A Multi-Centre, Prospective, Observational Post-Marketing Surveillance to Investigate the Long-Term Safety of SPIKEVAX BIVALENT and SPIKEVAX X Injection Under Routine Clinical Care in Korea

The main objective of the surveillance is to evaluate the incidence of the adverse events (AEs), and other safety related information in South-Korean population.

开始日期2023-03-10

申办/合作机构

ModernaTX, Inc.

100 项与 Elasomeran/Davesomeran 相关的临床结果

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项与 Elasomeran/Davesomeran 相关的文献（医药）

2024-12-01·VACCINE

Incidence of ischemic stroke after COVID-19 bivalent booster vaccination in an integrated health system

Article

作者: Sharff, Katie A ; Johnson, Eric S ; Tandy, Thomas K ; Lewis, Paul F ; Sharff, Katie A. ; Lewis, Paul F. ; Johnson, Eric S. ; Tandy, Thomas K.

We conducted a retrospective cohort study of Kaiser Permanente Northwest patients 18 years and older who were vaccinated with the COVID-19 bivalent vaccine between September 1, 2022 and March 1, 2023. We replicated the Vaccine Safety Datalink (VSD) rapid cycle analysis protocol to identify cases of ischemic stroke or transient ischemic attack (TIA) in the 21 days following vaccination using ICD-10-CM diagnosis codes in the primary position. The incidence of ischemic stroke or TIA was 34.3 per 100,000 (95 % CI, 17.7-59.9) in patients 65 years or older who received the bivalent Pfizer vaccine. Although a safety signal was detected in this study, further investigation is warranted to validate an association between COVID-19 vaccination and risk of ischemic stroke. Replication of the VSD case definition confirmed the exceptionally high positive predictive value in identifying ischemic stroke or TIA within 21 days of Pfizer bivalent vaccination in individuals 65 years and older. Two physician adjudication with chart review and confirmation of ischemic stroke cases allowed accurate absolute incidence estimates of stroke per 100,000 vaccine recipients and is helpful in calculation of net benefit for policy recommendations and shared decision-making.

2024-11-29·JAPANESE JOURNAL OF INFECTIOUS DISEASES

Antibody Responses and Infection Prevention following the Sixth Vaccination using the BA.1 bivalent COVID-19 vaccine among Healthcare workers during the XBB variant Dominance in Japan

Article

作者: Saito, Kengo ; Hanaoka, Hideki ; Yokote, Koutaro ; Nakajima, Hiroshi ; Yamagishi, Kazutaka ; Yokota, Shou ; Shiko, Yuki ; Kawasaki, Kenji ; Igari, Hidetoshi ; Chiba, Hitoshi ; Taniguchi, Toshibumi ; Ido, Eiji ; Yahaba, Misuzu ; Asano, Haruna ; Matsushita, Kazuyuki ; Herai, Yoriko ; Murata, Shota ; Yoshikawa, Hiroshi

The effect of antibodies elicited by bivalent mRNA vaccines (original and omicron BA.1) on preventing coronavirus disease 2019 (COVID-19) onset in the presence of the XBB variant remains unknown. A prospective cohort study conducted at Chiba University Hospital examined healthcare workers who received their sixth vaccination with the Pfizer-BioNTech COVID-19 bivalent mRNA vaccine (original and omicron BA.1). Researchers quantitatively measured serum anti-spike (S) antibody levels. Participants not infected during the 60-day observation period after vaccination had significantly higher S antibody titers than those who were newly infected (27756 U/mL, 95% CI [24988-30831 U/mL] vs. 15321 U/mL, 95% CI [10824-21688 U/mL], p<0.05). The risk of infection decreased by 84% when the S antibody titer exceeded 15500 U/ml. Neutralizing antibody titers against the XBB.1.16 and XBB.1.42 variants were higher in age- and sex-matched noninfected individuals than in newly infected individuals during the post-vaccination observation period. S antibody titers were highly correlated with neutralizing antibody titers. In conclusion, after the sixth COVID-19 vaccination with the bivalent mRNA vaccine (original and omicron BA.1), high S antibody titers correlated with disease prevention, even in the presence of XBB variants.

