Respiratory Syncytial Virus Vaccine(Moderna)

RFK Jr.s attacks on vaccines go beyond changing the childhood immunization schedule. Now hes taking aim at vaccine R&D itself. During the postwar decades, American medical science reached a sort of financial equilibrium: The government would fund basic scientific research with billions of dollars in academic grants, then entrust the subsequent development of health-giving products to private enterprise. The arrangement hasnt always worked in the publics interest some companies have marketed drugs developed from government-funded research at ridiculously high prices. And the government has never exercised its march-in rights to force drugmakers to make those products widely and publicly available on reasonable terms, potentially including accessible pricing. Still, as Ive reported , a 2020 study found that funding from the National Institutes of Health played a role in research associated with every new drug approved by the Food and Drug Administration from 2010 to 2019. The funding produced 22,000 patents. — RFK Jr. appointee Kirk Milhoan proposes making the public into guinea pigs by questioning the measles vaccine So theres no question that as a boon for public health, the arrangement has stood the test of time. Until now. Under its secretary, the anti-vaccine activist Robert F. Kennedy Jr., the Department of Health and Human Services has taken aim at publicly funded R&D and thrown the regulation of new drug development into chaos. Most recently, on Feb. 3 the FDA issued a so-called Refuse-to-File letter to the biotech company Moderna over a flu vaccine the company developed using its mRNA technology, which was the core of its COVID-19 vaccine and is at the center of Modernas pipeline of developmental vaccines against cancer, HIV, Lyme disease, respiratory syncytial virus (RSV) and many other conditions. The letter, which was signed by Vinay Prasad, the vaccine critic who is now director of the FDAs Center for Biologics Evaluation and Research, was more than merely a rejection of Modernas clinical testing of the vaccine; it was a refusal even to examine Modernas data, which the company says was derived from tests on nearly 44,000 subjects. The FDA rejected Modernas application because the company refused to follow very clear FDA guidance from 2024 on how the clinical trial should proceed, HHS spokesman Andrew Nixon told me by email. The agency didnt respond to my request for comment on Kennedys policies during his year in office. The company disputed that. It says it consulted with the FDA in designing its clinical trial and received the agencys approval for its protocol, in writing. The agency did not raise any objections ... at any time before the initiation of the study in September 2024, Moderna said in a news release after the rejection. The FDA reversed itself Wednesday, bowing to an appeal by the company, Moderna announced, saying the FDA will now review its application to license the flu shot . But the reversal only underscored the chaotic decision-making at the agency. Healthcare professionals say that the FDAs original efusal was way out of line and a shocking departure from the standard for refuse-to-file decisions. According to a 2021 study