量的混杂因素或流感病毒抗原漂移变异株的出现，这些变异株与疫苗病毒匹配度较差。
An increasing number of observational studies (21–40) have reported decreased vaccine effectiveness with increasing time after vaccination within an influenza season. The rate of waning effectiveness observed in these studies varied considerably and waning effects were inconsistent across age groups, seasons, and influenza virus types and subtypes; although several studies reported faster waning against influenza A(H3N2) viruses than against influenza A(H1N1) or influenza B viruses (25,31,35,40). A meta-analysis of 14 studies examining waning of influenza vaccine effectiveness using the test-negative design found a significant decline in effectiveness after vaccination against influenza A(H3N2) and influenza B but not against influenza A(H1N1) (45). In that study, VE against influenza A(H3N2) declined, on average, by 32 percentage points, from 45% during the first 3 months to 13% in the fourth to sixth months after vaccination. The rate of waning effectiveness also might vary with age; in several studies, waning was more pronounced among older adults (21,22,24,31,34,40). Several recent multiseason studies of waning protection found that the odds of influenza infection increased by 9% to 28% per month after vaccination among vaccinees of all ages and by 12% to 29% per month among vaccinees aged ≥65 years (33,39,40). There are fewer studies of waning specifically among children, with some reporting waning effectiveness (21,32,33,37,40) and others finding no evidence of waning effectiveness (30,39). Complicating the interpretation of studies of waning effectiveness is the fact that observed decreases in protection might be at least partially due to bias, unmeasured confounding, or emergence of antigenic drift variants of influenza viruses that are less well-matched to the vaccine viruses.
社区接种项目应在整个流感季保持疫苗诱导的保护与避免错过接种疫苗的机会或在流感暴发后接种疫苗之间取得平衡。虽然推迟接种可能会导致流感季内获得更强的免疫力，但推迟可能会导致错失接种机会以及在更有限的时间内导致接种困难。对美国老年人推迟接种的建模研究发现，如果推迟不导致总体接种覆盖率显著下降（因为有些人可能会推迟接种），则推迟接种是有益的（46–48）。在老年人中，如果疫苗覆盖率在轻度流感季中下降不超过6%（47）或在中度严重的流感季中下降约15%（46,48），推迟接种会有利。然而，这些结果对许多因素非常敏感，特别是疫苗有效性减退的速度，因此仍存在相当大的不确定性。
Community vaccination programs should balance persistence of vaccine-induced protection through the season with avoiding missed opportunities to vaccinate or vaccinating after onset of influenza circulation occurs. Although delaying vaccination might result in greater immunity later in the season, deferral might result in missed opportunities to vaccinate as well as difficulties in vaccinating a population within a more constrained period. Modeling studies examining the consequences of delaying vaccination (until September or October) among older adults in the United States found that delaying vaccination is beneficial if the delay does not cause a substantial reduction in overall vaccination coverage (because of failure of some persons who would prefer earlier vaccination to get vaccinated later in the fall) (46–48). Among older adults, delayed vaccination would be beneficial, on balance, if vaccine coverage declines by no more than 6% in a mild season (47) or by about 15% in a moderately severe season (46,48). However, these results are sensitive to many factors, especially the rate of waning of vaccine effectiveness, about which there remains considerable uncertainty.
接种工作应持续进行，因为流感季的持续时间各不相同，流感可能直到2月、3月或更晚才在某些社区开始活跃（20）。服务提供者应在健康检查中为尚未接种的人员提供流感疫苗，并在流感季内继续组织接种活动，包括在社区流感活动开始后。尽管建议在10月底前接种，但即便流感活动已经开始，在12月或之后接种的疫苗在大多数流感季中可能仍然有益。服务提供者应向已经在流感季内感染流感但尚未接种疫苗的未接种者提供流感疫苗，因为疫苗可能保护他们免受其他流感病毒的感染。
Vaccination efforts should continue throughout the season because the duration of the influenza season varies, and influenza activity might not occur in certain communities until February, March, or later (20). Providers should offer influenza vaccine at health care visits to those not yet vaccinated, and organized vaccination campaigns should continue throughout the influenza season, including after influenza activity has begun in the community. Although vaccination by the end of October is recommended, vaccine administered in December or later, even if influenza activity has already begun, might be beneficial in most influenza seasons. Providers should offer influenza vaccination to unvaccinated persons who have already become ill with influenza during the season because the vaccine might protect them against other circulating influenza viruses.
流感疫苗使用指南：特定人群和情况
Guidance for Influenza Vaccination in Specific Populations and Situations
面临严重流感医疗并发症的高风险人群
Populations at Higher Risk for Medical Complications Attributable to Severe Influenza
所有≥6月龄且没有禁忌症的人应每年接种流感疫苗。然而，预防流感的疫苗接种对于患有严重疾病和流感并发症风险增加的人以及与流感相关的门诊、急诊或医院就诊尤为重要。当疫苗供应有限时，疫苗接种工作应侧重于对没有禁忌症的严重流感并发症高风险者进行疫苗接种。包括以下人员（先后顺序并不意味着这些人群之间的等级或优先级）：
All persons aged ≥6 months who do not have contraindications should be vaccinated annually. However, vaccination to prevent influenza is particularly important for persons who are at increased risk for severe illness and complications from influenza and for influenza-related outpatient, emergency department, or hospital visits. When vaccine supply is limited, vaccination efforts should focus on vaccination of persons at higher risk for medical complications attributable to severe influenza who do not have contraindications. These persons include the following (order of listing does not imply hierarchy or prioritization among these populations):
·所有6至59月龄的儿童。
·All children aged 6 through 59 months.
·All persons aged ≥50 years.
·有慢性呼吸系统（包括哮喘）、心血管（不包括单纯高血压）、肾脏、肝脏、神经系统、血液系统或代谢性（包括糖尿病）疾病的成人和儿童。
·Adults and children who have chronic pulmonary (including asthma), cardiovascular (excluding isolated hypertension), renal, hepatic, neurologic, hematologic, or metabolic disorders (including diabetes mellitus).
·任何原因导致免疫功能受损者（包括但不限于药物或HIV感染引起的免疫抑制）。
·Persons who are immunocompromised due to any cause (including but not limited to immunosuppression caused by medications or HIV infection).
·在流感季期间正在怀孕或即将怀孕的人。
·Persons who are or will be pregnant during the influenza season.
·接受含阿司匹林或水杨酸盐药物治疗的6月龄至18岁的儿童，可能面临流感病毒感染后发生Reye综合征的风险。
·Children and adolescents (aged 6 months through 18 years) who are receiving aspirin- or salicylate-containing medications and who might be at risk for experiencing Reye syndrome after influenza virus infection.
·Residents of nursing homes and other long-term care facilities.
·美国印第安人或阿拉斯加土著。
·American Indian or Alaska Native persons.
·极度肥胖者（成人BMI≥40）。
·Persons who are extremely obese (body mass index ≥40 for adults).
·IIV3或RIV3适用于所有推荐接种的人员，包括上述高风险人群。LAIV3不推荐用于某些人群（见表2“禁忌症和注意事项”）。
·IIV3 or RIV3 are suitable for all persons recommended for vaccination, including those in the risk groups listed. LAIV3 is not recommended for certain populations, including certain of these listed groups. Contraindications and precautions for the use of LAIV3 are noted (Table 2).
与高流感并发症风险的人群同住或其看护者
Persons Who Live with or Care for Persons at Higher Risk for Influenza-Related Complications
所有≥6月龄且没有禁忌症的人应每年接种流感疫苗。此外，还应强调为与严重流感引起的医疗并发症风险增加的人一起生活或其看护者接种疫苗。当疫苗供应有限时，疫苗接种工作应侧重于为流感相关并发症风险较高的人以及与这些人一起生活或其看护者接种疫苗，包括以下人员：
All persons aged ≥6 months without contraindications should be vaccinated annually. However, emphasis also should be placed on vaccination of persons who live with or care for those who are at increased risk for medical complications attributable to severe influenza. When vaccine supply is limited, vaccination efforts should focus on administering vaccination to persons at higher risk for influenza-related complications as well as persons who live with or care for such persons, including the following:
·医务人员，包括所有有潜在接触患者或感染性材料的付费和公益工作人员，如医生、护士、护理助理、护士从业者、医生助理、治疗师、技术人员、急救人员、牙医、药剂师、实验室人员、尸检人员、医学生和培训人员、合同工以及其他可能接触感染源的人（如文员、饮食、清洁、洗衣、安全、维保、行政、财务人员和志愿者）。ACIP此前已发布医疗人员接种的指南（49）。
·Health care personnel, including all paid and unpaid persons working in health care settings who have the potential for exposure to patients or to infectious materials. These personnel might include but are not limited to physicians, nurses, nursing assistants, nurse practitioners, physician assistants, therapists, technicians, emergency medical service personnel, dental personnel, pharmacists, laboratory personnel, autopsy personnel, students and trainees, contractual staff members, and others not directly involved in patient care but who might be exposed to infectious agents (e.g., clerical, dietary, housekeeping, laundry, security, maintenance, administrative, billing staff, and volunteers). ACIP guidance for vaccination of health care personnel has been published previously (49).
·Household contacts (including children aged ≥6 months) and caregivers of children aged ≤59 months (<5 years) and adults aged ≥50 years, particularly contacts of children aged <6 months.
·有医疗状况可将使其面临流感严重并发症风险的人员的家庭接触者（包括≥6月龄的儿童）和看护者。
·Household contacts (including children aged ≥6 months) and caregivers of persons with medical conditions that put them at higher risk for severe complications from influenza.
健康护理人员及这些人群的接触者（除了接触严重免疫抑制者需要处于防护环境的人）可以接种任何合适的流感疫苗。照顾需要处于防护环境的严重免疫抑制者的人不应接种LAIV3。ACIP和HICPAC此前推荐接种LAIV的医疗人员在接种后7天内避免照顾需要处于防护环境的严重免疫抑制者，接种LAIV的医院访客在接种后7天内应避免与此类人群接触（50）。不过，这些人员不需要限制照顾或探访免疫抑制较轻的人。
Health care personnel and persons who are contacts of persons in these groups (except for of contacts of severely immunocompromised persons who require a protected environment) can receive any influenza vaccine that is otherwise indicated. Persons who care for severely immunocompromised persons requiring a protected environment should not receive LAIV3. ACIP and the Healthcare Infection Control Practices Advisory Committee (HICPAC) have previously recommended that health care personnel who receive LAIV should avoid providing care for severely immunocompromised persons requiring a protected environment for 7 days after vaccination and that hospital visitors who have received LAIV should avoid contact with such persons for 7 days after vaccination (50). However, such persons need not be restricted from caring for or visiting less severely immunocompromised persons.
6至35月龄儿童的流感疫苗
Children Aged 6 Through 35 Months: Influenza Vaccine Dose Volumes
五种IIV3疫苗已批准用于≥6月龄的儿童（见表1）。其中四种是基于鸡胚制备（Afluria、Fluarix、FluLaval和Fluzone），一种是基于细胞制备（Flucelvax）。这些疫苗中，6至35月龄儿童的获批的疫苗如下（见表4）：
Five IIV3s are approved for children aged ≥6 months (Table 1). Four of these vaccines are egg based (Afluria, Fluarix, FluLaval, and Fluzone), and one is cell culture–based (Flucelvax). For these vaccines, the approved dose volumes for children aged 6 through 35 months are as follows (Table 4):
·Afluria：每剂0.25 mL。但0.25 mL的预充注射器版已不再供应。对于6至35月龄的儿童，必须从多人份剂型中抽取0.25 mL的剂型（51）。
·Afluria: 0.25 mL per dose. However, 0.25-mL prefilled syringes are no longer available. For children aged 6 through 35 months, a 0.25-mL dose must be obtained from a multidose vial (51).
·Fluarix：每剂0.5 mL（52）。
·Fluarix: 0.5 mL per dose (52).
·Flucelvax：每剂0.5 mL（53）。
·Flucelvax: 0.5 mL per dose (53).
