摘要：2025-26流感季信息包括：更新的疫苗组分；批准FluMist（鼻喷减毒活流感疫苗）可由本人或照护者进行接种；将Flublok（重组流感疫苗）的适用年龄下限从≥18岁扩大至≥9岁；并建议仅使用不含硫柳汞作为防腐剂的单剂量季节性流感疫苗。

这一主题已有的认知

What is already known about this topic?

流感疫苗可预防流感及其潜在并发症。免疫实施咨询委员会（ACIP）每个流感季都会发布流感疫苗接种建议。

Influenza vaccination protects against influenza and its potential complications. The Advisory Committee on Immunization Practices makes influenza vaccination recommendations for each influenza season.

本报告新增内容

What is added by this report?

2025-26流感季信息包括：更新的疫苗组分；批准FluMist（鼻喷减毒活流感疫苗）可由本人或照护者进行接种；将Flublok（重组流感疫苗）的适用年龄下限从≥18岁扩大至≥9岁；并建议仅使用不含硫柳汞作为防腐剂的单剂量季节性流感疫苗。

Information for the 2025-26 influenza season includes the updated vaccine composition, approval of FluMist (nasal spray live attenuated influenza vaccine) for self-administration or caregiver administration, expansion of the approved age threshold for Flublok (recombinant influenza Vaccine) from ≥18 years to ≥9 years, and a recommendation that only single-dose seasonal influenza vaccines not containing thimerosal as a preservative be used.

对公共卫生实践的意义

What are the implications for public health practice?

建议所有≥6月龄、无接种禁忌的人群进行常规年度流感疫苗接种，以预防流感及其并发症。

Routine annual influenza vaccination is recommended for all persons aged ≥6 months without a contraindication to vaccination to protect against influenza and its complications.

本报告更新了美国免疫实施咨询委员会（ACIP）关于2024-25流感季节性流感疫苗使用的建议。建议所有≥6月龄、无接种禁忌的人群常规每年接种流感疫苗。预计在2025-26流感季将有多种三价灭活流感疫苗（IIV3s）、三价重组流感疫苗（RIV3）和三价减毒活流感疫苗（LAIV3）可供使用。2025-26季的更新包括：

This report updates the 2024-25 recommendations of the Advisory Committee on Immunization Practices (ACIP) concerning the use of seasonal influenza vaccines in the United States. Routine annual influenza vaccination is recommended for all persons aged ≥6 months who do not have a contraindication to vaccination. Multiple formulations of the trivalent inactivated influenza vaccines (IIV3s), trivalent recombinant influenza vaccine (RIV3), and trivalent live attenuated influenza vaccine (LAIV3) are expected to be available for the 2025-26 influenza season. Updates for the 2025-26 season include

1）2025-26美国季节性流感疫苗的抗原组分；

2）美国食品药品监督管理局（FDA）批准FluMist（LAIV3）可由本人或照护者接种；

3）FDA批准将Flublok（RIV3）的适用年龄从≥18岁调整为≥9岁；

4）ACIP新增建议：≤18岁儿童、孕妇及所有成年人仅使用不含硫柳汞作为防腐剂的单剂量季节性流感疫苗。

1) antigenic composition of 2025-26 U.S. seasonal influenza vaccines,

2) Food and Drug Administration (FDA) approval of FluMist (LAIV3) for self-administration or caregiver administration,

3) FDA approval of a change in age indication for Flublok (RIV3) from ≥18 years to ≥9 years, and

4) 4) a new ACIP recommendation that children aged ≤18 years, pregnant women, and all adults receive seasonal influenza vaccines only in single-dose formulations that are free of thimerosal as a preservative.