of RTF letters published in the Journal of the American Medical Assn., only about 4% of all drug applications resulted in such a letter. In most cases, the problem was that the submitted data were incomplete and in about 26% the problem was that the applicant didnt follow FDA advice, including advice about the design of their clinical trials. According to Moderna, that wasnt the case with its flu vaccine. Normally, recipients of RTF letters keep them secret, generally out of embarrassment at being called out by the FDA for incomplete or suspect data; that Moderna made this one public suggests that it feels the problem lies elsewhere. The Moderna letter came just before Kennedys one-year anniversary as Health secretary. By almost any measure, his tenure has been disastrous for public health. Kennedy gets praise in some quarters for his campaign against food preservatives, but on balance his prescriptions have been far more negative than positive for the public interest. Measles, which was declared eliminated in the U.S. in 2020, meaning that there was no longer a threat of consistent spread over a yearlong period, is again spreading: The Centers for Disease Control and Prevention report 910 cases this year in the U.S., a trend almost certain to outstrip the 2,280 cases reported last year. The 2025 figure was the largest measles outbreak in the U.S. since 1992. The reason isnt hard to fathom. Its the result of doubts about the safety and efficacy of vaccines generally, and of the MMR vaccine (for measles, mumps and rubella) particularly, fostered by Kennedy and his minions. Although Kennedy has stated that parents should have their children vaccinated against measles, his endorsement has been lukewarm and often accompanied by advice about alternatives to vaccination or treatment . As it happens, the vaccination rate for U.S. kindergartners has dropped below the 95% level that marks herd immunity, in which immunization is so widespread that even a highly contagious disease like measles cant gain a foothold in an unvaccinated population. In the 2024-2025 school year, the CDC reported, the overall rate fell to 92.5% , leaving approximately 286,000 kindergartners at risk during the year. In South Carolina, where the most severe outbreak is raging (616 cases so far), the vaccination rate for measles has fallen to 91.2%. Kennedy has removed six vaccines from the recommended 17-vaccine childhood immunization schedule making vaccines for rotavirus, COVID-19, flu, meningococcal disease and hepatitis A and B and hepatitis B subject to shared clinical decision-making between parents and physicians, opening the door to lower vaccination rates for those conditions. Kennedy has stocked key public health advisory committees with anti-vax crusaders. He fired all 17 members of the CDCs Advisory Committee on Immunization Practices (ACIP), most of whom were experts in immunization, epidemiology, public health and related disciplines, and replacing them in part with anti-vaccine activists and skeptics. Alarmingly, the newly appointed ACIP chairman, Kirk Milhoan, a pediatric cardiologist, raised questions during a Jan. 22 podcast about whether we even need polio and measles vaccines today, given what he called superior