2025年8月22日美國食品藥品監(jiān)督管理局（FDA）宣布暫停 Valneva 公司基孔肯雅熱疫苗 Ixchiq 的上市許可，理由是 “嚴(yán)重安全隱患”，聲明中指出，Ixchiq疫苗 “似乎導(dǎo)致已接種的患者出現(xiàn)類似基孔肯雅熱癥狀”。聲明顯示，截至目前，監(jiān)管機(jī)構(gòu)已記錄到20多起接種者出現(xiàn)與類基孔肯雅熱癥狀相符的嚴(yán)重副作用報(bào)告。在這些案例中，有21人需住院治療，3人死亡，其中1例死于腦炎，且已證實(shí)與該疫苗有關(guān)聯(lián)。

此次叫停距離 FDA 本月初解除該疫苗對 60 歲以上人群的使用限制僅過去兩周，也讓這款 2023 年 11 月全球首個(gè)獲批的基孔肯雅熱疫苗正式退出美國市場。根據(jù)Valneva公司上周五發(fā)布的消息，該暫停決定“立即生效，要求Valneva停止在美國銷售和運(yùn)輸”Ixchiq疫苗。FDA的這一行動(dòng)為Valneva公司及其Ixchiq疫苗長達(dá)數(shù)月的困境畫上了階段性句號。

今年5月，F(xiàn)DA和CDC曾建議暫停在60歲及以上人群使用該疫苗，原因是“出現(xiàn)了包括神經(jīng)系統(tǒng)和心臟事件在內(nèi)的嚴(yán)重不良事件報(bào)告”。當(dāng)時(shí)，這兩個(gè)機(jī)構(gòu)已發(fā)現(xiàn)該年齡組有17例嚴(yán)重并發(fā)癥，其中兩例導(dǎo)致死亡。隨后在本月早些時(shí)候，F(xiàn)DA解除了這一暫停令，但建議針對老年患者群體，為該疫苗貼上更嚴(yán)格的標(biāo)簽。FDA要求Valneva公司修改Ixchiq疫苗的處方信息，明確該疫苗僅適用于“高暴露風(fēng)險(xiǎn)”人群，以預(yù)防基孔肯雅熱病毒感染。而該疫苗標(biāo)簽原先的表述為，Ixchiq適用于感染“風(fēng)險(xiǎn)增加”的人群。

此外，F(xiàn)DA還要求Valneva公司在疫苗相關(guān)說明中加入警示內(nèi)容，以反映Ixchiq疫苗上市后監(jiān)測到的這些情況，其中包括“與基孔肯雅熱嚴(yán)重并發(fā)癥相符的不良反應(yīng)，這些不良反應(yīng)已導(dǎo)致患者住院，其中1例死亡病例與腦炎相關(guān)”。

如今，該疫苗已被全面撤出市場。FDA在周五的最新公告中表示，“在大多數(shù)合理情況下，對該疫苗的獲益-風(fēng)險(xiǎn)分析總體顯示，其獲益并不大于風(fēng)險(xiǎn)”，若繼續(xù)為患者接種，“將對健康構(gòu)成威脅”。

資料顯示，Ixchiq是一種減毒活疫苗，于2023年11月成為首個(gè)獲得FDA批準(zhǔn)的基孔肯雅熱疫苗。該批準(zhǔn)是通過FDA的加速通道獲得的，這要求Valneva在確認(rèn)試驗(yàn)中驗(yàn)證該疫苗的臨床益處。在上周五的公告中，F(xiàn)DA提到了Ixchiq批準(zhǔn)的加速性質(zhì)，指出“該疫苗的臨床益處尚未在確認(rèn)性臨床研究中得到驗(yàn)證”。

▉ 從“首款獲批”到“使用受限”

Ixchiq?是一種減毒活疫苗，于2023年11月獲得FDA的加速批準(zhǔn)，成為美國首個(gè)且唯一獲批的基孔肯雅熱疫苗，用于18歲及以上暴露風(fēng)險(xiǎn)增加的個(gè)體。2024年6月，該疫苗獲得歐盟委員會(huì)的上市許可，用于12歲及以上人群。

