PIPELINE-RSV International Trial. Pregnancy and Infant PrEparedness pLatform IN Europe (PIPELINE)- RSV International Immunisation Adaptive Platform Trial.

RSV (which stands for Respiratory Syncytial Virus) is an infection that causes cold-like symptoms and is most common during winter months. Most people with RSV infection get better by themselves but babies and younger children can become very poorly. About 1 in 15 infants with confirmed RSV within the first 12 months of life will be hospitalised, and a very small proportion will be seriously ill and may die.
Currently there are two different prevention options that can be used to prevent RSV infection in babies. One is a vaccine given to the mother during pregnancy, and the other is a monoclonal antibody given by injection to the baby. Although both prevention options work well on their own and are safe, neither provides 100% protection to the infant. It is not known whether giving both medicines, one to the mother in pregnancy and one to the infant, would provide better protection than giving only one medicine - this is what the PIPELINE-RSV study will look at.
PIPELINE-RSV-International will recruit about 1500 pregnant women from across Europe in UK, Switzerland, the Netherlands and Belgium. A parallel trial, PIPELINE-RSV-France, running in France will recruit about 1000 pregnant women in France; the protocols will align on key aspects and the data will be analysed together. The study will include three study groups with different prevention options used in each: (1) a vaccine given to the mother in pregnancy, (2) an injection given to the baby at the beginning of RSV season, or (3) both a vaccine given to the mother in pregnancy and an injection given to the baby at around 4 months of age. Each mother-baby pair will be randomly allocated to group by a computer. The numbers of babies in each of these groups who acquire RSV will be compared. In some countries only two of the three study groups may be available.
Pregnant women and their babies will be followed until the baby reaches 12 months of age. Information will be collected about medically-important side effects either the mother or the baby had from their medicine(s) and any symptoms of RSV the baby had. Visits with the mother and baby will occur at birth, and 4 and 12 months later; these will ideally be in-person at birth and at 12 months. The mother will complete questionnaires via a Web-based platform to report any non-routine in-person visits, once in pregnancy and after the baby is born twice a month or monthly (more often in the winter), to also report baby's symptoms, to report their trial experience when the baby is 4 and 12 months' old, and to provide their views on vaccination at birth, and when the baby is 4 and 12 months' old. If the baby develops symptoms that might be RSV, their mother or another caregiver will be asked to take a sample using a swab from the baby's nose or mouth, and to send it by post for testing to find out if the baby has RSV.
As well as the main research study, there are also some substudies. A questionnaire will be given to women who consent to take part, to find out their motivations for joining the study and how they prefer to receive information about taking part in studies. A small number of women will be asked to take part in a study to look at how mothers' and babies' immune systems respond to the two different study prevention options , and to investigate different ways of collecting samples from their babies. In addition, researchers will use data from the study to see whether giving both medicines is cost-effective compared with giving just one medicine.
The study might be adapted in the future to look at other medicines for preventing RSV infection, when they become available.

Start Date01 Sep 2025

Sponsor / Collaborator

Penta Global Blockchain Foundation, Inc.

NCT07097012

/ Not yet recruitingPhase 4IIT

Concurrent Versus Sequential Administration of Tdap and RSV Vaccines in Pregnancy - A Pilot Feasibility Trial

