Pneumococcal polysaccharide conjugate vaccine

Appoints Emilio Emini and Lauren Silvernail to Board of Directors; Two Directors to Step Down at 2025 Annual Meeting Intends to Seek Stockholder Approval for Declassification of Board at 2025 Annual Meeting EMERYVILLE, Calif., Jan. 27, 2025 /PRNewswire/ -- Dynavax Technologies Corporation (Nasdaq: DVAX) (the "Company"), a commercial-stage biopharmaceutical company developing and commercializing innovative vaccines, today announced the following changes to its Board of Directors as part of its ongoing refreshment program: Emilio Emini, Ph.D. and Lauren Silvernail have been appointed to the Board, effective February 3, 2025. Dr. Emini will serve as a Class III director with an initial term expiring at the Company's 2027 Annual Meeting and Ms. Silvernail will serve as a Class I director with an initial term expiring at the Company's 2025 Annual Meeting. Peggy Phillips, who has served on the Dynavax Board since 2006, will retire from the Board at the 2025 Annual Meeting. Julie Eastland will step down from the Board at the 2025 Annual Meeting given her recent appointment as chief executive officer of another public company. The Board expects to appoint Ms. Silvernail as Chair of the Audit Committee and Scott Myers as Chair of the Compensation Committee following the 2025 Annual Meeting. The Board intends to seek stockholder approval at the 2025 Annual Meeting for the declassification of the Board. If stockholders approve the proposal, directors standing for election at the Company's 2026 Annual Meeting and thereafter will stand for one-year terms. Beginning with the Company's 2028 Annual Meeting, all directors will stand for election annually. Following the 2025 Annual Meeting, the Board will be comprised of nine directors, with six of its eight independent directors having been appointed since 2020. "Emilio and Lauren are two renowned leaders in their respective fields and we expect that their tremendous expertise will be immediately additive as the Company continues to execute its strategic plan and deliver for our stakeholders. Emilio has been at the forefront of some of the most notable vaccines and brings a unique perspective at the intersection of R&D, academia and public health and Lauren brings a track record of financial and operational prowess and board leadership experience within the biopharma space," said Scott Myers, Chairman of the Dynavax Board of Directors. "On behalf of the Board, I want to extend my gratitude to Peggy