Phase I Clinical Trial to Evaluate the Safety and Explore the Immunogenicity of a Candidate PCV13 in Healthy People Aged 2 Months (Minimum 6 Weeks) and Above

Streptococcus pneumoniae is a major cause of morbidity and mortality in children worldwide, resulting in up to 1 million pediatric deaths every year. Since the licensure of PCV7, PCV10, PCV13 and PCV15, the reported overall decline in invasive pneumococcal disease in hospitalized children younger than 5 years is approximately 60% around the world.
This is a single center, blinded, randomized, positive-controlled phase I clinical trial to evaluate the safety and explore the immunogenicity of a candidate PCV13 in healthy people aged 2 months (minimum 6 weeks) and above.

开始日期2022-11-01

申办/合作机构

武汉博沃生物科技有限公司

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100 项与 13价肺炎球菌结合疫苗（博沃生物）相关的临床结果

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100 项与 13价肺炎球菌结合疫苗（博沃生物）相关的转化医学

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100 项与 13价肺炎球菌结合疫苗（博沃生物）相关的专利（医药）

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项与 13价肺炎球菌结合疫苗（博沃生物）相关的文献（医药）

2024-09-20·MEDICINE

Immunization strategies for individuals with sickle cell anemia: A narrative review

Review

作者: Obeagu, Getrude Uzoma ; Obeagu, Emmanuel Ifeanyi

Sickle cell anemia (SCA) is a hereditary blood disorder characterized by the production of abnormal hemoglobin, leading to the formation of sickle-shaped red blood cells. These distorted cells can obstruct blood flow, causing vaso-occlusive crises and increasing the risk of severe infections due to functional asplenia and immune system dysregulation. Immunization is a crucial strategy to mitigate infection-related complications in individuals with SCA, necessitating a comprehensive and tailored vaccination approach. Current immunization guidelines for individuals with SCA recommend a combination of standard and additional vaccines to address their heightened susceptibility to infections. Key vaccines include pneumococcal conjugate (PCV13) and polysaccharide (PPSV23) vaccines, meningococcal conjugate (MenACWY) and serogroup B (MenB) vaccines, Haemophilus influenzae type b (Hib) vaccine, annual influenza vaccine, and hepatitis A and B vaccines. These vaccinations aim to provide broad protection against pathogens that pose significant risks to patients with SCA. Despite generally adequate immune responses, the variability in vaccine efficacy due to immune dysfunction necessitates booster doses and additional vaccinations. This narrative review highlights the importance of adhering to current immunization recommendations and addresses challenges such as access to care, vaccine hesitancy, and monitoring vaccination status.

2024-09-01·CLINICAL MICROBIOLOGY AND INFECTION

Comparative effectiveness of pneumococcal vaccination strategies to prevent invasive pneumococcal disease: a population-based cohort study at the veterans health administration in the United States

Article

作者: Perencevich, Eli N. ; Perencevich, Eli N ; Hasegawa, Shinya ; Goto, Michihiko ; Jones, Michael P ; Kakiuchi, Satoshi ; Jones, Michael P.

OBJECTIVES:

Comparative effectiveness of 13-valent pneumococcal conjugate vaccine (PCV13), 23-valent polysaccharide vaccine (PPSV23), and their combinations for adults in preventing invasive pneumococcal disease (IPD) has yet to be thoroughly investigated. We aimed to estimate the comparative effectiveness of preventing IPD, using population-based data from the Veterans Health Administration (VHA) in the United States.

METHODS:

We included all patients who were between 65 and 74 years, had established primary care within VHA between 2005 and 2021, and had not received any prior pneumococcal vaccination. We measured time-to-event from cohort enrolment to the onset of IPD, considering death a competing risk event, and used Cox regression models to estimate cause-specific hazards. PCV13 only, PPSV23 only, PCV13 after PPSV23, and PPSV23 after PCV13 were incorporated into models as time-dependent covariates. Patient demographics and comorbidities were also included in the model.

RESULTS:

A total of 3 044 067 patients were enrolled in the cohort, with 863 958 deaths (28.4%) and 1731 cases of IPD (0.06%) during the study period. The overall incidence rate of IPD in this population was 5.36 per 100 000 patient-years. A total of 921 070 patients (30.3%) received at least one dose of effective pneumococcal vaccine. In multivariate analysis adjusted for comorbidities, PCV13 alone was not associated with the reduced risk of IPD, whereas PPSV23 had protective association with IPD incidence (adjusted hazard ratio [aHR], 0.70; 95% CI, 0.59-0.83). When combined, PCV13 followed by PPSV23 had a stronger protective association (aHR, 0.54; [0.36-0.83]) compared with PPSV23 followed by PCV13 (aHR, 0.73; [0.58-0.91]).

DISCUSSION:

In this large cohort study at the VHA, the combination of PCV13 and PPSV23, particularly PCV13 followed by PPSV23, was associated with a lower risk of IPD, indicating additional benefits in combined vaccinations with potential importance in vaccination order. Further studies are needed to evaluate the effect of newer pneumococcal vaccines.

2024-07-01·WMJ : official publication of the State Medical Society of Wisconsin

Knowledge, Attitudes, and Behaviors Regarding Pneumococcal Vaccines in Adults 65 Years and Older in Primary Care in Wisconsin.

Article

作者: Hunter, Paul H ; Henningfield, Mary F ; Sampson, Lisa ; Yuroff, Alice

INTRODUCTION:

Although shared decision-making is highly valued, its implementation in clinical practice is suboptimal. Shared decision-making was included in the Centers for Disease Control and Prevention (CDC) recommendations for the pneumococcal conjugate vaccine 13 valent for older adults. As a first step to develop and test clinician educational resources to facilitate shared decision-making for pneumococcal vaccines for older adults, we completed a needs assessment to identify knowledge gaps, attitudes, and behaviors.

