[Translation] A randomized, double-blind, third-party open-label phase I clinical trial to evaluate the safety and immunogenicity of 20-valent pneumococcal polysaccharide conjugate vaccine (20vPnC) and 13-valent pneumococcal polysaccharide conjugate vaccine (13vPnC) in Chinese adults aged ≥ 50 years who had not received pneumococcal vaccination

主要目的：描述 20vPnC 和 13vPnC 的安全性特征次要目的：描述 20vPnC 和 13vPnC 诱导的免疫应答

[Translation]

Primary objective: To describe the safety profile of 20vPnC and 13vPnC Secondary objective: To describe the immune responses induced by 20vPnC and 13vPnC

Start Date06 Jul 2025

Sponsor / Collaborator

Pfizer Investment Co. Ltd.

[+4]

NCT07019909

/ Active, not recruitingPhase 1

A Phase 1, Randomized, Double-Blind, Third-Party-Unblinded Trial to Evaluate the Safety and Immunogenicity of 20-valent Pneumococcal Conjugate Vaccine (20vPnC) and 13-valent Pneumococcal Conjugate Vaccine (13vPnC) in Pneumococcal Vaccine-Naïve Adults 50 Years of Age and Older in China

This Phase 1, randomized, double-blind, third-party-unblinded study will be conducted at investigational sites in China. The purpose of the study is to learn about the safety and immune response of 20vPnC and 13vPnC in Chinese adults 50 years of age and older who did not receive any of pneumococcal vaccine in the past

Start Date06 Jul 2025

Sponsor / Collaborator

Pfizer Inc.

100 Clinical Results associated with Pneumococcal polysaccharide conjugate vaccine

100 Translational Medicine associated with Pneumococcal polysaccharide conjugate vaccine

100 Patents (Medical) associated with Pneumococcal polysaccharide conjugate vaccine

851

Literatures (Medical) associated with Pneumococcal polysaccharide conjugate vaccine

31 Dec 2025·Expert Review of Vaccines

Economic evaluation of childhood pneumococcal conjugate vaccination programs in Qinghai and Hainan provinces, China

Article

Author: Wang, Chaofan ; Zhang, Haijun ; Lai, Xiaozhen ; Wahl, Brian ; Deloria Knoll, Maria ; Fang, Hai ; Zhang, Haonan

BACKGROUND:

The burden of pneumococcal disease varies regionally in China, disproportionately affecting children in many provinces such as Qinghai and Hainan. Nevertheless, the absence of a pneumococcal conjugate vaccine (PCV) in the National Immunization Program (NIP) or local programs presents limited coverage. This study evaluated the health and economic impact of including PCV in immunization programs in Qinghai and Hainan.

RESEARCH DESIGN AND METHODS:

A decision tree Markov model was constructed to simulate health outcomes and lifetime costs among children under different 13-valent PCV (PCV13) vaccination strategies compared to current practices, from societal and healthcare perspectives. Data on epidemiology, vaccine efficacy, cost, and utility were obtained from the literature and open databases. Sensitivity analyses were conducted to explore parameter uncertainty.

RESULTS:

Including three-dose PCV13 in provincial programs at NIP coverage (98.91%) could avert 7100 episodes and 118 deaths in Qinghai, and 6200 episodes and 66 deaths in Hainan. It was cost-effective at the $68.2/dose in private market and cost-saving at the United Nations Children's Fund (UNICEF) recommended $25/dose for both provinces. Increasing coverage to 50% or 75% was also cost-effective. Sensitivity analyses confirmed the robustness of the results despite parameter uncertainty.

CONCLUSIONS:

Prioritizing PCV13 in immunization programs in Qinghai and Hainan could effectively reduce disease burden, improve population health, and promote health equity.

31 Dec 2025·Human Vaccines & Immunotherapeutics

The microbiological characteristics and diagnosis of Streptococcus pneumoniae infection in the conjugate vaccine era

Review

Author: Chen, Chih-Jung ; Tsai, Ming-Han ; Chen, Chih-Ho ; Chen, Chyi-Liang ; Su, Lin-Hui ; Chiu, Cheng-Hsun

Two pneumococcal conjugate vaccines, PCV15 and PCV20, were licensed in June 2021. PCV15 includes two additional serotypes (22F, 33F) beyond those in PCV13, while PCV20 adds seven more (8, 10A, 11A, 12F, 15B, 22F, 33F), covering approximately 30% of invasive pneumococcal disease (IPD) cases in adults. In June 2023, the US CDC's Advisory Committee on Immunization Practices (ACIP) recommended either PCV15 or PCV20 for all children aged < 5 years and children aged 2‒18 years with risk conditions. In June 2024, the FDA approved PCV21 for adults ≥ 18 years. In October 2024, ACIP recommended either PCV20 or PCV21 alone or PCV15 with PPSV23 for adults ≥ 50 years or 19-49 years with risk conditions. These advancements highlight the evolving landscape of pneumococcal vaccination. This review examines the molecular epidemiology of pneumococcal infections, advancements in diagnostic methods, and the anticipated public health impact of these vaccines in reducing pneumococcal disease burden.