本报告所述建议及先前涉及但未在本报告中更新的内容（仍适用于2025-26流感季）的完整总结，可在“Influenza | ACIP Recommendations for Vaccination”查阅。更多背景信息可见“Prevention and Control of Seasonal Influenza with Vaccines”。

A comprehensive summary of recommendations, including those discussed in this report, as well as previous recommendations concerning topics not addressed in this report and that remain unchanged for the 2025-26 season, is available at Influenza | ACIP Recommendations for Vaccination. Additional background information also is available at Prevention and Control of Seasonal Influenza with Vaccines.

美国免疫实施咨询委员会（ACIP）每年都会发布关于使用流感疫苗预防和控制季节性流感的建议。本报告总结了2024-25年度建议在2025-26流感季的更新内容。与以往流感季相同，仍建议所有≥6月龄、无接种禁忌的人群常规每年接种流感疫苗。目前有多种不同剂型的流感疫苗可供使用。本报告还概述了流感疫苗的接种禁忌和注意事项。更新的建议内容反映了ACIP于2025年4月15日和6月26日公开会议上的讨论结果。

The Advisory Committee on Immunization Practices (ACIP) provides annual recommendations for the use of influenza vaccines for the prevention and control of seasonal influenza in the United States. This report summarizes updates to the 2024-25 recommendations for use of seasonal influenza vaccines in the United States for the 2025-26 influenza season. As in previous seasons, routine annual influenza vaccination is recommended for all persons aged ≥6 months who do not have a contraindication to vaccination. Various formulations of influenza vaccines are available. Contraindications to and precautions for the use of influenza vaccines are summarized. Updated recommendations discussed in this report reflect discussions held during public ACIP meetings on April 15 and June 26, 2025.

本报告描述了2025-26流感季新增及更新的建议，同时也涵盖了若干保持与2024-25年度一致的主题，包括推荐接种的目标人群、接种时机、疫苗选择以及禁忌与注意事项。对于本报告未涉及的主题和特定人群，沿用2024-25年度的建议。本报告中的建议与更新取代了之前的相关建议。此外，2025-26流感季的完整建议汇总（涵盖本报告涉及和未涉及的内容）可在“Influenza | ACIP Recommendations for Vaccination”查阅。

This report describes new and updated recommendations for the 2025-26 season, as well as several topics for which recommendations remain unchanged from the 2024-25 season, including populations for whom influenza vaccination is recommended, timing of vaccination, selection of vaccines, and contraindications and precautions. Previous recommendations concerning topics and specific populations not discussed in this report remain unchanged from the 2024-25 season. Additional information on topics not addressed in this report are available the 2024-25 ACIP seasonal influenza vaccination recommendations (1). Recommendations and updates included in this report supersede previous recommendations. In addition, a comprehensive summary of the recommendations for the 2025-26 influenza season, including topics covered and not covered in this report, is available at Influenza | ACIP Recommendations for Vaccination.

ACIP流感工作组全年定期通过电话会议召开，审议将在ACIP会议上讨论的议题。对于美国食品药品监督管理局（FDA）推荐的季节性流感疫苗病毒抗原成分变化，以及与FDA已批准适应症和说明书一致的使用变更，不进行系统综述和证据评估。通常，对于新的建议或对现有建议的重大修改，会采用“循证推荐分级评估（GRADE）”方法进行系统综述和证据评估。

The ACIP Influenza Work Group meets by teleconference regularly throughout the year to review topics before they are discussed at ACIP meetings. Systematic review and evidence assessment are not performed for changes in the viral antigen composition of seasonal influenza vaccines recommended by the Food and Drug Administration (FDA) and changes that reflect use that is consistent with FDA-approved indications and prescribing information. Systematic review and evaluation of evidence using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach (2) are typically performed for new recommendations or substantial changes in current recommendations.