METHODS:

Primary care clinicians, pharmacists, and patient care staff completed a questionnaire on shared decision-making and pneumococcal vaccines. After the CDC recommended new pneumococcal vaccines and eliminated the role of shared decision-making, a revised questionnaire was distributed to additional clinicians in an effort to increase the sample size.

RESULTS:

Knowledge of pneumococcal vaccine recommendations was high among those who responded to knowledge questions (48 of 75 respondents). Although 96% of respondents believed shared decision-making for use of pneumococcal vaccines in adults 65 years or older was feasible, 25% responded that it would be "somewhat difficult" to explain potential harms and benefits of PCV13.

DISCUSSION:

Although shared decision-making was reported to be feasible, challenges implementing it are ongoing. Knowledge gaps regarding pneumococcal vaccines were observed, highlighting the need for ongoing medical education with changing vaccine recommendations.

项与 13价肺炎球菌结合疫苗（博沃生物）相关的新闻（医药）

2024-10-08

·BioSpace

Pfizer to Showcase Scientific Advancements in Respiratory and Other Infectious Diseases at IDWeek 2024

Presentations highlight momentum of Pfizer’s portfolio of infectious disease prevention and treatment options NEW YORK--(BUSINESS WIRE)-- Pfizer Inc. (NYSE: PFE) will present data across its infectious disease portfolio at the upcoming IDWeek 2024 congress, held in Los Angeles from October 16-19, 2024. Data in 49 abstracts from company- and collaborator-led studies, will highlight the advances Pfizer is making in helping prevent and treat infectious diseases. “Pfizer is at the forefront of vaccine and therapeutic development in respiratory and infectious diseases,” said Annaliesa Anderson, Ph.D., Senior Vice President and Head, Vaccine Research and Development, Pfizer. “IDWeek 2024 provides a crucial platform to showcase our innovative advancements and engage with the scientific community, as we work to effectively tackle the ongoing challenge posed by infectious diseases.” “As we approach another respiratory virus season, the importance of preventive vaccines and treatments to help keep us healthy is more apparent than ever,” said Luis Jodar, Ph.D., Chief Medical Affairs Officer, Vaccines/Antivirals, Pfizer. “We’re excited to present new, meaningful data that we hope will help further inform healthcare providers.” Pfizer will present research from its robust infectious disease portfolio, covering RSV, COVID-19, pneumococcal disease, Lyme disease, meningococcal disease, and serious bacterial and fungal infections. Details for Pfizer-sponsored, investigator-sponsored and collaborative research oral and poster presentations are below: Title/Abstract Number Presenting Name/Type Date/Time (PDT) Location ORAL & LATE-BREAKING PRESENTATIONS 580 - Pharmacokinetics (PK) and Safety of Nirmatrelvir/Ritonavir (NMV/r) in Non-Hospitalized Symptomatic Pediatric Patients Ages 6 Years and Older with COVID-19 Who Are at Increased Risk of Progression to Severe Disease (EPIC-Peds) Jacqueline Gerhart, PhD Oct 19 2:45 – 2:57 PM US PT 403 A 88 - Efficacy of Nirmatrelvir/Ritonavir in High-Risk Trial Participants With Prior SARS-CoV-2 Infection or Vaccination: A Pooled Analysis John M. McLaughlin, PhD Oct 17 10:42 – 10:54 AM US PT 411 165 - Real-world Abrysvo vaccine effectiveness (VE) against Respiratory Syncytial Virus (RSV)-related severe acute respiratory infection (ARI) hospitalizations and emergency department (ED) visits—Kaiser Permanente of Southern California (KPSC), November 2023-April 2024 Sara Tartof, PhD, MPH, (KPSC)* Oct 17 1:45 – 3:00 PM US PT 403A 571 – Safety and Immunogenicity of Coadministered Bivalent BNT162b2 COVID-19 Vaccine and Bivalent RSVpreF Respiratory Syncytial Virus Vaccine With and Without Quadrivalent Influenza Vaccine in Adults ≥ 65 Years of Age Rahsan Erdem, MD Oct 19 1:45 – 2:03 PM US PT 408 A POSTER PRESENTATIONS COVID-19 P - 1194 - Comparison of COVID-19 Inpatient Burden in Hospitalized Children Age < 5years, by SARS-CoV-2 Variant Kathleen M. Andersen, PhD MSc Oct 18 12:15 – 1:30 PM US PT Hall J & K P - 1906 - Early COVID-19 and Severity of Subsequent Omicron Infection in Ontario, Canada Caroline Kassee, MPH (Sinai Health)* Oct 19 12:15 – 1:30 PM US PT Hall J & K P - 1977 - Six-Month Trajectory of Symptoms of COVID-19 Fatigue by Age and BNT162b2 COVID-19 Vaccination Status: A Prospective Study Among Symptomatic US Adults Testing Positive for SARS-CoV-2 at a National Retail Pharmacy Manuela Di Fusco, PhD Oct 19 12:15 – 1:30 PM US PT Hall J & K P - 2047 - Public Health Impact and Economic Value of an Additional Dose of Pfizer-BioNTech XBB.1.5-adapted COVID-19 Vaccine for Older Adults in the United States Alon Yehoshua, PharmD, MS Oct 19 12:15 – 1:30 PM US PT Hall J & K P - 2048 - COVID-19 XBB.1.5 vaccine uptake based on state vaccine registries compared to national survey data Angela Cook, MS Oct 19 12:15 – 1:30 PM US PT Hall J & K P - 2054 - Effectiveness of a Single COVID-19 mRNA Vaccine Dose in Individuals Previously Infected with SARS-CoV-2: A Systematic Review Hannah R. Volkman, PhD, MPH Oct 19 12:15 – 1:30 PM US PT Hall J & K P - 2060 - Effectiveness of BNT162b2 COVID-19 Vaccination Against Long COVID Among Older Adults: A Nationwide Study Manuela Di Fusco, PhD Oct 19 12:15 – 1:30 PM US PT Hall J & K P - 2062 - COVID-19 XBB.1.5-adapted vaccine uptake in immunocompromised individuals using tokenized state vaccine registries Matthew A. Brouillette, MPH Oct 19 12:15 – 1:30 PM US PT Hall J & K P - 2017 - Patient Reported Outcomes of Nirmatrelvir/Ritonavir Treatment for High-risk, Nonhospitalized Adults with Symptomatic COVID-19 Ashley