Johnson & Johnson COVID-19 Vaccine Booster Shot Unanimously Recommended for Emergency Use Authorization by U.S. FDA Advisory Committee

美国FDA咨询委员会一致推荐强生新冠肺炎疫苗强化剂紧急使用授权

2021-10-16 08:00:07 Investing News Network

本文共4055个字,阅读需11分钟

Johnson & Johnson today announced the U.S. Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee unanimously voted 19-0 to recommend Emergency Use Authorization for a booster dose of the Johnson & Johnson COVID-19 vaccine for adults aged 18 and older at least two months following initial vaccination with the single-shot vaccine. The vote was based on findings from two Company … – Johnson & Johnson (NYSE: JNJ) (the Company) today announced the U.S. Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) unanimously voted 19-0 to recommend Emergency Use Authorization (EUA) for a booster dose of the Johnson & Johnson COVID-19 vaccine for adults aged 18 and older at least two months following initial vaccination with the single-shot vaccine. The vote was based on findings from two Company clinical trials, including the Phase 3 ENSEMBLE 2 study , which evaluated a booster dose of the Johnson & Johnson COVID-19 vaccine administered two months after the single-shot, as well as a large and robust real-world evidence study. The Company also presented data that support the increased potential of a booster when administered at six months. Phase 3 clinical data and real-world data both demonstrated the Johnson & Johnson single-shot COVID-19 vaccine was strong and long-lasting. “Today’s recommendation is based on the totality of evidence, with clinical and real-world data showing that while a single shot offers strong and long-lasting protection against COVID-19, a booster given after the single-dose primary vaccination increases protection, in particular against symptomatic COVID-19,” said Paul Stoffels , M.D., Vice Chairman of the Executive Committee and Chief Scientific Officer, Johnson & Johnson. “Johnson & Johnson is steadfast in its commitment to protect as many people globally as possible against the continued spread of COVID-19,” said Mathai Mammen , M.D., Ph.D., Global Head, Janssen Research & Development, Johnson & Johnson. “Today’s recommendation by the VRBPAC is another step toward ensuring that those who have received the single-shot Johnson & Johnson vaccine – or will receive it in the future – are provided the opportunity to increase their protection against COVID-19. We look forward to sharing these data with regulatory bodies and advisory groups around the world to address the continued threat of COVID-19.” The Company’s EUA amendment submission included results from the Phase 3 ENSEMBLE 2 study, which found a booster dose at two months provided 94 percent protection against symptomatic (moderate to severe/critical) COVID-19 in the United States (CI, 58%-100%) and 100 percent protection (CI, 33%-100%) against severe/critical COVID-19, at least 14 days post-booster vaccination. Also submitted were findings from a Phase 1/2a study evaluating a booster dose given six months after the first shot, which show antibody levels increased nine-fold one week after the booster, and