31 Dec 2025·Human Vaccines & Immunotherapeutics

Multidimensional analysis of costs and outcomes in a Colombian cohort of pediatric Streptococcus pneumoniae meningitis cases (2017–2022)

Article

Author: Londoño-Ruiz, Juan Pablo ; Coronell Rodríguez, Wilfrido ; Restrepo Cedeño, Alejandro ; Álvarez-Olmos, Martha I. ; López, Pio ; Suarez, Martha Alexandra ; Rojas Hernández, Juan Pablo ; Vasquez-Hoyos, Pablo ; Ramos Rodriguez, Nicolas I. ; Trujillo Honeysberg, Mónica Rosa ; Beltrán-Higuera, Sandra J. ; Barrero Barreto, Esther Rocio ; Mariño, Ana Cristina ; Lucia Leal, Aura ; Arango Ferreira, Catalina ; Patiño, Jaime Alberto ; Giraldo Gallo, Erika ; David Escobar Franco, Omar Huang ; Gutiérrez-Tobar, Ivan Felipe ; Montañez Ayala, Anita ; Espinosa Acuña, Fabio Enrique ; López Medina, Eduardo ; Camacho-Moreno, German ; Castro Montoya, Bibiana ; Moreno, Vivian Marcela

Streptococcus pneumoniae meningitis poses a significant public health challenge, imposing substantial burdens on healthcare systems. This study analyzed the costs and outcomes of pneumococcal meningitis in a Colombian cohort of children from 2017 to 2022, using correspondence analysis and cost assessment to explore the impact of vaccination. A retrospective cohort study was conducted, analyzing children under 18 years diagnosed with pneumococcal meningitis. A total of 55 cases were analyzed in this cohort study, which, while representative of confirmed cases in the country, reflects the rarity of the disease and poses statistical limitations. Direct healthcare costs were calculated in 2023 USD, and data were assessed using cluster and multiple correspondence analyses (MCA) to evaluate relationships between vaccination status, serotypes, clinical outcomes, and costs. The MCA revealed two main dimensions that collectively explained 31.2% of the total variance. Median direct healthcare costs were ~$2,900 (range ~$500-$21,000), with ICU admission as the primary cost driver. PCV13 vaccination correlated with lower overall patient costs and better clinical outcomes. MCA revealed clustering of vaccinated patients with favorable outcomes and reduced costs, while unvaccinated patients aligned with severe outcomes and higher expenses. This study explores the clinical and economic impact of pneumococcal meningitis in pediatric patients, highlighting the potential protective role of PCV13 vaccination. MCA provided an exploratory framework for examining relationships between vaccination status, serotypes, costs, and outcomes.

News (Medical) associated with Pneumococcal polysaccharide conjugate vaccine

13 Oct 2025

·www.businesswire.com

Pfizer to Highlight Advancements in Respiratory Health and Infectious Disease Research at IDWeek 2025