and Julie who have made innumerable contributions to Dynavax's growth and success over the years. Our ongoing efforts to refresh our Board with fresh perspective and expertise and enhance our governance profile are key pillars of our commitment to support Dynavax's long-term growth objectives and the changes announced today underscore this commitment." Dr. Emini said, "Dynavax has an important mission, one that I firmly share, and I am excited to work alongside the Board and the Dynavax team, a group of world-class innovators and scientists serving patients globally." Ms. Silvernail said, "Dynavax is a clear category leader with its lead asset, HEPLISAV-B, and I am eager to work with the Board to help advance the Company's strategic and financial initiatives to capitalize on its positive momentum." "We have started 2025 with strong momentum, achieving record annual revenue for HEPLISAV-B in 2024 and advancing our pipeline programs, while returning capital to our stockholders with our active $200 million share repurchase program. Through the execution of our strategic growth pillars with discipline and rigor, we will continue to focus on delivering value for our stockholders and other stakeholders, and I am looking forward to working alongside Emilio and Lauren as we look to capture the significant opportunities ahead," said Ryan Spencer, Chief Executive Officer of Dynavax. About Emilio Emini Dr. Emini brings over 40 years of experience as an executive and academic across the biopharmaceutical industry and global public health roles, helping to develop and deliver multiple anti-infectious disease interventions. Prior to his retirement, Dr. Emini served as Chief Executive Officer of the Bill & Melinda Gates Medical Research Institute and as the Director of the Foundation's Tuberculosis and HIV Programs. At the Merck Research Laboratories, from 1983 to 2004, Dr. Emini led the biological research that developed the first highly active antiretroviral therapies for HIV and led multiple vaccine research teams that contributed to many successful developments, including the vaccines for human papillomavirus and rotavirus. Following a two-year leave from the industry at the International AIDS Vaccine Initiative, Dr. Emini joined Wyeth/Pfizer as the Senior Vice President of Vaccine R&D where he led the development of the Prevenar 13® vaccine for prevention of pneumococcal disease. Dr. Emini holds a Bachelor of Science from Manhattan College and a Ph.D. in Microbiology from the Cornell