2024-10-01·Vaccine: X

Safety and antibody responses of Omicron BA.4/5 bivalent booster vaccine among hybrid immunity with diverse vaccination histories: A cohort study

Article

作者: Kanokudom, Sitthichai ; Suntronwong, Nungruthai ; Chansaenroj, Jira ; Duangchinda, Thaneeya ; Sudhinaraset, Natthinee ; Wongsrisang, Lakkhana ; Honsawek, Sittisak ; Vichaiwattana, Preeyaporn ; Pakchotanon, Pattarakul ; Chantima, Warangkana ; Poovorawan, Yong ; Aeemjinda, Ratchadawan ; Thatsanathorn, Thaksaporn

This cohort study, conducted between July and August 2023, evaluated the adverse events (AEs) and immune response to a bivalent mRNA-1273.222 (containing sequences of the original Wuhan-H1 strain and the Omicron BA.4/5 variant) booster vaccine in 122 participants. The study included individuals with diverse vaccination histories, and their responses were assessed based on anti-receptor binding domain (RBD) IgG levels and neutralizing antibodies against the wild-type, Omicron BA.5, and XBB.1.16 variants. Following administration of the BA.4/5 bivalent vaccine, AEs were generally mild to moderate and well-tolerated within a few days. There were no reports of vomiting and no serious AEs or death. The findings demonstrated robust immune responses, with significant increases in anti-RBD IgG levels, particularly in groups that had received 3 -6 doses before the booster dose. The BA.4/5 bivalent booster effectively induced neutralizing antibodies against the vaccine strains, providing robust neutralization, including the XBB.1.16 strain. The study also highlighted that individuals with hybrid immunity, especially those assumed infected with the BA.5 strain or who had been infected twice, showed higher levels of robust neutralizing activity against Omicron XBB.1.16. Overall, these results indicate that the BA.4/5 bivalent booster vaccines can induce potent and good antibody responses in emerging Omicron subvariants, supporting its efficacy as a booster in individuals with diverse vaccination histories.

项与 Elasomeran/Davesomeran 相关的新闻（医药）

2024-03-27

·生物制品圈

Moderna新冠疫苗mRNA-1283临床三期达到终点

2024 年 3 月 26 号，Moderna 官宣：第 4 个传染病项目新冠疫苗 mRNA-1283 已成功达到 3 期临床试验的主要终点。在 NextCOVE （NCT05815498） 3 期关键试验中，与 mRNA-1273.222 相比，mRNA-1283 被证明能够针对 Omicron BA.4/BA.5 和原始病毒株引发更高的免疫反应。重要的是，这种免疫优势在 65 岁以上的参与者中最为明显，这些人群仍然是出现 COVID-19 严重后果的最高风险人群。最常见的局部不良事件是注射部位疼痛。最常见的全身不良事件包括头痛、疲劳、肌痛和发冷。mRNA-1283 3 期临床试验数据的详细分析将在 3 月 27 日的公司疫苗日活动上分享，并在即将举行的科学会议上介绍。尤其值得关注的是，在冷藏温度下（2℃-8℃），mRNA-1283 存放稳定性得到显著改善。mRNA-1283 存放 12 个月时完整度是初始值的 62%，而 mRNA1273 存放 6 个月时完整度就已经降至初始值的 63%。这其实也很好理解，因为 mRNA1273 要比 mRNA-1283 长得多，RNA 越长越容易降解。此外，mRNA-1283 以预充式注射剂（pre-filled syringe）的形式提供的，为医务人员接种提供极大的便利。本以为新冠项目这会儿早该抛弃掉了，没想到，Moderna 还在稳步推进，而且，这个 mRNA-1283 项目还非常重要。为什么这么说呢？因为 Bancel 称 mRNA-1283 是针对流感和新冠组合疫苗 mRNA-1083 的关键组成部分，此次 3 期临床试验的里程碑数据让他们对种组合式疫苗的前景抱有极大的信心。仔细看了一下，CT05815498 三期临床试验起始于 2023 年 3 月 28 号，预计于今年 8 月 23 号完成，旨在评估在 12 岁及以上参与者中，mRNA-1283.222 作为加强剂量与 mRNA-1273.222 相比，预防新冠的安全性、免疫原性和相对疫苗功效。2022 年 10 月 7 号的时候，Moderna 团队就在 BioRxiv 上传了篇预印本文章：Development of SARS-CoV-2 mRNA vaccines encoding spike N-terminal and receptor binding domains，与编码全长 Spike 蛋白的 mRNA-1273 相比，编码 NTD-RBD（NTD 与 RBD 通过 G3SG3 接头连接，且拥有膜锚定区）候选疫苗 mRNA-1283 在抗原表达、抗体反应和冷藏温度 (2-8°C) 下的稳定性方面表现出明显提升。在小鼠模型中，相比 mRNA-1273 疫苗，mRNA-1283 可触发更强的免疫反应。一年后，此预印本文章发表于 Science Translation Medicine 。最后，跟大家分享一本非常有意思的书，作者记录了 Moderna 从起步到凭借新冠疫苗变为独角兽的全过程，既有人事争斗，也有成长过程的痛苦蜕变。只要你的独门绝技是坚实可靠的，Biotech 就会有无限的可能性。有句话这一两年很流行，动不动就被人搬出：这个世界是个草台班子。我不喜欢这种站在上帝视角，把事情幼稚化，给出一句不关痛痒的屁话。在任何伟大的公司或者平台，没有人能把未来看得清清楚楚，总是在慌乱和不确定中做出抉择，匆匆前行。重要的是，有些人愿意为了那个不确定的目标奋力搏击。在初创 Biotech 待久了，听到过太多的对于前景不明确和组织混乱的吐槽和抱怨。我觉得，既然选择了初创，只要老板一心推动事情往前走，哪怕是踉踉跄跄，不妨耐心点，给点时间，因为 Moderna 也是从你所谓的混乱中走出来的。识别微信二维码，添加生物制品圈小编，符合条件者即可加入生物制品微信群！请注明：姓名+研究方向！版权声明本公众号所有转载文章系出于传递更多信息之目的，且明确注明来源和作者，不希望被转载的媒体或个人可与我们联系(cbplib@163.com)，我们将立即进行删除处理。所有文章仅代表作者观点，不代表本站立场。