·FluLaval：每剂0.5 mL（54）。
·FluLaval: 0.5 mL per dose (54).
·Fluzone：每剂0.25 mL或0.5 mL。根据包装说明，可以用任意容量剂型接种（55）；不过0.25 mL的预充注射器版已不再供应。
·Fluzone: Either 0.25 mL or 0.5 mL per dose. Per the package insert, each dose can be given at either volume (55); however, 0.25-mL prefilled syringes are no longer available.
对于所有种类的IIV3，36御灵（3岁）及以上的人员应接种0.5 mL的剂型。健康儿童（2岁及以上）可以接种LAIV3，每次鼻喷0.2 mL（每个鼻孔0.1 mL）（56）。LAIV3不推荐用于某些人群，并且不批准用于2岁以下儿童或49岁以上成人（见禁忌症和注意事项，表2）。RIV3不批准用于18岁以下儿童（57）。高剂量流感疫苗（HD-IIV3）（58）和佐剂流感疫苗（aIIV3）（59）不批准用于65岁以下人员。
For all of these IIV3s, persons aged ≥36 months (≥3 years) should receive 0.5 mL per dose. Alternatively, healthy children aged ≥24 months (≥2 years) can receive LAIV3, 0.2 mL intranasally (0.1 mL in each nostril) (56). LAIV3 is not recommended for certain populations and is not approved for children aged <2 years or adults >49 years (see Contraindications and Precautions for the Use of LAIV3) (Table 2). RIV3 is not approved for children aged <18 years (57). High-dose inactivated influenza vaccine (HD-IIV3) (58) and adjuvanted inactivated influenza vaccine (aIIV3) (59) are not approved for persons aged <65 years.
应注意采用适龄疫苗和使用适当剂型。对于IIV3的推荐剂量可以从含有适量体积的预充注射器或多人份剂型中提取。多人份剂型只应用于包装说明中规定的最大剂次数量。瓶中剩余的疫苗在达到最大剂次数量后应丢弃，无论剩余体积或瓶中的剩余量如何。
Care should be taken to administer an age-appropriate vaccine at the appropriate volume for each dose. For IIV3s, the recommended volume can be administered from a prefilled syringe containing the appropriate volume (as supplied by the manufacturer) or a multidose vial. Multidose vials should be used only for the maximum number of doses specified in the package insert. Any vaccine remaining in a vial after the maximum number of doses has been removed should be discarded, regardless of the volume of the doses obtained or any remaining volume in the vial.
6月龄至8岁儿童：流感疫苗接种剂次
Children Aged 6 Months Through 8 Years: Number of Influenza Vaccine Doses
6月龄至8岁的儿童在首次接种流感疫苗的流感季需要接种2剂，且两剂之间间隔至少4周，从而获得最佳保护（60-63）。所需接种剂次取决于以下两个因素：1）2024-25流感疫苗首次接种时儿童的年龄，2）儿童在以前流感季节中接种的流感疫苗剂次。
Children aged 6 months through 8 years require 2 doses of influenza vaccine administered a minimum of 4 weeks apart during their first season of vaccination for optimal protection (60–63). Determination of the number of doses needed is based on 1) the child’s age at the time of the first dose of 2024–25 influenza vaccine and 2) the number of doses of influenza vaccine received in previous influenza seasons.
·对于6月龄至8岁的儿童，2024-25流感季节所需的疫苗剂次如下（见图）：
·For children aged 6 months through 8 years, the number of doses of influenza vaccine needed for the 2024–25 influenza season is determined as follows (Figure):
♢如果儿童在2024年7月1日之前已经接种了≥2剂三价或四价流感疫苗（每剂间隔≥4周），则2024-2025流感季只需接种1剂流感疫苗。之前的2剂流感疫苗不一定在同一流感季或连续的流感季中接种。
♢Those who have previously received ≥2 total doses of trivalent or quadrivalent influenza vaccine ≥4 weeks apart before July 1, 2024, require only 1 dose for the 2024–25 season. The previous 2 doses of influenza vaccine do not need to have been received in the same season or consecutive seasons.
♢如果儿童在2024年7月1日之前未接种≥2剂三价或四价流感疫苗（每剂间隔≥4周），或者其既往流感疫苗接种史不明，则需要接种2剂流感疫苗。两剂之间的间隔应为≥4周。需要接种2剂流感疫苗的6月龄至8岁的儿童应尽早接种第一剂（如果疫苗可用，包括7月和8月），以便第二剂（必须在≥4周后接种）能够在10月底之前完成。对于需要接种2剂疫苗的8岁儿童，即使在接种第一剂和第二剂之间转为9岁，仍应接种2剂。
♢Those who have not previously received ≥2 doses of trivalent or quadrivalent influenza vaccine ≥4 weeks apart before July 1, 2024, or whose previous influenza vaccination history is unknown, require 2 doses for the 2024–25 season. The interval between the 2 doses should be ≥4 weeks. Children aged 6 months through 8 years who require 2 doses of influenza vaccine should receive their first dose as soon as possible (including during July and August, if vaccine is available) to allow the second dose (which must be administered ≥4 weeks later) to be received, ideally, by the end of October. For children aged 8 years who require 2 doses of vaccine, both doses should be administered even if the child turns age 9 years between receipt of dose 1 and dose 2.
·9岁及以上的成年人和儿童在2024-2025季节只需接种1剂流感疫苗。
·Adults and children aged ≥9 years need only 1 dose of influenza vaccine for the 2024–25 season.
孕妇
Pregnant Persons
孕妇和产后妇女在流感季节期间面临更高的严重流感疾病和并发症风险，尤其是在孕中期和孕晚期。孕期接种流感疫苗与孕妇和产后妇女以及婴儿在出生最初几个月的呼吸道疾病和流感风险减少相关（41-44,64）。ACIP和美国妇产科医师学会建议孕期或可能在流感季节期间怀孕和分娩的女性接种流感疫苗（65）。可以使用IIV3或RIV3。孕期不应使用LAIV3，但产后可以使用。流感疫苗可以在孕期的任何时间接种（即任何孕期），包括在流感季节之前。对于处在7月和8月的孕晚期人群，如果疫苗可用，可以考虑在流感季前尽早接种，以提供对婴儿在出生最初几个月的保护，因为婴儿太小无法接种流感疫苗（41-44,64）。
Pregnant and postpartum persons are at higher risk for severe illness and complications from influenza, particularly during the second and third trimesters. Influenza vaccination during pregnancy is associated with reduced risk for respiratory illness and influenza among pregnant and postpartum persons as well as infants during the first months of life (41–44,64). ACIP and the American College of Obstetricians and Gynecologists recommend that persons who are pregnant or who might be pregnant or postpartum during the influenza season receive influenza vaccine (65). IIV3 or RIV3 can be used. LAIV3 should not be used during pregnancy but can be used postpartum. Influenza vaccine can be administered at any time during pregnancy (i.e., during any trimester), before and during the influenza season. Early vaccination (i.e., during July and August) can be considered for persons who are in the third trimester during these months if vaccine is available because this can provide protection for the infant during the first months of life when they are too young to be vaccinated (41–44,64).
尽管使用IIV为孕妇接种的经验丰富，但关于孕早期接种流感疫苗的数据有限。大多数研究未发现流感疫苗与不良孕期结果（包括自然流产）的关联（66-76）。2010-2011和2011-2012季节的观察性VSD研究发现，接种含H1N1pdm09的IIV与接种后28天自然流产的风险相关，前提是既往也接种了含H1N1pdm09的疫苗（77）。然而，在更大规模的VSD随访研究中，IIV与2012-2013、2013-2014和2014-2015季节的自然流产风险无关，不论是否在前一流感季接种（78）。
Although experience with the use of IIVs during pregnancy is substantial, data specifically reflecting administration of influenza vaccines during the first trimester are limited. Most studies have not noted an association between influenza vaccination and adverse pregnancy outcomes, including spontaneous abortion (miscarriage) (66–76). One observational Vaccine Safety Datalink (VSD) study conducted during the 2010–11 and 2011–12 seasons noted an association between receipt of IIV containing influenza A(H1N1)pdm09 and risk for miscarriage in the 28 days after receipt of IIV, when an H1N1pdm09-containing vaccine also had been received the previous season (77). However, in a larger VSD follow-up study, IIV was not associated with an increased risk for miscarriage during the 2012–13, 2013–14, and 2014–15 seasons, regardless of previous season vaccination (78).
对新近批准的流感疫苗（如基于细胞和重组技术制备的疫苗）在孕期使用的经验较少。对于ccIIV，2013年至2020年的VAERS报告回顾（79）和2017至2020年的前瞻性队列研究（80）中，未发现孕妇中出现意外安全事件的数据。一个在临床免疫接种安全评估（CISA）项目地点进行的RCT对比了RIV4和IIV4在382名孕妇中的安全性结果，支持RIV4在孕期接种的安全性（https://stacks.cdc.gov/view/cdc/122379）（81）。对于某些产品，存在孕期注册和监测研究，相关信息可在包装说明中找到。
There is less experience with the use of more recently licensed influenza vaccines (e.g., cell culture-based and recombinant vaccines) during pregnancy compared with previously available products. For ccIIV, a review of Vaccine Adverse Event Reporting System (VAERS) reports from 2013 through 2020 (79) and a prospective cohort study conducted from 2017 through 2020 (80) did not reveal unexpected safety events among pregnant persons. Data from a randomized controlled trial (RCT) conducted at Clinical Immunization Safety Assessment (CISA) Project sites comparing the safety of RIV4 versus IIV4 in 382 pregnant persons supported the safety of RIV4 in pregnancy (https://stacks.cdc.gov/view/cdc/122379) (81). Pregnancy registries and surveillance studies exist for certain products, for which information can be found in package inserts.
老年人
Older Adults
ACIP建议65岁及以上的成年人优先接种下列高剂量或佐剂流感疫苗中的任意一种：高剂量灭活流感疫苗（HD-IIV3）、重组流感疫苗（RIV3）或佐剂灭活流感疫苗（aIIV3）。如果在接种时没有这三种疫苗中的任何一种，则应接种其他适龄可用的流感疫苗（82,83）。
ACIP recommends that adults aged ≥65 years preferentially receive any one of the following higher dose or adjuvanted influenza vaccines: high-dose inactivated influenza vaccine (HD-IIV3), recombinant influenza vaccine (RIV3), or adjuvanted inactivated influenza vaccine (aIIV3). If none of these three vaccines is available at an opportunity for vaccine administration, then any other age-appropriate influenza vaccine should be administered (82,83).
65岁及以上的老年人面临较年轻人群更高的严重流感相关疾病、住院和死亡风险（4,84,85）。流感疫苗在这一人群中的效果通常较差（12）。HD-IIV、RIV和aIIV已与非佐剂SD-IIV在这一年龄组中进行了比较评估。其中两个疫苗，即HD-IIV和RIV，属于高剂量疫苗，每剂的HA抗原量比非佐剂SD-IIVs更高（HD-IIV3为60μg，RIV3为45μg，相比之下标准剂量疫苗为15μg）（57,58）。佐剂疫苗含有15μg的流感病毒HA抗原，每病毒量相当于非佐剂SD-IIVs，但包含MF59佐剂（59）。
Older adults (aged ≥65 years) are at increased risk for severe influenza-associated illness, hospitalization, and death compared with younger persons (4,84,85). Influenza vaccines are often less effective in this population (12). HD-IIV, RIV, and aIIV have been evaluated in comparison with nonadjuvanted SD-IIVs in this age group. Two of these vaccines, HD-IIV and RIV, are higher dose vaccines, which contain an increased dose of HA antigen per vaccine virus compared with nonadjuvanted SD-IIVs (60 μg for HD-IIV3 and 45 μg for RIV3, compared with 15 μg for standard-dose inactivated vaccines) (57,58). The adjuvanted vaccine contains 15 μg of HA per virus, similarly to nonadjuvanted SD-IIVs, but contains the adjuvant MF59 (59).
