A Parallel-group Prevention, Phase II, Partially Blinded, Multi-stage Study to Investigate the Immunogenicity and Safety of Pentavalent Meningococcal ABCYW Vaccine Formulations Compared With Licensed Meningococcal Vaccines When Administered Alone in Healthy Children (2 to 9 Years of Age) or Concomitantly With Routine Pediatric Vaccines in Toddlers (12 to 15 Months of Age) and Infants (2 Months of Age).

This study is the first study of Sanofi's Pentavalent Meningococcal ABCYW vaccine clinical development program to be conducted in the pediatric population below 10 years of age. The aim of the study is to assess 2 formulations of the MenPenta vaccine compared to licensed meningococcal vaccines when administered alone in children (Stage 1) or concomitantly with routine pediatric vaccines in toddlers (Stage 2) and infants (Stage 3).
Study details include:
The study duration per participant will be up to 12 months for children in Stage 1 and toddlers in Stage 2 and 16 to-19 months for infants in Stage 3.

Start Date05 Nov 2024

Sponsor / Collaborator

Sanofi Pasteur

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 2024

Sponsor / Collaborator-

NCT06202703 / RecruitingNot ApplicableIIT

Optimisation of Lymph Node Fine Needle Aspiration to Study Pneumococcal Vaccine-induced Immunity

Rationale Causing a wide range of infectious diseases, including pneumonia, otitis media and meningitis, S. pneumoniae represents an important global health problem. Pneumococcal vaccines are clinically effective in preventing invasive pneumococcal disease, but the underlying immune response is likely to differ due to the inclusion of T cell epitopes in the conjugate, but not purified polysaccharide vaccine. However, these differences remain scantly studied. Lymph node fine needle aspiration (FNA) has been recently described to study vaccine-induced germinal centre responses in depth and represents a promising tool to study the underlying immune mechanisms of pneumococcal vaccines. Insight into the underlying immune mechanisms of vaccines could improve future vaccine design, e.g. by refining dosing intervals.
Objective Determine timing of peak germinal centre B cell frequency following pneumococcal vaccination.
Main trial endpoints The main trial endpoint is represented by the frequency of germinal centre B cells (BGC) in lymph node aspirates at various time points after vaccination, as measured by spectral flow cytometry. Both total BGC cells and S. pneumoniae polysaccharide-specific BGC frequencies will be determined.
Trial design Pilot intervention study without a comparator.
Trial population Healthy individuals between the age of 20 - 40
Interventions Subjects will be vaccinated once with Prevenar13. FNA of the draining lymph node will be performed and blood will be drawn at baseline, followed by weekly collection during the first four weeks, every other week between weeks 4 - 8 and a final collection time point after 12 weeks, resulting in a total of 8 sampling time points over the course of three months. Draining lymph node size will be assessed by ultrasound every other day during the first two weeks and then alongside lymph node FNA for the remainder of the study.

Start Date15 Apr 2023

Sponsor / Collaborator

Academisch Ziekenhuis Leiden

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

998

Literatures (Medical) associated with Pneumococcal polysaccharide conjugate vaccine

01 Dec 2024·Infectious Diseases and Therapy

Global Epidemiology of Meningococcal Disease-Causing Serogroups Before and After the COVID-19 Pandemic: A Narrative Review

