Key Takeaways Reports suggest COVID-19 vaccines may be linked to 25 child deaths, pressuring major drugmakers.Moderna and BioNTech slid over 7% each, while Pfizer and Novavax fell nearly 4%.CDC advisory panel will review vaccine safety, use and coverage of vaccines on Sept. 18-19.Shares of prominent COVID-19 vaccine makers Moderna (MRNA), BioNTech (BNTX), Pfizer (PFE), and Novavax (NVAX) fell on Friday following reports that the Trump administration is preparing to link COVID-19 vaccines to the deaths of 25 ...

LOGIN SUBSCRIBE | FastCo Works advertisement BYÂ Anna-Louise Jackson Listen to this ArticleMore info 0:00 / 0:00 Pharma stocks took a fresh hit on Friday following a report in The Washington Post that the U.S. Food and Drug Administration reportedly plans to link COVID-19 vaccines with the deaths of 25 minors. Moderna shares fell 7.4% Friday to their lowest level since March 2020. The drop brought the drugmaker's year-to-date slump to more than 44%. The Cambridge, Massachusetts-based company is one of two m ...

The type of vaccine it's most famous for might be cast in a very unflattering light in the very near future..A star stock during the pandemic era wasn't shining so brightly on Friday. On a media report that the current presidential administration is preparing to link a set of fatalities to Covid vaccines, BioNTech's (BNTX -7.35%) share price declined by 7% across that day's trading session. The biotech company's decline was particularly notable given the essentially flat-line performance of the S&P 500 inde ...

Shares in Pfizer and Moderna fell 3.9% and 7.4%, respectively, Friday after a report that the Trump administration plans to link the deaths of 25 children to COVID vaccines.Trump health officials plan to include the claim in a presentation next week to a panel of advisors to the CDC that is considering new COVID vaccine recommendations, which can impact access to the shots and whether they’re free, according to the Washington Post.Those deaths were seemingly gathered from information submitted to the govern ...

Vials with Pfizer-BioNTech and Moderna coronavirus disease (COVID-19) vaccine labels are seen in this illustration picture taken March 19, 2021.Shares of Pfizer and Moderna fell on Friday after a report that Trump administration health officials plan to link Covid vaccines to the deaths of 25 children. The report from the Washington Post said officials plan to include the claim in a presentation next week to a key vaccine panel that advises the Centers for Disease Control and Prevention. That committee play ...

We do have a news alert today on COVID vaccines and for that we'll turn back to Angelica Peebles. Hi Angelica. Hey Carl.Well the Washington Post is reporting that Trump health officials plan to link coronavirus vaccines to the deaths of 25 children and that is that comes as next week this um the CDC advisers on vaccines will weigh how those co vaccines should be used going forward. This has obviously been a very contentious issue and the Washington Post is citing people familiar with this. We of course have ...

监管行动 - 美国FDA立即暂停IXCHIQ®许可证 要求公司停止在美国发货和销售该疫苗[1] - 暂停决定基于VAERS系统更新的4例新增严重不良事件报告 其中3例发生在70至82岁个体 1例发生在55岁个体[2] - FDA曾在8月6日解除对60岁及以上人群使用IXCHIQ®的建议暂停 本次突然转向基于境外发生的SAEs报告[2] 产品安全与公司立场 - 公司认为所有病例症状与临床试验及上市后经验一致 产品说明书已包含对老年人群的警告和预防措施[2] - 公司承诺维持最高安全标准 将继续与全球卫生机构积极沟通[3] - 首席执行官强调将继续为所有许可国家提供疫苗 重点保障中低收入流行国家的疫苗可及性[4] 财务影响与业务表现 - IXCHIQ®在2025年上半年贡献750万欧元收入 占公司9100万欧元总产品销售额的8.2%[4] - 部分销售额源于为应对留尼汪岛基孔肯雅热疫情的一次性疫苗交付[4] - 公司正在评估美国许可证永久撤销的潜在财务影响 但暂未修改收入指引[4] 疾病背景与市场机会 - 基孔肯雅病毒通过蚊媒传播 导致发热、严重关节痛和肌肉疼痛等症状 关节疼痛可能持续数周至数年[5] - 自2004年以来病毒已在110多个国家传播 2013-2023年美洲报告超过370万病例[6] - 世界卫生组织认定该疾病为重大公共卫生问题 预计随着气候变暖蚊媒地理扩散 医疗经济负担将加重[6] 公司战略与产品管线 - 公司专注于开发应对未满足医疗需求的传染病预防疫苗 采用首创、最佳或独家疫苗解决方案[7] - 现有三款自有旅行疫苗上市 商业收入用于支持研发管线推进[8][9] - 管线包含与辉瑞合作的莱姆病候选疫苗（最临床先进的四价志贺氏菌疫苗）以及寨卡病毒等公共卫生威胁疫苗[9]

文章核心观点 美国FDA和CDC建议暂停在老年人中使用Valneva公司的单剂量减毒活疫苗IXCHIQ，公司承诺配合调查并持续监测严重不良事件，同时多机构仍推荐该疫苗在特定年龄段使用 [1][4][5] 分组1：疫苗使用建议调整 - 美国FDA和CDC建议暂停在老年人中使用IXCHIQ，直至对严重不良事件的调查完成 [1] - 此前美国ACIP建议对65岁及以上人群使用IXCHIQ采取预防措施，欧洲EMA也暂停65岁以上人群使用该疫苗 [1] 分组2：公司应对措施 - 公司承诺维护最高安全标准，与各地区卫生当局积极合作，提供已知严重不良事件信息 [2] - 公司与卫生当局合作，预计对IXCHIQ获批地区的上市后安全报告进行正式审查，并会在评估结束后提供最新情况 [3] - 公司首席医学官支持预防措施，承诺继续监测严重不良事件，尤其关注留尼汪岛的疫苗接种活动 [4] 分组3：疫苗适用人群 - 公司认为该疫苗在大多数有潜在感染风险的人群中仍有积极的风险收益比 [5] - FDA和CDC推荐18至60岁人群使用IXCHIQ，EMA推荐12至64岁人群使用，法国HAS在留尼汪岛为18至64岁人群接种该疫苗以应对疫情 [5] 分组4：疾病介绍 - 基孔肯雅病毒通过受感染的伊蚊叮咬传播，会导致发热、关节和肌肉疼痛等症状，关节疼痛可能持续数周甚至数年 [6] - 2004年该疾病开始快速传播，在全球多地引发大规模疫情，2013至2023年美洲报告超370万例，世卫组织将其列为重大公共卫生问题 [7] 分组5：公司介绍 - 公司是一家专业疫苗公司，开发、生产和商业化预防性疫苗，专注于满足未满足的医疗需求 [8] - 公司有多款疫苗从早期研发推进到获批，目前正在销售三款自有旅行疫苗 [9] - 公司商业业务收入推动疫苗管线发展，包括与辉瑞合作的莱姆病疫苗候选药物、志贺氏菌疫苗候选药物等 [10]