HD-IIV、RIV和aIIV在某些研究中显示出相对获益，其中HD-IIV3的证据最多。与非佐剂SD-IIVs进行的随机效能研究数量较少（86-88），且覆盖的流感季节较少。主要是回顾性队列研究的观察性研究数量更多，包括更多的流感季节（89-99）。某些观察性研究报告了HD-IIV、RIV和aIIV相比于非佐剂SD-IIV的相对获益，特别是在预防流感相关住院方面。这种相对获益的大小因季节而存在差异，并非在所有研究中和所有季节中都有观察到，因此难以将结果推广到所有或大多数季节。直接比较HD-IIV、RIV和aIIV的研究较少，且未能支持任何一种疫苗在所有季节中都比其他疫苗始终如一的更优（89-91,94,100,101）。
HD-IIV, RIV, and aIIV have shown relative benefit compared with SD-IIVs in certain studies, with the most evidence available for HD-IIV3. Randomized efficacy studies comparing these vaccines with nonadjuvanted SD-IIVs against laboratory-confirmed influenza outcomes are few in number (86–88) and cover few influenza seasons. Observational studies, predominantly retrospective cohort studies using diagnostic code–defined (rather than laboratory-confirmed) influenza outcomes, are more numerous and include more influenza seasons (89–99). Certain observational studies have reported relative benefit for HD-IIV, RIV, and aIIV in comparison with nonadjuvanted SD-IIVs, particularly in prevention of influenza-associated hospitalizations. The size of this relative benefit has varied from season to season and is not observed in all studies in all seasons, making it difficult to generalize the findings to all or most seasons. Studies directly comparing HD-IIV, RIV, and aIIV with one another are few and do not support a conclusion that any one of these vaccines is consistently superior to the others across seasons (89–91,94,100,101).
免疫功能低下者
Immunocompromised Persons
ACIP建议免疫功能受损者（包括但不限于先天性和获得性免疫缺陷、因药物所致免疫抑制的人以及具有解剖性和功能性脾切除的人）接种IIV3或RIV3。所有人应接种适龄的流感疫苗（即批准用于其年龄的疫苗），除非18至64岁的实体器官移植受者正在接受免疫抑制药物治疗，可以选择HD-IIV3或aIIV3作为可接受选项（不优先于其他适龄可选择的IIV3或RIV3）。ACIP建议免疫功能受损者不应使用LAIV3，因为生物学角度存在可能因活疫苗中毒株引发疾病的风险。有关LAIV3在特定条件下的使用，详见剂型、管理、禁忌症和注意事项（表2）。
ACIP recommends that persons with compromised immunity (including but not limited to persons with congenital and acquired immunodeficiency states, persons who are immunocompromised due to medications, and persons with anatomic and functional asplenia) should receive IIV3 or RIV3. All persons should receive an age-appropriate influenza vaccine (i.e., one approved for their age), with the exception that solid organ transplant recipients aged 18 through 64 years who are receiving immunosuppressive medication regimens may receive either HD-IIV3 or aIIV3 as acceptable options (without a preference over other age-appropriate IIV3s or RIV3). ACIP recommends that LAIV3 not be used for immunocompromised persons because of the uncertain but biologically plausible risk for disease attributable to the live vaccine virus. Use of LAIV3 in persons with these and other conditions is discussed in more detail (see Dosage, Administration, Contraindications, and Precautions) (Table 2).
关于实体器官移植受者，涉及HD-IIV、双剂次SD-IIV和RIV与SD-IIV比较的系统评价和Meta分析表明，在这一人群中流感相关住院的可能性没有差异（GRADE确定性水平低）。然而，证据表明HD-IIV3和aIIV3相对于SD-IIV的免疫原性可能更好，相对来说，HD-IIV3和aIIV3的血清转化率更高（GRADE确定性水平：HD-IIV3 vs SD-IIV为中等，aIIV3 vs SD-IIV为低），特别是针对A(H1N1)型流感病毒、A(H3N2)型流感病毒和B型流感病毒。HD-IIV3和aIIV3与SD-IIV相比，没有增加移植排斥的风险的证据（GRADE确定性水平中等）。仅有一项研究包含儿童。没有关于RIV与SD-IIV对比的证据（https://www.cdc.gov/vaccines/acip/recs/grade/influenza-solid-organ-transplant.html；https://www.cdc.gov/vaccines/acip/recs/grade/influenza-solid-organ-transplant-etr.html）。
Regarding solid organ transplant recipients specifically, a systematic review and meta-analysis including seven studies pertaining to use of higher dose (HD-IIV, double-dose SD-IIV, and RIV) and MF59-adjuvanted influenza vaccines compared with SD-IIV in this population noted no difference in likelihood of influenza-associated hospitalization (GRADE certainty level Low). However, evidence suggested potentially improved immunogenicity, with greater likelihood of seroconversion for both HD-IIV3 and aIIV3 relative to SD-IIV (GRADE certainty level Moderate for HD-IIV3 vs SD-IIV and Low for aIIV3 vs SD-IIV) for the influenza A(H1N1), influenza A(H3N2), and influenza B vaccine components. There was no evidence of increased risk of graft rejection with either HD-IIV3 or aIIV3 relative to SD-IIV (GRADE certainty level Moderate). Only one study included children. No evidence was available for RIV vs SD-IIV (https://www.cdc.gov/vaccines/acip/recs/grade/influenza-solid-organ-transplant.html; https://www.cdc.gov/vaccines/acip/recs/grade/influenza-solid-organ-transplant-etr.html).
免疫功能低下状态包括多种具有不同严重感染风险的情况。在许多情况下，关于流感疫苗在特定免疫功能低下状态下的效果的数据有限（102）。可能需要考虑接种时间（例如，在免疫功能低下干预之前或之后接种）。美国传染病学会发布了针对特定免疫功能低下人群的疫苗选择和接种时间的详细指南（103）。患有某些疾病（如先天性免疫缺陷）的人，以及接受癌症化疗、移植后方案或免疫抑制药物的人，对流感疫苗的免疫反应可能会减弱。。
Immunocompromised states comprise a heterogeneous range of conditions with varying risks for severe infections. In many instances, limited data are available regarding the effectiveness of influenza vaccines in the setting of specific immunocompromised states (102). Timing of vaccination might be a consideration (e.g., vaccinating during a period either before or after an immunocompromising intervention). The Infectious Diseases Society of America has published detailed guidance for the selection and timing of vaccines for persons with specific immunocompromising conditions (103). Immune response to influenza vaccines might be blunted in persons with certain conditions, such as congenital immune deficiencies, and in persons receiving cancer chemotherapy, posttransplant regimens, or immunosuppressive medications.
接种流感疫苗后出现吉兰-巴雷综合征的个体
Persons with a History of Guillain-Barré Syndrome After Influenza Vaccination
在接种任何类型的流感疫苗后的6周内出现吉兰-巴雷综合征（GBS）病史的人被视为流感疫苗接种的注意事项（见表2）。这些人如果没有较高的流感严重并发症风险（见“高风险流感严重并发症人群”），并且已知在此前的流感疫苗接种后6周内出现过GBS，通常不应接种流感疫苗。作为接种的替代方案，疫苗提供者可以考虑为这些人使用流感抗病毒化学预防（104）。然而，对于那些在接种流感疫苗后6周内有GBS病史并且也有较高流感严重并发症风险的个体，流感疫苗的益处可能会超过潜在的风险。
A history of Guillain-Barré syndrome (GBS) within 6 weeks of a previous dose of any type of influenza vaccine is considered a precaution for influenza vaccination (Table 2). Persons who are not at higher risk for severe influenza complications (see Populations at Higher Risk for Medical Complications Attributable to Severe Influenza) and who are known to have experienced GBS within 6 weeks of a previous influenza vaccination typically should not be vaccinated. As an alternative to vaccination, providers might consider using influenza antiviral chemoprophylaxis for these persons (104). However, the benefits of influenza vaccination might outweigh the possible risks for certain persons who have a history of GBS within 6 weeks after receipt of influenza vaccine and who also are at higher risk for severe complications from influenza.
有鸡蛋过敏史的人
Persons with a History of Egg Allergy
ACIP建议所有≥6月龄的鸡蛋过敏者都接种流感疫苗。可以使用任何流感疫苗（无论是基于鸡胚制备的还是非鸡胚制备），只要符合受种者的年龄和健康状况即可（https://www.cdc.gov/vaccines/acip/recs/grade/influenza-egg-allergy.html；https://www.cdc.gov/vaccines/acip/recs/grade/influenza-egg-allergy-etr.html）。单纯的鸡蛋过敏不需要额外的安全措施，超出所有疫苗接种者建议的标准，无论以前对鸡蛋的反应如何。所有疫苗应在具备快速识别和处理急性过敏反应所需的人员和设备的环境中接种。
除RIV3（Flublok，获批用于≥18岁人群）和ccIIV3（Flucelvax，获批用于6月龄以上的人）外，大多数可用的流感疫苗都是通过在鸡胚中繁殖的病毒制备的，可能含有微量的鸡蛋蛋白，如卵清蛋白。在美国批准的、报告有卵清蛋白的流感疫苗通常残留很少（≤1μg/0.5mL）（51,52,54–56,58,59）。对鸡蛋过敏者接种基于鸡胚制备的流感疫苗的研究回顾未发现过敏性休克或严重过敏反应（105,106）。在VAERS报告中，曾记录到对鸡蛋过敏者接种非鸡胚制备的RIV后的严重过敏反应（107–109）。这些报告突显了基于鸡胚制备的流感疫苗观察到的反应可能存在由除鸡蛋蛋白以外的物质引起的可能性，并强调了在接种任何疫苗时准备好识别和处理严重过敏反应的重要性（无论过敏史如何）。
Most available influenza vaccines, with the exceptions of RIV3 (Flublok, licensed for persons aged ≥18 years) and ccIIV3 (Flucelvax, licensed for persons aged ≥6 months), are prepared by propagation of virus in embryonated eggs and might contain trace amounts of egg proteins, such as ovalbumin. Among those U.S.-licensed influenza vaccines for which ovalbumin content is reported, quantities are generally small (≤1 μg/0.5mL dose) (51,52,54–56,58,59). Reviews of studies of administration of egg-based influenza vaccines to persons with egg allergy have noted no cases of anaphylaxis or serious hypersensitivity reactions (105,106). Severe allergic reactions after administration of the egg-free vaccine RIV to egg-allergic persons have been noted in VAERS reports (107–109). These reports highlight both the possibility that observed reactions after egg-based influenza vaccines might be caused by substances other than egg proteins and the importance of being prepared to recognize and manage serious hypersensitivity reactions when administering any vaccine to any recipient (regardless of allergy history).
无论过敏史如何，疫苗接种后出现的严重和危及生命的反应在任何疫苗和任何疫苗接种者中都极少发生。在此提醒接种服务提供者，所有疫苗应在具备快速识别和处理急性过敏反应所需的人员和设备的环境中接种。所有接种服务提供者应熟悉其办公室的急救方案，并获得心肺复苏认证（110）。对鸡蛋过敏者没有特别推荐的疫苗接种观察时间。然而，ACIP建议接种提供者考虑在接种任何疫苗后观察患者（坐着或仰卧）15分钟，以减少晕厥发生的伤害风险（110）。
Severe and life-threatening reactions to vaccines can rarely occur with any vaccine and in any vaccine recipient, regardless of allergy history. Providers are reminded that all vaccines should be administered in settings in which personnel and equipment needed for rapid recognition and treatment of acute hypersensitivity reactions are available. All vaccination providers should be familiar with their office emergency plan and be certified in cardiopulmonary resuscitation (110). No postvaccination observation period is recommended specifically for egg-allergic persons. However, ACIP recommends that vaccination providers consider observing patients (seated or supine) for 15 minutes after administration of any vaccine to decrease the risk for injury should syncope occur (110).