Review

Author: Shen, Steven ; Peyrani, Paula ; Findlow, Jamie

Invasive meningococcal disease (IMD) is associated with high morbidity and mortality and predominantly caused by five Neisseria meningitidis serogroups (A/B/C/W/Y). Polysaccharide conjugate vaccines induce T-cell-dependent immune responses, are immunogenic in infants and adults, and reduce carriage, and vaccination of age groups associated with high-carriage can provide indirect protection in the unvaccinated (herd immunity). Successful vaccination programs must be tailored to local epidemiology, which varies geographically, temporally, and by age and serogroup. Serogroup A IMD once predominated globally, but has largely disappeared following mass vaccination programs. Serogroup B was a predominant cause of IMD in many global regions from 2010 to 2018, typically affecting younger age groups. Spread of serogroup C clonal complex-11 IMD in the 1990s prompted implementation of MenC vaccine programs in many countries, resulting in declines in prevalence. Serogroup C still caused > 20% of global IMD through the mid-2010s. Serogroup W became a significant contributor to global IMD after Hajj pilgrimage outbreaks in 2000; subsequent increases of endemic disease and outbreaks were reported pre-pandemic in many regions. Serogroup Y emerged in the 1990s as a significant cause of IMD throughout various regions and prevalence had increased or stabilized from 2010 to 2018. Serogroup X is uncommon outside the African meningitis belt, and its prevalence has declined since before the COVID-19 pandemic. Global IMD declines during the pandemic were followed by resurgences generally caused by serogroups that were prevalent pre-pandemic and affecting mainly unvaccinated age groups (particularly adolescents/young adults). Recent IMD epidemiology underscores the importance of vaccinating at-risk age groups against regionally prevalent serogroups; for example, the anti-serogroup X component of the recently prequalified MenACWXY vaccine is likely to provide limited protection outside the African meningitis belt. In other regions, comprehensive vaccination against MenB and MenACWY, which could be streamlined by the recently approved MenABCWY vaccine, seems more appropriate.

01 Nov 2024·JOURNAL OF INFECTION

Comparison of short- and long-term humoral immune responses to pneumococcal polysaccharide and glycoconjugate vaccines in an HIV-infected population

Article

Author: Whitelegg, Alison ; MacLennan, Calman A. ; Birtwistle, Jane ; Plant, Timothy ; Shields, Adrian ; Manavi, Kaveh ; Richter, Alex ; Hodson, James ; Masuka, Sindiso ; MacLennan, Calman A ; Faustini, Siân E ; Drayson, Mark T ; Chigiga, Joyful ; Singo, Mebie ; Faustini, Siân E. ; Drayson, Mark T. ; Richter, Alex G

BACKGROUND:

Immunisation is recommended internationally to protect against pneumococcal infections in HIV-infected adults. However, vaccination schedule designs are mostly based on studies of initial rather than long-term antibody responses. This UK observational study investigated the short- and long-term antibody responses to polysaccharide and glycoconjugate pneumococcal vaccines in an adult HIV-infected cohort.

METHODS:

We studied a subgroup of 152 of 839 participants from the AIR (Assessment of Immune Responses to Routine Immunisations in HIV-infected Adults, ISRCTN95588307) study that had received pneumococcal vaccinations and had blood samples collected pre- and post-vaccination, as well as at least annually for four subsequent calendar years. Patients received either Pneumovax-23 (PPV, N = 89) or Prevenar-13 (PCV, N = 63) as their primary vaccine, with immunity assessed by measuring IgG antibody concentrations for 12 pneumococcal polysaccharide serotypes (PnPS). The primary outcome was achieving IgG antibody concentrations above the recommended World Health Organisation (WHO) threshold of 0.35 µg/mL for at least 8/12 of the PnPS assessed (WHO_≥8/12PnPS). Patients who did not achieve WHO_≥8/12PnPS after the primary vaccination were offered further vaccination with PCV; booster vaccinations with PCV were additionally offered to those where antibody levels subsequently fell below the WHO_≥8/12PnPS threshold.

RESULTS:

Patients receiving PCV as their primary pneumococcal vaccine were significantly more likely to achieve WHO_≥8/12PnPS after a single vaccine dose than those receiving PPV (54% vs. 33%, p = 0.012). This difference persisted following booster vaccination with PCV, with cumulative rates of WHO_≥8/12PnPS in those receiving PCV vs. PPV as the primary vaccine of 88% vs. 67% and 100% vs. 85% after receiving up to one and two booster vaccinations, respectively. Where WHO_≥8/12PnPS was achieved, this persisted significantly longer in those receiving PCV as their primary vaccine compared to PPV (median: 23.5 vs. 11.1 months; p = 0.010).