NEW YORK--(BUSINESS WIRE)--Pfizer Inc. (NYSE: PFE, “Pfizer”) will present data across its infectious disease portfolio at the upcoming IDWeek 2025 congress, held in Atlanta from October 19-22, 2025. Data in 46 abstracts from company- and collaborator-led studies will showcase significant advancements in preventing and treating infectious diseases. “IDWeek 2025 offers a critical opportunity to highlight our cutting-edge scientific progress and collaborate with global health experts in our ongoing battle against infectious diseases,” said Annaliesa Anderson, Ph.D., Senior Vice President and Chief Vaccines Officer, Pfizer. “At Pfizer, we continue to prioritize innovation and rigorous data generation through clinical studies and real-world analysis supporting the vaccines and therapeutics for our infectious disease pipeline.” Presentations will include research from Pfizer’s diverse infectious disease portfolio, including COVID-19, respiratory syncytial virus (RSV), pneumococcal disease, Lyme disease, meningococcal disease, and other serious bacterial and viral infections. Details for the oral and poster presentations are below: Title/Abstract Number Presenting Name/Type Date/Time (ET) Location ORAL & LATE-BREAKING PRESENTATIONS Attitudes about COVID and Community Engagement with Patients (ACCEPt): Global Survey Reveals the Ongoing Impact of Long COVID-19 on Medically Vulnerable Populations, Five Years On R Paredes Oct 22 4:15 – 4:30PM B211-B212 Effectiveness of the JN.1-adapted BNT162b2 COVID-19 Vaccine in High-Risk Groups against Hospitalization in Europe: A Test-Negative Case-Control using the id.DRIVE Platform H Volkman Oct 21 1:45 – 3:00PM B401-B402 Real-world Abrysvo Vaccine Effectiveness (VE) against Respiratory Syncytial Virus (RSV)-related Lower Respiratory Tract Disease (LRTD) Hospitalizations and Emergency Department Admissions over Two RSV Seasons—Kaiser Permanente of Southern California (KPSC), October 2023–April 2025 S Tartof Oct 20 3:15 – 4:30PM B401-B402 Immunosuppression and RSV Prefusion F Protein Vaccine Effectiveness in Older Adults: A Prespecified sub analysis from the DAN-RSV Trial A Jensen Oct 20 3:15 – 4:30PM B401-B402 POSTER PRESENTATIONS COVID-19 COVID-19 vaccine uptake in children aged 1 - 4 years from state vaccine registry data through March 2024 T Ahi Oct 22 12:15 PM Poster Hall B4-5 Public Health and Economic Impact of Increased Uptake of an Additional Dose of Pfizer-BioNTech KP.2-Adapted COVID-19 Vaccine, 2024-2025 Formula, Among US Adults ≥ 65 Years of Age A Yehoshua 12:15 PM Poster Hall B4-5 Physician Perceptions and Decision-Making Factors in Prescribing COVID-19 Antivirals: Qualitative Research Findings M Fernandez 12:15 PM Poster Hall B4-5 Ibuzatrelvir Potently Reduced Viral RNA Levels Despite the High Rate of Anti-S Seropositivity: a Post Hoc Analysis of Serology in the Phase 2b Study in Adults Without Risk Factors for Severe COVID-19 JH Kim 12:15 PM Poster Hall B4-5 Inpatient Burden of Respiratory Syncytial Virus, COVID-19, or Influenza in the United States Among Children < 5 Years of Age K Andersen 12:15 PM Poster Hall B4-5 Severity of Omicron COVID-19 variants: a global systematic literature review D Malhotra 12:15 PM Poster Hall B4-5 COVID-19 Case Attack Rate Differences by Vaccination Status and Vaccine Effectiveness among US Nursing Home Residents, October 5, 2024 to January 5, 2025 F Khan 12:15 PM Poster Hall B4-5 Invasive Group B Streptococcus (GBS) Invasive Group B Streptococcus among hospitalized pregnant and postpartum women, 2016-2024: a Unites States database study S Willis 12:15 PM Poster Hall B4-5 Long-Term Healthcare Utilization and Expenditures for Infants with Invasive Bacterial Infections During Birth Hospitalizations K Schley 12:15 PM Poster Hall B4-5 Lyme Disease Risk Perception and Communication about Lyme Disease Prevention by Healthcare providers: A Mixed-Methods Study N Patel 12:15 PM Poster Hall B4-5 Gestational Lyme disease incidence and pregnancy-related outcomes among women in the United States, 2015-2024 S Willis 12:15 PM Poster Hall B4-5 Healthcare Costs Associated With Lyme Disease Among Medicare Fee-for-Service Beneficiaries in the United States: A Retrospective Claims-Based Study H Yu 12:15 PM Poster Hall B4-5 Meningococcal Disease Need for Broad Protection Against Invasive Meningococcal Disease Among US College Students J Presa 12:15 PM Poster Hall B4-5 Characterization of Factor H Binding Protein Expression for Neisseria meningitidis Serogroup B Isolates, 2015–2022 K Weiss 12:15 PM Poster Hall B4-5 Clinical Development of MenABCWY (PenbrayaTM), a Broadly Protective Pentavalent Meningococcal Vaccine L Zoloras 12:15 PM Poster Hall B4-5 Utility of the Pentavalent MenABCWY Meningococcal Vaccine (PenbrayaTM) Within Alternative US Meningococcal Vaccination Schedules J Presa 12:15 PM Poster Hall B4-5 Ten-year retrospective review of medical records at five hospitals in the United States highlights the potential for under-detection of invasive meningococcal disease F Angulo 12:15 PM Poster Hall B4-5 Awareness, Attitudes and Perceptions of Meningococcal Vaccines among Caregivers of Adolescents in the United States J Presa 12:15 PM Poster Hall B4-5 Pneumococcal Disease Re-evaluating economic & health impact of PCV20 in adults using real-world effectiveness data J Vietri 12:15 PM Poster Hall B4-5 Invasive pneumococcal pneumonia: is bacteremia the appropriate indication of severity? P Peyrani 12:15 PM Poster Hall B4-5 Variability in Case-Ascertainment Methodology and Rates of Adult Invasive Pneumococcal Disease using a US Healthcare Claims Database A Miles 12:15 PM Poster Hall B4-5 Temporal Trends in Rates of Hospitalized Pneumonia among US Adults and Residual Disparities