尽管鸡蛋过敏既不是任何流感疫苗的禁忌症，也不是注意事项，但与鸡蛋以外的疫苗成分过敏及此前对流感疫苗的过敏反应相关的禁忌症和注意事项（见“既往对流感疫苗过敏者”以及“剂型、给药、禁忌症和注意事项”）（表2和表3）。
Although egg allergy is neither a contraindication nor precaution to the use of any influenza vaccine, there are contraindications and precautions related to allergies to vaccine components other than egg and to previous allergic reactions to influenza vaccines (see Persons with Previous Allergic Reactions to Influenza Vaccines and Dosage, Administration, Contraindications, and Precautions) (Tables 2 and 3).
既往对流感疫苗过敏者
Persons with Previous Allergic Reactions to Influenza Vaccines
与所有疫苗一样，流感疫苗含有可能引发过敏和过敏性休克的各种成分。大多数流感疫苗的说明书中列出了对疫苗任何成分或既往接种的任何流感疫苗有严重过敏史（例如过敏性休克）作为禁忌症（51,52,54–56,58,59）。对于ccIIV3和RIV3，对任何疫苗成分的严重过敏史被列为禁忌症；没有特别标示对其他流感疫苗的过敏反应的禁忌症（53,57）。但尽管罕见，流感疫苗接种后可能发生严重的过敏反应，即使在既往没有出现或已知过敏的个体中也是如此。疫苗成分和辅料可以在说明书中找到。然而，未经过进一步评估（即，特定过敏的评估和测试）识别致病因子可能较困难。接种RIV后报告了严重的过敏反应，其中有些发生在报告了以前对鸡蛋或流感疫苗过敏反应的人群中，这可能代表了这些个体对过敏表现的易感性（107–109）。由于这些罕见但严重的过敏反应可能发生，ACIP建议如下（表3）：
As is the case for all vaccines, influenza vaccines contain various components that might cause allergic and anaphylactic reactions. Most influenza vaccine package inserts list among contraindications to their use a history of previous severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine or to a previous dose of any influenza vaccine (51,52,54–56,58,59). For ccIIV3 and RIV3, a history of a severe allergic reaction to any vaccine component is listed as a contraindication; no labeled contraindication is specified for a history of allergic reaction to any other influenza vaccine (53,57). However, severe allergic reactions, although rare, can occur after influenza vaccination, even among persons with no previous reactions or known allergies. Vaccine components and excipients can be found in package inserts. However, identifying the causative agent without further evaluation (i.e., through evaluation and testing for specific allergies) can be difficult. Severe allergic reactions after vaccination with RIV have been reported to VAERS, certain of which have occurred among persons reporting previous allergic reactions to egg or to influenza vaccines and that might represent a predisposition to allergic manifestations in affected persons (107–109). Because these rare but severe allergic reactions can occur, ACIP recommends the following for persons with a history of severe allergic reaction to a previous dose of an influenza vaccine (Table 3):
·对于基于鸡胚制备的IIV3和LAIV3：
·For egg-based IIV3s and LAIV3:
♢既往对任何流感疫苗（即任何价次的基于鸡胚制备的IIV、ccIIV、RIV或LAIV）有严重过敏史（例如过敏性休克）是未来接种所有基于鸡胚制备的IIV3和LAIV3的禁忌症。每种基于鸡胚制备的IIV3和LAIV3也禁止对该疫苗的任何成分（不包括鸡蛋；见“既往对流感疫苗过敏者”）有严重过敏史（如超敏反应）的人使用。
♢A history of severe allergic reaction (e.g., anaphylaxis) to any influenza vaccine (i.e., any egg-based IIV, ccIIV, RIV, or LAIV of any valency) is a contraindication to future receipt of all egg-based IIV3s and LAIV3. Each individual egg-based IIV3 and LAIV3 is also contraindicated for persons who have had a severe allergic reaction (e.g., anaphylaxis) to any component of that vaccine (excluding egg; see Persons with a History of Egg Allergy).
·对于ccIIV3：
·For ccIIV3:
♢既往对任何价次的基于鸡胚制备的IIV、RIV或LAIV有严重过敏史（例如过敏性休克）是使用ccIIV3的注意事项。如果在这种情况下接种ccIIV3，疫苗接种应在住院或门诊医疗环境中进行，并应由能够识别和处理严重过敏反应的医疗提供者监督。接种服务者还可以考虑咨询过敏科医生以帮助确定引起过敏反应的疫苗成分。
♢A history of a severe allergic reaction (e.g., anaphylaxis) to any egg-based IIV, RIV, or LAIV of any valency is a precaution for the use of ccIIV3. If ccIIV3 is administered in such instances, vaccination should occur in an inpatient or outpatient medical setting and should be supervised by a health care provider who is able to recognize and manage severe allergic reactions. Providers also can consider consultation with an allergist to help determine the vaccine component responsible for the allergic reaction.
♢对任何价次的ccIIV或ccIIV3的任何成分有严重过敏史（例如过敏性休克）是未来接种ccIIV3的禁忌症。
♢A history of a severe allergic reaction (e.g., anaphylaxis) to any ccIIV of any valency or to any component of ccIIV3 is a contraindication to future receipt of ccIIV3.
·对于RIV3：
·For RIV3:
♢对任何价次基于鸡胚制备的IIV、ccIIV或LAIV有严重过敏史（例如过敏性休克）是使用RIV3的注意事项。如果在这种情况下接种RIV3，疫苗接种应在住院或门诊医疗环境中进行，并应由能够识别和处理严重过敏反应的医疗提供者监督。接种服务提供者还可以考虑咨询过敏专科医生以帮助确定引起过敏反应的疫苗成分。
♢A history of a severe allergic reaction (e.g., anaphylaxis) to any egg-based IIV, ccIIV, or LAIV of any valency is a precaution for the use of RIV3. If RIV3 is administered in such instances, vaccination should occur in an inpatient or outpatient medical setting and should be supervised by a health care provider who is able to recognize and manage severe allergic reactions. Providers can also consider consultation with an allergist to help determine the vaccine component responsible for the allergic reaction.
♢对任何价次的RIV或RIV3的任何成分有严重过敏史（例如过敏性休克）是未来接种RIV3的禁忌症。
♢A history of a severe allergic reaction (e.g., anaphylaxis) to any RIV of any valency or to any component of RIV3 is a contraindication to future receipt of RIV3.
旅行者的疫苗接种
Vaccination Issues for Travelers
在北半球和南半球的温带气候区，流感活跃具有季节性特征，北半球大约在10月至5月之间发生，南半球在4月至9月之间发生。在热带地区，流感可能全年发生（111）。流感活动的时间以及流感病毒的主要类型和亚型在不同地理区域有所不同（112）。旅行者可能会在前往流感流行地区或作为来自流感流行地区的大型旅游团体（如游轮）旅行者时接触流感病毒（113–116）。
In temperate climate regions of the Northern and Southern Hemispheres, influenza activity is seasonal, occurring during approximately October–May in the Northern Hemisphere and April–September in the Southern Hemisphere. In the tropics, influenza might occur throughout the year (111). The timing of influenza activity and predominant types and subtypes of influenza viruses in circulation vary by geographic region (112). Travelers can be exposed to influenza when traveling to an area where influenza is circulating or when traveling as part of large tourist groups (e.g., on cruise ships) that include persons from areas of the world where influenza viruses are circulating (113–116).
希望减少流感风险的旅行者应考虑接种流感疫苗，最好是在出发前至少2周。特别是对于居住在美国并且有较高流感并发症风险的人，如果他们计划前往热带地区、南半球流感季节（4月至9月）或与旅游团体或选择游轮旅行，他们应该考虑在出发前接种流感疫苗。如果这些高风险人群在旅行前已接种了前一流感季节的流感疫苗，应与医疗提供者咨询，讨论流感及其他旅行相关疾病的风险。在即将到来的流感季节的疫苗可用之前或接种了前一季南半球流感疫苗的人，都应在接下来的秋冬季节接种当前的美国季节性流感疫苗。
Travelers who want to reduce their risk for influenza should consider influenza vaccination, preferably at least 2 weeks before departure. In particular, persons who live in the United States and are at higher risk for influenza complications and who were not vaccinated with influenza vaccine during the previous Northern Hemisphere fall or winter should consider receiving influenza vaccination before departure if they plan to travel to the tropics, to the Southern Hemisphere during the Southern Hemisphere influenza season (April–September), or with organized tourist groups or on cruise ships to any location. Persons at higher risk who received the previous season’s influenza vaccine before travel should consult with their health care provider to discuss the risk for influenza and other travel-related diseases before embarking on travel during the summer. All persons (regardless of risk status) who are vaccinated in preparation for travel before the upcoming influenza season’s vaccine is available, or who received the immediately preceding Southern Hemisphere influenza vaccine, should receive the current U.S. seasonal influenza vaccine the following fall or winter.
针对南半球的流感疫苗的病毒组成可能与北半球疫苗不同。对于在南半球流感季节前往南半球的人来说，在出发前接种当前的美国批准南半球流感疫苗配方可能是合理但难以实施的，这是由于南半球疫苗组分配方的疫苗在美国难以获取或不可用。大多数南半球流感疫苗配方在美国未获批准，通常也不进行商业化销售。有关流感疫苗和旅行的更多信息，请访问 https://wwwnc.cdc.gov/travel/diseases/influenza-seasonal-zoonotic-and-pandemic。有关全球流感监测的其他信息，请访问 https://www.who.int/tools/flunet。
Influenza vaccine formulated for the Southern Hemisphere might differ in viral composition from the Northern Hemisphere vaccine. For persons traveling to the Southern Hemisphere during the Southern Hemisphere influenza season, receipt of a current U.S.-licensed Southern Hemisphere influenza vaccine formulation before departure might be reasonable but might not be feasible because of limited access to or unavailability of Southern Hemisphere formulations in the United States. Most Southern Hemisphere influenza vaccine formulations are not licensed in the United States, and they are typically not commercially available. More information on influenza vaccines and travel is available at https://wwwnc.cdc.gov/travel/diseases/influenza-seasonal-zoonotic-and-pandemic. Additional information on global influenza surveillance by region is available at https://www.who.int/tools/flunet.
流感抗病毒药物的使用
Use of Influenza Antiviral Medications
对接受流感抗病毒药物治疗或化学预防的人员，接种任何IIV3或RIV3是可以接受的。关于在使用流感抗病毒药物的情况下接种LAIV3的数据尚不完整。然而，流感抗病毒药物可能会干扰LAIV3的作用，因为该疫苗含有活流感病毒。
Administration of any IIV3 or RIV3 to persons receiving influenza antiviral medications for treatment or chemoprophylaxis of influenza is acceptable. Data concerning vaccination with LAIV3 in the setting of influenza antiviral use are not available. However, influenza antiviral medications might interfere with the action of LAIV3 because this vaccine contains live influenza viruses.
LAIV3的说明书指出，如果在接种疫苗前48小时至14天内使用流感抗病毒药物可能会降低疫苗的效果（56）。然而，较新的流感抗病毒药物peramivir和baloxavir的半衰期比oseltamivir和zanamivir更长，peramivir约为20小时（117），baloxavir约为79小时（118），如果在接种疫苗前>48小时使用，可能会干扰LAIV3的作用。流感抗病毒药物与LAIV3的潜在相互作用尚未研究，理想的给药间隔尚不清楚。假设至少需要5个半衰期来显著降低药物水平（119），可以合理地假设，如果在接种疫苗前5天至接种后2周内使用peramivir，可能会干扰LAIV3的机制；如果在接种疫苗前17天至接种后2周内使用baloxavir，可能会形成干扰。流感抗病毒药物与LAIV3之间可能发生干扰的间隔时间可能在存在延迟药物清除的医疗条件下（例如肾功能不全）进一步延长。在这些期间内使用这些药物的人员应接种另一种合适的流感疫苗（例如IIV3或RIV3）。
The package insert for LAIV3 notes that influenza antiviral agents might reduce the effectiveness of the vaccine if administered within the interval from 48 hours before to 14 days after vaccination (56). However, the newer influenza antivirals peramivir and baloxavir have longer half-lives than oseltamivir and zanamivir, approximately 20 hours for peramivir (117) and 79 hours for baloxavir (118), and could potentially interfere with the replication of LAIV3, if administered >48 hours before vaccination. Potential interactions between influenza antivirals and LAIV3 have not been studied, and the ideal intervals between administration of these medications and LAIV3 are not known. Assuming a period of at least 5 half-lives for substantial decrease in drug levels (119), a reasonable assumption is that peramivir might interfere with the mechanism of LAIV3 if administered from 5 days before through 2 weeks after vaccination and baloxavir might interfere if administered from 17 days before through 2 weeks after vaccination. The interval between influenza antiviral receipt and LAIV3 during which interference might occur could be further prolonged in the presence of medical conditions that delay medication clearance (e.g., renal insufficiency). Persons who receive these medications during these periods before or after receipt of LAIV3 should be revaccinated with another appropriate influenza vaccine (e.g., IIV3 or RIV3).