CONCLUSIONS:

Immunisation with PCV resulted in quantitatively greater antibody responses than immunisation with PPV in a cohort of HIV-infected UK adults. Individuals receiving PCV as their primary vaccine required fewer total pneumococcal vaccine doses to achieve WHO_≥8/12PnPS and experienced greater duration of time above this threshold than those with PPV as the primary vaccine. However, the median longevity of both vaccine responses was relatively short, which supports the use of ongoing booster doses using high-valency glycoconjugate vaccines to sustain WHO_≥8/12PnPS threshold antibody levels.

14 Oct 2024·Cureus Journal of Medical Science

Oswald Avery: Pioneer of Bacterial Vaccines and the First to Discover the Function of DNA

Review

Author: Berbers, Guy ; Dekker, Karen ; Rijkers, Ger

Dr. Oswald Theodore Avery (1877-1955), M.D., played an immense role in the biological and medical field because of his groundbreaking research. All his life, he worked on Streptococcus pneumoniae, the bacterium that causes pneumonia. He discovered the principle of polysaccharide conjugate vaccines, which now save the lives of millions of children and the elderly. He found that bacteria can transfer plasmids; most importantly, he identified that deoxyribonucleic acid (DNA) is the carrier of genetic information instead of the (at that time widely accepted) protein theory. Though he was never awarded the Nobel Prize, his work was the basis for countless achievements building on his foundation, ranging from effective vaccines to gene transfer technologies.

News (Medical) associated with Pneumococcal polysaccharide conjugate vaccine

03 Dec 2024

·www.echemi.com

Over 2,000 Layoffs in 19 Global Pharma Companies, Johnson & Johnson and Merck Restructure Operations in China

According to the latest monitoring data, at least 19 pharmaceutical companies globally announced layoffs or business streamlining plans in November. The impact on multinational pharmaceutical companies operating in China has been particularly significant, with Johnson & Johnson and Merck implementing layoffs in the country. Johnson & Johnson's layoffs in China reached 2,000 people, approximately 20% of its total workforce, mainly affecting the surgical division. The layoffs were primarily due to declining company performance, especially in its ultrasound knife business, which saw its market share plunge from 95% to less than 30%. Since the second quarter of this year, Johnson & Johnson has also undergone business adjustments, with several senior executives, including the president of China, Song Weiqun, leaving the company. Merck also conducted staff reductions in its China division, although the exact number of layoffs has not been specified, primarily affecting the diabetes department. Due to the impact of centralized procurement policies, Merck's diabetes drug business has suffered significantly, forcing the company to take measures to drastically reduce costs. In recent years, centralized procurement policies have driven down drug prices, leading to significant profit reductions for pharmaceutical companies, which have had to scale back or sell their operations in China in response. For example, Pfizer sold its PCV13 vaccine business and conducted extensive layoffs. In this context, other pharmaceutical companies have also announced restructuring plans. Sana Biotechnology is shifting its research focus from cancer to autoimmune diseases and has undergone strategic restructuring, though it has not disclosed the number of layoffs. Viracta Therapeutics, focusing on precision oncology, announced approximately 42% layoffs to concentrate resources on its Nana-val development project. Aurinia laid off 45% of its workforce due to an inability to find a buyer, aiming to maintain cash flow. A gene sequencing company announced a 40% reduction in staff and the termination of all therapeutic projects due to declining business and cash flow issues. Marinus Pharmaceuticals announced a 45% reduction in staff following the failure of its core drug in Phase III clinical trials. Adaptimmune stated it would lay off 33% of its workforce in Q1 2025, aiming to save $300 million over the next four years and achieve break-even by 2027. Additionally, companies such as Gilead, Sensei Biotherapeutics, Sonata, Lexicon Pharmaceuticals, Bristol-Myers Squibb, Alector, Medigene, Novartis, and Kronos Bio have also announced layoffs or restructuring plans to respond to the current challenges in the pharmaceutical industry. These measures reflect the strategies adopted by the pharmaceutical industry in the face of market changes and policy adjustments.