流感工作组会审查证据，并将其纳入ACIP的“从证据到建议（EtR）”框架中，以指导拟提交ACIP表决的建议的制定。由于季节性流感疫苗接种的重申建议未涉及新的建议或重大变化，因此本次建议无需进行GRADE或EtR评估。然而，GRADE和EtR框架曾用于制定先前的一些建议，包括：≥65岁成人流感疫苗接种（2022年6月）、有鸡蛋过敏史人群（2023年6月）、以及18-64岁实体器官移植受者（2024年6月）的接种建议。

Evidence is reviewed by the ACIP Influenza Work Group, and work group considerations are included within the ACIP Evidence to Recommendations (EtR) framework to guide the development of recommendations proposed for a vote by ACIP (2,3). Because the reaffirmed recommendations for seasonal influenza vaccination had no new recommendations or substantial changes, this recommendation did not require performance of GRADE or EtR. However, GRADE and the EtR framework were used in the development of the previous recommendations mentioned in this report for influenza vaccination of adults aged ≥65 years (4,5) (June 2022), persons with a history of egg allergy (6,7) (June 2023), and solid organ transplant recipients aged 18 through 64 years (8,9) (June 2024).

GRADE和EtR框架未用于制定避免使用含硫柳汞防腐剂的季节性流感疫苗的建议，该议题、建议及措辞均未在流感工作组中讨论。

GRADE and EtR were not used to develop the recommendation to avoid seasonal influenza vaccines containing thimerosal as a preservative, and this topic, recommendation, and recommendation language were not discussed by the Influenza Work Group.

本报告对2024-25年度建议提出了四项更新，其中包括三项FDA批准的标签变更和一项在2025年6月ACIP会议讨论后通过的新建议。

Four updates to the 2024-25 recommendations are presented in this report. These include three FDA-approved labeling changes and a new recommendation approved through discussion at the June 2025 ACIP meeting.

▪ 2025年3月，FDA发布了2025-26年度美国批准流感疫苗的抗原组分建议。

▪ 2024年9月，FDA批准FluMist（LAIV3）用于自我接种（适用于18-49岁人群），或由≥18岁的照护者为2-17岁的儿童和青少年接种。预计自我接种或照护者接种的FluMist将在2025-26流感季供应。

▪ 2025年3月，FDA扩大了Flublok（RIV3）的适用人群，将原本仅批准用于≥18岁人群的适应症扩展至9-17岁儿童和青少年。目前Flublok已获批用于≥9岁人群。

▪ 2025年6月26日，ACIP新增建议：≤18岁儿童、孕妇和所有成年人仅接种不含硫柳汞作为防腐剂的单剂量季节性流感疫苗。

▪ In March 2025, FDA issued recommendations for the antigenic composition of 2025-26 U.S.-approved influenza vaccines (10).

▪ In September 2024, FDA approved FluMist (LAIV3) for self-administration (for recipients aged 18 through 49 years) or administration by a caregiver aged ≥18 years (for children and adolescents aged 2 through 17 years). FluMist for self-administration or caregiver administration is anticipated to become available during the 2025-26 season (11).

▪ In March 2025, FDA expanded approval of Flublok (RIV3), previously approved for persons aged ≥18 years, to children and adolescents aged 9 through 17 years. Flublok is now approved for persons aged ≥9 years (12).

▪ On June 26, 2025, ACIP made a new recommendation that children aged ≤18 years, pregnant women, and all adults receive seasonal influenza vaccines only in single-dose formulations that are free of thimerosal as a preservative.

根据对美国及全球流感监测数据的审查，2025–26流感季在美国供应的所有流感疫苗均为三价疫苗，含有以下血凝素抗原：

Based on review of U.S. and global influenza surveillance data (10), all influenza vaccines available in the United States during the 2025–26 season will be trivalent vaccines containing hemagglutinin derived from

▪ 1）甲型流感A/Victoria/4897/2022 (H1N1)pdm09类似株（适用于鸡胚疫苗）或A/Wisconsin/67/2022 (H1N1)pdm09类似株（适用于细胞培养和重组疫苗）；

▪ 2）甲型流感A/Croatia/10136RV/2023 (H3N2)类似株（适用于鸡胚疫苗）或A/District of Columbia/27/2023 (H3N2)类似株（适用于细胞培养和重组疫苗）；

▪ 3）乙型流感B/Austria/1359417/2021（Victoria系）类似株。

▪ 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/Croatia/10136RV/2023 (H3N2)-like virus (for egg-based vaccines) or an influenza A/District of Columbia/27/2023 (H3N2)-like virus (for cell culture–based and recombinant vaccines); and

▪ 3) an influenza B/Austria/1359417/2021 (Victoria lineage)-like virus.

