美國(guó)疾病預(yù)防控制中心剛剛更新了針對(duì)2025-26年流感季的疫苗應(yīng)用建議，第一時(shí)間翻譯全文給大家作為參考，表格中英雙語(yǔ)對(duì)照在文末，點(diǎn)擊“閱讀原文”可以直接跳轉(zhuǎn)至原文鏈接以及了解參考文獻(xiàn)信息。以下是全文主要內(nèi)容：

季節(jié)性流感的預(yù)防與控制：美國(guó)免疫實(shí)施咨詢委員會(huì)（ACIP）建議——2025-26流感季

Prevention and Control of Seasonal Influenza with Vaccines: Recommendations of the Advisory Committee on Immunization Practices — United States, 2025-26 Influenza Season

概要

Summary

這一主題已有的認(rèn)知

What is already known about this topic?

流感疫苗可預(yù)防流感及其潛在并發(fā)癥。免疫實(shí)施咨詢委員會(huì)（ACIP）每個(gè)流感季都會(huì)發(fā)布流感疫苗接種建議。

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

本報(bào)告新增內(nèi)容

What is added by this report?

2025-26流感季信息包括：更新的疫苗組分；批準(zhǔn)FluMist（鼻噴減毒活流感疫苗）可由本人或照護(hù)者進(jìn)行接種；將Flublok（重組流感疫苗）的適用年齡下限從≥18歲擴(kuò)大至≥9歲；并建議僅使用不含硫柳汞作為防腐劑的單劑量季節(jié)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.

對(duì)公共衛(wèi)生實(shí)踐的意義

What are the implications for public health practice?

建議所有≥6月齡、無(wú)接種禁忌的人群進(jìn)行常規(guī)年度流感疫苗接種，以預(yù)防流感及其并發(fā)癥。

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

摘要

Abstract

本報(bào)告更新了美國(guó)免疫實(shí)施咨詢委員會(huì)（ACIP）關(guān)于2024-25流感季節(jié)性流感疫苗使用的建議。建議所有≥6月齡、無(wú)接種禁忌的人群常規(guī)每年接種流感疫苗。預(yù)計(jì)在2025-26流感季將有多種三價(jià)滅活流感疫苗（IIV3s）、三價(jià)重組流感疫苗（RIV3）和三價(jià)減毒活流感疫苗（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美國(guó)季節(jié)性流感疫苗的抗原組分；

2）美國(guó)食品藥品監(jiān)督管理局（FDA）批準(zhǔn)FluMist（LAIV3）可由本人或照護(hù)者接種；

3）FDA批準(zhǔn)將Flublok（RIV3）的適用年齡從≥18歲調(diào)整為≥9歲；

4）ACIP新增建議：≤18歲兒童、孕婦及所有成年人僅使用不含硫柳汞作為防腐劑的單劑量季節(jié)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.

本報(bào)告所述建議及先前涉及但未在本報(bào)告中更新的內(nèi)容（仍適用于2025-26流感季）的完整總結(jié)，可在“Influenza | ACIP Recommendations for Vaccination”查閱。更多背景信息可見(jiàn)“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.

引言

Introduction

美國(guó)免疫實(shí)施咨詢委員會(huì)（ACIP）每年都會(huì)發(fā)布關(guān)于使用流感疫苗預(yù)防和控制季節(jié)性流感的建議。本報(bào)告總結(jié)了2024-25年度建議在2025-26流感季的更新內(nèi)容。與以往流感季相同，仍建議所有≥6月齡、無(wú)接種禁忌的人群常規(guī)每年接種流感疫苗。目前有多種不同劑型的流感疫苗可供使用。本報(bào)告還概述了流感疫苗的接種禁忌和注意事項(xiàng)。更新的建議內(nèi)容反映了ACIP于2025年4月15日和6月26日公開(kāi)會(huì)議上的討論結(jié)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.

本報(bào)告描述了2025-26流感季新增及更新的建議，同時(shí)也涵蓋了若干保持與2024-25年度一致的主題，包括推薦接種的目標(biāo)人群、接種時(shí)機(jī)、疫苗選擇以及禁忌與注意事項(xiàng)。對(duì)于本報(bào)告未涉及的主題和特定人群，沿用2024-25年度的建議。本報(bào)告中的建議與更新取代了之前的相關(guān)建議。此外，2025-26流感季的完整建議匯總（涵蓋本報(bào)告涉及和未涉及的內(nèi)容）可在“Influenza | ACIP Recommendations for Vaccination”查閱。

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.