University Graduate School of Medicine. About Lauren Silvernail Ms. Silvernail has three decades of experience leading finance and business development functions across the pharmaceutical industry. She most recently served as Chief Financial Officer and Executive Vice President of Corporate Development of Evolus, Inc., from 2018 until her retirement in 2022, where she led fundraising, financial and partnership activities including establishing the infrastructure for the U.S. commercial launch of the company's first approved product. Previously, she served as Chief Financial Officer and Chief Business Officer at Revance Therapeutics, Inc., where she led the company's initial public offering and subsequent rounds of financing. Prior to that, Ms. Silvernail was Chief Financial Officer and Executive Vice President of Corporate Development at ISTA Pharmaceuticals until its sale to Bausch & Lomb. Prior to that, she held corporate development roles at Allergan and other companies. Ms. Silvernail is currently a director and Audit Committee Chair of Harrow and previously served as a director and Audit Committee Chair at Harpoon Therapeutics until its successful sale to Merck and a director and Corporate Governance Committee chair at Nicox S.A. She earned an M.B.A. in finance and accounting from the Anderson Graduate School of Management at UCLA, and a B.A. in Biophysics from the University of California, Berkeley. About Dynavax Dynavax is a commercial-stage biopharmaceutical company developing and commercializing innovative vaccines to help protect the world against infectious diseases. The Company has two commercial products, HEPLISAV-B® vaccine [Hepatitis B Vaccine (Recombinant), Adjuvanted], which is approved in the U.S., the European Union and Great Britain for the prevention of infection caused by all known subtypes of hepatitis B virus in adults 18 years of age and older, and CpG 1018® adjuvant, currently used in HEPLISAV-B and multiple adjuvanted COVID-19 vaccines. For more information about our marketed products and development pipeline, visit . Forward-Looking Statements This press release contains "forward-looking" statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, which are subject to a number of risks and uncertainties. All statements that are not historical facts are forward-looking statements. Forward-looking statements can generally be identified by the use of words such as "anticipate," "believe," "continue," "could," "estimate," "expect," "forecast," "intend," "will," "may," "plan," "project," "potential," "seek," "should," "think," "toward," "will," "would" and similar expressions, or the negatives thereof, or they may use future dates. Forward-looking statements made in this document include statements regarding the Company's plans to submit a declassification proposal at its 2025 Annual Meeting, expected contributions from newly appointed directors, the planned resignation of certain directors, anticipated committee appointments, expectations regarding delivering value for our stockholders, and our future growth and long-term performance. Actual results may differ materially from those set forth in this press release due to the risks and uncertainties inherent in our business, including, the risk that circumstances surrounding or leading up to our 2025 Annual Meeting may change, risks relating to our ability to commercialize and supply HEPLISAV-B, and risks related to the implementation of our long-term growth objectives, as well as other risks detailed in the "Risk Factors" section of our Quarterly Report on Form 10-Q for the three months ended September 30, 2024 and periodic filings made thereafter, as well as discussions of potential risks, uncertainties and other important factors in our other filings with the U.S. Securities and Exchange Commission. These forward-looking statements are made as of the date hereof, are qualified in their entirety by this cautionary statement and we undertake no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available. Information on Dynavax's website at is not incorporated by reference in our current periodic reports with the SEC. For Investors/Media: Paul Cox [email protected] 510-665-0499 Nicole Arndt [email protected] 510-665-7264 SOURCE Dynavax Technologies WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

2025年1月16日，美国CDC免疫实践和咨询委员会（ACIP）同步发布儿童和≥19岁成人免疫接种计划，该接种计划源于2024年10月ACIP会议通过的内容。 与往年相同，2025 年成人免疫接种计划由ACIP推荐并得到CDC、美国医师学会、内科医师学会、家庭医师学会、妇产科医师学会、药剂师协会等的批准。 本文仅列举9款需求度相对较高、在美上市的成人疫苗，如需2025年儿童疫苗接种计划请登录官网自行获取。具体如下： NO.1 关于接种间隔的说明 4周=28天，≥4个月，按日历月决定。 在最低年龄或间隔前≤4天接种的疫苗剂量被视为有效。 比最低年龄或最短间隔早≥5天接种的任何疫苗剂量不应被视为有效，应重复接种。 重复剂量应在无效剂量后按建议的最小间隔间隔。 如果疫苗接种史不完整或未知，请接种推荐的疫苗。 如果两剂之间的间隔时间延长，请勿重新开始或增加疫苗系列的剂量。 NO.2 流感疫苗/IIV3 推荐的流感疫苗已从四价更改为三价，以与FDA批准的2024-25年流感季节疫苗产品保持一致。 传统灭活流感疫苗：即三价流感灭活疫苗（IIV3或ccIIV3，鸡胚或细胞生产），≥19岁成年人每年接种1剂，但≥65岁人群建议首选改进工艺的流感疫苗。 改进工艺流感疫苗：即佐剂三价流感疫苗（aIIV3）、高剂量流感疫苗（HD-IIV3）和重组流感疫苗（RIV3）。实体器官移植者每年接种1剂，HD-IIV3和aIIV3是接受免疫抑制药物的19-64岁实体器官移植受者可接受的选择，但不优先于其他适龄健康人群接种IIV3或 RIV3。 