流感疫苗与其他疫苗同时接种
Administration of Influenza Vaccines with Other Vaccines
IIV3和RIV3可以与其他灭活疫苗或活疫苗同时或先后接种。同时接种时，不同注射类疫苗应在不同的解剖部位进行接种。如果与流感疫苗同时接种的疫苗更可能引起局部注射部位反应（例如HD-IIV3和aIIV3），应尽可能在不同的肢体上接种。LAIV3可以与其他活疫苗或灭活疫苗同时接种。然而，如果两个活疫苗未同时接种，则至少应在接种一个活疫苗（如LAIV3）后等待4周再接种另一个活疫苗（110）。
IIV3s and RIV3 can be administered simultaneously or sequentially with other inactivated vaccines or live vaccines. Injectable vaccines that are given concomitantly should be administered at separate anatomic sites. Vaccines that are administered at the same time as influenza vaccines that might be more likely to be associated with local injection site reactions (e.g., HD-IIV3 and aIIV3) should be given in different limbs, if possible. LAIV3 can be administered simultaneously with other live or inactivated vaccines. However, if two live vaccines are not given simultaneously, at least 4 weeks should pass after administration of one live vaccine (such as LAIV3) before another live vaccine is administered (110).
近年来，多种含有非铝佐剂的疫苗已在美国获准用于预防各种传染病。包括AS01B（在重组带状疱疹亚单位疫苗[RZV]中）（120）、AS01E（在呼吸道合胞病毒疫苗中）（121）、MF59（在aIIV3中）（59），以及细胞毒性磷酸鸟苷寡脱氧核糖核酸（在Heplisav-B，重组乙型肝炎疫苗中）（122）。有关这些疫苗与其他佐剂或非佐剂疫苗（包括COVID-19疫苗）的同时接种的数据有限。RZV与非佐剂IIV4的同时接种已经研究过，未发现免疫原性下降或安全性问题（123）。一项针对≥65岁人群的CISA RCT发现，同时接种第一剂RZV和四价佐剂灭活流感疫苗的参与者与同时接种第一剂RZV和四价高剂量灭活流感疫苗的参与者相比，至少有一种严重的局部或全身反应的比例无显著区别（124）。关于两个含非铝佐剂疫苗的同时或先后接种的免疫原性和安全性数据有限，且先后接种的理想间隔时间尚不清楚。在Shingrix和非佐剂IIV4的研究中（123），大多数反应性症状在4天内消退。由于关于同时接种两个或更多含非铝佐剂的疫苗的安全性数据有限以及非佐剂流感疫苗的可用性，在需要同时接种流感疫苗和其他含非铝佐剂的疫苗的情况下，可以考虑选择非佐剂流感疫苗。然而，如果某种特定疫苗不可用，疫苗接种不应延迟。如对所有疫苗的推荐，含非铝佐剂的疫苗应与同时接种的其他疫苗在不同的解剖部位进行接种（110）。
In recent years, multiple vaccines containing nonaluminum adjuvants have been licensed for use in the United States for the prevention of various infectious diseases. Examples include AS01B (in Shingrix, recombinant zoster subunit vaccine [RZV]) (120), AS01E (in Arexvy, respiratory syncytial virus vaccine) (121) MF59 (in Fluad [aIIV3]) (59), and cytosine phosphoguanine oligodeoxynucleotide (in Heplisav-B, recombinant hepatitis B surface antigen vaccine) (122). Data are limited regarding coadministration of these vaccines with other adjuvanted or nonadjuvanted vaccines, including COVID-19 vaccines. Coadministration of RZV with nonadjuvanted IIV4 has been studied, and no evidence of decreased immunogenicity or safety concerns was noted (123). A CISA RCT in persons aged ≥65 years found that the proportion of participants with at least one severe local or systemic reaction was not higher after simultaneous administration of RZV dose 1 and quadrivalent adjuvanted inactivated influenza vaccine compared with simultaneous administration of RZV dose 1 and quadrivalent high-dose inactivated influenza vaccine (124). Data on the immunogenicity and safety of simultaneous or sequential administration of two nonaluminum adjuvant–containing vaccines are limited, and the ideal interval between such vaccines when given sequentially is not known. In the study of Shingrix and nonadjuvanted IIV4 (123), most reactogenicity symptoms resolved within 4 days. Because of the limited data on the safety of simultaneous administration of two or more vaccines containing nonaluminum adjuvants and the availability of nonadjuvanted influenza vaccine options, selection of a nonadjuvanted influenza vaccine can be considered in situations in which influenza vaccine and another vaccine containing a nonaluminum adjuvant are to be administered concomitantly. However, influenza vaccination should not be delayed if a specific vaccine is not available. As recommended for all vaccines, vaccines with nonaluminum adjuvants should be administered at separate anatomic sites from other vaccines that are given concomitantly (110).
对于最近批准的新疫苗，关于其与流感疫苗同时接种的数据可能有限或正在累积。提供者应咨询最新的CDC/ACIP推荐和指南，以获取最新信息。
For more recently introduced and new vaccines, data informing simultaneous administration with influenza vaccines might be limited or evolving. Providers should consult current CDC/ACIP recommendations and guidance for up-to-date information.
流感疫苗组分及可用疫苗
Influenza Vaccine Composition and Available Vaccines
2024-2025年流感季的流感疫苗组分
Influenza Vaccine Composition for the 2024–25 Season
·A/Victoria/4897/2022 (H1N1)pdm09-类似株
·A/Thailand/8/2022 (H3N2)-类似株
·B/Austria/1359417/2021 (Victoria谱系)-类似株
·an influenza A/Victoria/4897/2022 (H1N1)pdm09-like virus,
·an influenza A/Thailand/8/2022 (H3N2)-like virus, and
·an influenza B/Austria/1359417/2021 (Victoria lineage)-like virus.
2024-2025年流感季，美国基于细胞制备的灭活疫苗（ccIIV3）和重组疫苗（RIV3）的毒株将包含：
For the 2024–25 season, U.S. cell culture–based inactivated (ccIIV3) and recombinant (RIV3) influenza vaccines will contain HA derived from
·A/Wisconsin/67/2022 (H1N1)pdm09-类似株
·A/Massachusetts/18/2022 (H3N2)-类似株
·B/Austria/1359417/2021 (Victoria谱系)-类似株
·an influenza A/Wisconsin/67/2022 (H1N1)pdm09-like virus,
·an influenza A/Massachusetts/18/2022 (H3N2)-like virus, and
·an influenza B/Austria/1359417/2021 (Victoria lineage)-like virus
2024-2025年流感季可用的疫苗
Vaccines Available for the 2024–25 Season
在美国批准的流感疫苗的具体类型和品牌取决于疫苗制造商，关于预计可用的疫苗及其批准的适应症和使用的信息反映了目前的认知，并可能在未来发生变化。
Availability of specific types and brands of licensed seasonal influenza vaccines in the United States is determined by the manufacturers of the vaccines. Information presented concerning vaccines expected to be available and their approved indications and usage reflects current knowledge and is subject to change.
2024-2025季将提供多种流感疫苗（表1）。对于许多疫苗接种者，可能会在批准的适应症和ACIP推荐范围内使用不同类型或品牌的疫苗。应参考当前的处方信息和ACIP建议以获取最新信息。不同类型流感疫苗的禁忌症和注意事项汇总在（表2和表3），剂型信息汇总在（表4）。
Various influenza vaccines will be available for the 2024–25 season (Table 1). For many vaccine recipients, more than one type or brand of vaccine might be appropriate within approved indications and ACIP recommendations. Current prescribing information and ACIP recommendations should be consulted for up-to-date information. Contraindications and precautions for the different types of influenza vaccines are summarized (Tables 2 and 3), as are dose volumes (Table 4).
并非所有流感疫苗在任何特定的应用环境或地理位置都可能均衡供应。当有适当的疫苗可用时，不应因等待特定产品而延迟接种。在这些指导原则和批准的适应症范围内，ACIP不对任何一种流感疫苗相对于其他疫苗的使用作出优先推荐，除非是在选择适用于≥65岁人群的流感疫苗时（参见“老年人”部分）。
Not all influenza vaccines are likely to be uniformly available in any specific practice setting or geographic locality. Vaccination should not be delayed to obtain a specific product when an appropriate one is available. Within these guidelines and approved indications, ACIP makes no preferential recommendation for the use of any one influenza vaccine over another when more than one licensed and recommended vaccine is available, except for selection of influenza vaccines for persons aged ≥65 years (see Older Adults).
剂型、给药方式、禁忌症和注意事项
Dosage, Administration, Contraindications, and Precautions
三价灭活流感疫苗（IIV3s）
Trivalent Inactivated Influenza Vaccines (IIV3s)
可用疫苗：与近年来的季节一样，预计2024-2025流感季将提供多种灭活流感疫苗（IIVs）；所有这些疫苗都预计为三价（IIV3s）。标准剂量、未添加佐剂的IIV3s被批准用于年龄最小为6月龄的人群。然而，对于某些IIV3s，获批的儿童剂型与较大儿童和成人不同（表4）。应注意给予适当的剂型。两种IIV3s，即MF59佐剂的IIV3 Fluad（aIIV3）和高剂量的IIV3 Fluzone High-Dose（HD-IIV3），仅被批准用于≥65岁的人群，但对于接受免疫抑制治疗的18至64岁实体器官移植受者而言也是可接受的选项，但并不优先于其他适龄IIV3s或RIV3。
Available Vaccines. As in recent seasons, various inactivated influenza vaccines (IIVs) are expected to be available for 2024–25 (Table 1); all are expected to be trivalent (IIV3s). Standard-dose, nonadjuvanted IIV3s are licensed for persons aged as young as 6 months. However, for certain IIV3s, the approved dose volume for children aged 6 through 35 months differs from that for older children and adults (Table 4). Care should be taken to administer the appropriate dose volume. Two IIV3s, the MF59-adjuvanted IIV3 Fluad (aIIV3) and the high-dose IIV3 Fluzone High-Dose (HD-IIV3), are approved only for persons aged ≥65 years, but are acceptable options for solid organ transplant recipients aged 18 through 64 years who are receiving immunosuppressive medication regimens, without a preference over other age-appropriate IIV3s or RIV3.
