RSV Vaccine / Pfizer - LARVOL DELTA

Timing Matters: Missed Opportunity to Prevent RSV Cases in Older Adults in Germany: A Markov Model Analysis (ISPOR-EU 2025) - "As a case example, we use RSV vaccines recommended for older adults in Germany. A validated Markov model was applied to the German population with German epidemiological and cost data, a one-year time horizon and a 0% discount rate... The findings highlight the serious patient impact of delayed vaccine implementation and the need to accelerate access to STIKO recommended vaccinations."

Clinical • Infectious Disease • Respiratory Syncytial Virus Infections

Estimated Incidence of Hospitalisations and Deaths Attributable to Respiratory Syncytial Virus Infections in Adults in Norway between 2010 and 2019: A Time-Series Modelling Study. (PubMed, J Epidemiol Glob Health) - "RSV significantly contributes to hospitalisations and deaths in adults in Norway, particularly among older adults and younger adults with underlying diseases. The introduction of RSV vaccines can have a substantial public health impact in reducing the burden of RSV-attributable cardiovascular and respiratory events."

Journal • Cardiovascular • Infectious Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections

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 & Trial Design. (PubMed, Am Heart J) - P4 | "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."

Journal • Geriatric Disorders • Respiratory Diseases • Respiratory Syncytial Virus Infections

Disparities in Respiratory Syncytial Virus Vaccine Uptake in the Medicare Fee-for-Service Population During 2023-2024 Season. (PubMed, J Am Geriatr Soc) - "Vaccination to prevent RSV disease began during the 2023-2024 season where less than a quarter of the Medicare FFS population was vaccinated. Disparities in uptake were observed by race and ethnicity, socioeconomic status, geography, comorbidity status, and by age group. These results highlight the need for more targeted public health efforts to improve vaccination among those at high risk for severe RSV disease."

Journal • Medicare • Reimbursement • US reimbursement • Hepatology • Pulmonary Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections

Respiratory syncytial virus (RSV) infections in adults: Current trends and recommendations for prevention - a global challenge from a local perspective. (PubMed, Hum Vaccin Immunother) - "Recently, three vaccines (RSVPreF3, RSVpreF, and mRNA-1345) have been approved for adults to date. In this article, we aimed to review the characteristics of RSV infections in adults and the evidence on the safety and efficacy of RSV vaccines, with a glimpse of the current situation in Türkiye- one of the low- and middle- income countries (LMICs)."

Journal • Review • Infectious Disease • Influenza • Preventive care • Respiratory Diseases • Respiratory Syncytial Virus Infections

Disparities in Respiratory Syncytial Virus Vaccine First Season Uptake Among the Medicare Fee-For-Service Population (ATS 2025) - "RSV vaccine uptake was low in the first season of availability. Disparities in uptake were observed by race, socioeconomic status, geography, and by age group. These results highlight the need for more targeted public health efforts to improve vaccination among those at high risk for severe RSV disease."

Clinical • Medicare • Reimbursement • US reimbursement • Cardiovascular • Hepatology • Influenza • Nephrology • Pulmonary Disease • Renal Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections

Cost-Effectiveness Analysis of Bivalent Respiratory Syncytial Virus Prefusion F Vaccine for Adults 60 Years of Age and Older in Japan (ISPOR 2025) - "As of December 2024, RSV vaccines are not included in the routine national immunization program... RSVpreF vaccination was a cost-effective strategy for the prevention of RSV disease in Japanese adults 60 years of age and older. The introduction of RSV vaccination has the potential to improve public health by reducing RSV cases and saving lives in Japan."

Clinical • Cost effectiveness • HEOR • Respiratory Diseases • Respiratory Syncytial Virus Infections

Favorable Nonclinical Safety Profile of RSVpreF Bivalent Vaccine in Rats and Rabbits. (PubMed, Vaccines (Basel)) - "It is the only RSV vaccine approved for both maternal immunization to protect infants and active immunization of older adults (≥60 years) and 18-59-year-old individuals with high-risk conditions for prevention of RSV disease...In both studies, robust immune responses to both RSV A and B antigens were observed, especially with the Al(OH)3 formulation. RSVpreF was well-tolerated both locally and systemically without any adverse effects on reproductive and developmental endpoints."