treatment opportunities for sick children now than in the 1950s and 1960s, when those vaccines were introduced, such as better sanitation, and pediatric hospitals and ICUs. We take care of children much differently now, he said. What were going to have, Milhoan said, is a real-world experience of when unvaccinated people get measles, what is the new incidence of hospitalization? Whats the incidence of death? He labeled vaccine mandates as a heavy-handed authoritarian approach. He advocated placing not public health but individual autonomy in the forefront of peoples decisions about whether to get vaccinated. But that turns the fundamental concept of public health on its head, because individual decision-making can place a whole community, and others such as unvaccinated infants, at risk. That brings us back to the Moderna case. The mRNA technology has been hailed as a breakthrough, in part because it allows new formulations to be developed quickly in response to newly emergent variants of viruses or other pathogens as has happened with COVID and flu. In August, Kennedy terminated $500 million in government contracts for mRNA research, asserting that the data show these vaccines fail to protect effectively against upper respiratory infections like COVID and flu. When it comes to COVID, exactly the opposite is true. The vaccines that we had available in this country against COVID were mRNA vaccines, vaccines that have saved millions of lives in the U.S. alone over the last few years, and many more worldwide, Harvard epidemniologist Bill Hanage said after the cutbacks. Now suddenly were hit with a roadblock to further study them, to further develop them, and so the promise of these vaccines is suddenly being strangled almost at birth in this country. What really disturbs professionals is the FDAs injection of inconsistency into its reviews of drug applications. In drug development, lack of regulatory clarity and consistency can be more damaging than regulation itself , observes Ruxandra Teslo, a genomics expert who studies clinical trial practices. Clear rules, even when stringent, can be understood and navigated. But unclear or constantly shifting expectations can be much harder to efficiently deal with. Moderna makes the same point: The industry depends on clear, transparent rules that are applied consistently in order to make the long-term investments that benefit Americans, its spokesman Christopher Ridley told me by email. According to Moderna, the FDAs review of its flu application turned out to be anything but clear and transparent. The company consulted with FDA officials before launching the trial of its mRNA flu shot in 2024, proposing that half its 40,000 subjects receive the new shot and half an existing flu vaccine. The FDA proposed that it test its shot against a different shot, which has a higher dose for the over-65 population. Moderna resisted, but agreed to provide test subjects with enhanced disclosures on its informed consent form, to which the FDA assented. The company says the FDA did not raise any objections to the companys plans after the submission of the protocol in April 2024 or at any time before the initiation of the study in September 2024. Ultimately, it says, it did submit