S. Cha-Silva, PharmD, MS Oct 19 12:15 – 1:30 PM US PT Hall J & K Lyme Disease P - 599 - 6-Valent, OspA-Based VLA15 Lyme Disease Vaccine Candidate Against Lyme Borreliosis in a Healthy Pediatric and Adult Study Population: A Phase 2 Study Update James H. Stark, PhD Oct 17 12:15 – 1:30 PM US PT Hall J & K P - 1287 - Incidence of Symptomatic Lyme Borreliosis in Nine European Countries, 2018−2022 Frederick Angulo, DVM PhD Oct 18 12:15 – 1:30 PM US PT Hall J & K P - 1291 - Racial disparities in Lyme disease among beneficiaries of US Medicaid and Medicare L. Hannah Gould, PhD, MS, MBA Oct 18 12:15 – 1:30 PM US PT Hall J & K P - 1293 - Healthcare Costs Associated with Lyme Disease in a U.S. Insured Population Holly Yu, MSPH Oct 18 12:15 – 1:30 PM US PT Hall J & K Meningococcal Disease P - 1299 - Epidemiology of Invasive Meningococcal Disease in the United States: Review of Recent Data and Identified Risk Factors Jessica Presa, MD Oct 18 12:15 – 1:30 PM US PT Hall J & K P - 1304 - Public Health Impact of changes to Meningococcal vaccination platform in the United States Katharina Schley, Dr. rer pol. Oct 18 12:15 – 1:30 PM US PT Hall J & K Pneumococcal disease P - 8 - Assessment of 13-valent pneumococcal conjugate vaccine effectiveness among people living with HIV in the United States Amanda C. Miles, MPH Oct 17 12:15 – 1:30 PM US PT Hall J & K P - 628 - Real-world impact of pneumococcal conjugate vaccines on vaccine serotypes and cross-reacting non-vaccine serotypes Kevin Apodaca, MPH Oct 17 12:15 – 1:30 PM US PT Hall J & K P - 629 - The health and economic impact of the PCV15 and PCV20 priming series during the first year of life in the US Mark Rozenbaum, PhD, M.B.A Oct 17 12:15 – 1:30 PM US PT Hall J & K Respiratory Syncytial Virus (RSV) P - 673 - Respiratory Syncytial Virus (RSV) Hospitalizations During Off-Season Months Among Infants in US Amy W. Law, PharmD Oct 17 12:15 – 1:30 PM US PT Hall J & K P - 674 - The Economic Burden of Infant RSV Among US Caregivers Amy W. Law, PharmD Oct 17 12:15 – 1:30 PM US PT Hall J & K P - 40 - Impact of case and control selection on influenza vaccine effectiveness (VE) among adults aged 40 years and older hospitalized with acute respiratory illness (ARI) during 2022-2023 using a test negative design (TND): secondary analysis of the North America Multi-Specimen Study Negar Aliabadi, MD, MS Oct 17 12:15 – 1:30 PM US PT Hall J & K P - 1204 - Hospitalizations Associated with Respiratory Syncytial Virus (RSV) Illness Among Children and Adolescents in Ontario, Canada Sazini Nzula, PhD Oct 18 12:15 – 1:30 PM US PT Hall J & K P - 1205 - Impact of the COVID-19 Pandemic on Hospitalizations Associated with Respiratory Syncytial Virus (RSV) Illness Among Children and Adolescents in Ontario, Canada Sazini Nzula, PhD Oct 18 12:15 – 1:30 PM US PT Hall J & K P - 677 - Estimation of Respiratory Syncytial Virus-Attributable Hospitalizations Among Older Adults in Japan between 2015 and 2018: An Administrative Health Claims Database Analysis Asuka Yoshida, PhD Oct 17 12:15 – 1:30 PM US PT Hall J & K P - 680 - Estimated Respiratory Syncytial Virus (RSV)-Related Hospitalizations and Deaths Among Adults in Norway between 2010–2019 Caihua Liang, MD, PhD Oct 17 12:15 – 1:30 PM US PT Hall J & K P - 682 - The Risk of Cardiorespiratory Events for Up to 180 days Following Respiratory Syncytial Virus (RSV) Infection Hospitalization: A Self-Controlled Case Series Analysis Caihua Liang, MD, PhD Oct 17 12:15 – 1:30 PM US PT Hall J & K P – 683 – Estimation of RSV-Attributable Cardiovascular and Respiratory Hospitalizations in Adults in Germany, Between 2015-2019 Caroline Beese Oct 17 12:15 – 1:30 PM US PT Hall J & K P - 604 - Preliminary real-world Abrysvo vaccine effectiveness (VE) against Respiratory Syncytial Virus (RSV)-related lower respiratory tract disease (LRTD) hospitalizations and emergency department (ED) visits—Kaiser Permanente of Southern California (KPSC) November 2023-April 2024 Negar Aliabadi, MD, MS Oct 17 12:15 – 1:30 PM US PT Hall J & K P - 53 - Trends in Co-administration of Adult Vaccinations in the US Retail Pharmacy Setting Reiko Sato, PhD Oct 17 12:15 – 1:30 PM US PT Hall J & K P - 603 - Potential Public Health Impact of Respiratory Syncytial Virus (RSV) Vaccines for Prevention of RSV Among Older Adults in the United States Reiko Sato, PhD Oct 17 12:15 – 1:30 PM US PT Hall J & K P - 600 - Efficacy Of a Bivalent RSVpreF Vaccine in Older Adults Across a Second RSV Season John Woodside, PhD Oct 17 12:15 – 1:30 PM US PT Hall J & K P - 596 - Immunobridging Demonstrating Effectiveness of the Bivalent Respiratory Syncytial Virus (RSV) Prefusion F Subunit Vaccine in Adults 18-59 Years of Age at High Risk of Severe RSV Disease in a Phase 3 Trial: The C3671023 MONeT Study Results Elliot N. DeHaan, MD Oct 17 12:15 – 1:30 PM US PT Hall J & K P - 681 - Estimated Incidence of Respiratory Syncytial Virus (RSV)-Related Hospitalizations for Acute Respiratory Infections (ARIs), including Community Acquired Pneumonia (CAP), in Adults in Germany Caihua Liang, MD, PhD Oct 17 12:15 – 1:30 PM US PT Hall J & K P - 605 - Bivalent RSV Prefusion F-Based Subunit Vaccine Generates High and Durable Neutralizing Titers Across an Entire RSV Season Among Older Adults Tarek Mikati, MD, MPH Oct 17 12:15 – 1:30 PM US PT Hall J & K P - 595 - Public Health Impact of RSVpreF Vaccination on Older Adult Disease Outcomes Daniel Eiras, MD, MPH Oct 17 12:15 – 1:30 PM US PT Hall J & K P - 21 - Comparison of Three RSV Vaccine Lower Respiratory Tract Disease Primary Endpoint Definitions for Adult Vaccine Sarah E. Williams, MD. MPH Oct 17 12:15 – 1:30 PM US PT Hall J & K P - 2357 - Respiratory Syncytial Virus (RSV) Disease Burden Among Adults in Primary Care Settings in High-Income Countries: A Systematic Review and Modelling Study You Li; multiple Pfizer co-authors Oct 19 12:15 – 1:30 PM US PT Hall J & K Aztreonam-Avibactam P - 105 - Aztreonam-Avibactam Compared with Adjunctive Colistin Combined with Meropenem for the Treatment of Serious Gram-Negative Bacterial Infections: Subgroup Analysis of the Phase 3 REVISIT Study Heidi Leister-Tebbe, BSN Oct 17 12:15-1:30 PM US PT Hall J & K P - 1080 Aztreonam-Avibactam Activity Against Gram-negative Bacteria Isolated From Patients with Pneumonia from Europe, Asia, and Latin America (2021–2023) Helio S. Sader, MD, PhD, FIDSA Oct 18 12:15 – 1:30 PM US PT Hall J & K P - 1256 - Pharmacokinetic/Pharmacodynamic (PK/PD) Target Attainment Analyses for Aztreonam-Avibactam Dosing Regimens Susan Raber*, PharmD, MPH Oct 17 12:15 – 1:30 PM US PT Hall J & K P - 1508 - In Vitro Activity of Aztreonam-Avibactam Against Enterobacterales Isolates Producing Multiple β-lactamases Collected Globally as a Part of the ATLAS Global Surveillance Program From 2018-2022 Mark Estabrook*, PhD Oct 17 12:15 – 1:30 PM US PT Hall J & K P - 1509 - In Vitro Activity of Aztreonam-Avibactam Against Enterobacterales Isolated From Pediatric and Adult Patients Collected During the ATLAS Global Surveillance Program, 2018-2022 Mark Estabrook*, PhD Oct 18 12:15 – 1:30 PM US PT Hall J & K Isavuconazole P - 1168 - Activity of Isavuconazole and Comparator Agents Against Pediatric Fungal Isolates Collected from 2017–2023 in a Global Surveillance Program Marisa Winkler, MD, PhD Oct 17 12:15 – 1:30 PM US PT Hall J & K Ceftazidime-Avibactam P- 1506 - In Vitro Activity of Ceftazidime-Avibactam and Comparator Agents Against Pseudomonas aeruginosa Collected from Patients with Presumed Hospital- and Community-Acquired Respiratory Tract Infections as a Part of the ATLAS Global Surveillance Program 2018-2022 Mark Estabrook, PhD Oct 17 12:15 – 1:30 PM US PT Hall J & K P- 1507 - In Vitro Activity of Ceftazidime-Avibactam Against Enterobacterales Isolates Producing Multiple β-lactamases Collected Globally as a Part of the ATLAS Global Surveillance Program from 2018-2022 Mark Estabrook, PhD Oct 17 12:15 – 1:30 PM US PT Hall J & K * =multiple Pfizer co-authors Prescribing Information for Pfizer Medicines Please see full Prescribing Information for ABRYSVO ® (Respiratory Syncytial Virus Vaccine) or visit and . Please see full Prescribing Information for COMIRNATY ® (COVID-19 Vaccine, mRNA) or visit . Please see full Prescribing Information for CRESEMBA ® (Isavuconazonium Sulfate) or visit Please see full Prescribing Information for PAXLOVID TM (Nirmatrelvir and Ritonavir) or visit . Please see full Prescribing Information for PREVNAR 20 TM (Pneumococcal 20-valent Conjugate Vaccine) or visit . Please see full Prescribing Information for PREVNAR 13 ® (Pneumococcal 13-valent Conjugate Vaccine). Please see full Prescribing Information for ZAFICEFTA ® (Ceftazidime-Avibactam). About Pfizer: Breakthroughs That Change Patients’ Lives At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world’s premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For 175 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at . In addition, to learn more, please visit us on and follow us on X at @Pfizer and @Pfizer News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer . DISCLOSURE NOTICE: The information contained in this release is as of October 8, 2024. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments. This release contains forward-looking information about Pfizer’s infectious disease pipeline, in-line products and product candidates, including their potential benefits, that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risk and uncertainties include, among other things, uncertainties regarding the commercial success of Pfizer’s infectious disease products and product candidates; the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for our clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; risks associated with interim and preliminary data; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from our clinical studies; whether and when any drug applications, biologics license applications and/or emergency use authorization applications may be filed in any jurisdictions for any potential indication for Pfizer’s product candidates; whether and when any such applications that may be pending or filed for any of Pfizer’s product candidates may be approved by regulatory authorities, which will depend on myriad factors, including making a determination as to whether the product’s benefits outweigh its known risks and determination of the product’s efficacy and, if approved, whether any such product candidates will be commercially successful; decisions by regulatory authorities impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of Pfizer’s products or product candidates, including development of products or therapies by other companies; manufacturing capabilities or capacity; uncertainties regarding the impact of COVID-19 on Pfizer’s business, operations and financial results; and competitive developments. A further description of risks and uncertainties can be found in Pfizer’s Annual Report on Form 10-K for the fiscal year ended December 31, 2023, and in its subsequent reports on Form 10-Q, including in the sections thereof captioned “Risk Factors” and “Forward-Looking Information and Factors That May Affect Future Results”, as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at and . Contacts Media Contact: PfizerMediaRelations@Pfizer.com +1 (212) 733-1226 Investor Contact: IR@Pfizer.com +1 (212) 733-4848