与2024–25流感季疫苗相比，此次更新涉及甲型流感A(H3N2)组分。

This composition reflects an update in the influenza A(H3N2) component compared with that contained in the vaccines during the 2024–25 influenza season (10).

继续建议所有≥6月龄、无接种禁忌的人群常规每年接种流感疫苗。以下为接种时机、疫苗选择、接种方式及禁忌与注意事项的相关信息。

Routine annual influenza vaccination of all persons aged ≥6 months who do not have a contraindication to vaccination continues to be recommended. Information on timing, selection, administration, and contraindications and precautions follows.

对于大多数在当季仅需接种1剂流感疫苗的人群，理想接种时间为9月或10月。然而，只要流感病毒仍在传播且疫苗未过期，接种应在10月后及整个流感季持续进行。

For most persons who require 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.

对于大多数人群，不推荐在7月或8月接种，因为疫苗诱导的免疫可能在流感季中后期减弱，特别是老年人群。然而，如果担心之后无法接种，7月或8月接种也可考虑。以下将进一步说明接种时机的考虑因素。

Vaccination during July and August is not recommended for most groups because of potential waning of vaccine-induced immunity during the influenza season (13–33), particularly among older adults (13,14,16,23,26,32). However, vaccination during July or August may be considered for any recipient if there is concern that later vaccination might not be possible. Considerations for timing of vaccination follow.

▪ 大多数成人（尤其是≥65岁者）及妊娠早中期女性：除非担心之后无法接种，否则应避免在7月和8月接种。

▪ 需要接种2剂流感疫苗的儿童：6月龄至8岁的儿童，如在2025年7月1日前未接种过≥2剂三价或四价流感疫苗，或其接种史不明，则当季需接种2剂流感疫苗（见补充图表）。这些儿童应尽早接种第一剂（若有疫苗可供，即使在7月或8月也可接种），以便至少间隔4周后接种第二剂，最好在10月底前完成。

▪ 仅需接种1剂流感疫苗的儿童：对于当季仅需1剂的儿童，7月和8月接种是可考虑的。虽然各年龄组均观察到接种后免疫力随季节减弱的现象，但针对儿童的研究报道较少。此外，这类儿童可能会在暑期末接受入学前的健康检查，此时也可作为接种机会。

▪ 妊娠晚期女性：对于妊娠第三孕期且正处于7月或8月的女性，可考虑在此期间接种。多项研究表明，孕期接种与婴儿出生后头几个月（尚不能接种流感疫苗时）降低流感患病风险相关。对于妊娠早期或中期的女性，如无接种障碍，最好推迟至9月或10月接种。

▪ Most adults (particularly those aged ≥65 years) and pregnant women 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.

▪ Children who require 2 influenza vaccine doses. Children aged 6 months through 8 years who did not receive ≥2 trivalent or quadrivalent influenza vaccine doses before July 1, 2025, or whose influenza vaccination history is unknown, require 2 doses of influenza vaccine for the season (Supplementary Figure). These children should receive their first dose as early as possible (including during July and August, if vaccine is available) to permit receipt of the second dose (which must be administered ≥4 weeks later), ideally by the end of October.

▪ Children who require only 1 influenza vaccine 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 during the season has been observed among all age groups (13–33), fewer studies report this specifically among children (13,22,24,25,29,31,32). Moreover, children in this group might visit health care providers during the late summer months for a medical examination before the start of school, which represents a vaccination opportunity.

