A Phase 2a, Observer-Blind, Randomized, Controlled, Age-De-Escalation, Single-center Interventional Study to Evaluate the Safety, Reactogenicity, and Immune Response of the GVGH iNTS-TCV Vaccine Against Invasive Nontyphoidal Salmonella (iNTS) Disease and Typhoid Fever, Including Dose and Schedule Finding in Infants, in Africa

The purpose of this study is to evaluate the safety, reactogenicity, and immune response induced by the GlaxoSmithKline Biologicals SA (GSK) Vaccines Institute for Global Health (GVGH) invasive nontyphoidal Salmonella-typhoid conjugate (iNTS-TCV) vaccine in infants with the first dose administered at 6 months of age (MOA) or 6 weeks of age (WOA).

Start Date16 Feb 2026

Sponsor / Collaborator

GSK Plc

TCTR20230923001

/ Not yet recruitingPhase 4

Immunogenicity and Safety of Pneumococcal 13-valent Conjugate Vaccine between Weuphoria and Prevnar 13 in Thai Older People

Start Date01 Nov 2025

Sponsor / Collaborator-

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

620

Literatures (Medical) associated with Pneumococcal polysaccharide conjugate vaccine

31 Dec 2026·JOURNAL OF MEDICAL ECONOMICS

Cost-effectiveness analysis of a 20-valent pneumococcal conjugate vaccine for pneumococcal disease prevention in the Slovak pediatric population

Article

Author: Nassar, Thea Paoula ; Šebo, Peter ; Hroncova, Dagmar ; Wannaadisai, Warisa ; Kuchta, Lubos

BACKGROUND:

Slovakia has introduced pneumococcal conjugate vaccines (PCVs) in the national immunization program (NIP) since 2011. Recently licensed for use in the pediatric population in Europe, the 20-valent pneumococcal conjugate vaccine (PCV20) is poised to become a new potential standard of care (SoC) in the pediatric national immunization program (NIP). Therefore, this study aims to assess the cost-effectiveness and the clinical and economic outcomes of the PCV20 compared to PCV13 and PCV15 in Slovakian infants.

METHODS:

A decision-analytic Markov model was employed to estimate the cost-effectiveness of implementing PCV20 versus two lower-valent PCVs in Slovakian infants aged over 10 years. Health outcomes comprised cases of pneumococcal disease, life years, and quality-adjusted life years (QALY). Economic outcomes included vaccination- and disease-associated costs. Outcomes were evaluated for the entire population to capture full vaccine benefits (indirect effects). Epidemiological inputs were sourced from local surveillance reports or published literature. Direct and indirect vaccine effects (VE) were estimated from vaccine impact, effectiveness, and clinical studies of PCV7 and PCV13. Economic inputs were informed by local studies and 2024 Slovak national reimbursement cost. Comprehensive deterministic sensitivity analysis and scenario analyses were examined. The study assumed a willingness-to-pay threshold (WTP) of €40,377/QALY.

RESULTS:

Over 10 years, PCV20 3 + 1 was predicted to prevent over 810 invasive pneumococcal disease (IPD) cases, 885,000 pneumonia cases, 6,600 otitis media (OM) cases, and 16,600 disease-associated deaths compared with PCV13 2 + 1. The disease prevention subsequently resulted in €326.7 million direct medical costs savings, 96,430,859 additional QALYs gain and an ICER of €1,349/QALY. Comparable trends were observed versus PCV15 2 + 1, with PCV20 preventing more pneumococcal disease cases, providing greater additional QALYs, and being cost-effective under the prespecified threshold. Results were consistent across base case and scenario analyses.

CONCLUSIONS:

Implementing PCV20 into the Slovakian pediatric NIP is projected to yield the most significant clinical and economic benefits compared to the two lower-valent PCVs, due to its more extensive protection against a broader range of pneumococcal serotypes. Despite an additional cost of dose and visit, PCV20 was estimated to be cost-effective at the Slovak WTP threshold versus other SoC options over a 10-year time horizon.

01 Mar 2026·VACCINE

Safety, immunogenicity, and lot consistency of a 13-valent pneumococcal conjugate vaccine in Chinese children aged 2–5 years: A phase III study

Article

Author: Lai, Xin ; Shi, Liwei ; Chen, Jingjing ; Li, Hong ; Mo, Yi ; Yuan, Lin ; Shen, Fang ; Yan, Xuemei

BACKGROUND:

Pneumococcal conjugate vaccines have significantly reduced the global morbidity and mortality burdens of pneumococcal disease in children under five years of age, but supply constraints remain. We evaluated the safety, immunogenicity, and lot-to-lot consistency of a tetanus toxoid-conjugated 13-valent pneumococcal conjugate vaccine (PCV13) in Chinese children aged 2-5 years.