方法

Methods

流感工作組活動(dòng)

Influenza Work Group Activities

ACIP流感工作組全年定期通過(guò)電話會(huì)議召開(kāi)，審議將在ACIP會(huì)議上討論的議題。對(duì)于美國(guó)食品藥品監(jiān)督管理局（FDA）推薦的季節(jié)性流感疫苗病毒抗原成分變化，以及與FDA已批準(zhǔn)適應(yīng)癥和說(shuō)明書(shū)一致的使用變更，不進(jìn)行系統(tǒng)綜述和證據(jù)評(píng)估。通常，對(duì)于新的建議或?qū)ΜF(xiàn)有建議的重大修改，會(huì)采用“循證推薦分級(jí)評(píng)估（GRADE）”方法進(jìn)行系統(tǒng)綜述和證據(jù)評(píng)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.

流感工作組會(huì)審查證據(jù)，并將其納入ACIP的“從證據(jù)到建議（EtR）”框架中，以指導(dǎo)擬提交ACIP表決的建議的制定。由于季節(jié)性流感疫苗接種的重申建議未涉及新的建議或重大變化，因此本次建議無(wú)需進(jìn)行GRADE或EtR評(píng)估。然而，GRADE和EtR框架曾用于制定先前的一些建議，包括：≥65歲成人流感疫苗接種（2022年6月）、有雞蛋過(guò)敏史人群（2023年6月）、以及18-64歲實(shí)體器官移植受者（2024年6月）的接種建議。

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劑的季節(jié)性流感疫苗的建議，該議題、建議及措辭均未在流感工作組中討論。

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.

流感疫苗接種建議的更新

Updates to the Influenza Vaccination Recommendations

本報(bào)告對(duì)2024-25年度建議提出了四項(xiàng)更新，其中包括三項(xiàng)FDA批準(zhǔn)的標(biāo)簽變更和一項(xiàng)在2025年6月ACIP會(huì)議討論后通過(guò)的新建議。

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，F(xiàn)DA發(fā)布了2025-26年度美國(guó)批準(zhǔn)流感疫苗的抗原組分建議。

?2024年9月，F(xiàn)DA批準(zhǔn)FluMist（LAIV3）用于自我接種（適用于18-49歲人群），或由≥18歲的照護(hù)者為2-17歲的兒童和青少年接種。預(yù)計(jì)自我接種或照護(hù)者接種的FluMist將在2025-26流感季供應(yīng)。

?2025年3月，F(xiàn)DA擴(kuò)大了Flublok（RIV3）的適用人群，將原本僅批準(zhǔn)用于≥18歲人群的適應(yīng)癥擴(kuò)展至9-17歲兒童和青少年。目前Flublok已獲批用于≥9歲人群。

?2025年6月26日，ACIP新增建議：≤18歲兒童、孕婦和所有成年人僅接種不含硫柳汞作為防腐劑的單劑量季節(jié)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.

2025–26流感季疫苗組分

Vaccine Composition for the 2025–26 Influenza Season

根據(jù)對(duì)美國(guó)及全球流感監(jiān)測(cè)數(shù)據(jù)的審查，2025–26流感季在美國(guó)供應(yīng)的所有流感疫苗均為三價(jià)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類似株（適用于雞胚疫苗）或A/Wisconsin/67/2022 (H1N1)pdm09類似株（適用于細(xì)胞培養(yǎng)和重組疫苗）；

?2）甲型流感A/Croatia/10136RV/2023 (H3N2)類似株（適用于雞胚疫苗）或A/District of Columbia/27/2023 (H3N2)類似株（適用于細(xì)胞培養(yǎng)和重組疫苗）；

?3）乙型流感B/Austria/1359417/2021（Victoria系）類似株。

?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.

與2024–25流感季疫苗相比，此次更新涉及甲型流感A(H3N2)組分。

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).

2025–26流感季疫苗接種建議

Recommendations for Influenza Vaccination for the 2025–26 Season

繼續(xù)建議所有≥6月齡、無(wú)接種禁忌的人群常規(guī)每年接種流感疫苗。以下為接種時(shí)機(jī)、疫苗選擇、接種方式及禁忌與注意事項(xiàng)的相關(guān)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.