疫苗临床3期临床2期临床结果

2023-02-09

·医药观澜

深度！沙利文发布《人用疫苗市场研究报告》

▎本文由弗若斯特沙利文投稿疫苗的发明是人类最伟大的公共卫生成就，也是最具成本效益的、最有效的预防控制传染病的手段。尤其自新冠疫情爆发以来，社会各界对于疫苗产业的关注度与日俱增。新冠疫情中，多种不同技术路径的疫苗均被应用于实际防疫中，其中以核酸疫苗为代表的新技术路径疫苗的成功研发为疫苗产业带来了重要变革。弗若斯特沙利文（Frost & Sullivan，简称“沙利文”）于2023年2月8日正式发布《人用疫苗市场发展现状与未来趋势研究报告》（以下简称“《报告》”），对全球和中国疫苗行业进行深入分析，从患者需求、治疗现状、技术发展、市场增长、资本热度及行业格局等多方面，挖掘疫苗领域存在的巨大未满足需求，追踪行业和技术发展脉络，分析市场发展背后的驱动因素。Part 1 人用疫苗行业概览人用疫苗概述疫苗是以病原微生物或其组成成分、代谢产物为起始材料，采用生物技术制备而成，用于预防、治疗人类相应疾病的生物制品。疫苗接种人体后可刺激免疫系统产生特异性体液免疫和（或）细胞免疫应答，使人体获得对相应病原微生物的免疫力。来源：文献检索，沙利文分析从临床目的上来说，疫苗分为预防性疫苗及治疗性疫苗；从技术路径上来说，疫苗主要分为减毒活疫苗、灭活疫苗、类毒素疫苗、多糖（结合）疫苗、重组蛋白疫苗、核酸疫苗、病毒载体疫苗。《报告》详细梳理了人用疫苗的定义、发展历史、作用机制、技术路径对比、疫苗研发趋势分析以及新冠疫情对人用疫苗行业的影响，更多详细内容可参见完整版报告。疫苗佐剂概述佐剂是指能够辅助抗原应答，调节免疫反应强度和类型的物质。佐剂的作用包括在制品中提高抗原的免疫原性、改变免疫应答性质、减少免疫成功所需的抗原量及免疫剂次数、提高免疫功能低下人群的免疫应答等。来源：文献检索，沙利文分析根据FDA的《佐剂和佐剂预防性疫苗安全性评估的监管考量》，佐剂可大致分为三大类。第一大类包括增强抗原递呈细胞和/或淋巴结的抗原递送，从而改善免疫反应的佐剂。例如铝盐、油和水乳剂（如诺华公司的MF59和GSK的AS03）以及脂质体。第二大类包括免疫刺激剂或称免疫增强剂。其主要通过受体介导发送的信号调节免疫反应的质量。例如PIKA双链RNA以及MPL可激活Toll样受体3，Toll样受体4、QS21、CpG、细胞因子等。最后，第三大类由上述前两种类型组合而成，称为组合佐剂或“佐剂系统”。《报告》详细梳理了疫苗佐剂的分类、发展挑战以及未来趋势，更多详细内容可参见完整版报告。Part 2 人用疫苗市场规模与发展趋势《报告》对中国及全球人用疫苗市场规模、头部疫苗厂商销售情况、疫苗产品获批及在研情况、市场驱动力以及未来发展趋势进行了分析，更多详细内容可参考完整版报告。Part 3 人用疫苗细分领域市场分析细分领域 —— 人乳头瘤病毒（HPV）疫苗人乳头瘤病毒（HPV）是生殖道最常见的病毒感染，可在性行为中经皮肤接触而感染。依据各型 HPV 与子宫颈癌发生的危险性不同分为高危型和低危型。不同类型的人乳头状瘤病毒（HPV）可导致不同类型的感染，低危HPV类型感染可导致包括明显的生殖器尖锐湿疣以及不明显的宫颈、阴道、外阴、尿道、阴茎、肛门尖锐湿疣，还有普通皮肤疣病；高危HPV类型感染可导致癌症。在世界范围内，HPV高风险菌株的致癌率约为5%，引发的癌症包括宫颈癌、肛门癌、头颈癌、阴茎癌、阴道癌和外阴癌、口咽癌。来源：文献检索，沙利文分析截至2022年12月31日，中国获批上市的HPV疫苗有5种，皆采用重组蛋白疫苗技术；中国处于临床研究阶段的人乳头瘤病毒疫苗共有20种，市场竞争较为激烈。据统计，2021年的中国HPV疫苗批签发量为2,960.2万支，默沙东的佳达修和佳达修9占据了大部分份额，国产二价疫苗由于获批时间较晚目前占据市场份额较低。来源：中检局，沙利文分析《报告》详细梳理了中国已获批HPV疫苗产品以及在研管线，并对HPV疫苗市场发展驱动力及未来发展趋势进行了分析，更多详细内容可参考完整版报告。细分领域 —— 带状疱疹（VZV）疫苗水痘-带状疱疹病毒是已知可导致人类感染的8种疱疹病毒之一，全世界均有分布。VZV感染在临床上会引起两种不同的疾病形式：水痘和带状疱疹。该疾病主要通过吸入含病毒的飞沫，直接接触水痘或带状疱疹皮疹，或气溶胶传播。