data showing that its mRNA shot outperformed a high-dose vaccine. As a result, Moderna says it was blindsided by the Prasad letter refusing to even consider Modernas data. The FDAs reversal came after the company agreed to study the flu shots effect on older adults. So where are we now? During his Senate confirmation hearing last year, Kennedy promised radical transparency for the American people in the actions and policies of the Department of Health and Human Resources. In the Moderna case and many others, the agencys actions have been as transparent as mud. And the public is left confused and ever less healthy. The following AI-generated content is powered by Perplexity. The Los Angeles Times editorial staff does not create or edit the content. The Department of Health and Human Services under Kennedy has undermined publicly funded research and development by terminating $500 million in government contracts for mRNA vaccine research, claiming the data show these vaccines fail to protect effectively against upper respiratory infections [1] , despite contrary evidence showing mRNA vaccines have saved millions of lives in the U.S. and worldwide. Kennedy has created regulatory chaos through inconsistent FDA guidance, exemplified by the agencys rejection of Modernas flu vaccine application without examining the companys clinical data from nearly 44,000 subjects, a departure from standard practice where only about 4% of drug applications result in such refusals [1] . The removal of vaccines from the recommended childhood immunization schedule and replacement of all 17 members of the CDCs Advisory Committee on Immunization Practices with anti-vaccine activists has directly contributed to declining vaccination rates and a resurgence of measles, with the 2025 outbreak marking the largest in the U.S. since 1992 [1] . Kennedy has stocked key public health advisory committees with individuals who question the necessity of foundational vaccines like polio and measles, advocating for individual autonomy over public health considerations, which fundamentally undermines community protection and places vulnerable populations at risk [1] . Despite promising radical transparency during Senate confirmation hearings, Kennedys actions have lacked transparency, leaving the public confused about vaccine policies and regulatory standards [1] . Kennedy has stated that he believes vaccines have a critical role in healthcare and that his focus is on ensuring scientific safety studies and efficacies are available so people can make informed individual assessments, arguing he is pro-safety rather than anti-vaccine [2] . Supporters of vaccine policy review argue that reassessing vaccine ingredients, schedules, and safety monitoring represents appropriate scientific scrutiny rather than obstruction, with Kennedys team arguing that examining evidence on issues like thimerosal in vaccines reflects legitimate safety concerns [1] . Some contend that prioritizing individual clinical decision-making between parents and physicians over mandates represents a shift toward personal autonomy in medical choices, with the newly appointed committee chairman arguing that modern medical capabilities and improved sanitation reduce the necessity of certain vaccines that were critical in earlier decades [1] . 