接種時(shí)機(jī)

Timing of Vaccination

對(duì)于大多數(shù)在當(dāng)季僅需接種1劑流感疫苗的人群，理想接種時(shí)間為9月或10月。然而，只要流感病毒仍在傳播且疫苗未過(guò)期，接種應(yīng)在10月后及整個(gè)流感季持續(xù)進(jìn)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.

對(duì)于大多數(shù)人群，不推薦在7月或8月接種，因?yàn)橐呙缯T導(dǎo)的免疫可能在流感季中后期減弱，特別是老年人群。然而，如果擔(dān)心之后無(wú)法接種，7月或8月接種也可考慮。以下將進(jìn)一步說(shuō)明接種時(shí)機(jī)的考慮因素。

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.

?大多數(shù)成人（尤其是≥65歲者）及妊娠早中期女性：除非擔(dān)心之后無(wú)法接種，否則應(yīng)避免在7月和8月接種。

?需要接種2劑流感疫苗的兒童：6月齡至8歲的兒童，如在2025年7月1日前未接種過(guò)≥2劑三價(jià)或四價(jià)流感疫苗，或其接種史不明，則當(dāng)季需接種2劑流感疫苗（見(jiàn)補(bǔ)充圖表）。這些兒童應(yīng)盡早接種第一劑（若有疫苗可供，即使在7月或8月也可接種），以便至少間隔4周后接種第二劑，最好在10月底前完成。

?僅需接種1劑流感疫苗的兒童：對(duì)于當(dāng)季僅需1劑的兒童，7月和8月接種是可考慮的。雖然各年齡組均觀察到接種后免疫力隨季節(jié)減弱的現(xiàn)象，但針對(duì)兒童的研究報(bào)道較少。此外，這類兒童可能會(huì)在暑期末接受入學(xué)前的健康檢查，此時(shí)也可作為接種機(jī)會(huì)。

?妊娠晚期女性：對(duì)于妊娠第三孕期且正處于7月或8月的女性，可考慮在此期間接種。多項(xiàng)研究表明，孕期接種與嬰兒出生后頭幾個(gè)月（尚不能接種流感疫苗時(shí)）降低流感患病風(fēng)險(xiǎn)相關(guān)。對(duì)于妊娠早期或中期的女性，如無(wú)接種障礙，最好推遲至9月或10月接種。

?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.

疫苗選擇

Selection of Vaccine

與以往年度相同，2025–26流感季將有多種流感疫苗可供使用（見(jiàn)表1）。除禁忌癥和注意事項(xiàng)（見(jiàn)表2、表3）外，ACIP在疫苗選擇上提出以下建議：

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歲兒童、孕婦及所有成年人應(yīng)僅接種不含硫柳汞作為防腐劑的單劑量流感疫苗。

?所有人應(yīng)接種適合其年齡的流感疫苗（即獲批適用該年齡段的疫苗）。例外情況是：18–64歲正在接受免疫抑制治療的實(shí)體器官移植受者，可選擇三價(jià)高劑量滅活流感疫苗（HD-IIV3）或三價(jià)加佐滅活流感疫苗（aIIV3）作為可接受的方案（但不優(yōu)先于其他適齡的IIV3或三價(jià)重組流感疫苗RIV3）。

?除≥65歲成年人外，ACIP對(duì)其他年齡組在多種獲批且推薦的疫苗可選時(shí)不提出優(yōu)先推薦。對(duì)于≥65歲成年人，優(yōu)先推薦以下任一高劑量或加佐疫苗：HD-IIV3、RIV3或aIIV3。如在接種時(shí)上述三種疫苗均不可用，應(yīng)使用其他任何適齡流感疫苗。

?LAIV3不推薦用于孕婦、免疫功能低下者、特定疾病患者，或正在使用、近期使用或即將使用流感抗病毒藥物的人群（見(jiàn)表2）。此外，LAIV3不應(yīng)接種于<2歲或>49歲的人群。

?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 <2 or >49 years.