随着年龄的增长，VZV特异性T细胞的增殖能力下降，使得细胞免疫减弱，长期潜伏于神经的VZV更容易被激活。近年来有研究显示，带状疱疹发病趋于年轻化，尤其是处于亚健康状态、肿瘤、艾滋病患者等免疫力低下人群。来源：文献检索，沙利文分析带状疱疹通常累及胸腰部皮肤，还可累及膝状神经节、眼带和口腔，严重时可能导致带状疱疹后神经痛（PHN），给患者带来极大的疾病负担。来源：文献检索，沙利文分析全球上市主要使用的带状疱疹疫苗分为带状疱疹减毒活疫苗和重组带状疱疹疫苗两种。带状疱疹减毒活疫苗最早由Merck开发上市，但尚未在中国上市。中国唯一一款获批的带状疱疹疫苗为GSK的Shringrix，采用重组蛋白技术路径制备。截至2022年12月31日，中国处于临床阶段的带状疱疹疫苗共7款，其中4款为减毒活疫苗，3款为重组蛋白疫苗。据统计，于2020年和2021年，中国带状疱疹疫苗的批签发量分别为1.6和0.6百万支，产值规模分别为26亿和9亿人民币。来源：中检局，沙利文分析《报告》详细梳理了中国已获批带状疱疹疫苗产品以及在研管线，并对带状疱疹疫苗市场发展驱动力及未来发展趋势进行了分析，更多详细内容可参考完整版报告。细分领域 —— 人用狂犬疫苗狂犬病病毒是一种核糖核苷酸型弹状病毒，在犬、猫等哺乳动物中传播的毒力很强，感染后一旦出现临床症状，病死率几乎100%，是世界上病死率最高的传染病。全球每年狂犬病死亡例数约59,000例，主要发生在亚洲和非洲。中国为狂犬病流行国家，根据中国疾病预防控制中心的数据，中国每年约有4,000万狂犬病暴露人群，而中国暴露后人群的狂犬病疫苗接种率仅为35%左右。2021年狂犬病报告死亡数位居法定报告传染病前五，给人民群众生命健康带来严重威胁。目前临床尚无治疗狂犬病的有效方法，因此暴露后预防至关重要，主要通过接种人用狂犬病疫苗和注射被动免疫制剂。来源：中检局，沙利文分析人类狂犬病疫苗市场可以根据用于培养疫苗的不同细胞基质来划分。不同的细胞基质有不同的特点，需要不同的制造工艺。目前用于狂犬病疫苗生产的细胞基质包括原代细胞（地鼠肾细胞和鸡胚细胞）和传代细胞（Vero细胞和人二倍体细胞）。截至2022年12月31日，中国获批上市的人用狂犬病疫苗共有20种，其中人用狂犬疫苗（Vero细胞）共13种、人用狂犬疫苗（地鼠肾细胞）共6种、人用狂犬疫苗（人二倍体细胞）共1种；中国正处于临床研究阶段的人用狂犬病疫苗共有24种，其中Vero细胞共13种，人二倍体细胞共8种，鸡胚细胞共3种。2017-2021年中国人用狂犬疫苗批签发量呈先下降后上升的波动态势，受2018年长春长生疫苗事件，宁波荣安、广州诺诚GMP认证问题而产生的影响，2018-2019年中国狂犬疫苗批签发量持续下降。新冠疫情导致居民户外活动出行时间减少，在家与动物接触时间延长，狂犬病暴露风险增大，对狂犬疫苗需求有所增长。2021年中国狂犬疫苗批签发量为88.0万支，比2020年增长12.0%。来源：中检局，沙利文分析2017-2021年中国人用狂犬病疫苗市场产值呈先下降后上升的波动态势。受部分狂犬疫苗生厂商停产影响，2018-2019年狂犬病疫苗批签发量的下降导致产值规模有所下降。2020年，随着疫苗行业监管趋严和狂犬疫苗生产工艺提升，导致狂犬疫苗生产成本增加，上海、河北、内蒙、海南等省各家企业的狂犬疫苗中标价均有所提升。同时，随着接种率的提高和高价值狂犬病疫苗进入市场，产值规模增加。截至2021年，我国人用狂犬病疫苗产值规模达到了约94亿元。从细胞类型拆分来看，中国按批签发量有88.8%的狂犬病疫苗采用了基于Vero细胞的生产技术，这与Vero细胞狂犬病疫苗获批的厂家数量多、Vero细胞狂犬病疫苗产量大、价格低，具备一定的性价比有关。人二倍体细胞疫苗和地鼠肾细胞疫苗分别占比为5.8%和5.4%。来源：中检局，沙利文分析美国按销量口径有71.3%的狂犬病疫苗采用了基于鸡胚细胞的生产技术，人二倍体细胞疫苗占比28.7%。这可能与人二倍体细胞疫苗单价昂贵，产量较低有关。来源：MIDAS，沙利文分析《报告》详细梳理了中国已获批人用狂犬疫苗产品以及在研管线，并对人用狂犬疫苗市场发展驱动力及未来发展趋势进行了分析，更多详细内容可参考完整版报告。细分领域 —— 流行性感冒病毒疫苗流行性感冒（简称流感）是一种由流感病毒引起的传染性呼吸道疾病，一般表现为急性起病、发热等症状。