▪ Pregnant women in the third trimester. Vaccination during July and August can be considered for women who are in the third trimester of pregnancy 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 (34–38). For pregnant women in the first or second trimester during July and August, waiting until September or October to vaccinate is preferable, unless there is concern that later vaccination might not be possible.

与以往年度相同，2025–26流感季将有多种流感疫苗可供使用（见表1）。除禁忌症和注意事项（见表2、表3）外，ACIP在疫苗选择上提出以下建议：

As in past years, various influenza vaccines will be available for the 2025–26 influenza season (Table 1). In addition to contraindications and precautions (Table 2) (Table 3), considerations for vaccine selection include the following recommendations from ACIP:

▪ ≤18岁儿童、孕妇及所有成年人应仅接种不含硫柳汞作为防腐剂的单剂量流感疫苗。

▪ 所有人应接种适合其年龄的流感疫苗（即获批适用该年龄段的疫苗）。例外情况是：18–64岁正在接受免疫抑制治疗的实体器官移植受者，可选择三价高剂量灭活流感疫苗（HD-IIV3）或三价加佐灭活流感疫苗（aIIV3）作为可接受的方案（但不优先于其他适龄的IIV3或三价重组流感疫苗RIV3）。

▪ 除≥65岁成年人外，ACIP对其他年龄组在多种获批且推荐的疫苗可选时不提出优先推荐。对于≥65岁成年人，优先推荐以下任一高剂量或加佐疫苗：HD-IIV3、RIV3或aIIV3。如在接种时上述三种疫苗均不可用，应使用其他任何适龄流感疫苗。

▪ LAIV3不推荐用于孕妇、免疫功能低下者、特定疾病患者，或正在使用、近期使用或即将使用流感抗病毒药物的人群（见表2）。此外，LAIV3不应接种于49岁的人群。

▪ Children aged ≤18 years, pregnant women, and all adults should receive seasonal influenza vaccines only in single-dose formulations that are free of thimerosal as a preservative.

▪ All persons should receive an age-appropriate influenza vaccine (i.e., 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 trivalent high-dose inactivated influenza vaccine (HD-IIV3) or trivalent adjuvanted inactivated influenza vaccine (aIIV3) as acceptable options (without a preference over other age-appropriate IIV3s or trivalent recombinant influenza vaccine [RIV3]) (8,9).

▪ 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. Among adults aged ≥65 years any one of the following higher dose or adjuvanted influenza vaccines is preferentially recommended: HD-IIV3, RIV3, or aIIV3. If none of these three vaccines is available at an opportunity for vaccine administration, any other available age-appropriate influenza vaccine should be used (4,5).

▪ LAIV3 is not recommended during pregnancy, for immunocompromised persons, for persons with certain medical conditions, or for persons who are receiving, have recently received, or are about to receive influenza antiviral medications (Table 2). LAIV3 should not be administered to persons aged 49 years.

在2025年7月1日前，若6月龄至8岁的儿童已接种过≥2剂间隔≥4周的三价或四价流感疫苗，则2025–26流感季仅需接种1剂。此前两剂不要求在同一或连续流感季完成。

Children aged 6 months through 8 years who have received ≥2 previous doses of trivalent or quadrivalent influenza vaccine ≥4 weeks apart before July 1, 2025, should receive 1 dose of 2025–26 influenza vaccine. The previous 2 doses are not required to have been received during the same or consecutive influenza seasons.

如6月龄至8岁的儿童未接种过≥2剂间隔≥4周的三价或四价流感疫苗，或其接种史不明，则本季需接种2剂，间隔≥4周（见补充图）。对于需要2剂的8岁儿童，即使在两剂间达到9岁，也应完成两剂接种。

Children aged 6 months through 8 years who have not received ≥2 doses of trivalent or quadrivalent influenza vaccine administered ≥4 weeks apart before July 1, 2025, or whose influenza vaccination history is unknown, should receive 2 doses of 2025–26 influenza vaccine ≥4 weeks apart (Supplementary Figure). For children aged 8 years who require 2 doses of vaccine, both doses should be administered even if the child reaches age 9 years between receipt of dose 1 and receipt of dose 2.