The goal of this clinical trial is to learn if the RSV vaccine (protects against respiratory syncytial virus) and Tdap vaccine (protects against pertussis) are most effective in pregnant individuals when taken together at the same visit, or separately at different visits. This clinical trial will also learn about the safety and immune responses of these vaccines in pregnancy.
The Main question:
-Is it possible to run a successful trial that tests how safe and effective it is to give Tdap and RSV vaccines in pregnancy either at the same time or one after the other, at different visits?
The Secondary question:
-To determine how safe and how well the Tdap and RSV vaccines work when given in pregnancy either at the same time or one after the other, at different visits.
The Exploratory (optional participation) questions:
* To measure the levels of antibodies against whooping cough (pertussis) and RSV in mothers at 7 and 19 months after giving birth, depending on whether they got the vaccines at the same time or one after the other during pregnancy.
* To measure whooping cough antibody levels in the babies at 2, 7, and 19 months of age, whose mothers who received the vaccines in pregnancy.
* To measure the levels of RSV antibodies in the mothers' breast milk at 1 week, 2 weeks, 4 weeks, and 2 months after giving birth.
Participants will be randomly assigned to Group 1 (vaccines given at the same time, same visit) or Group 2 (vaccines given one after the other, at different visits).
There are 4 visits as part of the main study, and 6 additional visits as part of the optional study (exploratory questions).
Visit 1-2: Blood collection and vaccines administered Visit 3-4: Blood work (cord blood sample collection from infant, after delivery, if possible) Visit 5-8: Breast milk collection Visit 8-10: Blood collection (infant blood collection only at Visit 8).
Participants will be asked to keep a diary of symptoms throughout the study.

Start Date01 Sep 2025

Sponsor / Collaborator

Canadian Immunization Research Network

[+6]

NCT07122661

/ Active, not recruitingNot Applicable

STudy of Real World vaccinE Effectiveness of maTernal RSVpreF vaccinatiON Against Respiratory Syncytial Virus (RSV) in Hospitalised Infants in Australia

This Pfizer-sponsored real-world retrospective non-interventional study will be conducted within a research network comprised of independent hospitals across Australia using data collected during routine standard of care clinical encounters available in health records, supplemented with information from the official national immunisation registry, the Australian Immunisation Register. Additional data from accredited pathology laboratories will be included. There will be no active enrollment of study participants, no direct contact with study participants, and no collection of any primary data outside of the standard of care.
This study will use a test negative design to evaluate real-world vaccine effectiveness of RSVpreF vaccination during pregnancy against RSV-associated outcomes in infants.

Start Date11 Aug 2025

Sponsor / Collaborator

Pfizer Inc.

100 Clinical Results associated with RSVpreF

100 Translational Medicine associated with RSVpreF

100 Patents (Medical) associated with RSVpreF

417

Literatures (Medical) associated with RSVpreF

01 Jan 2026·AMERICAN HEART JOURNAL

A pragmatic individually randomized trial to evaluate bivalent RSV prefusion F protein–based vaccine effectiveness for preventing RSV hospitalizations in adults aged 60 years or above (DAN-RSV): Rationale and trial design

Article

Author: Zhang, Pingping ; Skovdal, Mette ; Schwarz, Claudia ; Moulton, Lawrence H ; Modin, Daniel ; Solomon, Scott D ; Begier, Elizabeth ; Gonzalez, Elisa ; Larsen, Lykke ; Gessner, Bradford D ; Biering-Sørensen, Tor ; Skaarup, Kristoffer G ; Lindholm, Matias G ; Dalager-Pedersen, Michael ; Claggett, Brian L ; Christensen, Sine H ; Martel, Cyril Jean-Marie ; Stæhr Jensen, Jens Ulrik ; Larsen, Carsten S ; Wiese, Lothar ; Aliabadi, Negar ; Køber, Lars ; Johansen, Niklas D ; Lassen, Mats C Højbjerg

BACKGROUND:

Respiratory syncytial virus (RSV) can cause serious illness in older adults and those with chronic conditions. While the bivalent RSVpreF vaccine has been shown to protect against RSV-related respiratory tract disease, its impact on severe RSV-related and broader cardiorespiratory hospitalizations remains untested in a fully powered randomized trial. This pragmatic, individually randomized, open-label, parallel-group trial aims to evaluate RSVpreF vaccine effectiveness (VE) in reducing the risk of RSV-related and all-cause cardiorespiratory hospitalizations in adults aged 60 and older.