小罗伯特·肯尼迪对疫苗的抨击已不仅限于改变儿童免疫接种计划，如今他将矛头直接指向了疫苗研发本身。 战后数十年间，美国医学界达成了一种资金平衡模式：政府通过数十亿美元的学术拨款资助基础科学研究，随后将保健产品的后续开发交由私营企业负责。 这一安排并非总是符合公众利益——某些企业将政府资助研发的药物以高得离谱的价格推向市场。而政府从未行使"介入权"强制制药商以"合理"条款（其中可能包括可负担的定价）广泛公开供应这些产品。 尽管如此，正如我所报道的，2020年的一项研究发现，美国国立卫生研究院的资助在2010年至2019年间与美国食品药品监督管理局批准的每一种新药相关的研究中都发挥了作用。这些资助共产生了22,000项专利。 ——小罗伯特·肯尼迪任命的柯克·米尔霍恩质疑麻疹疫苗，提议将公众当作实验对象 毫无疑问，这一安排作为公共卫生领域的福音，经受住了时间的考验。 直到现在。 在反疫苗活动人士小罗伯特·F·肯尼迪（Robert F. Kennedy Jr.）担任部长期间，美国卫生与公众服务部将矛头指向公共资助的研发项目，并使新药开发的监管陷入混乱。 最近，美国食品药品监督管理局（FDA）于2月3日向生物技术公司莫德纳（Moderna）发出所谓的"拒绝受理"信函，涉及该公司利用其mRNA技术研发的一款流感疫苗。该技术曾是莫德纳新冠疫苗的核心，如今也是其研发管线中的关键——包括针对癌症、艾滋病、莱姆病、呼吸道合胞病毒（RSV）及多种其他疾病的在研疫苗。 这封信由现任美国食品药品监督管理局（FDA）生物制品评价与研究中心主任、疫苗批评者维奈·普拉萨德（Vinay Prasad）签署，其内容不仅是对莫德纳公司疫苗临床试验的否决，更是拒绝审查该公司宣称基于近4.4万名受试者测试得出的数据。 美国卫生与公众服务部发言人安德鲁·尼克松通过邮件向我透露，FDA之所以拒绝Moderna的申请，是因为该公司拒绝遵循2024年FDA关于临床试验应如何进行的明确指导。该机构未就肯尼迪在任一年期间的政策回应我的置评请求。 该公司对此提出异议。莫德纳表示，在设计临床试验时曾与美国食品药品监督管理局（FDA）进行磋商，并以书面形式获得了该机构对其试验方案的批准。莫德纳在遭拒后发布的新闻稿中称：“在2024年9月研究启动前的任何时间点，FDA均未提出任何异议。” 莫德纳公司周三宣布，美国食品药品监督管理局（FDA）已改变立场，应公司上诉要求，FDA将重新审查其流感疫苗的上市申请。但这一反转恰恰凸显了该机构决策过程的混乱。 医疗专业人士指出，美国食品药品监督管理局（FDA）最初的拒绝决定严重偏离常规，其驳回申请的标准令人震惊。根据《美国医学会杂志》2021年对拒绝受理函（RTF）的研究显示，在所有药物申请中，仅有约4%会收到此类信函。 在大多数情况下，问题在于提交的数据不完整；约26%的案例中，问题在于申请人未遵循美国食品药品监督管理局（FDA）的建议，包括关于临床试验设计的建议。但莫德纳公司表示，其流感疫苗不存在此类问题。 通常情况下，收到FDA（美国食品药品监督管理局）RTF（拒绝提交）信函的企业会对此保密，主要是因数据不完整或可疑被点名而感到尴尬；而莫德纳公司此次选择公开信函内容，暗示其认为问题根源并不在自身。 这封来自Moderna的信件恰好在肯尼迪就任卫生部长一周年之际到来。无论从何种标准衡量，他的任期对公共卫生来说都是一场灾难。尽管肯尼迪因反对食品防腐剂的运动而获得某些群体的赞誉，但总体而言，他的政策方案对公众利益的负面影响远大于正面作用。 麻疹于2020年在美国被宣布消灭，意味着这种疾病已不再具有持续传播一年以上的威胁，但如今再度出现蔓延趋势。美国疾病控制与预防中心报告称，今年全美已出现910例病例，这一数字几乎肯定会超过去年报告的2280例。 2025年的数据显示，这是美国自1992年以来最大规模的麻疹疫情爆发。究其原因并不难理解——这主要源于肯尼迪及其追随者长期散布的对疫苗（尤其是麻疹、腮腺炎和风疹三联疫苗MMR）安全性与有效性的质疑。尽管肯尼迪曾表态支持家长为孩子接种麻疹疫苗，但其态度始终模棱两可，且总在建议中夹杂着疫苗接种替代方案或替代疗法的内容。 当前，美国幼儿园儿童的疫苗接种率已跌破95%的群体免疫标准线——该标准意味着免疫覆盖率足够广泛，即使如麻疹这类高传染性疾病也难以在未接种人群中传播。美国疾病控制与预防中心（CDC）报告显示，2024-2025学年整体接种率降至92.5%，导致该学年约28.6万名幼儿园儿童面临感染风险。在南卡罗来纳州（目前爆发最严重，累计616例病例），麻疹疫苗接种率已下滑至91.2%。 肯尼迪已将6种疫苗从推荐的17种儿童免疫接种计划中移除，包括轮状病毒、新冠病毒、流感、脑膜炎球菌病以及甲型和乙型肝炎疫苗。这些疫苗的接种现在需由家长和医生共同商议决定（即“共享临床决策”），此举可能导致这些疾病的疫苗接种率下降。 肯尼迪（Kennedy）在关键的公共卫生咨询委员会中安插了反疫苗运动人士。他解雇了美国疾病控制与预防中心（CDC）免疫实践咨询委员会（ACIP）的全部17名成员，其中多数是免疫学、流行病学、公共卫生及相关领域的专家，并部分替换为反疫苗活动人士和怀疑论者。 令人担忧的是，新上任的美国免疫实践咨询委员会（ACIP）主席、儿科心脏病专家柯克·米尔霍恩在1月22日的播客中提出质疑：鉴于当前患病儿童拥有比他所谓的上世纪五六十年代——即脊髓灰质炎和麻疹疫苗刚问世时——更优越的治疗条件（如更完善的卫生设施、儿科医院和重症监护室），如今我们是否还需要这些疫苗。 “如今我们照顾孩子的方式已大不相同。”他说道。 “我们将要面对的是，”米尔霍恩说，“一个真实世界的情况：未接种疫苗的人群感染麻疹后，新增住院率是多少？死亡率又是多少？” 他将疫苗强制令称为一种“高压威权”手段，并主张在人们决定是否接种疫苗时，应将“个人自主权而非公共卫生”置于首要考量位置。 但这完全颠覆了公共卫生的基本理念，因为个人的决策可能将整个社区以及未接种疫苗的婴儿等群体置于风险之中。 这让我们再次回到莫德纳的案例。mRNA技术被誉为一项重大突破，部分原因在于它能够快速开发新配方以应对新出现的病毒变种或其他病原体——正如我们在新冠和流感疫情中所见证的那样。 8月，肯尼迪终止了价值5亿美元的mRNA研究政府合同，并声称“数据显示，这些疫苗无法有效预防新冠肺炎和流感等上呼吸道感染。” 在新冠问题上，情况恰恰相反。哈佛大学流行病学家比尔·哈纳吉在经费削减后表示："我国此前使用的新冠疫苗均为mRNA疫苗，仅过去几年就在美国挽救了数百万人的生命，全球范围内更是拯救了无数生命。如今我们突然遭遇研究受阻、开发停滞的困境，这些疫苗的潜力几乎在诞生之初就被扼杀了。" 真正令专业人士感到不安的是，美国食品药品监督管理局（FDA）在药品审批过程中存在标准不一的问题。 研究临床试验实践的基因组学专家鲁克桑德拉·特斯洛（Ruxandra Teslo）指出："在药物研发中，监管要求缺乏明确性和一致性可能比监管本身更具破坏性。清晰的规则即使严苛，也能被理解和遵循；但模糊或不断变化的预期则往往令人难以有效应对。" Moderna公司表达了同样的观点。该公司发言人克里斯托弗·里德利（Christopher Ridley）通过电子邮件告诉我：“行业依赖于清晰透明的规则，这些规则需要始终如一地执行，以便进行长期投资，造福美国人民。” 莫德纳公司表示，美国食品药品监督管理局（FDA）对其流感疫苗申请的审查过程既不清晰也不透明。该公司在2024年启动mRNA流感疫苗试验前曾与FDA官员进行磋商，提议在4万名受试者中，一半接种新型疫苗，另一半接种现有流感疫苗。