所有≥9岁人群仅需接种1剂2025–26流感疫苗。

All persons aged ≥9 years need only 1 dose of a 2025–26 influenza vaccine.

注射型流感疫苗（灭活疫苗和重组疫苗）采用肌肉注射。FDA批准的常规剂量为所有年龄组0.5 mL，但有两个例外（见表1）：

Injectable influenza vaccines (i.e., inactivated and recombinant influenza vaccines) are administered intramuscularly. FDA-approved dose volumes are 0.5 mL for all age groups, with two exceptions (Table 1).

Afluria (IIV3)：6–35月龄儿童批准剂量为0.25 mL/剂；≥3岁儿童和成人为0.5 mL/剂。Afluria的0.5 mL预充注射器不可用于

The approved dose volume for Afluria (IIV3) is 0.25 mL per dose for children aged 6 through 35 months. The dose volume for children aged ≥3 years and adults is 0.5 mL per dose (39). The Afluria 0.5-mL prefilled syringes should not be administered to children aged

Fluzone (IIV3)：6–35月龄儿童每剂可用0.25 mL或0.5 mL；≥3岁儿童和成人为0.5 mL/剂。虽然无0.25 mL预充注射器，但0.5 mL预充注射器可用于所有≥6月龄人群。不再推荐使用含硫柳汞防腐剂的多剂量流感疫苗。

The approved dose volume for Fluzone (IIV3) is either 0.25 mL or 0.5 mL per dose for children aged 6 through 35 months. Children aged ≥3 years and adults should receive 0.5 mL per dose (40). Although 0.25-mL prefilled syringes are not available, the Fluzone 0.5-mL prefilled syringes can be used for all persons aged ≥6 months. Use of multidose seasonal influenza vaccine formulations containing thimerosal as a preservative is no longer recommended.

每种流感疫苗均明确标注：对该疫苗任何成分有严重过敏反应（如过敏性休克）病史者为禁忌接种人群（见表2、表3）。疫苗成分详见产品说明书。对鸡蛋严重过敏（如过敏性休克）病史是含鸡蛋蛋白残留的鸡胚基IIV3和LAIV3的标注禁忌症。然而，ACIP建议所有≥6月龄的鸡蛋过敏者均应接种流感疫苗，且可使用任何适合其年龄和健康状况的流感疫苗（无论是否基于鸡胚制备）。该建议基于20项研究的证据（其中16项为IIV研究，1项为病毒体疫苗研究，3项为LAIV研究），这些研究考察了鸡蛋过敏者在接种流感疫苗（单剂量或分次接种方案）后的反应，其中13项包括有严重过敏或过敏性休克病史者。结果未见过敏性休克发生（GRADE证据确定性：极低）。因此，仅有鸡蛋过敏并不需要除常规接种安全措施以外的额外措施，无论既往对鸡蛋过敏反应的严重程度如何。

Each influenza vaccine has a labeled contraindication for persons with a history of a severe allergic reaction (e.g., anaphylaxis) to any component of that vaccine (Table 2) (Table 3) (11,12,39–45). Vaccine components are listed in product package inserts. A history of severe allergic reaction (e.g., anaphylaxis) to egg is a labeled contraindication to the use of egg-based IIV3s and LAIV3, which might contain residual egg protein (11,39–41,43–45). However, ACIP recommends that all persons aged ≥6 months with egg allergy should receive influenza vaccine and that any influenza vaccine (egg based or non–egg based) that is otherwise appropriate for the recipient’s age and health status may be used (6,7). This recommendation was based on a review of evidence from 20 studies (16 of IIVs, one of virosomal influenza vaccine, and three of LAIV) that examined reactions after administration of seasonal influenza vaccines to egg-allergic persons via either full single-dose or split-dose administration protocols (13 of which reported inclusion of persons with a history of severe reaction or anaphylaxis to egg). No instances of anaphylaxis were reported (GRADE certainty level: very low) (6). Egg allergy alone necessitates no additional safety measures for influenza vaccination beyond those recommended for any recipient of any vaccine, regardless of severity of previous reaction to egg.