劑次數(shù)量、接種途徑及劑量體積

Number of Doses, Route of Administration, and Dose Volumes

在2025年7月1日前，若6月齡至8歲的兒童已接種過(guò)≥2劑間隔≥4周的三價(jià)或四價(jià)流感疫苗，則2025–26流感季僅需接種1劑。此前兩劑不要求在同一或連續(xù)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月齡至8歲的兒童未接種過(guò)≥2劑間隔≥4周的三價(jià)或四價(jià)流感疫苗，或其接種史不明，則本季需接種2劑，間隔≥4周（見(jiàn)補(bǔ)充圖）。對(duì)于需要2劑的8歲兒童，即使在兩劑間達(dá)到9歲，也應(yīng)完成兩劑接種。

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歲人群僅需接種1劑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（滅活疫苗和重組疫苗）采用肌肉注射。FDA批準(zhǔn)的常規(guī)劑量為所有年齡組0.5 mL，但有兩個(gè)例外（見(jiàn)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月齡兒童批準(zhǔn)劑量為0.25 mL/劑；≥3歲兒童和成人為0.5 mL/劑。Afluria的0.5 mL預(yù)充注射器不可用于<3歲兒童，且無(wú)0.25 mL預(yù)充注射器可用。由于不再推薦使用含硫柳汞防腐劑的多劑量流感疫苗，目前ACIP未推薦Afluria用于6–35月齡兒童。

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 <3 years, and 0.25-mL prefilled syringes are not available. Because use of multidose seasonal influenza vaccine formulations containing thimerosal as a preservative is no longer recommended, there is currently no ACIP-recommended formulation of Afluria for children aged 6 through 35 months.

Fluzone (IIV3)：6–35月齡兒童每劑可用0.25 mL或0.5 mL；≥3歲兒童和成人為0.5 mL/劑。雖然無(wú)0.25 mL預(yù)充注射器，但0.5 mL預(yù)充注射器可用于所有≥6月齡人群。不再推薦使用含硫柳汞防腐劑的多劑量流感疫苗。

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.

禁忌與注意事項(xiàng)

Contraindications and Precautions

每種流感疫苗均明確標(biāo)注：對(duì)該疫苗任何成分有嚴(yán)重過(guò)敏反應(yīng)（如過(guò)敏性休克）病史者為禁忌接種人群（見(jiàn)表2、表3）。疫苗成分詳見(jiàn)產(chǎn)品說(shuō)明書(shū)。對(duì)雞蛋嚴(yán)重過(guò)敏（如過(guò)敏性休克）病史是含雞蛋蛋白殘留的雞胚基IIV3和LAIV3的標(biāo)注禁忌癥。然而，ACIP建議所有≥6月齡的雞蛋過(guò)敏者均應(yīng)接種流感疫苗，且可使用任何適合其年齡和健康狀況的流感疫苗（無(wú)論是否基于雞胚制備）。該建議基于20項(xiàng)研究的證據(jù)（其中16項(xiàng)為IIV研究，1項(xiàng)為病毒體疫苗研究，3項(xiàng)為L(zhǎng)AIV研究），這些研究考察了雞蛋過(guò)敏者在接種流感疫苗（單劑量或分次接種方案）后的反應(yīng)，其中13項(xiàng)包括有嚴(yán)重過(guò)敏或過(guò)敏性休克病史者。結(jié)果未見(jiàn)過(guò)敏性休克發(fā)生（GRADE證據(jù)確定性：極低）。因此，僅有雞蛋過(guò)敏并不需要除常規(guī)接種安全措施以外的額外措施，無(wú)論既往對(duì)雞蛋過(guò)敏反應(yīng)的嚴(yán)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.

對(duì)于既往對(duì)某種特定流感疫苗發(fā)生嚴(yán)重過(guò)敏反應(yīng)（如過(guò)敏性休克）的人群，禁止再次接種該疫苗。說(shuō)明書(shū)中明確：所有基于雞胚制備的IIV3和LAIV3均禁用于既往對(duì)任何流感疫苗發(fā)生嚴(yán)重過(guò)敏反應(yīng)的人群。是否可考慮使用非雞胚基流感疫苗取決于此前嚴(yán)重過(guò)敏反應(yīng)與哪種疫苗類型相關(guān)（見(jiàn)表2、表3）。接種醫(yī)生也可考慮轉(zhuǎn)診過(guò)敏專科，以幫助識(shí)別致敏成分。所有接種場(chǎng)所應(yīng)具備識(shí)別和處理急性過(guò)敏反應(yīng)的條件。

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（無(wú)論是否伴發(fā)熱）是接種的一般注意事項(xiàng)。既往在接種流感疫苗后6周內(nèi)發(fā)生格林–巴利綜合征者，被視為接種所有流感疫苗的注意事項(xiàng)（見(jiàn)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).