轻症流感常与普通感冒表现相似，但其发热和全身症状更明显；重症病例可出现病毒性肺炎、继发细菌性肺炎、急性呼吸窘迫综合征、休克、弥漫性血管内凝血、心血管和神经系统等肺外表现及多种并发症。流感病情从轻度到重度甚至死亡均有可能发生。来源：文献检索，沙利文分析流行性感冒病毒根据病毒核蛋白和基质蛋白抗原分为甲、乙、丙和丁型。来源：文献检索，沙利文分析所有年龄段的人群都可能感染流感，主要发生在老年人、年幼儿童、肥胖者、孕产妇和有慢性基础疾病（如哮喘、糖尿病或心脏病）者等高危人群，更易发展为重症流感甚至死亡。每年接种流感疫苗是预防流感的有效手段，可以显著降低接种者罹患流感和发生严重并发症的风险。截至2022年12月31日，中国获批上市的流感疫苗共22款，其中四价流感疫苗共有7款，三价流感疫苗共15款；临床在研的流行性感冒病毒疫苗多为四价苗，截至统计时间共有17款疫苗处于临床研究阶段。从 2017年-2021年批签发量的变化趋势来看，2018年批签发量有明显下降，随后三年逐步回升。2018年受到长春长生疫苗事件、北京科兴厂区停电等各种原因，多家疫苗企业停供流感疫苗。2019年批签发回归正常，但由于流感疫苗在往年接种率低，流感疫苗又具备生产周期长的特点，厂家未能提前做好准备，在2019年流感爆发期出现“一针难求”的现象。2020年受新冠疫情的影响，国家卫健委大力宣传和推行，大众防范流感的意识逐步提高，接种意愿大幅增强，加之各厂商增加产能，2020年流感疫苗批签发量达到新高。四价灭活流感疫苗自 2018 年上市以来快速放量，2020 年四价流感批签发量超过三价流感疫苗，成为占比最大品种。来源：中检局，沙利文分析2021年中国流感疫苗市场产值规模约为61亿元人民币，主要受健康意识提高和政府支持国家免疫等总体因素推动。此外，考虑到目前发达国家普遍使用四价流感疫苗，中国流感疫苗市场也将被四价疫苗所取代，预计未来将出现快速增长。《报告》详细梳理了中国已获批流感疫苗产品以及在研管线，并对流感市场发展驱动力及未来发展趋势进行了分析，更多详细内容可参考完整版报告。细分领域 —— 肺炎球菌疫苗肺炎球菌是一种常见于鼻子和喉咙的革兰氏阳性菌，常定植于呼吸道及口腔中。正常情况下，肺炎球菌并不致病，但当寄生的环境发生变化时，肺炎球菌则会引发感染。肺炎球菌所引发的细菌性肺炎是全球儿童和老年人致病、住院、甚至致死的重要原因之一，并占人体感染性肺炎的80%。来源：《中国卫生健康统计年鉴》，沙利文分析由于采用抗生素治疗肺炎球菌性疾病存在严重的耐药性问题，接种肺炎球菌疫苗为目前最有效的对抗肺炎球菌疾病的方式。肺炎球菌疫苗主要包括13价肺炎球菌多糖结合疫苗以及23价肺炎球菌多糖疫苗两种。截至2022年12月31日，中国共有3款13价肺炎球菌多糖结合疫苗和5款23价肺炎球菌多糖疫苗获批上市；9款13价肺炎球菌多糖结合疫苗以及4款23价肺炎球菌多糖疫苗处于临床研究阶段。截至2021年底，PCV13总批签发量约为1,756万支，同比增长61.2%。由于23价肺炎球菌疫苗接种后，只能引起人体体液免疫产生抗体而不能产生适应性免疫，外加其对2岁以下儿童无效，23价肺炎球菌疫苗批签发两增速较缓。2021年受到新冠疫苗接种的影响，PPSV23总批签发量下降至约1,061万支。来源：中检局，沙利文分析PCV13和PPSV23因保护效力好可分别在儿童和老人中大幅降低死亡率，具有较佳的成本效益，因此成为重磅非免疫规划疫苗。2017至2021年中国肺炎球菌疫苗市场的产值规模以74.0%的复合年增长率大幅增长，其中PCV13占据主要市场。《报告》详细梳理了中国已获批肺炎球菌疫苗产品以及在研管线，并对肺炎球菌市场发展驱动力及未来发展趋势进行了分析，更多详细内容可参考完整版报告。Part 4 疫苗行业资本表现情况《报告》详细梳理了中国疫苗研发公司融资情况、疫苗企业合作开发情况、疫苗管线交易情况以及疫苗企业并购情况，更多详细内容可参考完整版报告。Part 5 疫苗公司介绍成大生物：辽宁成大生物股份有限公司始创于2002年6月，是一家专注于人用疫苗研发、生产和销售的生物科技公司。成大生物深耕人用疫苗领域多年，通过自主研究和创新，构建了“生物反应器规模化制备疫苗的工艺平台技术”，突破了疫苗生产过程中的大规模细胞培养制备高品质疫苗的技术难题。