by Race and Socioeconomic Status A Miles 12:15 PM Poster Hall B4-5 Demographic and Clinical Characteristics, by Pneumococcal Serotype, of Adults Hospitalized with Community Acquired Pneumonia in the US L Grant 12:15 PM Poster Hall B4-5 Differences in invasive pneumococcal disease clinical presentations and serotype distribution among children with and without underlying risk factors K Hulten 12:15 PM Poster Hall B4-5 Nasopharyngeal Colonization in South Texas Children Less Than 6 Years of Age With or Without Lower Respiratory Tract Infections K Hulten 12:15 PM Poster Hall B4-5 Real-world effectiveness of 20-valent pneumococcal conjugate vaccine among adults 65-74, 75-84, and ≥85 years of age in the United States A Miles 12:15 PM Poster Hall B4-5 Uptake and Series Completion with Pneumococcal Conjugate Vaccine by Social Determinants of Health among Children in the United States A Miles 12:15 PM Poster Hall B4-5 Influenza Symptom Burden During the First Week of Acute Influenza Infection Among US Adults: An Interim Analysis of a Nationwide Prospective Study during the 2024/25 Season T Hu 12:15 PM Poster Hall B4-5 The Burden of Influenza on Health-Related Quality of Life and Work Productivity During the First Week of infection Among US Adults: An Interim Analysis of a Nationwide Prospective Study T Hu 12:15 PM Poster Hall B4-5 The Socioeconomic Value of Adult Respiratory Vaccination in the United States: A Benefit-Cost Analysis T Hu 12:15 PM Poster Hall B4-5 Respiratory Syncytial Virus (RSV) How do recent population-level RSVpreF vaccine impact results from the United Kingdom relate to previously reported vaccine effectiveness results? N Aliabadi 12:15 PM Poster Hall B4-5 Bivalent RSV Prefusion F-Based Subunit Vaccine Recipients with Chronic Kidney Disease Achieved High Neutralizing Titers One Month After Vaccination F Rahman 12:15 PM Poster Hall B4-5 Immunogenicity and Safety of Bivalent Respiratory Syncytial Virus (RSVpreF) Vaccine In Non-Pregnant HIV Infected Older Adults T Mikati 12:15 PM Poster Hall B4-5 Estimating Risk of Guillain-Barré Syndrome in US Medicare-Enrolled Older Adults Following Medically Attended Respiratory Syncytial Virus Disease: A Self-Controlled Case Series Analysis C Liang 12:15 PM Poster Hall B4-5 Time to Testing, Diagnosis, and Hospitalization Among Pediatric and Adult Patients with RSV in Two Seasons: A Real-World Data Analysis using Electronic Health Records in US W Tang 12:15 PM Poster Hall B4-5 Time-Series Model Estimation of RSV-Attributable Respiratory Hospitalizations and Mortality in Adults in Finland C Liang 12:15 PM Poster Hall B4-5 Burden of Hospitalizations Due to Respiratory Syncytial Virus (RSV) in Adults ≥50 Years of Age and Those with Congestive Heart Failure or Chronic Obstructive Pulmonary Disease Exacerbations A Tippett 12:15 PM Poster Hall B4-5 What if Adult RSV Vaccine Uptake in the US was High Like in Scotland? Missed Opportunities to Reduce Public Health and Economic Burden of RSV R Sato 12:15 PM Poster Hall B4-5 Strategies to promote adult vaccination against respiratory pathogens: a narrative literature review E Williams 12:15 PM Poster Hall B4-5 Attributes of Point-of-Care Nucleic Acid Amplification Tests for Respiratory Syncytial Virus (RSV): Results of a Systematic Literature Review K Date 12:15 PM Poster Hall B4-5 RSV Signs and Symptoms at Time of Hospitalization among Pediatric and Adult Population with RSV in Two Seasons: A Real-World Data Analysis using Electronic Health Records in US W Tang 12:15 PM Poster Hall B4-5 Tick-Borne Encephalitis (TBE) Tick-borne encephalitis (TBE) in international travelers and TBE vaccine recommendations for travelers to Europe F Angulo 12:15 PM Poster Hall B4-5 Prescribing Information for Pfizer Medicines Please see full Prescribing Information for ABRYSVO® (Respiratory Syncytial Virus Vaccine) or visit https://abrysvoadult.pfizerpro.com. Please see full Prescribing Information for COMIRNATY® (COVID-19 Vaccine, mRNA) or visit https://comirnatyhcp.com. Please see full Prescribing Information including BOXED WARNING for PAXLOVIDTM (Nirmatrelvir and Ritonavir) or visit https://paxlovid.pfizerpro.com. Please see full Prescribing Information for PREVNAR 20® (Pneumococcal 20-valent Conjugate Vaccine) or visit https://prevnar20.pfizerpro.com. Please see full Prescribing Information for PREVNAR 13® (Pneumococcal 13-valent Conjugate Vaccine). Please see full Prescribing Information for PENBRAYA® (Meningococcal Groups A, B, C, W, and Y Vaccine) or visit https://penbraya.pfizerpro.com. Please see full Prescribing Information for TRUMENBA® (Meningococcal Group B Vaccine) or visit https://trumenba.pfizerpro.com. Please see full Prescribing Information for TICOVAC™. 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 www.Pfizer.com. In addition, to learn more, please visit us on www.Pfizer.com 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 13, 2025. 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; risks and uncertainties related to changes to vaccine or other healthcare policy in the U.S.; uncertainties regarding the ability to obtain or maintain recommendations from vaccine advisory or technical committees and other public health authorities and uncertainties regarding the commercial impact of any such recommendations, including uncertainties related to the potential impact of narrowing recommended patient populations; challenges related to public vaccine confidence or awareness; risks and uncertainties related to issued or future executive orders or other new, or changes in, laws or regulations; 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, 2024 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 www.sec.gov and www.pfizer.com.