METHODS:

DAN-RSV is randomizing Danish adults 1:1 to receive either RSVpreF or no RSV vaccine. The trial uses nationwide registries for recruitment, where eligible citizens are identified and invited via the national electronic messaging system and can provide electronic informed consent remotely. Baseline, safety, and outcome data are collected through the national health registries using the civil registration number provided at consent. Up to 130,000 participants will be enrolled during the 2024/2025 winter season. The primary objective is to assess vaccine effectiveness (VE) against RSV-related respiratory tract disease hospitalization. Secondary endpoints include RSV-related and all-cause lower respiratory tract disease hospitalizations, RSV-related and all-cause cardiorespiratory hospitalizations, and all-cause death.

CONCLUSION:

DAN-RSV is an innovative trial combining the gold standard of individual randomization with pragmatic data collection via centralized health records and national health registries. This design offers a feasible approach to assess the impact of RSVpreF on clinically meaningful cardio-respiratory outcomes in adults ≥60 years in a real-world setting - while minimizing bias through use of randomization. The results will support cost-effectiveness analyses and inform future vaccination policies.

TRIAL REGISTRATION:

NCT06684743, registered November 9, 2024 (https://clinicaltrials.gov/study/NCT06684743).

31 Dec 2025·Expert Review of Vaccines

Potential public health and economic impact of maternal vaccination with bivalent respiratory syncytial virus prefusion F (RSVpreF) vaccine for the prevention of acute respiratory infection among infants in the United States

Article

Author: Shea, Kimberly M. ; Gessner, Bradford D. ; Averin, Ahuva ; Pugh, Sarah ; Weycker, Derek ; Atwood, Mark ; Quinn, Erin ; Cane, Alejandro ; Law, Amy W. ; Atwell, Jessica E.

BACKGROUND:

The U.S. Advisory Committee on Immunization Practices recommends use of bivalent stabilized prefusion F subunit vaccine (RSVpreF) among pregnant persons to protect their infants against lower respiratory tract illness due to RSV (RSV-LRTI).

RESEARCH DESIGN AND METHODS:

Using a cohort model depicting clinical outcomes and economic costs of RSV acute respiratory infection (RSV-ARI) among US infants from birth to age 1 year, we evaluated the impact of seasonally administered maternal RSVpreF versus no intervention. Outcomes included cases of medically attended RSV-ARI, RSV-related deaths, medical costs, and indirect costs. Costs were reported in 2023 US$.

RESULTS:

Among the 3.7 million US infants aged <12 months each year, a total of 1,148,967 RSV-ARI cases (hospital: 48,384; emergency department [ED]: 246,118; outpatient clinic [OC]: 854,465) were projected to occur, yielding total annual costs of $2.4 billion (direct: $1.7B; indirect: $0.7B). With 54.9% uptake, RSVpreF would prevent 89,908 cases (hospital: 10,308; ED: 20,538; OC: 59,062), corresponding with a $368 million decrease (direct: $286 M; indirect: $81 M) in total 1-year costs.

CONCLUSION:

Even with limited uptake and without considering benefits to pregnant persons or reductions in RSV-related sequelae, maternal vaccination with RSVpreF would substantially reduce the public health and economic burden of RSV-ARI in US infants.

31 Dec 2025·Human Vaccines & Immunotherapeutics

Cost-effectiveness of immunization strategies to protect infants against respiratory syncytial virus in the Netherlands

Article

Author: Atwood, Mark ; van den Boer, Jennie ; Langedijk, Annefleur C. ; van den Dungen, Floris ; Averin, Ahuva ; Smit, Lucy ; Law, Amy ; Quinn, Erin ; Harteveld, Lisette ; Mendes, Diana ; van Houten, Marlies