METHODS:

In this randomized, Phase III study, 1800 healthy children aged 2-5 years were enrolled and randomized (1:1:1) to receive a single dose of one of three consecutive manufacturing lots of PCV13. Safety and reactogenicity were assessed up to 30 days post-vaccination, and serious adverse events (SAEs) up to 180 days. Immunogenicity was evaluated 30 days post-vaccination by measuring serotype-specific IgG concentrations using ELISA. The primary objective was to demonstrate lot-to-lot consistency based on predefined equivalence criteria for geometric mean concentration (GMC) ratios; seropositivity and safety outcomes were secondary endpoints.

RESULTS:

The prespecified primary objective was met: for all 13 vaccine serotypes, pairwise serotype-specific IgG geometric mean ratios (GMRs) between the three manufacturing lots fell within the predefined equivalence margins (0.5-2.0). By Day 30, seropositivity rates (IgG ≥0.35 μg/mL) were ≥ 99% for 12 serotypes and 85.6-88.3% for serotype 3. Solicited local and systemic reactions were predominantly mild or moderate in severity and occurred at similar frequencies across groups; rates of SAEs and unsolicited adverse events considered related to vaccination were low.

CONCLUSION:

This tetanus toxoid-conjugated PCV13 met prespecified criteria for lot-to-lot manufacturing consistency and showed favorable immunogenicity and safety profiles in children aged 2-5 years, supporting its licensed use in this age group. The vaccine may help strengthen the global supply of pneumococcal conjugate vaccines, particularly in regions with unmet pediatric vaccination needs.

01 Feb 2026·VACCINE

Determining the dose-response relationship for pneumococcal conjugate vaccines: a nested analysis of the fractional dose PCV trial

Article

Author: Ragab, Sarah ; Karani, Angela ; Tabu, Collins ; Shangala, Jimmy ; Scott, J Anthony G ; Mwalekwa, Laura ; Lucinde, Ruth ; Berkley, James A ; Gallagher, Katherine E ; Gardiner, Elizabeth ; Martinez-de-Albeniz, Irene ; Goldblatt, David ; Hamaluba, Mainga ; Smith, Peter G ; Bottomley, Christian ; Kaniu, M Wanjiru ; Badaud, Suaad ; Otiende, Mark ; Twi-Yeboah, Louise ; Mugo, Daisy ; Were, Fred ; Mutahi, Mary

BACKGROUND:

The relationship between polysaccharide dose and immune response to pneumococcal conjugate vaccines (PCV) has never been established. An individually randomized controlled clinical trial was conducted in Kenyan infants to assess whether immune responses after fractional doses of PCV10 (Synflorix, GlaxoSmithKline plc.) or PCV13 (Prevnar13, Pfizer Inc.) were non-inferior to full-dose schedules (ClinicalTrials.org: NCT03489018; Pan African Clinical Trial Registry: PACTR202104717648755). We analysed these data to describe the serotype-specific dose-response relationships and evaluate factors associated with the immune response.

METHODS:

We analysed data from participants who received PCV doses at 6 and 14 weeks of age, with immunogenicity assessed at 18 weeks of age. Participants received 20 %, 40 % or full doses of PCV10 or PCV13. We used mixed-effects linear regression models to estimate the dose-response relationships between polysaccharide dose and log-transformed IgG concentrations and to determine factors associated with immune response. We estimated the minimum dose required to obtain a high (≥95 %) probability of an immunological response above the level considered to be associated with protection using logistic regression.

RESULTS:

1342 infants were included. The polysaccharide dose, product, child's ethnicity, sex, maternal age, and interval between second PCV dose and immunogenicity sample were independently associated with IgG concentrations elicited by the primary schedule. For PCV13, the relationship between dose and log(IgG) was best described by a quadratic function for serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 19A and 23F, whereas a log-dose model was the best fit for serotypes 14, 18C and 19F. For PCV10, a linear relationship was the best fit for serotypes 1, 6B, 7F, 9V and 23F and log-dose model was the best fit for 4, 5, 14, 18C and 19F.

CONCLUSION:

Our findings suggest that available PCV10/13 could be reformulated to optimize protective responses.

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.

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Indication	Country/Location	Organization	Date
Otitis Media	United States	Wyeth Pharmaceuticals LLC	24 Feb 2010
Pneumococcal Infections	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

Developing

10 top R&D records.