continued to climb to 12-fold higher four weeks after the booster. The vaccine, when given as a booster or primary dose, was generally well-tolerated, with no new safety signals observed in the two-dose ENSEMBLE 2 trial compared with single-dose studies. The submission also included data from a large and robust U.S. real-world evidence study, conducted from March to July 31, 2021 , and recently extended to August 31, 2021 . These real-world data demonstrated the single-dose Johnson & Johnson COVID-19 vaccine showed stable vaccine effectiveness of 76 percent (CI, 75%-77%) for COVID-19-related infections and 81 percent (CI, 79%-84%) for COVID-19-related hospitalizations, with no evidence of reduced effectiveness over the study duration of six months – including when the Delta variant became dominant in the U.S. (sequencing data were not available for analysis). Johnson & Johnson remains committed to helping end this pandemic as quickly as possible and is committed to diligently generating and evaluating real-world evidence, as well as evidence from its ongoing clinical trial program. The Company anticipates a decision from the FDA on the EUA amendment for a booster dose of the Johnson & Johnson COVID-19 vaccine in the coming days, and plans to submit relevant data to other regulators, the World Health Organization (WHO) and National Immunization Technical Advisory Groups (NITAGs) worldwide to inform decision-making on local vaccine administration strategies, as needed. The Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) will discuss the use of boosters and provide a potential recommendation on October 21 . In the U.S., there is sufficient supply to support boosting to those who have received the more than 15.1 million doses of the Johnson & Johnson COVID-19 vaccine that have been administered as primary vaccinations. The Johnson & Johnson single-shot COVID-19 vaccine, developed by its Janssen Pharmaceutical Companies of Johnson & Johnson, received initial EUA in the United States on February 27, 2021 and Conditional Marketing Authorization (CMA) by the European Commission on March 11 . The World Health Organization (WHO) issued Emergency Use Listing on March 12 , and the Company received an interim recommendation by the Strategic Advisory Group of Experts (SAGE) on Immunization for the WHO on March 17 . Many more authorizations have been granted in countries worldwide, and regulatory submissions are ongoing. For more information on the Company’s multi-pronged approach to helping combat the pandemic, visit: www.jnj.com/covid-19 . Authorized Use The Janssen COVID-19 vaccine is authorized for use in the U.S. under an Emergency Use Authorization (EUA) for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 18 years of age and older. IMPORTANT SAFETY INFORMATION WHAT SHOULD YOU MENTION TO YOUR VACCINATION PROVIDER BEFORE YOU GET THE JANSSEN COVID-19 VACCINE? Tell the vaccination provider about all of your medical conditions, including if you: WHO SHOULD NOT GET THE JANSSEN COVID-19 VACCINE? You should not get the Janssen COVID-19 Vaccine if you: HOW IS THE JANSSEN COVID-19 VACCINE GIVEN? The Janssen COVID-19 