基孔肯雅熱 (Chikungunya) 是一種由埃及伊蚊或白紋伊蚊傳播的病毒性疾病，可導(dǎo)致發(fā)熱、嚴(yán)重關(guān)節(jié)痛等，對老年人和免疫力低下者威脅尤甚。Ixchiq?的獲批曾被視為公共衛(wèi)生領(lǐng)域的一大進(jìn)展。然而，此次不良事件報(bào)告無疑為這款“明星疫苗”的前景蒙上了陰影。老年人群體往往伴有多種基礎(chǔ)疾病，免疫系統(tǒng)反應(yīng)也與年輕人不同，這使得疫苗在他們身上的安全性評估更為復(fù)雜和嚴(yán)峻。盡管FDA強(qiáng)調(diào)VAERS報(bào)告的不良事件與疫苗接種的因果關(guān)系尚待確認(rèn)，但監(jiān)管機(jī)構(gòu)的審慎態(tài)度已清晰可見。

面對突如其來的監(jiān)管調(diào)整，Valneva公司迅速做出反應(yīng)，表示正與全球衛(wèi)生當(dāng)局緊密合作，全面審查相關(guān)安全性數(shù)據(jù)，并將在疫苗所有已上市地區(qū)啟動(dòng)對安全性報(bào)告的正式評估。公司強(qiáng)調(diào)將致力于確保疫苗的安全性與有效性。

▉ 8月22日美國FDA報(bào)道

FDA Update on the Safety of Ixchiq (Chikungunya Vaccine, Live). FDA Suspends Biologics License: FDA Safety Communication

AUDIENCE: Patient, Health Care Professional, Pharmacy, Cardiology, Neurology, Internal Medicine, Family Practice, Travel Clinics

UPDATE:On August 22, 2025, the US FDA’s Center for Biologics Evaluation and Research (CBER) has suspended the biologics license for Valneva Austria GmbH’s Ixchiq (Chikungunya Vaccine, Live). This vaccine was initially approved by FDA under the accelerated approval pathway in November of 2023 for the prevention of disease caused by the chikungunya virus (CHIKV) in individuals 18 years of age and older who are at increased risk of exposure to CHIKV. CBER’s decision is based on serious safety concerns related to the vaccine, which appears to be causing chikungunya-like illness in vaccine recipients. There has been one death from encephalitis directly attributable to the vaccine (CSF PCR was + for the vaccine strain of the virus) and over 20 reported serious adverse events that were consistent with chikungunya-like illness. Reported serious adverse events have included 21 hospitalizations and 3 deaths. Furthermore, the clinical benefit of the vaccine has not yet been verified in confirmatory clinical studies. CBER’s benefit-risk analysis broadly shows the vaccine does not have benefits outweighing risks, under most plausible scenarios. For these reasons, CBER believes this vaccine is not safe and that continued administration to the public would pose a danger to health.

On August 6, 2025, FDA lifted a pause in the use of Ixchiq in individuals 60 years of age and older and approved required updated labeling for Ixchiq, including revising the indication, and adding limitations of use and enhanced warnings and precautions to reflect serious postmarketing adverse reactions including hospitalizations and encephalitis in a person who died, with risk noted for individuals 65 years and older with chronic medical conditions.

On May 9, 2025, FDA issued a safety communication informing the public that the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) jointly recommended a pause in the use of Ixchiq (Chikungunya Vaccine, Live) in individuals 60 years of age and older while the Agencies undertook an investigation of postmarketing reports of serious adverse events, including neurologic and cardiac events, in individuals who have received the vaccine.

The November 9, 2023, approval of Ixchiq included a warning in the Prescribing Information informing that the vaccine may cause severe or prolonged chikungunya-like adverse reactions. Ixchiq contains a live, weakened version of the chikungunya virus and may cause symptoms in the vaccine recipient similar to those experienced by people who have chikungunya.

BACKGROUND:Ixchiq contains a live, weakened version of the chikungunya virus and may cause symptoms similar to those of chikungunya disease. Some of the postmarketing reports include adverse events that are consistent with severe complications of chikungunya disease, resulting in hospitalization; one person died from encephalitis.

Continuous monitoring and assessment of the safety of all vaccines remains an FDA priority. Suspected adverse events may be reported to the Vaccine Adverse Event Reporting System (VAERS), which is co-managed by FDA and CDC.

病毒學(xué)界一直在關(guān)注并報(bào)道基孔肯雅病毒的相關(guān)研究進(jìn)展

聲明：

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百度搜索及網(wǎng)絡(luò)自媒體，僅對新聞來源負(fù)責(zé)。而對疫苗真實(shí)效果屬于技術(shù)層面，基于科學(xué)負(fù)責(zé)態(tài)度病毒學(xué)界暫不予以評價(jià)，期待更多專業(yè)解讀后再行報(bào)道。