VaccinePhase 3Financial Statement

24 Oct 2024

·www.biospace.com

CDC Panel Recommends Merck and Pfizer Pneumococcal Vaccines for Adults Aged 50-64

The CDC’s Advisory Committee on Immunization Practices on Wednesday backed the use of Merck’s Capvaxive and Pfizer’s Prevnar 20 in adults between 50-64 years of age, opening a bigger market for the respective companies. An expert panel of the U.S. Centers for Disease Control and Prevention on Wednesday supported the broader use of pneumococcal vaccines, including adults between 19 and 49 years with certain risk factors, according to Reuters . The CDC’s Advisory Committee on Immunization Practices (ACIP) voted 14–1 in favor of expanding the agency’s guidance for pneumococcal vaccines—such as Merck ’s Capvaxive and Pfizer ’s Prevnar 20—to cover adults aged 50 to 64 years. These recommendations are not yet final and will still need final approval from the CDC director and the Department of Health and Human Services. Still, the new guidelines could unlock a bigger patient pool for Merck and Pfizer. Currently, the CDC only recommends pneumococcal vaccination for older adults 65 years and above , as well as in young adults aged 19 through 65 with certain risk conditions. A Merck spokesperson in an emailed statement welcomed the results of the ACIP vote, calling it a “potentially practice-changing decision” that could contribute to better immunization rates and health outcomes. The ACIP’s recommendations, if approved by the CDC director, “can help advance how we protect our communities from invasive pneumococcal disease and pneumococcal pneumonia,” the spokesperson said. Merck’s Capvaxive, which the FDA approved in June 2024 , is a 21-valent vaccine that targets the most prevalent serotypes, which cause around 84% of invasive pneumococcal disease in adults 50 years and older. A few weeks after approval, the CDC’s ACIP unanimously endorsed the use of Capvaxive. According to a Merck press release following the ACIP vote, the panel specifically recommends Capvaxive for adults aged 50 years and above who have not yet been immunized with a pneumococcal conjugate vaccine. The shot can also be given to vaccine-naïve younger adults 19 to 49 years with “certain underlying medical conditions” and other risk factors. The ACIP vote on Wednesday also presents a potential boon to Pfizer, which markets the 20-valent Prevnar 20. The FDA first approved the vaccine in June 2021 for adults 18 and above, and then in April 2023 to allow for pediatric use. Prevnar 20 improves upon Pfizer’s previous pneumococcal vaccine—Prevnar 13, which only covered 13 virus serotypes—and targets additional serotypes known to cause invasive pneumococcal disease or are associated with high fatality rates and antibiotic resistance. As in the case of Capvaxive, the ACIP on Wednesday backed the use of Prevnar 20 in older adults 50 years and older, and in 19-to-49-year-olds with certain risk factors, according to a Pfizer press release .

Drug ApprovalVaccine

08 Oct 2024

·www.biospace.com

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

VaccinePhase 3Phase 2Clinical Result

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
Pneumonia, Bacterial	JP	Pfizer Inc.	18 Jun 2013
Otitis Media	US	Wyeth Pharmaceuticals LLC	24 Feb 2010
Acute otitis media	EU	Pfizer Europe MA EEIG	09 Dec 2009
Acute otitis media	IS	Pfizer Europe MA EEIG	09 Dec 2009
Acute otitis media	LI	Pfizer Europe MA EEIG	09 Dec 2009
Acute otitis media	NO	Pfizer Europe MA EEIG	09 Dec 2009
Invasive streptococcal disease	EU	Pfizer Europe MA EEIG	09 Dec 2009
Invasive streptococcal disease	IS	Pfizer Europe MA EEIG	09 Dec 2009
Invasive streptococcal disease	LI	Pfizer Europe MA EEIG	09 Dec 2009
Invasive streptococcal disease	NO	Pfizer Europe MA EEIG	09 Dec 2009
Pneumonia, Pneumococcal	EU	Pfizer Europe MA EEIG	09 Dec 2009
Pneumonia, Pneumococcal	IS	Pfizer Europe MA EEIG	09 Dec 2009
Pneumonia, Pneumococcal	LI	Pfizer Europe MA EEIG	09 Dec 2009
Pneumonia, Pneumococcal	NO	Pfizer Europe MA EEIG	09 Dec 2009
Pneumococcal Infections	JP	Wyeth KK	16 Oct 2009