Vaccine will be given to you as an injection into the muscle. The Janssen COVID-19 Vaccine vaccination schedule is a single dose . WHAT ARE THE RISKS OF THE JANSSEN COVID-19 VACCINE? Side effects that have been reported with the Janssen COVID-19 Vaccine include: Severe Allergic Reactions There is a remote chance that the Janssen COVID-19 Vaccine could cause a severe allergic reaction. A severe allergic reaction would usually occur within a few minutes to one hour after getting a dose of the Janssen COVID-19 Vaccine. For this reason, your vaccination provider may ask you to stay at the place where you received your vaccine for monitoring after vaccination. Signs of a severe allergic reaction can include: Blood Clots with Low Levels of Platelets Blood clots involving blood vessels in the brain, lungs, abdomen, and legs along with low levels of platelets (blood cells that help your body stop bleeding), have occurred in some people who have received the Janssen COVID-19 Vaccine. In people who developed these blood clots and low levels of platelets, symptoms began approximately one to two-weeks following vaccination. Reporting of these blood clots and low levels of platelets has been highest in females ages 18 through 49 years. The chance of having this occur is remote. You should seek medical attention right away if you have any of the following symptoms after receiving Janssen COVID-19 Vaccine: These may not be all the possible side effects of the Janssen COVID-19 Vaccine. Serious and unexpected effects may occur. The Janssen COVID-19 Vaccine is still being studied in clinical trials. Guillain Barré Syndrome Guillain Barré syndrome (a neurological disorder in which the body’s immune system damages nerve cells, causing muscle weakness and sometimes paralysis) has occurred in some people who have received the Janssen COVID-19 Vaccine. In most of these people, symptoms began within 42 days following receipt of the Janssen COVID-19 Vaccine. The chance of having this occur is very low. You should seek medical attention right away if you develop any of the following symptoms after receiving the Janssen COVID-19 Vaccine: WHAT SHOULD I DO ABOUT SIDE EFFECTS? If you experience a severe allergic reaction, call 9-1-1, or go to the nearest hospital. Call the vaccination provider or your healthcare provider if you have any side effects that bother you or do not go away. Report vaccine side effects to FDA/CDC Vaccine Adverse Event Reporting System (VAERS). The VAERS toll-free number is 1-800-822-7967 or report online to https://vaers.hhs.gov/reportevent.html . Please include “Janssen COVID-19 Vaccine EUA” in the first line of box #18 of the report form. In addition, you can report side effects to Janssen Biotech Inc. at 1-800-565-4008. Please read Emergency Use Authorization (EUA) Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) including full EUA Prescribing Information available at www.JanssenCOVID19Vaccine.com/EUA-factsheet About Johnson & Johnson At Johnson & Johnson, we believe good health is the foundation of vibrant lives, thriving communities and forward progress. That’s why for more than 130 years, we have