The European Medicines Agency has authorized two interventions to prevent lower respiratory tract disease due to respiratory syncytial virus (RSV-LRTD) in infants: nirsevimab, a monoclonal antibody, and bivalent stabilized prefusion F subunit maternal vaccine (RSVpreF). In the Netherlands, RSV-LRTD protection is recommended for all infants with nirsevimab given preferential recommendation over RSVpreF. We evaluated cost-effectiveness of various intervention strategies to prevent RSV in the Netherlands. We employed a cohort model to evaluate clinical and economic outcomes associated with RSV-LRTD during the first year of life among infants receiving RSVpreF with complementary nirsevimab and, alternatively, nirsevimab alone versus no intervention. Model inputs, based principally on Dutch data, include rates of disease, case-fatality, general mortality; disutility; and costs of interventions, medical care, treatment-related travel, and disease-associated work loss. Uptake of interventions assumed 70%; effectiveness was based on a published study using Phase III trial data. Analyses were conducted from the societal perspective using 2023 EUR; annual discount rates were 3% for costs and 1.5% for quality-adjusted life-years (QALYs). With no intervention, there were 10,482 RSV-LRTD cases with total associated costs of € 17.4M. Nirsevimab alone prevented 4,905 cases, yielding 100 QALYs; total costs increased by € 59.3M due to high intervention costs and cost-effectiveness was € 592,404/QALY (vs. no intervention). RSVpreF with complementary nirsevimab for infants prevented 4,723 cases, yielding 108 QALYs; total costs increased by € 35.5M and cost-effectiveness was € 329,187/QALY (vs. no intervention). Maternal RSVpreF with complementary nirsevimab was more cost-effective than nirsevimab alone.

389

News (Medical) associated with RSVpreF

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

07 Aug 2025

·endpoints.news

CDC adopts advisors' recommendation for Merck’s infant RSV antibody

The CDC now recommends the use of Merck’s recently-approved RSV antibody in infants, after advisors to the agency voted in favor of the product in June. CDC Director Susan Monarez adopted the recommendation of the Advisory Committee on Immunization Practices on Monday after taking the helm of the agency last week. Merck’s Enflonsia was approved by the FDA earlier in June to prevent RSV lower respiratory tract disease in infants entering their first respiratory virus season. Inclusion of the antibody in CDC’s guidelines was the final step for Merck as it challenges Sanofi and AstraZeneca’s Beyfortus in the market. Beyfortus raked in almost $2 billion in sales in 2024 after being approved in 2023. The June ACIP meeting was the first since HHS Secretary Robert F. Kennedy Jr. fired and replaced the committee’s roster of members. Two of the seven new members had voted against the drug, raising safety concerns with the RSV antibodies. Retsef Levi, a supply chain professor at MIT, had issues with what he believed was an imbalance in deaths, specifically highlighting Beyfortus’ clinical trial data despite that product not being up for recommendation. Cody Meissner, the only former ACIP member to be included in the rebuilt panel, voted for the drug and underscored the real-world benefit that Beyfortus and Pfizer’s maternal RSV vaccine had demonstrated so far. “This is a truly spectacular accomplishment,” Meissner said at the meeting. Kennedy last month adopted guidance made by the previous ACIP panelists in April, recommending adult RSV vaccines for people 50 to 59 at higher risk of severe disease. Kennedy also recently adopted a June recommendation from the rebuilt ACIP panel to continue annual flu shots but remove thimerosal from them . That ingredient has been a source of consternation from people hesitant or skeptical about vaccination, and its alleged risks have been pushed by Children’s Health Defense, an organization Kennedy used to run. But the FDA notes that vaccines without thimerosal are available and that a “robust body of peer-reviewed scientific studies” have concluded that vaccines with the ingredient are safe.