鼻喷减毒流感疫苗：即LAIV3，建议19-49岁成年人每年接种1剂，但为了防止严重免疫抑制的患者罹患流感，接触这些人群的医疗、护理人员不应接种。 NO.3 肺炎球菌疫苗/PCV&PPSV PCV：肺炎球菌多糖结合疫苗；PPSV：肺炎球菌多糖疫苗。 常规接种 ≥50岁：以前未接种过PCV13、PCV15、PCV20或PCV21或既往疫苗接种史未知，建议接种1剂PCV15或PCV20或PCV21。 如果使用PCV15，请在PCV15给药后至少1年接种1剂PPSV23（对于免疫功能低下*、人工耳蜗或脑脊液渗漏的成年人，可以使用至少8周的间隔）。 如果既往使用的是PCV7，也同样建议接种1剂。 以前只接种过PCV13：在最后一剂PCV13后，至少间隔1年建议再接种1剂PCV20或1剂PCV21。 以前只接种过PPSV23：在最后一剂PPSV23后至少间隔1年建议再接种1剂PCV15或1 剂PCV20或1剂PCV21。 反过来，如果此前接种了PCV15，则不建议再额外接种PPSV23。 以前曾接种过PCV13和PPSV23，但在≥65岁时未接种 PPSV23：在最后一次肺炎球菌疫苗剂量后至少5年接种1剂PCV20或1剂PCV21。 既往接种过PCV13和PPSV23，并且PPSV23是在≥65岁接种的：是否决定在最后一剂肺炎球菌疫苗后至少5年接种1剂PCV20或1剂PCV21，需要根据共同的临床决策。 特殊情况 年龄在19-49岁之间,患有某些基础疾病或其他风险因素**，并且: 以前未接种过PCV13、PCV15、PCV20或PCV21或既往疫苗接种史未知:1剂PCV15或1剂PCV20或1剂PCV21。 如果使用PCV15,请在PCV15给药后至少1年接种1剂PPSV23(对于免疫功能低下*、人工耳蜗或脑脊液渗漏的成年人，可以使用至少8周的的间隔) 以前只接种了PCV7：遵循上述建议。 以前只接种过PCV13：在最后一次PCV13剂量后至少1年接种1剂PCV20或1剂PCV21。 以前只接种过PPSV23：剂量PCV15或1剂PCV20或PCV20或PCV21,在最后一次PPSV23剂量后至少1年。如果使用PCV15,则不建议额外接种PPSV23剂量。 以前接种过PCV13和1剂PPSV23：在最后一剂肺炎球菌疫苗后至少5年接种1剂PCV20或1剂PCV21。 已接种PCV20或PCV21的19岁及以上成人：不建议额外接种肺炎球菌疫苗剂量。 妊娠：由于数据有限,不推荐使用PCV或PPSV23。 有关怀孕期间肺炎球菌疫苗接种的PPSV23不可用：年满19岁且已接种PCV15但尚未完成PPSV23系列接种的成年人，如果无法再获得PPSV23，则可以接种1剂PCV20或1剂PCV21来完成该系列接种。 *免疫功能低下的情况：慢性肾功能衰竭、肾病综合征、免疫缺陷、医源性免疫抑制、全身性恶性肿瘤、HIV 感染、霍奇金病、白血病、淋巴瘤、多发性骨髓瘤、实体器官移植、先天性或获得性无脾、镰状细胞病或其他血红蛋白病。 **基础疾病或其他危险因素包括酗酒、慢性心脏/肝脏/肺病、慢性肾功能衰竭、吸烟、人工耳蜗、先天性或获得性无脾、脑脊液漏、糖尿病、全身性恶性肿瘤、HIV 感染、霍奇金病、免疫缺陷、医源性免疫抑制、白血病、淋巴瘤、多发性骨髓瘤、肾病综合征、实体器官移植或镰状细胞病或其他血红蛋白病。 NO.4 人乳头瘤病毒疫苗/HPV 常规接种 ≤26 岁的女性或女性：根据初次接种疫苗时的年龄或健康状态完成2剂或3剂接种。 初次接种疫苗时年龄为9-14岁：只接种了1剂，或2剂间隔不到5个月，则需重复接种。 初次接种疫苗时年龄为9-14 岁：至少间隔 5 个月接受 2 剂，完成2剂程序后无需额外剂量。 初次接种疫苗时年满15 岁：0、1-2 个月、6 个月时接种3剂（最小间隔：1-2剂最少4周；2-3剂最少12周；1-3剂最少5个月。如果接种过早，则需重复接种） 当使用推荐的接种间隔完成任何价次的任何HPV疫苗系列时，不建议增加额外的剂量。 共享决策 27-45 岁的成年人：根据共同的临床决策，完成2剂系列（如果在9-14岁开始时）或3剂系列（如果在≥15岁开始时） 特殊情况 上述建议的常规和补种免疫接种或共同临床决策的年龄范围也适用于特殊情况。 免疫功能低下的情况，包括HIV感染：完整的3剂系列，即使对于在9-14岁开始接种疫苗的人也是如此。 怀孕：接种疫苗前不需要进行妊娠试验。不建议在怀孕后之前接种HPV疫苗。如果在怀孕期间无意中接种疫苗，则无需干预。 NO.5 带状疱疹疫苗/VZV 常规接种 ≥50岁：无论既往带状疱疹疫苗史或带状疱疹疫苗活疫苗（ZVL、Zostavax）疫苗接种史，建议间隔2-6个月接种2剂重组带状疱疹疫苗（RZV、Shingrix），最短间隔4周。 如果接种过早，需要保证最短间隔后再次接种1剂。 带状疱疹疫苗接种不需要既往水痘的血清学证据。但是如果有明确的水痘易感的血清学证据，疫苗服务提供者应首先遵循ACIP指南进行水痘疫苗接种。 RZV不适用于预防水痘，并且也关于水痘或水痘疫苗接种史的人中使用RZV的数据有限。 特殊情况 免疫功能低下的情况（包括HIV感染者，无论CD4计数如何），建议接种2剂重组带状疱疹疫苗（RZV、Shingrix），间隔 2-6个月（最短间隔4周，如果接种过早，需要再次接种1剂）。 目前不推荐孕期接种RZV，需要妊娠结束后接种。 NO.6 乙型肝炎疫苗/HepB 常规接种 19至59岁：完成2剂、3剂或4剂程序，不同接种程序，对应的疫苗品类不同。 年龄≥60岁且没有已知的HBV感染危险因素的人可（may）全程接种HBV疫苗。 年龄在≥60岁且有已知HBV感染危险因素的人应当（should）接种HBV疫苗。 任何≥60岁的成年人如果要求接种乙肝疫苗，都应当（should）接种乙肝疫苗系列。 