公司目前已经形成了产业化梯队，目前已有1款狂犬疫苗“成大速达®”以及1款乙脑疫苗“成大利宝®”上市，公司当前共有6款疫苗进入临床实验阶段，覆盖狂犬病、流行性感冒、脑脊髓膜炎、肺炎球菌感染、甲肝等多种疾病。青赛生物：上海青赛生物科技有限公司于2017年4月在上海市金山区设立，并于2022年12月荣登“2022年中国医药新锐创新力量”榜单提名。青赛生物专注于人用疫苗的研发和产业化，拥有病毒反向遗传技术平台，能够从基因层面对病毒基因组开展精确定向改造，以高效获得特定表型的重组病毒株；亦拥有疫苗产品评价及检测技术平台，可开展病毒性疫苗的生产用毒株构建与评价，并建立相应的检测方法，为创新疫苗的开发奠定基础。青赛生物研发管线由6个品种组成，覆盖包括狂犬病、腮腺炎以及轮状病毒感染3种传染病。其中，公司研发的人用狂犬病疫苗为国内首款以鸡胚成纤维细胞为生产细胞基质的临床阶段的狂犬病疫苗；公司通过病毒反向遗传操作技术平台开发的基因重组腮腺炎减毒活疫苗为全球首个进入临床研究的非A基因型腮腺炎减毒活疫苗。瑞科生物：江苏瑞科生物技术股份有限公司始创于2012年，是一家以自主研发技术为核心驱动力的创新型疫苗公司，致力于打造覆盖研发、生产及商业化的创新型疫苗。公司深耕疫苗领域多年，目前已构建先进的新型佐剂、蛋白工程、免疫评价、mRNA疫苗四大创新技术平台。公司是全球少数几家有能力研制新型佐剂系统的公司之一，并以新型佐剂平台为核心，与抗原优化设计和免疫评技术相协同，持续开发性能领先的重磅疫苗品种。公司在研管线丰富，拥有共12款临床在研管线，覆盖包括宫颈癌&生殖器疣、新冠肺炎、带状疱疹、成人结核病、流感以及手足口病在内的多项疾病。依生生物：依生生物制药有限公司是一家集研发、生产和销售为一体的全球化专业生物制药公司，致力于开发抗肿瘤和抗病毒感染的创新生物治疗药物。公司拥有全球独创、具有自主知识产权的PIKA皮卡免疫调节技术平台，开发出创新型疫苗和治疗性生物大分子产品。公司的皮卡技术和疫苗产品三次获得“国家新药创制项目”的支持。依生生物拥有已上市销售的依生君安™狂犬病疫苗，在研产品线包括皮卡狂犬病疫苗、皮卡重组蛋白新冠疫苗、皮卡免疫抗癌产品、皮卡乙肝、皮卡流感疫苗等多种产品。依生生物在中国北京、新加坡、美国马里兰皆设有独资研发中心，并在中国沈阳拥有大规模化GMP疫苗生产基地。依生生物独家研发的PIKA免疫调节技术于全球30多个国家获得共60项专利。请扫描以下二维码获取完整报告本文来自于弗若斯特沙利文，医药观澜已获得弗若斯特沙利文授权发布。免责声明：药明康德内容团队专注介绍全球生物医药健康研究进展。本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。

疫苗核酸药物

100 项与 13价肺炎球菌结合疫苗（博沃生物）相关的药物交易

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研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
肺炎球菌感染	临床1期	中国	辽宁成大生物股份有限公司	2022-11-01
肺炎球菌感染	临床1期	中国	武汉博沃生物科技有限公司	2022-11-01
肺炎	临床1期	中国	武汉博沃生物科技有限公司	2022-11-01
肺炎	临床1期	中国	辽宁成大生物股份有限公司	2022-11-01

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临床结果

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分期

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


EULAR2020	N/A	白塞病/贝赫切特综合征	88	Pneumococcal 13-valent vaccine	壓獵範餘遞廠鹹蓋憲糧(獵醖糧範築顧夢憲網選) = 選壓齋襯繭艱壓顧餘遞積艱餘餘願積鬱餘築憲 (艱齋糧構襯製構繭獵觸 ) 更多	-	2020-06-03
				Pneumococcal 13-valent vaccine	壓獵範餘遞廠鹹蓋憲糧(獵醖糧範築顧夢憲網選) = 糧簾鹽蓋艱壓窪淵齋觸積艱餘餘願積鬱餘築憲 (艱齋糧構襯製構繭獵觸 ) 更多