VaccineDrug Approval

23 Jul 2025

·www.businesswire.com

As RSV Season Approaches, the Federation of Medical Women of Canada Urges National Response to Protect Infants Across the Country

TORONTO--(BUSINESS WIRE)--Today, the Federation of Medical Women of Canada (FMWC) released its latest white paper through the Maternal RSV Task Force—a national group of experts in maternal, infant, and public health—highlighting the urgent need for equitable access to maternal RSV prevention across Canada. With the 2025–2026 RSV season approaching, the task force is calling for immediate action to protect infants, especially healthy, full-term newborns who account for the majority of severe RSV cases. Respiratory Syncytial Virus (RSV) is the leading cause of infant hospitalizations in Canada, with 1 in 50 infants hospitalized during their first year of life1. The RSV virus causes upper and lower respiratory tract infections (LRTI)2, and babies who develop LRTI in early childhood have almost double the risk of premature death from respiratory disease relative to unaffected individuals.3 Although two newly approved RSV immunization options have been authorized by Health Canada — a maternal vaccine RSVpreF (Abrysvo™, Pfizer) and a monoclonal antibody for infants nirsevimab (Beyfortus™, Sanofi) — access remains inconsistent across provinces and territories. Ontario is leading by covering both RSVpreF for pregnant women and pregnant people and nirsevimab for infants, yet provinces like B.C. only cover the older monoclonal antibody, palivizumab, for high-risk infants — leaving 98% of infants unprotected and at risk for RSV.4 “With two safe and effective immunization options now available, we have the tools to protect infants from RSV—but awareness, access, and equity remain critical challenges,” says Dr. Vivien Brown, Family Physician and Co-Chair of the FMWC Maternal RSV Task Force. “This white paper highlights the urgent need for national coordination, public funding, and ongoing education to ensure that every pregnant woman and pregnant person, regardless of where they live, can protect their infant from this serious and preventable disease.” The white paper outlines 13 short- and long-term recommendations to improve RSV prevention in Canada, including: Public funding for RSV immunization (maternal vaccine year-round; nirsevimab seasonally) Authorizing pharmacists to administer publicly funded vaccines Tailoring education for a range of healthcare providers, including midwives and pharmacists Engaging with manufacturers to clarify the predicted availability of immunization options Implementing a universal, national immunization registry Strengthening national guidance on vaccination and provincial implementation “This is fundamentally about health equity,” says Dr. Shelley Ross, Family Physician and Co-Chair of the FMWC Maternal RSV Task Force. “Our hope is that by providing a clear, evidence-based roadmap that outlines the steps we can take as a united healthcare system, we can close the gaps and ensure every infant in Canada has the opportunity to be protected from RSV, regardless of geography or circumstance.” The task force also launched RSVProtect.ca, a national hub for healthcare providers and the public, offering up-to-date information and comprehensive educational resources on RSV and RSV protection strategies. The FMWC urges pregnant women and pregnant people to speak with their healthcare providers about RSV prevention options and calls on policymakers to help close the access gap as the upcoming 2025–2026 RSV season begins. For more details on the FMWC Maternal RSV White Paper and its recommendations, please visit www.rsvprotect.ca. About FMWC The Federation of Medical Women of Canada (FMWC) is a national organization recognized for its leadership and advocacy for women's evolving health. We are committed to promoting the well-being and health of women and women-identifying individuals both within the medical profession and society at large. The FMWC has a 100-year history in Canada, is a member of the non-governmental organization (NGO) section of the Department of Global Affairs at the United Nations (UN) and is a member of the Medical Women's International Association (MWIA), making us a part of the Economic and Social Council of the UN (ECOSO). For more information, please visit: www.fmwc.ca. 1 Government of Canada. Respiratory syncytial virus (RSV) vaccines: Canadian Immunization Guide. https://www.canada.ca/en/public-health/services/publications/healthy-living/canadian- immunization-guide-part-4-active-vaccines/respiratory-syncytial-virus.html. Updated May 14, 2025. Accessed May 21, 2025. 2 Sanchez-Martinez A, Moore T, Freitas TS, et al. Recent advances in the prevention and treatment of respiratory syncytial virus disease. J Gen Virol. 2025;106(4). doi: 10.1099/jgv.0.002095 3 Zar HJ, Cacho F, Kootbodien T, et al. Early-life respiratory syncytial virus disease and long-term respiratory health. Lancet Respir Med. 2024;12(10):810-821. 4 Paes B, Brown V, Courtney E, et al. Optimal implementation of an Ontario nirsevimab program for respiratory syncytial virus (RSV) prophylaxis: Recommendations from a provincial RSV expert panel. Hum Vaccin Immunother. 2024;20(1):2429236.