VaccineClinical ResultPhase 2

21 May 2025

·www.fiercepharma.com

SK defeats Pfizer in Korean patent feud, opening new lines of business for pneumococcal vaccine

While SK still has to wait until 2027 to manufacture and sell SKYPneumo in Korea, the company plans to “initiate new business in pneumococcal conjugate vaccines” by exporting individual components of its shot to countries with high demand. Some five years into a pneumococcal vaccine patent dispute in South Korea, SK Bioscience has emerged victorious over Pfizer.The win frees up the company to export its shot—which protects against 13 types of pneumococcal bacteria—to various other countries as SK holds out for a domestic launch in 2027. The Supreme Court of Korea has sided with SK on the matter, ruling that the Korean company did not violate a composition patent on Pfizer’s pneumococcal shot Prevnar 13 by shipping components and finished research doses of its own 13-valent immunization, PCV13, to Russia.Korean regulators approved SK’s 13-valent pneumococcal conjugate vaccine under the name SKYPneumo back in 2016, SK explained in a Wednesday press release. Still, the outcome of a previous patent feud with Pfizer has blocked SK from producing and selling its shot in Korea until 2027, when the relevant Pfizer patents are slated to expire.Pfizer filed its latest lawsuit in 2020 after SK exported PCV13 components and finished doses for research to a Russian drugmaker in 2018 and 2019, alleging that this violated the prior settlement, Korea Biomedical Review reports."This latest court decision is meaningful in that it ensures a competitively developed vaccine in Korea does not go to waste but instead finds new opportunity,” Jaeyong Ahn, SK’s CEO, said in a statement. “We will leverage this momentum to improve access to premium vaccines, contribute to a stable global vaccine supply, and achieve sustainable growth." While SK still has to wait until 2027 to manufacture and sell SKYPneumo in Korea, the company said on Wednesday that it plans to “initiate new business in pneumococcal conjugate vaccines” by exporting individual components of its shot to countries with high demand, like those in Southeast Asia and Latin America.SK added that it’s exploring technology transfers through local partnerships, as well.Beyond SKPYneumo, the Korean vaccine specialist is currently developing a 21-valent pneumococcal conjugate shot with partner Sanofi that entered phase 3 testing late last year. SK and Sanofi are also tinkering with a next-generation pneumococcal vaccine that’s expected to offer broader protection than currently approved immunizations. Meanwhile, SK hasn’t only been going up against Pfizer in Korean patent litigation.Late last month, the company notched a win in a patent invalidation suit against Moderna, successfully knocking down the company’s Korean patent tied to mRNA vaccine technology.