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Bacteremia	Phase 3	CN	John Wyeth & Brother Ltd.	23 Jun 2018
Bacteremia	Phase 3	CN	Pfizer Ltd.	23 Jun 2018
Bacteremia	Phase 3	CN	Wyeth Pharmaceuticals LLC	23 Jun 2018
Bacteremia	Phase 3	CN	Pfizer Investment Co. Ltd.	23 Jun 2018
Meningitis	Phase 3	CN	Wyeth Pharmaceuticals LLC	23 Jun 2018
Meningitis	Phase 3	CN	Pfizer Ltd.	23 Jun 2018
Meningitis	Phase 3	CN	John Wyeth & Brother Ltd.	23 Jun 2018
Meningitis	Phase 3	CN	Pfizer Investment Co. Ltd.	23 Jun 2018
invasive Streptococcus pneumoniae infection	Phase 3	CN	Wyeth Pharmaceuticals LLC	04 Sep 2012
invasive Streptococcus pneumoniae infection	Phase 3	CN	Wyeth Lederle Vaccines SA	04 Sep 2012

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03691610 (CTgov)	Phase 3	Meningococcal Infections	950	MenACYW conjugate vaccine (Infants: Group 1)	jhgqygamwy(udqaurdzbg) = kfkqmcpcvj kitwvpofxi (zhjhyxipss, ucolwotisn - yxzvvclhft) View more	-	25 Jun 2024
				MENVEO (Infants: Group 2)	jhgqygamwy(udqaurdzbg) = mivdqetlky kitwvpofxi (zhjhyxipss, sbvkemoxng - zgjupskpah) View more
NCT04535037 (CTgov)	Phase 4	Diphtheria	500	DTPa-HBV-IPV/Hib+Pneumococcal 13-valent conjugate vaccine (Infanrix Hexa)	rqhthhtvkf(punglchwra) = pdbwlcywpb klgbohykoi (lhsblffdwr, bcpdwltubc - negnxtcsat) View more	-	27 Mar 2024
				Pneumococcal 13-valent conjugate vaccine+DTaP5-HBV-IPV-Hib (Vaxelis)	rqhthhtvkf(punglchwra) = uyxemiyimw klgbohykoi (lhsblffdwr, ttwxgshphi - jowffypoyn) View more
NCT03630705 (MET33, CTgov)	Phase 3	Meningococcal Infections	525	Rubella Virus Vaccine Live+W) Tetanus Toxoid Conjugate Vaccine+Pneumococcal 13-valent Conjugate Vaccine+Rotavirus Vaccine, Live, Pentavalent (Group 1: MenACYW Conjugate Vaccine (Mexico))	vlaxfgzzli(wgsrtihikc) = ydkqyvnobt juufzreasq (rihhdlzcqg, qnvbjzhlvb - sfoxpftcxu) View more	-	19 Oct 2023
				Rubella Virus Vaccine Live+W) Tetanus Toxoid Conjugate Vaccine+Hepatitis B Vaccine+Pneumococcal 13-valent Conjugate Vaccine (Group 3: MenACYW Conjugate Vaccine (Russian Federation))	xbvtyhfhlx(ysyehugzav) = qpinnvpjlz evlenrlqrb (aqgfmlqkhd, gkdxbpjmkx - kownevluyd) View more
NCT03673462 (MET41, CTgov)	Phase 3	Meningococcal Infections	2,797	W) tetanus toxoid Conjugate vaccine (MenACYW Conjugate vaccine)+Diphtheria, Tetanus, Acellular Pertussis, Poliovirus+Varicella Virus Vaccine+Hepatitis B Vaccine+Pneumococcal 13-valent Conjugate Vaccine (Group 1: MenACYW Conjugate Vaccine)	gtxwwuncvm(lrdzguaxjw) = ugwxjwoegt wksmrbnown (odfjkrpczc, njivitxaej - lnmhkacsxm) View more	-	05 Oct 2023