VaccineClinical Study

100 Deals associated with RSVpreF

R&D Status

Approved

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Indication	Country/Location	Organization	Date
Pneumonia due to respiratory syncytial virus	European Union	Pfizer Europe MA EEIG	23 Aug 2023
Pneumonia due to respiratory syncytial virus	Iceland	Pfizer Europe MA EEIG	23 Aug 2023
Pneumonia due to respiratory syncytial virus	Liechtenstein	Pfizer Europe MA EEIG	23 Aug 2023
Pneumonia due to respiratory syncytial virus	Norway	Pfizer Europe MA EEIG	23 Aug 2023
Respiratory Syncytial Virus Infections	United States	Pfizer Inc.	31 May 2023
Lower Respiratory Tract Infections	Canada	Pfizer Canada ULC	04 Jan 2023

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Herpes Zoster	Phase 3	United States	Pfizer Inc.	04 Apr 2025
Influenza, Human	Phase 3	Australia	Pfizer Inc.	13 Apr 2022
Respiratory Tract Infections	Phase 3	United States	Pfizer Inc.	17 Jun 2020
Respiratory Tract Infections	Phase 3	Japan	Pfizer Inc.	17 Jun 2020
Respiratory Tract Infections	Phase 3	Argentina	Pfizer Inc.	17 Jun 2020
Respiratory Tract Infections	Phase 3	Australia	Pfizer Inc.	17 Jun 2020
Respiratory Tract Infections	Phase 3	Brazil	Pfizer Inc.	17 Jun 2020
Respiratory Tract Infections	Phase 3	Canada	Pfizer Inc.	17 Jun 2020
Respiratory Tract Infections	Phase 3	Chile	Pfizer Inc.	17 Jun 2020
Respiratory Tract Infections	Phase 3	Denmark	Pfizer Inc.	17 Jun 2020