aimed to keep people well at every age and every stage of life. Today, as the world’s largest and most broadly-based healthcare company, we are committed to using our reach and size for good. We strive to improve access and affordability, create healthier communities, and put a healthy mind, body and environment within reach of everyone, everywhere. We are blending our heart, science and ingenuity to profoundly change the trajectory of health for humanity. Learn more at www.jnj.com . Follow us at @JNJNews. About the Janssen Pharmaceutical Companies of Johnson & Johnson At Janssen, we’re creating a future where disease is a thing of the past. We’re the Pharmaceutical Companies of Johnson & Johnson, working tirelessly to make that future a reality for patients everywhere by fighting sickness with science, improving access with ingenuity, and healing hopelessness with heart. We focus on areas of medicine where we can make the biggest difference: Cardiovascular & Metabolism, Immunology, Infectious Diseases & Vaccines, Neuroscience, Oncology, and Pulmonary Hypertension. Learn more at www.janssen.com . Follow us at @JanssenGlobal. Cautions Concerning Forward-Looking Statements This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 regarding development of a potential preventive vaccine for COVID-19. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of the Janssen Pharmaceutical Companies, and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson’s Annual Report on Form 10-K for the fiscal year ended January 3, 2021 , including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in the company’s most recently filed Quarterly Report on Form 10-Q, and the company’s subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov , www.jnj.com or on request from Johnson & Johnson. None of the Janssen Pharmaceutical Companies nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments. View original content to download multimedia: https://www.prnewswire.com/news-releases/johnson–johnson-covid-19-vaccine-booster-shot-unanimously-recommended-for-emergency-use-authorization-by-us-fda-advisory-committee-301401523.html SOURCE Johnson & Johnson News Provided by Canada Newswire via QuoteMedia
强生公司今天宣布,美国食品药品监督管理局疫苗和相关生物制品咨询委员会一致以19比0的投票结果,建议在首次接种单针疫苗后至少两个月,为18岁及以上的成年人紧急使用强生新冠肺炎疫苗的加强剂量授权。投票是基于两家公司的调查结果… -强生公司(纽约证券交易所代码:JNJ)(该公司)今天宣布,美国食品药品监督管理局(FDA)疫苗和相关生物制品咨询委员会(VRBPAC)一致以19比0的投票结果,建议为18岁及以上的成年人在首次接种单针疫苗后至少两个月的时间内提供强生新冠肺炎疫苗的加强剂量紧急使用授权(EUA)。 投票是基于两项公司临床试验的发现,包括第三阶段集成2研究,该研究评估了单次注射两个月后注射的强生新冠肺炎疫苗的加强剂量,以及一项大型和强有力的现实世界证据研究。该公司还提供了数据,支持在六个月时使用助推器的潜力增加。3期临床数据和现实世界数据都表明强生单次注射新冠肺炎疫苗是强大和持久的。 强生公司执行委员会副主席兼首席科学官保罗·斯托菲尔斯(Paul Stoffels)医学博士说:“今天的建议是基于全部证据,临床和现实世界的数据显示,虽然单次注射提供了对新冠肺炎病毒的强大而持久的保护,但单剂初级疫苗接种后给予的助推器增加了保护,尤其是对有症状的新冠肺炎病毒的保护。” 强生公司让桑研发公司全球负责人、医学博士马泰·曼门(Mathai Mammen)表示:“强生公司坚定不移地致力于保护全球尽可能多的人免受新冠肺炎病毒的持续传播。”“VRBPAC今天的建议是向确保那些已经接受单次注射强生疫苗的人--或者将来将接受这种疫苗的人--有机会增加对新冠肺炎的保护迈出的又一步。我们期待着与世界各地的监管机构和咨询小组分享这些数据,以应对新冠肺炎的持续威胁。“ 该公司提交的EUA修正案包括第三阶段集成2研究的结果,该研究发现,在强化疫苗接种后至少14天,两个月的强化剂量对美国症状性(中度至重度/危重)新冠肺炎提供了94%的保护(CI,58%-100%)和对重度/危重新冠肺炎提供了100%的保护(CI,33%-100%)。还提交了1/2期a研究的发现,该研究评估了第一次注射后6个月给予的加强剂量,显示抗体水平在加强剂量后一周增加了9倍,并在加强剂量后四周继续攀升至12倍。 