对于既往对某种特定流感疫苗发生严重过敏反应（如过敏性休克）的人群，禁止再次接种该疫苗。说明书中明确：所有基于鸡胚制备的IIV3和LAIV3均禁用于既往对任何流感疫苗发生严重过敏反应的人群。是否可考虑使用非鸡胚基流感疫苗取决于此前严重过敏反应与哪种疫苗类型相关（见表2、表3）。接种医生也可考虑转诊过敏专科，以帮助识别致敏成分。所有接种场所应具备识别和处理急性过敏反应的条件。

For persons who have had a severe allergic reaction (e.g., anaphylaxis) to a specific influenza vaccine, further receipt of that vaccine is contraindicated. Per package inserts, all egg-based IIV3s and LAIV3 are contraindicated for persons who have had a severe allergic reaction (e.g., anaphylaxis) to any influenza vaccine. Recommendations concerning consideration of non–egg-based influenza vaccines for such persons depends on the type of influenza vaccine associated with the previous severe allergic reaction (Table 2) (Table 3). Providers also might consider consulting with an allergist to help identify the vaccine component responsible for the reaction. Clinical settings in which vaccines are administered should be equipped to recognize and manage acute allergic reactions (46).

中度或重度急性疾病（无论是否伴发热）是接种的一般注意事项。既往在接种流感疫苗后6周内发生格林–巴利综合征者，被视为接种所有流感疫苗的注意事项（见表2）。

Moderate or severe acute illness with or without fever is a general precaution for vaccination (46). A history of Guillain-Barré syndrome 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).

除说明书列出的LAIV3禁忌症外，ACIP还将若干其他情况视为LAIV3接种的禁忌或注意事项（见表2）。此外，LAIV3未获批准用于49岁人群，不应在这些人群中接种。

In addition to labeled contraindications for LAIV3 that are listed in the package insert, ACIP also considers several other conditions to be contraindications or precautions to the use of LAIV3 (Table 2). In addition, LAIV3 is not approved for and should not be given to persons aged 49 years.

FluMist (LAIV3)：2024年9月，FDA批准鼻喷减毒活流感疫苗FluMist（LAIV3）可用于自我接种（18–49岁人群）或由≥18岁的照护者为2–17岁的儿童及青少年接种。预计自2025–26流感季起，FluMist将通过“FluMist Home”项目提供自我或照护者接种服务，消费者需提交相关信息以确认订购资格。符合条件者订购的疫苗将以冷链运输方式配送至订单地址。ACIP对FluMist自我或照护者接种的建议、禁忌及注意事项与医疗机构接种相同（见表2、表3）。FluMist仍将可由医疗机构订购与接种。

FluMist (LAIV3). In September 2024, FDA approved the nasal spray live attenuated influenza vaccine FluMist (LAIV3) for self-administration (for recipients aged 18 through 49 years) or administration by a caregiver aged ≥18 years (for children and adolescents aged 2 through 17 years) (11). FluMist for self-administration or caregiver administration is anticipated to become available during the 2025–26 season via the FluMist Home program, through which consumers provide information to determine their eligibility to order the vaccine (47). For persons who meet eligibility criteria to receive FluMist, vaccine will be shipped under temperature-controlled conditions to the address provided by the person placing the order. ACIP recommendations, contraindications, and precautions for use of FluMist for self-administration or caregiver administration are the same as those for health care provider administration (Table 2) (Table 3). FluMist will continue to be available for ordering and administration by health care providers.