VaccinePhase 3Drug ApprovalPatent InfringementmRNA

21 May 2025

·www.prnewswire.com

SK bioscience Wins Patent Lawsuit Against Pfizer Over Pneumococcal Vaccine

No patent infringement found in exports of individual conjugate bulk substances and research-use finished products of PCV13 to Russia Company plans to export PCV13 vaccine components "We aim for the global PCV market with our 21-valent and next-generation pneumococcal vaccines currently under development." SEONGNAM, South Korea, May 21, 2025 /PRNewswire/ -- SK bioscience, a global innovative vaccine and biotech company committed to promoting human health from prevention to cure, today announced that it the Supreme Court of Korea has ruled in its favor in a patent infringement lawsuit filed by large global pharmaceutical giant Pfizer over its 13-valent pneumococcal conjugate vaccine (PCV13). In 2020, Pfizer claimed that SK bioscience's export of PCV13 individual conjugate bulk substances and research-use finished products to Russia infringed on the composition patent of its vaccine, Prevnar 13. Continue Reading SK bioscience L HOUSE manufacturing plant However, the Supreme Court ruled that the individual conjugates comprising PCV13 do not fall within the scope of Pfizer's patent claims, thereby upholding the lower court's ruling in favor of SK bioscience. The Court also confirmed that the production and supply of PCV13 finished products for research purposes did not constitute patent infringement. SK bioscience successfully developed Korea's first 13-valent pneumococcal conjugate vaccine, SKYPneumo, in 2016. However, due to the ongoing patent dispute with Pfizer, the company has been prohibited from manufacturing and selling the vaccine in Korea until 2027, when the related patents set to expire. Following the ruling, SK bioscience now plans to initiate new business in pneumococcal conjugate vaccines by exporting individual components of PCV13 to countries with high vaccine demand, such as those in Southeast Asia and Latin America. Technology transfers through local partnerships are also being pursued in parallel. Looking ahead, SK bioscience aims to expand its presence in the global pneumococcal vaccine market. From 2027, the company will be able to manufacture and sell SKYPneumo domestically. In addition, the company is developing a 21-valent pneumococcal conjugate vaccine with global pharmaceutical company Sanofi, which entered Phase 3 global clinical in late 2024. Simultaneously, the two companies are also working on a next-generation pneumococcal vaccine that is expected to offer broader protection than current options. The global pneumococcal vaccine market continues to grow. According to Global Market Insights, the market is projected to grow at a compound annual rate of approximately 5.6% to reach USD 15.1 billion (approximately KRW 21.55 trillion) by 2034. This growth is driven by expanded vaccination programs and support from governments and international organizations like WHO and Gavi. SK bioscience's strong track record in public vaccine supply and cooperation with global health organizations positions it well for future expansion. Jaeyong Ahn, CEO of SK bioscience, said, "This latest court decision is meaningful in that it ensures a competitively developed vaccine in Korea does not go to waste but instead finds new opportunity. We will leverage this momentum to improve access to premium vaccines, contribute to a stable global vaccine supply, and achieve sustainable growth." Meanwhile, SK bioscience recently secured a definitive legal victory in a patent invalidation suit against Moderna, successfully challenging the biotech giant's Korean patent related to messenger RNA (mRNA) vaccine technology. The contested patent covers 'modified nucleosides, nucleotides, and nucleic acids and their uses.' This case, which invalidated the only registered mRNA manufacturing patent in Korea, regarded as a major step in reducing patent-related risks and removing barriers to innovation for domestic companies engaged in mRNA research and development. About SK bioscience SK bioscience is an innovative vaccine and biotech company, committed to vaccine development and manufacturing to enable more equitable access to vaccines around the world. Leveraging strengths on cutting-edge technologies, SK bioscience has been dedicated to promoting human health from prevention to cure across the globe. With the cooperation of domestic and international governments, regulatory agencies, healthcare providers, doctors, and medical experts, all of the SK colleagues are passionately committed to providing high-quality vaccines to those who need them and better public healthcare solutions. - SK bioscience Website - SK bioscience Linkedin Contact SK bioscience Communications Team Changhyun Jin ([email protected]) Jeannie S. Pak ([email protected]) SOURCE SK bioscience WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

VaccinePatent InfringementmRNAPhase 3

100 Deals associated with Pneumococcal polysaccharide conjugate vaccine

External Link

KEGG	Wiki	ATC	Drug Bank
-	Pneumococcal polysaccharide conjugate vaccine	J07AL02	-