然而FDA建议该公司采用另一种疫苗作为对照进行测试，该对照疫苗针对65岁以上人群的剂量更高。 莫德纳公司最初有所保留，但最终同意在知情同意书中向受试者提供更详尽的信息披露，美国食品药品监督管理局（FDA）对此表示认可。该公司表示，FDA对其计划“在2024年4月提交方案后，或2024年9月研究启动前的任何时间均未提出任何异议”。最终，莫德纳提交的数据表明，其mRNA疫苗的效果优于高剂量疫苗。 Moderna表示，普拉萨德的来信拒绝考虑Moderna的数据，令其措手不及。此前该公司已同意研究流感疫苗对老年人的影响，但FDA随后改变了立场。 那么现状如何？去年在参议院确认听证会上，肯尼迪曾向美国民众承诺，卫生与公众服务部的行动和政策将保持“彻底透明”。然而在莫德纳事件等诸多案例中，该机构的行动却如泥潭般浑浊不清，导致公众困惑不已，健康状况每况愈下。 以下由人工智能生成的内容由Perplexity提供技术支持。《洛杉矶时报》编辑团队未参与内容创作或修改。 肯尼迪领导下的美国卫生与公众服务部以"数据显示mRNA疫苗无法有效预防上呼吸道感染"为由，终止了价值5亿美元的mRNA疫苗研究政府合同[1]，此举削弱了公共资助的研发工作。然而有相反证据表明，mRNA疫苗在美国乃至全球范围内已挽救了数百万人的生命。 肯尼迪（Kennedy）通过前后矛盾的美国食品药品监督管理局（FDA）指导方针制造了监管混乱。典型例证是该机构在未审查莫德纳（Moderna）公司近4.4万名受试者的临床数据情况下，就拒绝了其流感疫苗申请。这种做法违背了常规流程——通常仅有约4%的药物申请会遭到此类拒绝[1]。 将疫苗从推荐儿童免疫计划中移除，并用反疫苗活动人士取代美国疾病控制与预防中心（CDC）免疫实践咨询委员会全部17名成员的做法，直接导致疫苗接种率下降和麻疹疫情卷土重来。2025年的麻疹疫情成为美国自1992年以来规模最大的一次[1]。 肯尼迪（Kennedy）在关键的公共卫生咨询委员会中安插了一些质疑脊髓灰质炎和麻疹等基础疫苗必要性的人士，他们主张将个人自主权置于公共卫生考量之上，这种做法从根本上破坏了社区防护，并使弱势群体面临风险[1]。 尽管肯尼迪在参议院确认听证会上承诺实现“彻底透明”，但其实际行动却缺乏透明度，导致公众对疫苗政策和监管标准感到困惑[1]。 肯尼迪表示，他认为疫苗在医疗保健中发挥着关键作用，并强调其关注重点是确保提供科学的安全性和有效性研究，以便人们能够做出知情的个人评估。他辩称自己是“支持安全”而非反对疫苗[2]。 疫苗政策审查的支持者认为，重新评估疫苗成分、接种计划及安全监测属于合理的科学审查而非阻碍。肯尼迪团队指出，对硫柳汞等疫苗相关问题的证据审查，恰恰反映出对安全性问题的正当关切[1]。 有人认为，相较于强制规定，优先考虑家长与医生之间的个体化临床决策，体现了医疗选择中个人自主权的转向。新上任的委员会主席指出，现代医疗技术的进步和卫生条件的改善，降低了过去几十年中某些关键疫苗的必要性[1]。

mNEXSPIKE is the third Moderna vaccine authorized in the European Union, strengthening the Company's respiratory vaccine portfolio in Europe CAMBRIDGE, MA / ACCESS Newswire / February 17, 2026 / Moderna, Inc. (NASDAQ:MRNA) today announced that the European Commission (EC) has granted marketing authorization for mNEXSPIKE® (mRNA-1283), a new COVID vaccine, for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals aged 12 years and older. This marketing authorization follows the positive opinion adopted by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) and marks Moderna's third product authorized in the European Union, alongside Spikevax® and mRESVIA®, further strengthening the Company's respiratory vaccine portfolio in Europe. The marketing authorization is valid in all 27 European Union Member States, as well as Iceland, Liechtenstein and Norway. Moderna expects to make mNEXSPIKE available in Europe pending regulatory timelines and local market access pathways. "We welcome the European Commission's decision, which reflects the strength of the scientific data supporting mNEXSPIKE and our continued commitment to advancing innovative vaccines for populations most at risk," said Stéphane Bancel, Chief Executive Officer of Moderna. "COVID-19 has become an endemic respiratory disease, with older adults continuing to bear a disproportionate burden of severe outcomes. Europe represents a key region for respiratory vaccines, and we are pleased to have a new vaccine available to help protect Europeans when the EU COVID market reopens starting this year in some markets." The EC decision is supported by results from a randomized, observer-blind, active-controlled Phase 3 clinical trial (EudraCT: 2023-000884-30; ClinicalTrials.gov: NCT05815498), which enrolled approximately 11,400 participants aged 12 years and older. The primary efficacy objective of the study was to demonstrate non-inferior vaccine efficacy against COVID-19 starting 14 days after