Flublok (RIV3)：2025年3月，FDA将Flublok（RIV3）的适用人群从原先的≥18岁扩展至9–17岁儿童和青少年。目前Flublok的批准年龄范围为≥9岁。该批准基于一项非随机、开放标签研究，比较了Flublok四价疫苗（RIV4）在9–17岁人群与18–49岁成人中的免疫原性和安全性。结果显示，RIV4在免疫原性上达到非劣效标准（所有4种组分在接种后第29天，两组几何平均滴度比值双侧95%置信区间下限>0.667，血清转换率差异的双侧95%置信区间下限>–10%）。在9–17岁儿童和青少年中，最常见的不良反应（≥10%受试者出现）为：注射部位疼痛（34.4%）、肌痛（19.3%）、头痛（18.5%）、乏力（16.1%）。Flublok未获批、亦不推荐用于

Flublok (RIV3). In March 2025, FDA expanded approval of Flublok (RIV3), previously approved only for persons aged ≥18 years, to children and adolescents aged 9 through 17 years. The new labeled age indication for Flublok is ≥9 years (12). Approval was based on a nonrandomized open-label study comparing immunogenicity and safety of Flublok Quadrivalent (RIV4) among children and adolescents aged 9 through 17 years with immunogenicity and safety in adults aged 18 through 49 years (12,48). Flublok Quadrivalent met prespecified criteria for noninferiority of immunogenicity (lower limit of the two-sided 95% CI of the geometric mean titer ratios between age groups of >0.667 and lower limit of the two-sided 95% CI of the difference in seroconversion rates of >–10% at day 29 postvaccination for all four viral components). Among children and adolescents aged 9 through 17 years, the most common adverse reactions (occurring in ≥10% of participants) were injection site pain (34.4%), myalgia (19.3%), headache (18.5%), and malaise (16.1%) (12). Flublok is not approved or recommended for children aged

所有作者均已完成并提交《国际医学期刊编辑委员会》潜在利益冲突披露表。未披露任何潜在利益冲突。

Committee of Medical Journal Editors form for the disclosure of potential conflicts of interest. No potential conflicts of interest were disclosed.

本报告包含关于以下人群流感疫苗超说明书使用的讨论：有鸡蛋过敏史者，以及18–64岁实体器官移植受者。

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.

鸡蛋过敏者：对于大多数三价灭活流感疫苗（IIV3）和三价减毒活流感疫苗（LAIV3），若既往对疫苗或其任何成分（某些疫苗含鸡蛋成分）发生严重过敏反应（如过敏性休克），则属标注禁忌症。然而，ACIP建议所有≥6月龄的鸡蛋过敏者均应接种流感疫苗。任何适合其年龄与健康状况的流感疫苗（无论是否基于鸡胚制备）均可使用。

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 trivalent inactivated influenza vaccines (IIV3s) and trivalent live attenuated influenza vaccine (LAIV3). However, ACIP recommends that all persons aged ≥6 months with egg allergy receive influenza vaccine. Any influenza vaccine (egg based or non–egg based) that is otherwise appropriate for the recipient’s age and health status can be used.

实体器官移植受者（18–64岁）：三价高剂量灭活流感疫苗（HD-IIV3）和三价加佐灭活流感疫苗（aIIV3）目前仅批准用于≥65岁人群。然而，ACIP建议正在接受免疫抑制治疗的18–64岁实体器官移植受者可选择接种HD-IIV3或aIIV3，作为可接受的选项，对比其他适龄IIV3或三价重组流感疫苗（RIV3）并无优先推荐。

With regard to solid organ transplant recipients aged 18 through 64 years, the trivalent high-dose inactivated influenza vaccine (HD-IIV3) and trivalent 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 trivalent recombinant influenza vaccine (RIV3).

来源：卤煮疫苗