除說(shuō)明書(shū)列出的LAIV3禁忌癥外，ACIP還將若干其他情況視為L(zhǎng)AIV3接種的禁忌或注意事項(xiàng)（見(jiàn)表2）。此外，LAIV3未獲批準(zhǔn)用于<2歲或>49歲人群，不應(yīng)在這些人群中接種。

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 <2 or >49 years.

近期流感疫苗標(biāo)簽變更

Recent Influenza Vaccine Labeling Changes

FluMist (LAIV3)：2024年9月，F(xiàn)DA批準(zhǔn)鼻噴減毒活流感疫苗FluMist（LAIV3）可用于自我接種（18–49歲人群）或由≥18歲的照護(hù)者為2–17歲的兒童及青少年接種。預(yù)計(jì)自2025–26流感季起，F(xiàn)luMist將通過(guò)“FluMist Home”項(xiàng)目提供自我或照護(hù)者接種服務(wù)，消費(fèi)者需提交相關(guān)信息以確認(rèn)訂購(gòu)資格。符合條件者訂購(gòu)的疫苗將以冷鏈運(yùn)輸方式配送至訂單地址。ACIP對(duì)FluMist自我或照護(hù)者接種的建議、禁忌及注意事項(xiàng)與醫(yī)療機(jī)構(gòu)接種相同（見(jiàn)表2、表3）。FluMist仍將可由醫(yī)療機(jī)構(gòu)訂購(gòu)與接種。

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，F(xiàn)DA將Flublok（RIV3）的適用人群從原先的≥18歲擴(kuò)展至9–17歲兒童和青少年。目前Flublok的批準(zhǔn)年齡范圍為≥9歲。該批準(zhǔn)基于一項(xiàng)非隨機(jī)、開(kāi)放標(biāo)簽研究，比較了Flublok四價(jià)疫苗（RIV4）在9–17歲人群與18–49歲成人中的免疫原性和安全性。結(jié)果顯示，RIV4在免疫原性上達(dá)到非劣效標(biāo)準(zhǔn)（所有4種組分在接種后第29天，兩組幾何平均滴度比值雙側(cè)95%置信區(qū)間下限>0.667，血清轉(zhuǎn)換率差異的雙側(cè)95%置信區(qū)間下限>–10%）。在9–17歲兒童和青少年中，最常見(jiàn)的不良反應(yīng)（≥10%受試者出現(xiàn)）為：注射部位疼痛（34.4%）、肌痛（19.3%）、頭痛（18.5%）、乏力（16.1%）。Flublok未獲批、亦不推薦用于<9歲兒童。

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 <9 years.

利益關(guān)系披露與超說(shuō)明書(shū)使用

Disclosure of Relationship and Unlabeled Use All authors have completed and submitted the International

所有作者均已完成并提交《國(guó)際醫(yī)學(xué)期刊編輯委員會(huì)》潛在利益沖突披露表。未披露任何潛在利益沖突。

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

本報(bào)告包含關(guān)于以下人群流感疫苗超說(shuō)明書(shū)使用的討論：有雞蛋過(guò)敏史者，以及18–64歲實(shí)體器官移植受者。

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.

雞蛋過(guò)敏者：對(duì)于大多數(shù)三價(jià)滅活流感疫苗（IIV3）和三價(jià)減毒活流感疫苗（LAIV3），若既往對(duì)疫苗或其任何成分（某些疫苗含雞蛋成分）發(fā)生嚴(yán)重過(guò)敏反應(yīng)（如過(guò)敏性休克），則屬標(biāo)注禁忌癥。然而，ACIP建議所有≥6月齡的雞蛋過(guò)敏者均應(yīng)接種流感疫苗。任何適合其年齡與健康狀況的流感疫苗（無(wú)論是否基于雞胚制備）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.

實(shí)體器官移植受者（18–64歲）：三價(jià)高劑量滅活流感疫苗（HD-IIV3）和三價(jià)加佐滅活流感疫苗（aIIV3）目前僅批準(zhǔn)用于≥65歲人群。然而，ACIP建議正在接受免疫抑制治療的18–64歲實(shí)體器官移植受者可選擇接種HD-IIV3或aIIV3，作為可接受的選項(xiàng)，對(duì)比其他適齡IIV3或三價(jià)重組流感疫苗（RIV3）并無(wú)優(yōu)先推薦。

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).