mNEXSPIKE compared to that after the comparator vaccine, mRNA-1273 (Spikevax), Moderna's original COVID-19 vaccine. In the trial, participants received either a 10 μg dose of mNEXSPIKE or a 50 μg dose of Spikevax. mNEXSPIKE showed a 9.3% higher relative vaccine efficacy compared to Spikevax in individuals aged 12 years and older, and in a descriptive subgroup analysis, a 13.5% higher relative vaccine efficacy in adults aged 65 years and older. In the Phase 3 trial, mNEXSPIKE was found to have a similar safety pro Spikevax, with fewer local reactions and comparable systemic reactions. The most commonly solicited adverse reactions were injection pain, fatigue, headache and myalgia. Moderna has already received regulatory approval for mNEXSPIKE in the U.S., Canada and Australia, and continues to pursue approvals in additional markets worldwide. About Moderna Moderna is a pioneer and leader in the field of mRNA medicine. Through the advancement of its technology platform, Moderna is reimagining how medicines are made to transform how we treat and prevent diseases. Since its founding, Moderna's mRNA platform has enabled the development of vaccines and therapeutics across infectious diseases, cancer, rare diseases and more. With a global team and a unique culture, driven by the company's values and mindsets, Moderna's mission is to deliver the greatest possible impact to people through mRNA medicines. For more information about Moderna, please visit modernatx.com and connect with us on X, Facebook, Instagram, YouTube and LinkedIn. mNEXSPIKE ® , Spikevax® and mRESVIA® are registered trademarks of Moderna. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including statements regarding: the availability of mNEXSPIKE in Europe; the opportunity in the European respiratory vaccine market and Moderna's geographical expansion; the safety pro mNEXSPIKE; and potential approvals in additional markets worldwide. In some cases, forward-looking statements can be identified by terminology such as "will," "may," "should," "could," "expects," "intends," "plans," "aims," "anticipates," "believes," "estimates," "predicts," "potential," "continue," or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond Moderna's control and which could cause actual results to differ materially from those expressed or implied by these forward-looking statements. These risks, uncertainties, and other factors include, among others, those risks and uncertainties described under the heading "Risk Factors" in Moderna's Annual Report on Form 10-K for the fiscal year ended December 31, 2024, filed with the U.S. Securities and Exchange Commission (SEC), and in subsequent filings made by Moderna with the SEC, which are available on the SEC's website at . Except as required by law, Moderna disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements are based on Moderna's current expectations and speak only as of the date of this press release. Moderna Contacts Media: Chris Ridley Head of Global Media Relations +1 617-800-3651 Chris.Ridley@modernatx.com Investors: Lavina Talukdar Senior Vice President & Head of Investor Relations +1 617-209-5834 Lavina.Talukdar@modernatx.com SOURCE: Moderna, Inc. View the original press release on ACCESS Newswire