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Pneumonia, Bacterial	Japan	Pfizer Inc.	18 Jun 2013
Otitis Media	United States	Wyeth Pharmaceuticals LLC	24 Feb 2010
Acute otitis media	European Union	Pfizer Europe MA EEIG	09 Dec 2009
Acute otitis media	Iceland	Pfizer Europe MA EEIG	09 Dec 2009
Acute otitis media	Liechtenstein	Pfizer Europe MA EEIG	09 Dec 2009
Acute otitis media	Norway	Pfizer Europe MA EEIG	09 Dec 2009
invasive Streptococcus pneumoniae infection	European Union	Pfizer Europe MA EEIG	09 Dec 2009
invasive Streptococcus pneumoniae infection	Iceland	Pfizer Europe MA EEIG	09 Dec 2009
invasive Streptococcus pneumoniae infection	Liechtenstein	Pfizer Europe MA EEIG	09 Dec 2009
invasive Streptococcus pneumoniae infection	Norway	Pfizer Europe MA EEIG	09 Dec 2009
Pneumonia, Pneumococcal	European Union	Pfizer Europe MA EEIG	09 Dec 2009
Pneumonia, Pneumococcal	Iceland	Pfizer Europe MA EEIG	09 Dec 2009
Pneumonia, Pneumococcal	Liechtenstein	Pfizer Europe MA EEIG	09 Dec 2009
Pneumonia, Pneumococcal	Norway	Pfizer Europe MA EEIG	09 Dec 2009
Pneumococcal Infections	Japan	Wyeth KK	16 Oct 2009

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Bacteremia	Phase 3	China	Pfizer Ltd.	23 Jun 2018
Meningitis	Phase 3	China	Pfizer Ltd.	23 Jun 2018
Sepsis	Phase 3	China	Pfizer Ltd.	23 Jun 2018
Polyarthritis	Phase 3	France	Pfizer Inc.	27 Sep 2013
Polyarthritis	Phase 3	Monaco	Pfizer Inc.	27 Sep 2013
Rheumatoid Arthritis	Phase 3	France	Pfizer Inc.	27 Sep 2013
Rheumatoid Arthritis	Phase 3	Monaco	Pfizer Inc.	27 Sep 2013
Pneumonia	Phase 3	Sweden	Pfizer Inc.	01 Mar 2009
Vaccine-Preventable Diseases	Phase 3	Japan	Wyeth AB	01 Sep 2007
Hemophilus influenza infection	Phase 2	Australia	GSK Plc	01 Mar 2003