				W 135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine (MENVEO®)+Diphtheria, Tetanus, Acellular Pertussis, Poliovirus+Varicella Virus Vaccine+Hepatitis B Vaccine+Pneumococcal 13-valent Conjugate Vaccine (Group 2: MENVEO®)	gtxwwuncvm(lrdzguaxjw) = mymhysvwhl wksmrbnown (odfjkrpczc, adoszetvdw - obitvuwwdn) View more
NCT05372575 (CTgov)	Not Applicable	Pneumonia	300	13vPnC (13vPnC Cohort)	ilscmskzzb(gkevgyiioz): Geometric Mean Ratio (GMR) = 13.16 (95.0% CI, 8.99 - 19.28); GMR = 5.88 (95.0% CI, 4.32 - 8.01); GMR = 17.98 (95.0% CI, 12.07 - 26.78); GMR = 2.42 (95.0% CI, 1.9 - 3.08); GMR = 6.35 (95.0% CI, 4.68 - 8.61); GMR = 6.64 (95.0% CI, 4.92 - 8.97); GMR = 9.42 (95.0% CI, 6.91 - 12.83); GMR = 3.89 (95.0% CI, 2.96 - 5.1); GMR = 62.13 (95.0% CI, 40.16 - 96.12); GMR = 16.37 (95.0% CI, 11.22 - 23.89); GMR = 4.25 (95.0% CI, 3.22 - 5.62); GMR = 8.73 (95.0% CI, 6.24 - 12.21); GMR = 8.33 (95.0% CI, 6.15 - 11.29) View more	-	03 Oct 2023
				13vPnC (Non-13vPnC Cohort)
NCT02274415 (DREVAC, Pubmed)	Phase 2	Anemia, Sickle Cell	128	13-valent pneumococcal vaccine (PCV13/PPSV23)	svknpsrrpo(mydalfimyt) = sfszgpkfwy lwbvhscdcu (xpnpxfjyqk ) View more	Positive	27 Jan 2023
				13-valent pneumococcal vaccine (PPSV23 alone)	svknpsrrpo(mydalfimyt) = rdezjbgqcn lwbvhscdcu (xpnpxfjyqk ) View more
NCT03439657 (Pubmed \| J Infect)	Phase 3	-	913	Adjuvanted Recombinant Zoster Vaccine	qxtwfipnri(opgqwurnuh): P-Value = 1.02 View more	Positive	25 Dec 2021
				13-valent Pneumococcal Conjugate Vaccine
NCT03550313 (CTgov)	Phase 2	Pneumococcal Infections	565	c7vPnC+Prevnar 13 (Group 1: c7vPnC and Prevnar 13 Co-administration)	bqreqbextu(rukpxttoza) = zauxumalgv jkpibrjmwh (xvylmlhhim, jeyixbvfpc - rmnzncjybk) View more	-	30 Nov 2021
				c7vPnC (Group 2: c7vPnC and Prevnar 13 Staggered Administration)	bqreqbextu(rukpxttoza) = kgwilbnlqc jkpibrjmwh (xvylmlhhim, ayqofdmrdw - dnyrtsmpjm) View more
NCT03439657 (CTgov)	Phase 3	Herpes Zoster	913	HZ/su vaccine GSK1437173A+Prevenar13 (Co-Ad Group)	ilyovvithm(dpdebtnqpq) = ctncrqxpev aqwyrkgysd (ggeedjugew, fqratirgey - awberjpudb) View more	-	18 Mar 2021
				HZ/su vaccine GSK1437173A+Prevenar13 (Control Group)	urlpcsdwyd(odemxdyoog) = yyvmflakgs elzocftlix (qddqwieqtx, nhslrhvrxi - rmzlqxppyn) 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))	wmxctwyyap(hdrutvhexf) = zbndvuleve zqveoowjdm (khaufvfijn, dkfdrxfoyh - acdjpxtgsy) View more	-	19 Jan 2021
				Laboratory Biomarker Analysis+Pneumococcal 13-valent Conjugate Vaccine (Arm II (Pneumococcal 13-valent Conjugate Vaccine))	wmxctwyyap(hdrutvhexf) = mseuisaqmx zqveoowjdm (khaufvfijn, bddkezfehw - wobgxkxjwn) View more

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