HBV感染的风险因素包括： 慢性肝病，包括丙型肝炎、肝硬化、脂肪肝、酒精性肝病、自身免疫性肝炎、丙氨酸转氨酶(ALT)或天冬氨酸转氨酶(AST)患者、HIV感染性暴露风险，例如HBSAg阳性的性伴侣、非一夫一妻制关系的性活跃者、寻求性传播感染评估或治疗的人、男男性行为者、当前或近期使用注射毒品、经皮或粘膜接触血液的风险，例如HBSAg阳性者的家庭接触者、发育障碍者设施的居民和工作人员、有合理预期接触血液或血液污染体液风险的医疗保健和公共安全人员、维持透析(包括中心或家庭血液透析和脂腹膜透析)的人，透析前患者和糖尿病患者*、监禁、在乙型肝炎重度或中度流行国家/地区旅行。 特殊人群： 透析患者：如果使用透析配方1ml=40mcg，建议完成3剂程序的乙肝疫苗。如果使用透析配方为2ml而非1ml者，建议完成4剂程序的乙肝疫苗。 ≤20岁的免疫功能低下患者：透析患者除了可以选择以上程序，也可选择2剂或3剂程序的其他乙肝疫苗。 *≥60岁患有糖尿病：基于共同的临床决策，完成如上所述的2剂、3剂或4剂程序。 NO.7 甲型肝炎疫苗/HepA 常规接种 任何未完全接种疫苗并要求接种疫苗的人（不需要确定风险因素）：完成2剂HepA疫苗接种，不同标签的甲肝疫苗接种间隔不同。 特殊情况 任何没有全剂量接种疫苗且有HAV感染风险或HAV感染重症的人：如上所述，全程完成2剂HepA接种，或3剂甲肝-乙肝联合疫苗。 风险因素包括： 慢性肝病，包括乙型肝炎、丙型肝炎、肝硬化、脂肪肝、酒精性肝病、自身免疫性肝炎、丙氨酸转氨酶（ALT）或天冬氨酸转氨酶（AST）水平大于正常上限两倍的人。 HIV感染、男男性行为者、注射或非注射吸毒、无家可归者 在研究实验室中接触HAV，或接触感染HAV的非人灵长类动物 在甲型肝炎重度或中度流行国家/地区旅行：可以使用甲乙肝联合疫苗的0、7 和21-30天以3剂的加速时间表接种，然后在12个月时进行加强剂量。 从甲型肝炎重度或中度流行国家/地区抵达后的前60天内与国际收养者（例如，家庭或常规保姆）密切个人接触：计划收养后立即接种第1剂，最好在被收养人到达前至少2周。 怀孕期间有感染风险或怀孕期间感染的严重后果 暴露环境，包括为使用注射或非注射药物的人提供服务的医疗保健机构，或为发育障碍者提供的集体住宅和非住宿日托机构（不需要个体风险因素筛查） NO.8 水痘疫苗/VRV 一般人群 如果没有水痘免疫史或对水痘免疫力的证据，建议间隔4-8周接种2剂水痘疫苗。如果之前接种过1剂，则应至少间隔4周再接种1剂。 对水痘存在免疫力的证据为：1980年以前在美国出生（除孕妇和医护人员），有间隔4-8周的2剂水痘疫苗接种史证明文件，医疗机构确诊的患有过水痘或带状疱疹病史者，以及免疫或疾病的实验室证据。 特殊人群 无水痘免疫力证据的孕妇：妊娠期间禁止接种。分娩后至出院前，按一般人群的常规程序接种1剂或2剂。 无水痘免疫力证据的医务人员：按一般人群的常规程序接种1剂或2剂。 HIV感染：CD4 百分比≥15%和CD4计数≥200个细胞/mm3无免疫力证据：可以考虑接种疫苗（2剂，间隔3个月）。CD4百分比<15%或CD4 计数<200个细胞/mm3的HIV感染者禁止接种。 NO.9 呼吸道合胞病毒疫苗/RSV 孕期女性 在美国大陆的大部分地区，从9月到次年1月，怀孕32周0天至36周零6天的19-49岁孕妇，应接种1剂辉瑞的Abrysvo。 无论既往是否感染RSV，都应接种RSV疫苗，其他孕龄和非流行季怀孕者不建议接种。 已经接种过Abrysvo但后续怀孕者，暂无数据支持接种额外剂次。 呼吸道合胞病毒单抗：使用nirsevimab（RSV 单克隆抗体）进行婴儿免疫接种，以预防婴儿严重的呼吸道合胞病毒病。 既往怀孕期间接种 RSV 疫苗的孕妇所生的婴儿，应接种nirsevimab。 年龄≥75岁者 若既往未接种过RSV疫苗，则建议接种1剂。不建议接种额外剂量，包括既往接种过RSV疫苗者。 特殊情况 年龄60-74岁：未接种疫苗且患严重RSV疾病的风险增加**：1剂(Arexvy或Abrysvo或mResvia)，不建议额外接种。 以前接种过疫苗：不建议额外剂量。没有数据可以告诉我们是否需要要额外的剂量。 **人们可以自我证明存在风险因素。以下医疗状况和其他状况会增加患严重 RSV 疾病的风险：慢性心血管疾病,例如心力衰竭、冠状动脉疾病、先天性心脏病病。不包括孤立性高血压。慢性肺病或呼吸系统疾病,例如慢性阻塞性肺病、肺气肿、哮喘尚质性肺病、囊性纤维化。终末期肾病或依赖血液透析或其他肾脏替代疗法。糖尿病并发慢性肾病、神经病变、视网膜病变或其他终末器官损伤需要胰岛素或钠-葡萄糖协同转运蛋白2(SGLT2)抑制剂治疗的糖尿病。导致气道清除受损或呼吸肌无力的神经或神经肌肉疾病,例如,中风后吞咽困难、肌菱缩侧索硬化症、肌肉萎缩症。排除无气道清除功能受损的卒中中病史。慢性肝病,例如肝硬化慢性血液病,例如镰状细胞病、地中海贫血。严重肥胖(体重指数≥40kg/m2)。中度或重度免疫功能低下。住在疗养院。医疗保健提供者确定会增加因病毒性呼吸道感染而患重病风险的其他慢性疾病或风险因素,例如虚弱、担心存在未确诊的慢性疾病、居住在难以升级及医疗护理的偏远或农村社区。 NO.10 麻腮风疫苗/MMR 常规接种 无麻腮风免疫力证据的19-64岁人群，建议接种1剂或2剂，具体取决于适应症。 免疫力证据：1957 年之前出生（医护人员除外，见下文）、接受MMR 疫苗的文件、免疫力或疾病的实验室证据（未经实验室确认的疾病诊断不是免疫力的证据）。 特殊人群： 没有禁忌症、无风疹疫苗免疫史的非孕期育龄期女性，建议接种1剂。孕期禁止接种，分娩后、出院前可接种1剂。 CD4百分比≥15% 且CD4计数≥200个细胞/mm3的HIV感染至少6个月，且无对麻疹、腮腺炎或风疹免疫的证据：至少间隔4周完成2剂系列接种。CD4百分比<15%或CD4计数<200个细胞/mm3的HIV感染禁止接种MMR。 高等教育机构的学生、国际旅行者以及免疫功能低下者的家庭或密切个人接触者，若没有证据表明他们对麻疹、腮腺炎或风疹有免疫力：若此前未接种过MMR，则至少间隔4周完成 2剂程序。如果之前接受过1剂MMR，则间隔至少1剂。