标准剂量、未添加佐剂的IIV3s每剂含15μg的HA（0.25mL剂型中含有7.5μg的流感病毒HA）。2024-2025流感季的这一类别中预计将包括五种不同的疫苗（表1）。其中四种是基于鸡胚制备的疫苗（Afluria, Fluarix, FluLaval, 和Fluzone），一种是基于细胞制备的疫苗（Flucelvax [ccIIV3]）。所有这些疫苗均已批准用于≥6月龄人群。基于鸡胚制备和基于细胞制备的疫苗在制造过程中所用的候选疫苗毒株生长的基质有所不同。对于IIV3s Afluria（51）、Fluarix（52）、FluLaval（54）和Fluzone（55），参考疫苗病毒在鸡蛋中繁殖。对于Flucelvax（ccIIV3），候选疫苗毒株在Madin-Darby犬肾细胞中繁殖（53）。
Standard-dose, nonadjuvanted IIV3s contain 15 μg of HA per vaccine virus in a 0.5-mL dose (7.5 μg of HA per vaccine virus in a 0.25-mL dose). For 2024–25, this category is expected to include five different vaccines (Table 1). Four of these are egg-based vaccines (Afluria, Fluarix, FluLaval, and Fluzone), and one is a cell culture–based vaccine (Flucelvax [ccIIV3]). All are approved for persons aged ≥6 months. Egg-based and cell culture–based vaccines differ in the substrate in which reference vaccine viruses supplied to the manufacturer are propagated in quantities sufficient to produce the needed number of doses of vaccine. For the IIV3s Afluria (51), Fluarix (52), FluLaval (54), and Fluzone (55), reference vaccine viruses are propagated in eggs. For Flucelvax (ccIIV3), reference vaccine viruses are propagated in Madin-Darby canine kidney cells instead of eggs (53).
另外两种IIV3s在2024-2025季将仅批准用于≥65岁的人群。这些疫苗为基于鸡胚制备的疫苗。三价高剂量灭活流感疫苗（Fluzone High-Dose；HD-IIV3）每剂疫苗中含60μg的流感病毒HA（共180μg），每剂剂量为0.5mL（58）。三价佐剂灭活流感疫苗（Fluad；aIIV3）每剂疫苗中含15μg流感病毒HA（共45μg），并含有MF59佐剂（59）。
Two additional IIV3s that will be available for the 2024–25 season are approved only for persons aged ≥65 years. These vaccines are egg based. Trivalent high-dose inactivated influenza vaccine (Fluzone High-Dose; HD-IIV3) contains 60 μg of HA per vaccine virus (180 μg total) in a 0.5-mL dose (58). Trivalent adjuvanted inactivated influenza vaccine (Fluad; aIIV3) contains 15 μg of HA per vaccine virus (45 μg total) and MF59 adjuvant (59).
剂型和给药途径：未添加佐剂的标准剂量IIV3s获批用于6月龄及以上儿童。这些IIV3s中的某些剂型在低龄儿童与较大儿童和成人之间有所不同。应注意每剂接种正确的剂型（参见6至35月龄儿童：流感疫苗剂次）（表1和表4）：
Dosage and Administration. Standard-dose nonadjuvanted IIV3s are approved for children aged as young as 6 months. Certain of these IIV3s are approved at different dose volumes for very young children than for older children and adults. Care should be taken to administer the correct dose volume for each needed dose (see Children Aged 6 Through 35 Months: Influenza Vaccine Dose Volumes) (Tables 1 and 4):
·Afluria：6至35月龄儿童的获批剂型为0.25mL每剂。≥36个月（≥3岁）的人群应接种0.5mL每剂（51）。
·Afluria: The approved dose volume for children aged 6 through 35 months is 0.25 mL per dose. Persons aged ≥36 months (≥3 years) should receive 0.5 mL per dose (51).
·Fluarix：所有≥6月龄人群的获批剂型为0.5mL每剂（52）。
·Fluarix: The approved dose volume is 0.5 mL per dose for all persons aged ≥6 months (52).
·Flucelvax：所有≥6月龄人群的获批剂型为0.5mL每剂（53）。
·Flucelvax: The approved dose volume is 0.5 mL per dose for all persons aged ≥6 months (53).
·FluLaval：所有≥6月龄人群的获批剂型为0.5mL每剂（54）。
·FluLaval: The approved dose volume is 0.5 mL per dose for all persons aged ≥6 months (54).
·Fluzone：6至35月龄人群的获批剂型为0.25mL或0.5mL每剂。≥36个月（≥3岁）的人群应接种0.5mL每剂的剂型（55）。
·Fluzone: The approved dose volume for children aged 6 through 35 months is either 0.25 mL or 0.5 mL per dose. Persons aged ≥36 months (≥3 years) should receive 0.5 mL per dose (55).
如果预充注射器不可用，可以从多人份剂型中抽取适当体积的疫苗。需要注意的是，剂量与剂次不同。对于2024-2025季需要接种2剂疫苗的儿童，剂次间需间隔≥4周，无论具体使用的IIV3和每剂剂量如何（参见6个月至8岁儿童：流感疫苗剂量次数）（见图）。
If prefilled syringes are not available, the appropriate volume can be administered from a multidose vial. Of note, dose volume is distinct from the number of doses. Children in this age group who require 2 doses for 2024–25 need 2 separate doses administered ≥4 weeks apart, regardless of the specific IIV3 used and volume given for each dose (see Children Aged 6 Months Through 8 Years: Number of Influenza Vaccine Doses) (Figure).
对于36月龄（3岁）至17岁儿童和≥18岁成年人，所有IIV3s的剂型为0.5mL每剂。如果意外给予了较小的疫苗剂量（例如0.25mL），则应在同一次接种中补齐剩余体积的剂量，或如果难以测量所需的剩余剂量，直接再次使用全剂量进行重复接种也是可以接受的。如果错误在受种者离开接种地点后才被发现，则应在受种者可以返回时尽快重新接种全剂量。对于儿童意外接种成人使用的剂型，应按单剂次计算。
For children aged 36 months (3 years) through 17 years and adults aged ≥18 years, the dose volume for all IIV3s is 0.5 mL per dose. If a smaller vaccine dose (e.g., 0.25 mL) is inadvertently administered to a person aged ≥36 months, the remaining volume needed to make a full dose should be administered during the same vaccination visit or, if measuring the needed remaining volume is a challenge, administering a repeat dose at the full volume is acceptable. If the error is discovered later (after the recipient has left the vaccination setting), a full dose should be administered as soon as the recipient can return. Vaccination with a formulation approved for adult use should be counted as a single dose if inadvertently administered to a child.
IIV3s通过肌内注射（IM）给药。对于成年人和较大儿童，推荐接种部位为三角肌。婴儿和较小儿童应在大腿前外侧接种。关于IM注射的部位和针头长度选择的更多具体指导见《免疫接种最佳实践指南》（110）。IIV3中的Afluria获得了采用PharmaJet Stratis无针注射器进行IM注射的许可，适用于18至64岁人群（51）。该年龄组的人群可以使用有针注射器或特定的无针注射器接种Afluria。6月龄至17岁儿童和≥65岁成年人应仅通过有针注射器接种此疫苗。其他IIV3s没有获得使用无针注射器接种的许可。
IIV3s are administered intramuscularly (IM). For adults and older children, the deltoid muscle is the preferred site. Infants and younger children should be vaccinated in the anterolateral thigh. Additional specific guidance regarding site selection and needle length for IM injection is provided in the General Best Practice Guidelines for Immunization (110). One IIV3, Afluria, is licensed for IM injection via the PharmaJet Stratis jet injector for persons aged 18 through 64 years (51). Persons in this age group can receive Afluria via either needle and syringe or this specific jet injection device. Children aged 6 months through 17 years and adults aged ≥65 years should receive this vaccine by needle and syringe only. No other IIV3s are licensed for administration by jet injector.
IIV3s的禁忌症和注意事项：有关特定流感疫苗的禁忌症和注意事项的信息应参考生产厂家说明书以及更新的CDC和ACIP指南。每种IIV3，无论是基于鸡胚制备还是基于细胞制备，都将有严重过敏反应史的人群（对任何疫苗成分）标注为禁忌症（表2和表3）。然而，尽管鸡蛋是所有除ccIIV3外的IIV3s的成分，但ACIP对有蛋过敏的人群使用流感疫苗有特别的建议（参见“有鸡蛋过敏史的患者”）。所有基于鸡胚制备的IIV3s对既往对任何流感疫苗（任何蛋制IIV、ccIIV、RIV或LAIV）的疫苗有严重过敏反应史（例如，过敏性休克）的人群是禁忌。ccIIV3的使用对既往对任何ccIIV（任何价次）有严重过敏反应史（例如，过敏性休克）的人群是禁忌。对其他任何流感疫苗（即，任何基于鸡胚制备的IIV、RIV或任何价次的LAIV）有严重过敏反应史的人群，在使用ccIIV3时应格外小心（见“对流感疫苗有过敏反应史的患者”）（表2和表3）。如果在这种情况下接种ccIIV3，应在住院或门诊医疗环境中进行，并由能够识别和处理严重过敏反应的医疗提供者监督。接种服务提供者还可以考虑咨询过敏科医生，以帮助识别导致过敏反应的疫苗成分。有关疫苗成分的信息可以在每种疫苗的说明书中找到。对于不能接种疫苗的人群，特别是那些因严重流感而面临更高医疗并发症风险的人群，可以考虑预防性使用抗病毒药物来预防流感（104）。
Contraindications and Precautions for the Use of IIV3s. Manufacturer package inserts and updated CDC and ACIP guidance should be consulted for information on contraindications and precautions for individual influenza vaccines. Each IIV3, whether egg based or cell culture based, has a labeled contraindication for persons with a history of a severe allergic reaction to any component of that vaccine (Tables 2 and 3). However, although egg is a component of all IIV3s other than ccIIV3, ACIP makes specific recommendations for the use of influenza vaccine for persons with egg allergy (see Persons with a History of Egg Allergy). All egg-based IIV3s are contraindicated in persons who have had a severe allergic reaction (e.g., anaphylaxis) to a previous dose of any influenza vaccine (any egg-based IIV, ccIIV, RIV, or LAIV of any valency). Use of ccIIV3 is contraindicated in persons who have had a severe allergic reaction (e.g., anaphylaxis) to any ccIIV of any valency. A history of severe allergic reaction (e.g., anaphylaxis) to any other influenza vaccine (i.e., any egg-based IIV, RIV, or LAIV of any valency) is a precaution for the use of ccIIV3 (see Persons with Previous Allergic Reactions to Influenza Vaccines) (Tables 2 and 3). If ccIIV3 is administered in such an instance, vaccination should occur in an inpatient or outpatient medical setting and should be supervised by a health care provider who is able to recognize and manage severe allergic reactions. Providers can also consider consultation with an allergist to help identify the vaccine component responsible for the reaction. Information about vaccine components can be found in the package inserts for each vaccine. Prophylactic use of antiviral agents is an option that can be considered for preventing influenza among persons who cannot receive vaccine, particularly for those who are at higher risk for medical complications attributable to severe influenza (104).
中度或严重急性疾病（无论是否有发热）是疫苗接种的一般注意事项（110）。在接种流感疫苗后的6周内有格林-巴利综合征（GBS）病史被视为所有流感疫苗使用的注意事项（表2）。
Moderate or severe acute illness with or without fever is a general precaution for vaccination (110). A history of GBS within 6 weeks after receipt of a previous dose of influenza vaccine is considered a precaution for the use of all influenza vaccines (Table 2).
三价重组流感疫苗（RIV3）
Trivalent Recombinant Influenza Vaccine (RIV3)
可用疫苗。一种名为Flublok重组流感疫苗（RIV3）预计将在2024–2025流感季节上市。RIV3获批用于18岁及以上人群。该疫苗含有在昆虫细胞系中表达的重组HA，使用来自细胞衍生流感病毒的基因序列制造，不使用流感毒株或鸡蛋（57）。
Available Vaccine. One recombinant influenza vaccine, Flublok (RIV3), is expected to be available during the 2024–25 influenza season. RIV3 is approved for persons aged ≥18 years. This vaccine contains recombinant HA produced in an insect cell line using genetic sequences from cell-derived influenza viruses and is manufactured without the use of influenza viruses or eggs (57).
剂量和给药途径。RIV3通过有针注射器进行肌内注射。每0.5毫升中含有来自每种疫苗病毒的45微克HA（总计135微克）。
Dosage and Administration. RIV3 is administered by IM injection via needle and syringe. A 0.5-mL dose contains 45 μg of HA derived from each vaccine virus (135 μg total).