这种疫苗作为强化剂或主剂量给予时,通常耐受性良好,与单剂量研究相比,在两剂量集成2试验中没有观察到新的安全信号。 提交的材料还包括一项大型、稳健的美国现实世界证据研究的数据,该研究于2021年3月至7月31日进行,最近延长至2021年8月31日。这些真实世界的数据表明,单剂量强生新冠肺炎疫苗对新冠肺炎相关感染的稳定疫苗效力为76%(CI,75%-77%),对新冠肺炎相关住院的稳定疫苗效力为81%(CI,79%-84%),在为期六个月的研究期间,没有证据表明效力降低--包括德尔塔变异毒株在美国占主导地位的时候(测序数据无法用于分析)。 强生公司仍然致力于帮助尽快结束这一流行病,并致力于努力生成和评估现实世界的证据,以及来自其正在进行的临床试验项目的证据。 该公司预计美国食品和药物管理局将在未来几天就强生新冠肺炎疫苗加强剂量的EUA修正案做出决定,并计划向其他监管机构、世界卫生组织(世卫组织)和世界各地的国家免疫技术咨询小组(NITAGs)提交相关数据,以根据需要为当地疫苗管理战略的决策提供信息。疾病控制和预防中心(CDC)免疫实践咨询委员会(ACIP)将于10月21日讨论助推器的使用,并提供一项潜在的建议。 在美国,有足够的供应来支持那些接受了1510多万剂强生新冠肺炎疫苗的人,这些疫苗是作为初级疫苗接种的。 强生公司旗下杨森制药公司开发的强生单针新冠肺炎疫苗于2021年2月27日在美国获得初步EUA,并于3月11日获得欧盟委员会的有条件上市授权(CMA)。世界卫生组织(WHO)于3月12日发布了紧急使用清单,该公司于3月17日收到了世界卫生组织免疫战略咨询专家小组(SAGE)的临时建议。世界各国已经批准了更多的授权,监管提交工作正在进行中。 欲了解更多关于该公司多管齐下帮助抗击这一流行病的信息,请访问:www.jnj.com/COVID-19 授权使用杨森新冠肺炎疫苗根据紧急使用授权(EUA)授权在美国使用,用于主动免疫,以预防由严重急性呼吸系统综合征冠状病毒2号(新型冠状病毒)在18岁及以上的个人中引起的冠状病毒疾病2019(新冠肺炎)。 重要安全信息 在你接种让桑新冠肺炎疫苗之前,你应该向你的疫苗接种提供者提到什么?告诉疫苗接种提供者您的所有医疗状况,包括如果您: 世界卫生组织不应该接种让桑新冠肺炎疫苗?如果你: 杨森新冠肺炎疫苗是如何接种的?让桑新冠肺炎疫苗将作为肌肉注射给你。杨森新冠肺炎疫苗接种计划是单剂。 杨森新冠肺炎疫苗有什么风险?据报道,杨森新冠肺炎疫苗的副作用包括: 严重过敏反应让桑新冠肺炎疫苗极有可能导致严重过敏反应。严重的过敏反应通常会在接种一剂让桑新冠肺炎疫苗后的几分钟到一小时内发生。出于这个原因,你的疫苗接种提供者可能会要求你在接种疫苗后留在你接种疫苗的地方进行监测。严重过敏反应的征兆包括: 一些接受让桑新冠肺炎疫苗的人出现了涉及大脑、肺部、腹部和腿部血管的血凝块以及低水平的血小板(帮助身体止血的血细胞)。在出现这些血凝块和低水平血小板的人中,症状在接种疫苗后大约一到两周开始。这些血凝块和低水平血小板的报告在18至49岁的女性中最高。发生这种情况的可能性很小。如果接种杨森新冠肺炎疫苗后出现以下任何症状,应立即就医: 这些可能不是让桑新冠肺炎疫苗可能的全部副作用。可能会发生严重和意想不到的影响。杨森新冠肺炎疫苗仍在临床试验中研究。 格林巴利综合征格林巴利综合征(一种神经系统疾病,身体免疫系统损害神经细胞,导致肌肉无力,有时瘫痪)发生在一些接种了让桑新冠肺炎疫苗的人身上。在这些人中,大多数人在接受让桑新冠肺炎疫苗后42天内开始出现症状。发生这种情况的机会很低。如果你在接种杨森新冠肺炎疫苗后出现以下任何症状,你应该立即就医: 副作用怎么办?如果你经历了严重的过敏反应,拨打9-1-1,或者去最近的医院。 如果你有任何副作用困扰你或没有消失,请打电话给疫苗接种提供者或你的医疗保健提供者。 向FDA/CDC疫苗不良事件报告系统(VAERS)报告疫苗副作用。VAERS的免费电话号码是1-800-822-7967或在线报告https://VAERS.hhs.gov/reportevent.html。请在报告表格第18栏第一行填写“杨森新冠肺炎疫苗EUA”。此外,您可以向让桑生物技术公司报告副作用,电话1-800-565-4008。 请阅读紧急使用授权(EUA)概况介绍,用于管理疫苗的医疗保健提供者(疫苗接种提供者),包括EUA处方的完整信息,请访问www.janssencovid19vaccine.com/eua-factsheet 关于强生在强生,我们相信良好的健康是充满活力的生活,繁荣的社区和前进的基础。这就是为什么130多年来,我们一直致力于让人们在每个年龄和每个阶段都保持健康。今天,作为世界上最大和基础最广泛的医疗保健公司,我们致力于利用我们的影响力和规模永远。我们努力改善获得和负担能力,创造更健康的社区,让每个人、每个地方都能获得健康的身心和环境。我们正将我们的心、科学和智慧融为一体,深刻地改变人类健康的轨迹。在www.jnj.com了解更多信息。请在@jnjnews关注我们。 关于让桑的强生制药公司,我们正在创造一个疾病已经成为过去的未来。我们是强生公司的制药公司,通过用科学对抗疾病,用独创性改善获得机会,用心灵治愈绝望,不知疲倦地努力使未来成为世界各地患者的现实。我们专注于我们能做出最大改变的医学领域:心血管和新陈代谢、免疫学、传染病和疫苗、神经科学、肿瘤学和肺动脉高压。在www.janssen.com了解更多信息。在@janssenglobal关注我们。 关于前瞻性声明的警告本新闻稿包含1995年私人证券诉讼改革法案中定义的关于开发新冠肺炎潜在预防性疫苗的“前瞻性声明”。告诫读者不要依赖这些前瞻性陈述。这些陈述是基于当前对未来事件的预期。如果基础假设证明不准确,或已知或未知风险或不确定性实现,实际结果可能与杨森制药公司和/或强生公司的预期和预测有很大差异。风险和不确定性包括但不限于:产品研发中固有的挑战和不确定性,包括临床成功和获得监管批准的不确定性;商业成功的不确定性;制造困难和延误;竞争,包括竞争对手取得的技术进步、新产品和专利;对专利的挑战;产品功效或安全问题导致产品召回或管制行动;保健产品和服务购买者行为和消费模式的变化;对适用法律和条例的修改,包括全球卫生保健改革;以及控制医疗费用的趋势。有关这些风险、不确定性和其他因素的进一步列表和描述,请参见强生公司截至2021年1月3日的年度报告10-K表,包括标题为“关于前瞻性陈述的警告说明”和“项目1A”的章节。风险因素“,并在该公司最近提交的季度报告表10-Q,以及该公司随后向证券交易委员会提交的文件中。这些文件的副本可在www.sec.gov、www.jnj.com或强生公司索取。杨森制药公司和强生公司都没有承诺因新的信息或未来的事件或发展而更新任何前瞻性声明。 查看原始内容以下载多媒体:https://www.prnewswire.com/news-releases/johnson-johnson-covid-vaccurine-booster-shot-uncommonusy-re荐-for-emergency-use-authorization-by-us-fda-advisory-committee-301401523.html 来源|强生 加拿大新闻通讯社通过QuoteMedia提供的新闻

以上中文文本为机器翻译,存在不同程度偏差和错误;偶尔因源网页结构局限,内容无法一次完整呈现。请理解并参考原站原文阅读。

阅读原文