临床3期疫苗信使RNA临床结果临床1期

2024-03-26

·BioSpace

Moderna Achieves Positive Interim Results from Phase 3 Trial of Next-Generation COVID-19 Vaccine

mRNA-1283 induced a more robust immune response compared to Spikevax® COVID-19 vaccine, mRNA-1273.222 Next-generation mRNA vaccine design offers the potential of longer shelf life and storage advantages, and paves the way for combination vaccine against influenza and COVID-19, mRNA-1083 CAMBRIDGE, MA / ACCESSWIRE / March 26, 2024 / Moderna, Inc. (NASDAQ:MRNA) today announced that mRNA-1283, the Company's next-generation COVID-19 vaccine, has successfully met the primary endpoints of its Phase 3 clinical trial, demonstrating a higher immune response against SARS-CoV-2 when compared to mRNA-1273.222, Moderna's licensed COVID-19 vaccine. "We are excited to announce our fourth infectious disease vaccine program with positive Phase 3 data, further validating our robust mRNA platform," said Stéphane Bancel, Chief Executive Officer of Moderna. "mRNA-1283 is a critical component of our combination vaccine against flu and COVID-19, mRNA-1083, and this milestone gives us confidence in our ability to bring this much needed vaccine to market." In the NextCOVE (NCT05815498) Phase 3 pivotal trial, mRNA-1283 was shown to elicit a higher immune response against both the Omicron BA.4/BA.5 and original virus strains of SARS-CoV-2, compared to mRNA-1273.222. Importantly, this benefit was most acutely seen in participants over the age of 65 years, the population that remains at highest risk for severe outcomes from COVID-19. The most common solicited local adverse event was injection site pain. The most common solicited systemic adverse events included headache, fatigue, myalgia and chills. The NEXTCove clinical trial is a randomized, observer-blind, active-controlled study of approximately 11,400 individuals aged 12 years and older in the United States, United Kingdom and Canada. mRNA-1283 was found to have a similar safety pro Moderna's approved COVID-19 vaccines. The storage, shelf life and pre-filled syringe presentation of mRNA-1283 could alleviate healthcare provider burden and potentially increase access into new settings to serve public health. A detailed analysis of the Phase 3 clinical trial data for mRNA-1283 will be shared at the Company's Vaccines Day event on March 27 and presented at upcoming scientific conferences. About Moderna Moderna is a leader in the creation of the field of mRNA medicine. Through the advancement of mRNA technology, Moderna is reimagining how medicines are made and transforming how we treat and prevent disease for everyone. By working at the intersection of science, technology and health for more than a decade, the company has developed medicines at unprecedented speed and efficiency, including one of the earliest and most effective COVID-19 vaccines. Moderna's mRNA platform has enabled the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases and autoimmune diseases. With a unique culture and a global team driven by the Moderna values and mindsets to responsibly change the future of human health, Moderna strives 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 (formerly Twitter), Facebook, Instagram, YouTube and LinkedIn. Spikevax® is a registered trademark 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 potential longer refrigerator shelf life and storage advantages of mRNA-1283 compared to Spikevax; and the ability of mRNA-1283 to maintain effectiveness compared to Spikevax. 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, 2023, 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: Elise Meyer Sr. Director, Corporate Communications +1 617-852-7041 Elise.Meyer@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 accesswire.com