RIV3的禁忌症和注意事项。应参考生产厂家说明书和更新的CDC及ACIP指南以获取有关特定流感疫苗的禁忌症和注意事项。RIV3对曾对任何RIV疫苗或RIV3的任何成分有严重过敏反应史（例如，过敏性休克）的人群是禁忌。对其他任何流感疫苗（即，任何基于鸡胚制备的IIV、ccIIV或任何价次的LAIV）有严重过敏反应史的人群使用RIV3时需格外小心。如果在这种情况下接种RIV3，应在住院或门诊医疗环境中进行，并由能够识别和处理严重过敏反应的医疗提供者监督。提供者还可以考虑咨询过敏科医生，以帮助识别导致反应的疫苗成分（表2和表3）。
Contraindications and Precautions for the Use of RIV3. Manufacturer package inserts and updated CDC and ACIP guidance should be consulted for information on contraindications and precautions for individual influenza vaccines. RIV3 is contraindicated in persons who have had a severe allergic reaction (e.g., anaphylaxis) to a previous dose of any RIV of any valency or to any component of RIV3. A history of a severe allergic reaction (e.g., anaphylaxis) to any other influenza vaccine (i.e., any egg-based IIV, ccIIV, or LAIV of any valency) is a precaution for the use of RIV3. If RIV3 is administered in such an instance, vaccination should occur in an inpatient or outpatient medical setting and should be supervised by a health care provider who is able to recognize and manage severe allergic reactions. Providers can also consider consulting with an allergist to help identify the vaccine component responsible for the reaction (Tables 2 and 3).
中度或严重急性疾病（有或没有发热）是疫苗接种的一般注意事项（110）。在接种流感疫苗后的6周内有GBS病史被视为所有流感疫苗的使用注意事项（表2）。RIV3未被批准用于18岁以下儿童。
Moderate or severe acute illness with or without fever is a general precaution for vaccination (110). A history of GBS within 6 weeks after receipt of a previous dose of influenza vaccine is considered a precaution for the use of all influenza vaccines (Table 2). RIV3 is not approved for children aged <18 years.
三价减毒活疫苗（LAIV3）
Trivalent Live Attenuated Influenza Vaccine (LAIV3)
可用疫苗。FluMist是一种三价减毒活疫苗（LAIV3），预计将在2024–2025流感季节上市。LAIV3获批用于2至49岁人群。LAIV3含有在鸡胚中繁殖的活的减毒流感病毒。这些病毒经过冷适应（使其在25℃[77℉]下才能有效复制）和温度敏感（使其在较高温度下仅能有限复制，A型流感病毒需低于39℃[102.2℉]，B型流感病毒需低于37℃ [98.6℉]）。减毒活疫苗的病毒在鼻咽部复制，这对促进免疫反应是必要的（56）。对于LAIV3与其他流感疫苗在特定适应症中的使用并没有明确的优先建议。
Available Vaccine. One live attenuated influenza vaccine, FluMist (LAIV3), is expected to be available during the 2024–25 influenza season. LAIV3 is approved for persons aged 2 through 49 years. LAIV3 contains live attenuated influenza viruses that are propagated in eggs. These viruses are cold adapted (so that they replicate efficiently at 25°C [77°F]) and temperature sensitive (so that their replication is restricted at higher temperatures, 39°C [102.2°F] for influenza A viruses and 37°C [98.6°] for influenza B viruses). The live attenuated vaccine viruses replicate in the nasopharynx, which is necessary to promote an immune response (56). No preference is expressed for LAIV3 versus other influenza vaccines used within specified indications.
剂量和给药途径。LAIV3通过预充的单次使用喷雾器进行鼻内给药，喷雾器含有0.2毫升疫苗。将约0.1毫升（即总喷雾器内容物的一半）喷入一个鼻孔，同时接种者保持坐立姿势。移除喷雾器上的剂量分隔夹，以便将剩余的剂量喷入另一个鼻孔。不需要吸入剂量。如果接种者在接种后立即打喷嚏，不应重复接种。然而，如果鼻塞可能妨碍疫苗送达鼻咽粘膜，则应考虑推迟接种，直到疾病解决，或接种其他适当的疫苗。每剂量0.2毫升含有10^6.5–7.5荧光聚焦单位的各型别疫苗毒株（56）。
Dosage and Administration. LAIV3 is administered intranasally using the supplied prefilled, single-use sprayer containing 0.2 mL of vaccine. Approximately 0.1 mL (i.e., one half of the total sprayer contents) is sprayed into the first nostril while the recipient is in the upright position. An attached dose-divider clip is removed from the sprayer to permit administration of the second half of the dose into the other nostril. Sniffing of the dose is not necessary. If the recipient sneezes immediately after administration, the dose should not be repeated. However, if nasal congestion is present that might impede delivery of the vaccine to the nasopharyngeal mucosa, deferral of administration should be considered until resolution of the illness, or another appropriate vaccine should be administered instead. Each total dose of 0.2 mL contains 10^6.5–7.5 fluorescent focus units of each vaccine virus (56).
禁忌症和注意事项。应参考疫苗生产厂家说明书和更新的CDC及ACIP指南以获取有关特定流感疫苗的禁忌症和注意事项。ACIP认为LAIV3的禁忌症和注意事项总结如下（表2）。这些包括说明书中列出的两个标注禁忌症（56）和其他与活病毒相关的不确定，但生物学上可能存在风险的情况或对LAIV使用的数据有限。LAIV3的禁忌症包括（表2和表3）：
Contraindications and Precautions for the Use of LAIV3. Manufacturer package inserts and updated CDC and ACIP guidance should be consulted for information on contraindications and precautions for individual influenza vaccines. Conditions considered by ACIP to be contraindications and precautions for the use of LAIV3 are summarized (Table 2). These include two labeled contraindications that appear in the package insert (56) and other conditions for which there is either uncertain but biologically plausible potential risk associated with live viruses or limited data for use of LAIV. Contraindications to use of LAIV3 include the following (Tables 2 and 3):
·对疫苗任何成分或对任何流感疫苗（即，任何价次的鸡胚制备的IIV、ccIIV、RIV或LAIV）曾有严重过敏反应史（例如，过敏性休克）（说明书中列出的禁忌症）。然而，虽然LAIV3含有鸡蛋成分，但ACIP对有鸡蛋过敏史的人群使用流感疫苗有特别建议（见“有鸡蛋过敏史的患者”）。
·Severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine or to a previous dose of any influenza vaccine (i.e., any egg-based IIV, ccIIV, RIV, or LAIV of any valency; a labeled contraindication noted in the package insert). However, although egg is a component of LAIV3, ACIP makes specific recommendations for the use of influenza vaccine for persons with egg allergy (see Persons with a History of Egg Allergy).
·同时服用阿司匹林或水杨酸盐药物的儿童和青少年，因为可能存在Reye综合征的风险（说明书中列出的禁忌症）。
·Children and adolescents receiving concomitant aspirin- or salicylate-containing medications, because of the potential risk for Reye syndrome (a labeled contraindication noted in the package insert).
·2至4岁的儿童，曾被诊断为哮喘，或其父母或看护者报告在过去12个月中，医疗提供者曾告知他们的孩子有喘息或哮喘，或医疗记录显示在过去12个月中有喘息发作。
·Children aged 2 through 4 years who have received a diagnosis of asthma or whose parents or caregivers report that a health care provider has told them during the preceding 12 months that their child had wheezing or asthma or whose medical record indicates a wheezing episode has occurred during the preceding 12 months.
·由于任何原因所致免疫抑制的儿童和成人，包括但不限于药物引起的免疫抑制、先天性或获得性免疫缺陷、HIV感染、解剖性脾切除或功能性脾切除（如镰状细胞贫血）。
·Children and adults who are immunocompromised due to any cause, including but not limited to immunosuppression caused by medications, congenital or acquired immunodeficiency states, HIV infection, anatomic asplenia, or functional asplenia (such as that due to sickle cell anemia).
·需要防护环境的严重免疫抑制者的密切接触者和看护者。
·Close contacts and caregivers of severely immunosuppressed persons who require a protected environment.
·孕妇。
·Pregnancy.
·有脑脊液与口咽、鼻咽、鼻腔或耳部或任何其他颅内脑脊液漏之间存在开放性通道的患者。
·Persons with active communication between the cerebrospinal fluid (CSF) and the oropharynx, nasopharynx, nose, or ear or any other cranial CSF leak.
·人工耳蜗植入者，由于植入后一段时期内可能存在脑脊液漏的可能性（如果不能使用灭活或重组疫苗，接种服务提供者可以考虑向专家咨询关于持续性脑脊液漏的风险）。
·Persons with cochlear implants, because of the potential for CSF leak that might exist for a period after implantation (providers might consider consultation with a specialist concerning the risk for persistent CSF leak if an inactivated or recombinant vaccine cannot be used).
·在过去48小时内接受过包括奥司他韦和扎那米韦在内的流感抗病毒药物治疗，在过去5天内接受过帕拉米韦治疗，在过去17天内接受过巴洛昔韦治疗。在存在药物清除延迟的疾病（如肾功能不全）的情况下，流感抗病毒药物的使用与LAIV3之间可能发生干扰的时间间隔可能会进一步延长。
·Receipt of influenza antiviral medication within the previous 48 hours for oseltamivir and zanamivir, previous 5 days for peramivir, and previous 17 days for baloxavir. The interval between influenza antiviral receipt and LAIV3 during which interference might potentially occur might be further prolonged in the presence of medical conditions that delay medication clearance (e.g., renal insufficiency).
使用LAIV3的注意事项包括（见表2和表3）：
Precautions to the use of LAIV3 include the following (Tables 2 and 3):
·中度或重度急性疾病，无论是否伴有发热。
·Moderate or severe acute illness with or without fever.
·在接种任何流感疫苗后的6周内有GBS病史。
·History of GBS within 6 weeks after receipt of any influenza vaccine.
·5岁及以上人群中的哮喘病史。
·Asthma in persons aged ≥5 years.
·其他潜在的医学情况（除禁忌症中列出的情况外），可能在感染野生型流感病毒后增加并发症的风险（例如，慢性肺部疾病、心血管疾病[单纯性高血压除外]、肾脏、肝脏、神经系统、血液系统或代谢性疾病[包括糖尿病]）。
·Other underlying medical condition (other than those listed under contraindications) that might predispose to complications after wild-type influenza virus infection (e.g., chronic pulmonary, cardiovascular [except isolated hypertension], renal, hepatic, neurologic, hematologic, or metabolic disorders [including diabetes mellitus]).
流感疫苗的存储和运输
Storage and Handling of Influenza Vaccines
在任何情况下都应查阅经批准的制造商提供的包装信息，以获取有关特定流感疫苗存储和运输的权威指导。通常，流感疫苗应避免光照，并在包装说明中推荐的温度下存储。推荐的存储温度通常为36℉–46℉（2℃–8℃），并应始终保持适当的制冷和温度监测。已冻结的疫苗应予以丢弃。关于合适的冰箱和温度监测设备的具体建议，可参阅https://www.cdc.gov/vaccines/hcp/storage-handling/?CDC_AAref_Val=https://www.cdc.gov/vaccines/hcp/admin/storage/toolkit/index.html。
In all instances, approved manufacturer packaging information should be consulted for authoritative guidance concerning storage and handling of specific influenza vaccines. Typically, influenza vaccines should be protected from light and stored at temperatures that are recommended in the package insert. Recommended storage temperatures are typically 36°F–46°F (2°C–8°C) and should be maintained at all times with adequate refrigeration and temperature monitoring. Vaccine that has frozen should be discarded. Specific recommendations for appropriate refrigerators and temperature monitoring equipment can be found in the Vaccine Storage and Handling Toolkit, available at https://www.cdc.gov/vaccines/hcp/storage-handling/?CDC_AAref_Val=https://www.cdc.gov/vaccines/hcp/admin/storage/toolkit/index.html.