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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
Pneumonia, Bacterial	Phase 3	China	Pfizer Ltd.	23 Jun 2018
Sepsis	Phase 3	China	Pfizer Ltd.	23 Jun 2018

Clinical Result

Indication

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Evaluation

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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)	ggxkriwjbm = xcjawcshqv qokbvuupdo (ggtubyreek, ugjcuuuykn - czqgndpjxe) View more	-	16 May 2025
				pneumococcal 13-valent conjugate vaccine+pembrolizumab (Phase 2 Dose Level 1)	bnrvjezrfe = pitumpcrfy fjvlqxyfmf (oluzxtecxw, kxgojlptwl - zhwzvjuoif) 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))	kepjwddcqw = gwffaqtbho kwaggglfii (maihogbzoj, jzawikmvlz - kysodmwqfr) View more	-	28 Feb 2025
				Trivalent Influenza Vaccine+Pneumococcal 13-valent Conjugate Vaccine (Arm II (Trivalent Influenza Vaccine, Prevnar))	kepjwddcqw = xmqmaepeuz kwaggglfii (maihogbzoj, bahdzvvtst - ahdandsqrr) View more
NCT04535037 (CTgov)	Phase 4	Diphtheria	500	DTPa-HBV-IPV/Hib+Pneumococcal 13-valent conjugate vaccine (Infanrix Hexa)	rivzzmtauc(qzycisgeko) = nywzmlifix htuoroixll (ivrfgaozuy, zscpfkagud - xiswspyzwg) View more	-	27 Mar 2024
				DTaP5-HBV-IPV-Hib+Pneumococcal 13-valent conjugate vaccine (Vaxelis)	rivzzmtauc(qzycisgeko) = xzxhdkztcu htuoroixll (ivrfgaozuy, ouzuqyzsjo - ympnaeoxir) View more
NCT05372575 (CTgov)	Not Applicable	Pneumonia	300	13vPnC (13vPnC Cohort)	wutuzweikl(asmjpyinng) = vmifytklgs tqnhbsddgz (igcvbgmbca, ayvlckqkpw - vhkqfnsuvg) View more	-	03 Oct 2023
				13vPnC (Non-13vPnC Cohort)	wutuzweikl(asmjpyinng) = iurlvyukpx tqnhbsddgz (igcvbgmbca, nfgmoqqzjx - eickamdtuu) View more
NCT02274415 (DREVAC, Pubmed)	Phase 2	Anemia, Sickle Cell	128	13-valent pneumococcal vaccinePPSV23eumococcal vaccine (PCV13/PPSV23)	ummvigkveq(kahvptaiop) = qevssflxdf fzrlnlnvru (tdyxvkavep ) View more	Positive	27 Jan 2023
				PPSV2313-valent pneumococcal vaccine (PPSV23 alone)	ummvigkveq(kahvptaiop) = xzdpjmhfjp fzrlnlnvru (tdyxvkavep ) View more
NCT03550313 (CTgov)	Phase 2	Pneumococcal Infections	565	c7vPnC+Prevnar 13 (Group 1: c7vPnC and Prevnar 13 Co-administration)	yflnxxjakr = vtxoflhvtt rmpurnhuyl (zgmyeptilm, ejobvpahuw - wgsxvpifix) View more	-	30 Nov 2021
				c7vPnC (Group 2: c7vPnC and Prevnar 13 Staggered Administration)	yflnxxjakr = ermppvacrp rmpurnhuyl (zgmyeptilm, lzrltvbsay - nyelmvhbfo) 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))	bmlkbfjagt = lbwfpubkzd avfetgmxub (itbhzjevvo, tlqtdaclcw - vyggcvkhzl) View more	-	19 Jan 2021
				Laboratory Biomarker Analysis+Pneumococcal 13-valent Conjugate Vaccine (Arm II (Pneumococcal 13-valent Conjugate Vaccine))	bmlkbfjagt = hivyohqogk avfetgmxub (itbhzjevvo, xjobbuwgeg - tajtfnrxqc) View more
NCT03548337 (CTgov)	Phase 4	-	301	MDV+rotavirus vaccine+13vPnC (13vPnC: Multi-dose Vial (With Preservative))	estashpkjr = vwajiotkfg lmdddnpckt (sthcyrdvit, xkoefctlgz - mmjmtqrlzv) View more	-	30 Sep 2020
				DTP-Hib-HBV vaccine+rotavirus vaccine+13vPnC (13vPnC: Single-dose Prefilled Syringe (Without Preservative))	estashpkjr = plnomegiot lmdddnpckt (sthcyrdvit, byzskhhmqs - oargrpnbby) View more
NCT03313050 (CTgov)	Phase 2	Pneumococcal Infections	511	c7vPnC (Stage 1: c7vPnC (50 to 64 Years of Age))	rzkbevolkg = ovqcewkuhx bxqfenupea (jwgcexscup, fmbsloinbv - thjwmfwgec) View more	-	04 Jun 2020
				tetanus, diphtheria, and acellular pertussis vaccine (Tdap) (Stage 1: Tdap (50 to 64 Years of Age))	rzkbevolkg = thebnmhzpo bxqfenupea (jwgcexscup, nswlxmwuni - yzmpjrfoyh) View more
NCT03777865 (CTgov)	Phase 4	-	100	13-Valent Pneumococcal Conjugate (13vPnC) Vaccine	kdjzdcclkg = mwwwrfesab zfkoiozrap (apbhvblzko, suceusjkfu - lsgcoomhoe) View more	-	21 Apr 2020

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