临床3期疫苗临床结果信使RNA

2023-02-26

·药融圈

Moderna 2022年财报：新冠疫苗大卖184亿美元

▲3月15-16日生物医药创新者峰会 · 限时免费报名中注：本文不构成任何投资意见和建议，以官方/公司公告为准；本文仅作医疗健康相关药物介绍，非治疗方案推荐（若涉及），不代表平台立场。任何文章转载需得到授权。2月23日，mRNA药物巨头Moderna发布2022年财报，2022全年营收192.63亿美元，同比增长4.29%；净利润83.62亿美元，同比下降31.47%；研发费用32.95亿美元，同比增长65.49%。Q4营收50.84亿美元，同比下降29.5%；Q4净利润14.65亿美元，同比下降69.9%。目前，Moderna总市值567亿美元。Moderna在Q4营收下降主要是由于新冠疫苗销量的减少，Moderna新冠疫苗产品Q4营收48.59亿美元，同比下降29.94%。目前，Moderna成功上市三款mRNA新冠疫苗产品，共有48个研发项目，其中4个项目已进入临床III期，9个项目进入临床II期。Moderna的三款新冠疫苗产品包括mRNA-1273（针对新冠病毒原始株Spike)、mRNA-1273.222（针对原始株Spike+变异株Omicron BA.4/5）和mRNA1273.214（针对原始株Spike+变异株Omicron）。在2022年，Moderna的三款新冠疫苗产品总营收高达184.35亿美元。然而，随着新冠疫情的放缓，Moderna预计今年新冠产品收入将大幅下降。Moderna在财报中预测2023年上半年的新冠疫苗收入约为20亿美元。那么在新冠疫情逐渐缓解后，Moderna后续增长点如何呢？除新冠疫苗外，Moderna的呼吸道合胞病毒（RSV）疫苗mRNA-1345、流感疫苗mRNA-1010、巨细胞病毒（CMV）疫苗mRNA-1647已进入临床III期。RSV疫苗mRNA-1345已在III期临床试验中达到主要疗效终点，并获得了美国FDA的突破性疗法认定（BTD），用于预防60岁或以上成人的呼吸道合胞病毒相关下呼吸道疾病（RSV-LRTD），mRNA-1345对RSV-LRTD的疫苗效力为83.7%。Moderna预计将在2023年上半年向美国FDA提交生物制品许可申请(BLA)。mRNA-1010是一款四价流感疫苗，用于预防甲型H1N1、甲型H3N2、乙型Victoria和乙型Yamagata流感病毒所致的流感。此前2月16日，Moderna公布了mRNA-1010关键III期临床的中期结果。同时，另一项平行III期临床也正在进行中，其首次中期数据预计将于今年Q1晚期公布。CMV疫苗mRNA-1647的关键III期临床试验正在进行中，本研究的招募工作已完成40%以上。Moderna目前共有48个研发项目，研发管线涉及传染病、呼吸道疾病、自身免疫病和癌症等多个领域。Moderna研发管线后疫情时代，新冠红利将难以持续。但在新冠疫苗大获成功后，凭借充足的资金和人员，Moderna计划推出多款疫苗，RSV疫苗、流感疫苗等或能成为Moderna新的增长点。信息参考：Moderna官网版权声明：本文转自生物药大时代，如不希望被转载的媒体或个人可与我们联系，我们将立即删除线下活动（点击即可查看）线上直播（点击即可查看）点分享点点赞点在看

财报临床3期信使RNA疫苗临床2期

100 项与 Elasomeran/Davesomeran 相关的药物交易

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