疫苗存放不应超过标签上的有效期。除有效期外，多人份疫苗还可能具有超过使用期（BUD），该时期明确了首次取用后的疫苗可存放的天数。首次取用后，多人份疫苗不应在超过BUD后使用。如果没有提供BUD，则应参考提供的有效期。多人份疫苗在使用间隙应返回至推荐的存储条件中。包装信息还可能规定了多人份疫苗中的最大应用剂次（无论剩余体积如何）。取出次数不超过规定剂次，剩余部分应予以丢弃。接种服务提供者应联系制造商获取有关允许的温度波动范围及其他未在包装标签中提及的存储和运输条件的详细信息。
Vaccines should not be used beyond the expiration date on the label. In addition to the expiration date, multidose vials also might have a beyond-use date (BUD), which specifies the number of days the vaccine can be kept once first accessed. After being accessed for the first dose, multidose vials should not be used after the BUD. If no BUD is provided, then the listed expiration date is to be used. Multidose vials should be returned to recommended storage conditions between uses. Package information might also specify a maximum number of doses contained in multidose vials (regardless of remaining volume). No more than the specified number of doses should be removed, and any remainder should be discarded. Providers should contact the manufacturer for information on permissible temperature excursions and other departures from recommended storage and handling conditions that are not discussed in the package labeling.
有关流感和流感疫苗的额外信息
Additional Sources of Information Regarding Influenza and Influenza Vaccines
流感监测、预防和控制
Influenza Surveillance, Prevention, and Control
疫苗不良事件报告系统（VAERS）
Vaccine Adverse Event Reporting System (VAERS)
国家疫苗伤害补偿计划（VICP）
National Vaccine Injury Compensation Program (VICP)
其他资源
Additional Resources
ACIP声明
ACIP Statements
免疫最佳最佳实践指南
General Best Practice Guidelines for Immunization:
COVID-19疫苗建议和指导
COVID-19 Vaccine Recommendations and Guidance
疫苗信息表
Vaccine Information Sheets
流感疫苗包装说明
Influenza Vaccine Package Inserts
CDC流感抗病毒指导
CDC Influenza Antiviral Guidance
美国传染病学会流感抗病毒指导
Infectious Diseases Society of America Influenza Antiviral Guidance
美国儿科学会指导
American Academy of Pediatrics Guidance
美国传染病学会免疫受损宿主疫苗接种指导
Infectious Diseases Society of America Guidance for Vaccination of Immunocompromised Hosts
美国妇产科医师学会
American College of Obstetricians and Gynecologists
致谢
Acknowledgments
（人名太多了不翻译了）
Voting members of the Advisory Committee on Immunization Practices: Helen Keipp Talbot, MD, Vanderbilt University, Nashville, Tennessee (Chair); Oliver Brooks, MD, Watts HealthCare Corporation, Los Angeles, California; Wilbur H. Chen, MD, University of Maryland School of Medicine, Baltimore, Maryland; Sybil Cineas, MD, Warren Alpert Medical School of Brown University, Providence, Rhode Island; Matthew F. Daley, MD, Kaiser Permanente Colorado, Aurora, Colorado; Denise J. Jamieson, MD, Carver College of Medicine, University of Iowa, Iowa City, Iowa; Camille Nelson Kotton, MD, Harvard Medical School, Boston, Massachusetts; Jamie Loehr, MD, Cayuga Family Medicine, Ithaca, New York; Sarah S. Long, MD, Drexel University College of Medicine, Philadelphia, Pennsylvania; Yvonne Maldonado, MD, Stanford University School of Medicine, Palo Alto, California; Robert Schechter, MD, California Department of Public Health, Richmond, California; Albert Shaw, MD, Yale School of Medicine, New Haven, Connecticut.
（人名太多了不翻译了）
Alicia Budd, MPH; Jessie Chung, MPH; Sascha Ellington, PhD; Brendan Flannery, PhD; Andrew Kroger, MD; Samantha Olson, MPH; David Shay, MD; Tom Shimabukuro, MD; and Tim Uyeki, MD; CDC.
ACIP流感疫苗工作组
ACIP Influenza Vaccine Work Group
（人名太多了不翻译了）
Jamie Loehr, MD, Ithaca, New York (Chair); Robert Atmar, MD, Houston, Texas; Kevin Ault, MD, Kalamazoo, Michigan; Edward Belongia, MD, Marshfield, Wisconsin; Henry Bernstein, DO, Hempstead, New York; Thomas Boyce, MD, Marshfield, Wisconsin; Timothy Brennan, MD, Silver Spring, Maryland; Kristina Angel Bryant, MD, Louisville, Kentucky; Doug Campos-Outcalt, MD, Phoenix, Arizona; Uzo Chukwuma, PhD, Rockville, Maryland; Sarah Coles, MD, Phoenix, Arizona; Frances Ferguson, MD, Newton, Georgia; Alicia Fry, MD, Atlanta, Georgia; Sandra Adamson Fryhofer, MD, Atlanta, Georgia; Krissy Moehling Geffel, PhD, Pittsburgh, Pennsylvania; Michael Ison, MD, Rockville, Maryland; Wendy Keitel, MD, Houston, Texas; Camille Kotton, MD, Boston, Massachusetts; Marie-Michèle Léger, MPH, Alexandria, Virginia; Susan Lett, MD, Boston, Massachusetts; Zackary Moore, MD, Raleigh, North Carolina; Rebecca L. Morgan, PhD, Cleveland, Ohio; Cynthia Nolletti, MD, Silver Spring, Maryland; Jesse Papenburg, MD, Montreal, Quebec, Canada; Jo Resnick, PhD, Silver Spring, Maryland; Chris Roberts, PhD; Rockville, Maryland; William Schaffner, MD, Nashville, Tennessee; Robert Schechter, MD, Richmond, California; Kenneth Schmader, MD, Durham, North Carolina; Tamara Sheffield, MD, Salt Lake City, Utah; Angela Sinilaite, MPH, Ottawa, Ontario, Canada; Peter Szilagyi, MD, Los Angeles, California; Helen Keipp Talbot, MD, Nashville, Tennessee Matthew Zahn, MD, Santa Ana, California.
1.Influenza Division, National Center for Immunization and Respiratory Diseases, CDC; 2.Immunization Safety Office, National Center for Emerging and Zoonotic Infectious Diseases, CDC; 3.Jamie Loehr, MD, Cayuga Family Medicine, Ithaca, New York
关系披露及非标记用途
Disclosure of Relationship and Unlabeled Use
所有作者已完成并提交了国际医学期刊编辑委员会的潜在利益冲突披露表格。没有披露潜在利益冲突。
All authors have completed and submitted the International Committee of Medical Journal Editors form for the disclosure of potential conflicts of interest. No potential conflicts of interest were disclosed.
本报告包括对流感疫苗存在过敏史和18至64岁实体器官移植受者中的非标记使用的讨论。对于有鸡蛋过敏史的人，严重过敏反应（例如，过敏性休克）和对疫苗或其任何成分（某些包括鸡蛋成分的疫苗）是大多数IIV3和LAIV3的标签禁忌症。然而，ACIP建议所有≥6月龄的鸡蛋过敏者都接种流感疫苗。任何适合接种者年龄和健康状态的流感疫苗（基于鸡胚或非鸡胚制备）均可使用。对于18至64岁接受免疫抑制药物方案的实体器官移植受者，虽然高剂量灭活流感疫苗（HD-IIV3）和佐剂灭活流感疫苗（aIIV3）被批准用于≥65岁人群，但ACIP建议18至64岁接受免疫抑制治疗的实体器官移植受者可以选择HD-IIV3或aIIV3，但并不优先于其他适龄的IIV3或RIV3。
This report includes discussion of the unlabeled use of influenza vaccines in the recommendations for persons with a history of egg allergy and for solid organ transplant recipients aged 18 through 64 years. With regard to persons with a history of egg allergy, history of severe allergic reaction (e.g., anaphylaxis) to the vaccine or any of its components (which include egg for certain vaccines) is a labeled contraindication to receipt of most IIV3s and LAIV3. However, ACIP recommends that all persons aged ≥6 months with egg allergy should receive influenza vaccine. Any influenza vaccine (egg based or nonegg based) that is otherwise appropriate for the recipient’s age and health status can be used. With regard to solid organ transplant recipients aged 18 through 64 years, the high-dose inactivated influenza vaccine (HD-IIV3) and adjuvanted inactivated influenza vaccine (aIIV3) are approved for persons aged ≥65 years. However, ACIP recommends that solid organ transplant recipients aged 18 through 64 years who are receiving immunosuppressive medication regimens may receive either HD-IIV3 or aIIV3 as acceptable options, without a preference over other age-appropriate IIV3s or RIV3.
CDC采纳ACIP建议的MMWR建议与报告、MMWR政策说明及免疫接种计划（儿童/青少年、成人）
CDC Adoption of ACIP Recommendations for MMWR Recommendations and Reports, MMWR Policy Notes, and Immunization Schedules (Child/Adolescent, Adult)
儿童、青少年和成人常规疫苗使用的疫苗建议由免疫实践咨询委员会（ACIP）制定。ACIP作为一个联邦顾问委员会，向CDC主任提供有关疫苗及相关制剂在美国平民中控制疫苗可预防疾病的专家建议和指导。儿童和青少年疫苗的常规使用建议尽可能与美国儿科学会（AAP）、美国家庭医师学会（AAFP）、美国妇产科医师学会（ACOG）、美国助产士学会（ACNM）、美国医师助理学会（AAPA）和国家儿科护士从业者协会（NAPNAP）的建议协调。成人疫苗的常规使用建议与AAFP、ACOG、ACNM、AAPA、美国内科医师学会（ACP）、美国药剂师协会（APhA）和美国医疗保健流行病学学会（SHEA）的建议协调。ACIP建议提交CDC主任审核，一旦采纳即成为CDC的官方政策，这些建议随后会在CDC的《发病率和死亡率周报》（MMWR）中发布。更多信息请访问https://www.cdc.gov/vaccines/acip。
Recommendations for routine use of vaccines in children, adolescents, and adults are developed by the Advisory Committee on Immunization Practices (ACIP). ACIP is chartered as a Federal Advisory Committee to provide expert external advice and guidance to the Director of CDC on use of vaccines and related agents for the control of vaccine preventable diseases in the civilian population of the United States. Recommendations for routine use of vaccines in children and adolescents are harmonized to the greatest extent possible with recommendations made by the American Academy of Pediatrics (AAP), the American Academy of Family Physicians (AAFP), the American College of Obstetricians and Gynecologists (ACOG), the American College of Nurse-Midwives (ACNM), the American Academy of Physician Associates (AAPA), and the National Association of Pediatric Nurse Practitioners (NAPNAP). Recommendations for routine use of vaccinations in adults are harmonized with recommendations of AAFP, ACOG, ACNM, AAPA, the American College of Physicians (ACP), the American Pharmacists Association (APhA), and the Society for Healthcare Epidemiology of America (SHEA). ACIP recommendations are forwarded to CDC’s Director and once adopted become official CDC policy. These recommendations are then published in CDC’s Morbidity and Mortality Weekly Report (MMWR). Additional information is available at https://www.cdc.gov/vaccines/acip.
图：6月龄至8岁儿童的流感疫苗剂次算法*——美国免疫实践咨询委员会，2024-2025年流感季。
*需要接种2剂流感疫苗的6月龄至8岁儿童应尽快接种第一剂（包括在7月和8月，如果疫苗可用），以便在10月底之前接种第二剂（第二剂必须在≥4周后接种）。对于需要2剂疫苗的8岁儿童，即使儿童在接种1剂和2剂疫苗之间年满9岁，也应接种两剂疫苗。
FIGURE. Influenza vaccine dosing algorithm for children aged 6 months through 8 years* — Advisory Committee on Immunization Practices, United States, 2024–25 influenza season.
* Children aged 6 months through 8 years who require 2 doses of influenza vaccine should receive their first dose as soon as possible (including during July and August, if vaccine is available) to allow the second dose (which must be administered ≥4 weeks later) to be received, ideally, by the end of October. For children aged 8 years who require 2 doses of vaccine, both doses should be administered even if the child turns age 9 years between receipt of dose 1 and dose 2.
References
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