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT06473519 (Amélie, CTgov)	Phase 3	Respiratory Syncytial Virus Infections	453	RSVpreF (RSVpreF (With Preservative, MDV))	ychwpopmpv(jnslodwhhc) = cegekstqnx wofwtulvvc (xexanhrqkr, jhuubwxonw - uuwhucjnan) View more	-	25 Sep 2025
				RSVpreF (RSVpreF (Without Preservative, SDV))	ychwpopmpv(jnslodwhhc) = usqzhbpnqh wofwtulvvc (xexanhrqkr, yrnmxvhdsh - eptmddhmlv) View more
NCT05842967 (MONET, CTgov)	Phase 3	Respiratory Syncytial Virus Infections	885	SSA+RSVpreF (SSA: RSVpreF)	vncllevakd = bkcxaevody rxkeeycdui (ukbgudwrfd, nbdnjfgjdt - bwekxphuky) View more	-	08 Aug 2025
				SSA (SSA: Placebo)	vncllevakd = lvrriaurqh rxkeeycdui (ukbgudwrfd, weggmugwxq - iivesfjnij) View more
NCT04424316 (MATISSE, CTgov)	Phase 3	Respiratory Tract Infections	14,727	RSVpreF (Infant Participants: RSVpreF)	ttrphpfqik = mnaslfbnbf ziyjqbvqcn (sgvgedwdgt, jcjolrpdax - txiobteuav) View more	-	11 Feb 2025
				placebo+RSVpreF (Infant Participants: Placebo)	ttrphpfqik = stuvcmfhlc ziyjqbvqcn (sgvgedwdgt, nxxdluvmqf - ssbtacsssc) View more
NCT05035212 (2021-003693-31, Pubmed \| Clin Infect Dis)	Phase 3	-	-	Bivalent RSV Prefusion F (RSVpreF) Vaccine (RSVpreF 120-µg)	aztnimlnhy(pmqhvbsvhw) = tekxnqeveo zvbqzkkdtq (knheiyntbr )	Positive	10 Feb 2025
				Bivalent RSV Prefusion F (RSVpreF) Vaccine (Placebo)	aztnimlnhy(pmqhvbsvhw) = nsdunprrbv zvbqzkkdtq (knheiyntbr )
NCT04424316 (MATISSE, Pubmed \| Obstet Gynecol)	Phase 3	Obstetric Labor, Premature	-	Bivalent Respiratory Syncytial Virus Prefusion F Protein Vaccine (RSVpreF)	cbhgphcjav(dwpoadrdlp) = no clinically significant increase in adverse events of special interest, including preterm birth, low birth weight, or neonatal hospitalization, was observed among pregnant people in the overall analysis xyypsboxgz (nkggrwmlci ) View more	Positive	02 Jan 2025
				Bivalent Respiratory Syncytial Virus Prefusion F Protein Vaccine (Placebo)
NCT05886777 (CTgov)	Phase 2	COVID-19 \| Infectious Lung Disorder	1,142	QIV+RSVpreF (Group 1: [RSVpreF + BNT162b2] + QIV)	evaxfzoicg = qqdzqezkcy ghgnjtvgah (uzceocjlrp, uugtuwpktz - erjqftcpsg) View more	-	18 Dec 2024
				Placebo+BNT162b2+RSVpreF (Group 2: [RSVpreF+BNT162b2] + Placebo)	evaxfzoicg = ufklggchqx ghgnjtvgah (uzceocjlrp, lixorvmumx - grzwmbtbee) View more
NCT05788237 (CTgov)	Phase 1	Influenza, Human	508	RSVpreF+qIRV (SSA: Group 1: RSVpreF + qIRV)	pzmxqknrmo = ysmfwbzouf vuehqougly (tuqijuitva, tuxqiacope - kqourdcply) View more	-	22 Nov 2024
				qIRV (SSA: Group 2: qIRV)	pzmxqknrmo = kisidmrqgx vuehqougly (tuqijuitva, argmgppqkz - xdwzqjatpi) View more
NCT05842967 (MONeT, PipelineReview) Manual	Phase 3	Respiratory Syncytial Virus Infections	203	ABRYSVO	enfpowrlru(nacexjniaz) = ABRYSVO was well-tolerated during the trial, showing a safety profile consistent with findings from other studies of the vaccine. mzolelvhnv (hokmecyjoh ) View more	Positive	12 Aug 2024
NCT04785612 (Phase 2a study, CTgov)	Phase 2	Respiratory Syncytial Virus Infections	70	RSVPreF (RSVPreF)	qmptveoxkz(xhkcczbpam) = sggulfrvdk scuabyewfb (gnxurmuraa, qvwoiwgrzi - tvwpimrgmi) View more	-	07 Aug 2024
				Placebo (Placebo)	qmptveoxkz(xhkcczbpam) = sbsghegwct scuabyewfb (gnxurmuraa, kzajvdvogo - vimauxriny) View more
NCT04424316 (MATISSE, Pubmed)	Phase 3	Respiratory Syncytial Virus Infections	-	RSVpreF vaccine	swsmascypj(anybwggigk) = nvuriagdfx qpeuxhnnbh (jjcoensooz ) View more	Positive	08 Jun 2024
				bivalent RSVpreF maternal vaccination (Placebo)	swsmascypj(anybwggigk) = cclfwnuluy qpeuxhnnbh (jjcoensooz ) View more

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