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03035331 (CTgov)	Phase 1/2	Recurrent Follicular Lymphoma \| Marginal zone lymphoma recurrent \| Primary mediastinal large B-cell lymphoma recurrent ... View more	11	pneumococcal 13-valent conjugate vaccine+pembrolizumab (Phase 1 Dose Level 1)	xpxhptrrxf = dtphsckmim cjbaraoppg (gbrcmuvift, mwhddesyhi - ziiuybqqep) View more	-	16 May 2025
				pneumococcal 13-valent conjugate vaccine+pembrolizumab (Phase 2 Dose Level 1)	agrrhpkzla = byrfxhlswr jbydmcltvp (ksekszqohg, ticbigrvpi - oyctcmtspp) View more
NCT04080531 (CTgov)	Phase 4	Plasma Cell Neoplasms \| Multiple Myeloma \| Influenza, Human	165	Trivalent Influenza Vaccine+Pneumococcal 13-valent Conjugate Vaccine (Arm I (Trivalent Influenza Vaccine, Prevnar))	dyhnkwswof = akpmvzptvk nnayhcmcfq (pynasjtzwy, ipekssruii - enihzhqrgo) View more	-	28 Feb 2025
				Trivalent Influenza Vaccine+Pneumococcal 13-valent Conjugate Vaccine (Arm II (Trivalent Influenza Vaccine, Prevnar))	dyhnkwswof = uftqmljsgn nnayhcmcfq (pynasjtzwy, xwlokckiuq - ydegtgwzid) View more
NCT04535037 (CTgov)	Phase 4	Diphtheria	500	DTPa-HBV-IPV/Hib+Pneumococcal 13-valent conjugate vaccine (Infanrix Hexa)	kfuxxqzkmm(fjilselwhw) = jhluoagvzw cveravtpev (ycaxmykjps, ngqtglvuya - sqochupudw) View more	-	27 Mar 2024
				Pneumococcal 13-valent conjugate vaccine+DTaP5-HBV-IPV-Hib (Vaxelis)	kfuxxqzkmm(fjilselwhw) = ozkwyzmcvi cveravtpev (ycaxmykjps, qngssvvkqt - gcfnnoftui) View more
NCT05372575 (CTgov)	Not Applicable	Pneumonia	300	13vPnC (13vPnC Cohort)	hjmkthxeyi(qtieacfabn) = ezytefybhm fkcxwwrwmm (jpvqbqgkal, lrnknbwwti - fevcctohjq) View more	-	03 Oct 2023
				13vPnC (Non-13vPnC Cohort)	hjmkthxeyi(qtieacfabn) = ofltledjqx fkcxwwrwmm (jpvqbqgkal, lunuztmwww - synebirpop) View more
NCT02274415 (DREVAC, Pubmed)	Phase 2	Anemia, Sickle Cell	128	13-valent pneumococcal vaccinePPSV23eumococcal vaccine (PCV13/PPSV23)	eqaehvxvga(lycmbcxjfd) = riilyumwjx qnxofixxyp (gtkyzztwxe ) View more	Positive	27 Jan 2023
				PPSV2313-valent pneumococcal vaccine (PPSV23 alone)	eqaehvxvga(lycmbcxjfd) = qakskzfcqs qnxofixxyp (gtkyzztwxe ) View more
NCT03550313 (CTgov)	Phase 2	Pneumococcal Infections	565	c7vPnC+Prevnar 13 (Group 1: c7vPnC and Prevnar 13 Co-administration)	xkrqbbybnu = tsdwziedhf mqkhvtqtnp (dsbotnkuyi, tafpreekjc - poahfawzfy) View more	-	30 Nov 2021
				c7vPnC (Group 2: c7vPnC and Prevnar 13 Staggered Administration)	xkrqbbybnu = cnbrxhxkui mqkhvtqtnp (dsbotnkuyi, vpqhqspkod - inukfdpike) View more
NCT03439657 (CTgov)	Phase 3	Herpes Zoster	913	HZ/su vaccine GSK1437173A+Prevenar13 (Co-Ad Group)	svcajunsst = xyuxulivxp pekdrqrica (otmenrmhby, kbtdhogior - kzbkwcgker) View more	-	18 Mar 2021
				HZ/su vaccine GSK1437173A+Prevenar13 (Control Group)	qojzsjmpzq(nntyiyocaj) = lhsipbnors aflomfmivk (ceczqmvxmi, nydaidekky - porldgfhhe) View more
NCT02309515 (CTgov)	Phase 2	Mannose-Binding Protein Deficiency \| Lymphocytosis \| Chronic Lymphocytic Leukemia ... View more	12	Laboratory Biomarker Analysis+Lenalidomide+Pneumococcal 13-valent Conjugate Vaccine (Arm I (Lenalidomide, Pneumococcal 13-valent Conjugate Vaccine))	mchkovuhkf = imnbqebhii edyhshvbuw (rptztqfelx, zuxvjfxmzd - isylyzsaqf) View more	-	19 Jan 2021
				Laboratory Biomarker Analysis+Pneumococcal 13-valent Conjugate Vaccine (Arm II (Pneumococcal 13-valent Conjugate Vaccine))	mchkovuhkf = gpwjwoamou edyhshvbuw (rptztqfelx, rqacnnptlt - ujyoyvpfnn) View more
NCT03548337 (CTgov)	Phase 4	-	301	MDV+rotavirus vaccine+13vPnC (13vPnC: Multi-dose Vial (With Preservative))	cohmmumufz = qgdkpqmjhu fkpyovqpif (nnpjwwupup, ixdfljogwl - tbzgpueruk) View more	-	30 Sep 2020
				DTP-Hib-HBV vaccine+rotavirus vaccine+13vPnC (13vPnC: Single-dose Prefilled Syringe (Without Preservative))	cohmmumufz = vqhzcbkfsa fkpyovqpif (nnpjwwupup, eybmgpongu - nxsnkakyom) View more
NCT03313050 (CTgov)	Phase 2	Pneumococcal Infections	511	c7vPnC (Stage 1: c7vPnC (50 to 64 Years of Age))	saazmcbvfh = yfwpgjfpiv spsjctroal (wjkqjusejw, aimfvryzhs - tbtlrjsrrw) View more	-	04 Jun 2020
				tetanus, diphtheria, and acellular pertussis vaccine (Tdap) (Stage 1: Tdap (50 to 64 Years of Age))	saazmcbvfh = dotwzpavqe spsjctroal (wjkqjusejw, ognkzbwofe - ophbosiatt) View more

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