Journal • Preclinical • Infectious Disease • Inflammation • Respiratory Diseases • Respiratory Syncytial Virus Infections

Potential Public Health Impact of Respiratory Syncytial Virus (RSV) Vaccines for Prevention of Lower Respiratory Tract Disease (LRTD) Due to RSV Among Older Adults in Canada (ISPOR-EU 2024) - "Moderna’s mRNA-1345 would reduce cases by 98,488, deaths by 1,136, and medical care costs by $198.8M. RSV vaccines have the potential to substantially reduce the clinical and economic burden of RSV-LRTD in older adults. Of the three vaccines, Pfizer’s RSVpreF would provide the greatest benefit due to its high year 2 efficacy and anticipated extended protection."

Clinical • Geriatric Disorders • Respiratory Diseases • Respiratory Syncytial Virus Infections

Immediate post-discharge care among US adults hospitalized with respiratory syncytial virus infection. (PubMed, BMC Pulm Med) - "Immediate post-discharge care needs among adults hospitalized with RSV, especially in older adults, can be considerable and comparable to influenza and acute MI discharges. With recently approved RSV vaccines, efforts to increase vaccination in older adults are needed to prevent RSV and associated healthcare consequences."

Journal • Observational data • Retrospective data • Cardiovascular • Infectious Disease • Influenza • Myocardial Infarction • Respiratory Diseases • Respiratory Syncytial Virus Infections

Potential Public Health Impact of Respiratory Syncytial Virus (RSV) Vaccines for Prevention of RSV Among Older Adults in the United States (IDWeek 2024) - No abstract available

Clinical • Infectious Disease • Respiratory Syncytial Virus Infections

Annual public health and economic burden of medically attended respiratory syncytial virus illnesses among US adults. (PubMed, Vaccine) - "Annual burden of RSV-LRTD among US adults-especially older adults and those of all ages with underlying medical conditions-is substantial. Preventive measures, such as recently approved RSV vaccines, have the potential to yield important improvements in public and patient health, and to reduce the economic burden of RSV-LRTD from the US healthcare system and societal perspectives."

HEOR • Journal • Geriatric Disorders • Infectious Disease • Pneumonia • Pulmonary Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections

RSVpreF Vaccine Elicits a Robust and Durable Immune Response Among Adults Aged 60 Years and Older Across an Entire RSV Season (ATS 2024) - "The RSV Vaccine Efficacy Study iN Older Adults Immunized against RSV Disease (RENOIR) is a phase 3, multicenter, randomized, double-blinded, placebo-controlled study evaluating vaccine efficacy (VE), immunogenicity, and safety in adults 60 years of age and older over two RSV seasons in Northern and Southern Hemisphere countries... Vaccination with bivalent RSVpreF elicits a strong immune response in adults 60 years of age and older, and the response remains durable throughout an entire RSV season and beginning of the subsequent season. Subgroup analyses support the previously observed consistent VE across different age and risk groups."

Clinical • Late-breaking abstract • Respiratory Diseases • Respiratory Syncytial Virus Infections

Potential Public Health Impact of Bivalent Respiratory Syncytial Virus Stabilized Prefusion F Subunit Vaccine (RSVpreF) Among Older Adults in Canada (ISPOR 2024) - "RSVpreF, Pfizer’s novel RSV vaccine, was recently approved by Health Canada to prevent RSV-LRTD in adults aged ≥60 years... Findings suggest use of RSVpreF among adults aged ≥60 years in Canada will considerably reduce the clinical and economic burden of RSV-LRTD."

Clinical • Respiratory Diseases • Respiratory Syncytial Virus Infections

Estimated Respiratory Syncytial Virus-Related Hospitalizations and Deaths Among Children and Adults in Spain, 2016-2019. (PubMed, Infect Dis Ther) - "When accounting for under-ascertainment, estimated RSV-attributable hospitalizations were higher than those reported based on standard-of-care RSV-specific codes in all age groups but particularly among older children and older adults. Like other respiratory viruses, RSV contributes to both respiratory and cardiovascular complications. Efficacious RSV vaccines could have a high public health impact in these age and risk groups."

Journal • Cardiovascular • Respiratory Diseases • Respiratory Syncytial Virus Infections

The road to developing an RSV vaccine for older adults (WVCE 2023) - No abstract available

Clinical • Respiratory Syncytial Virus Infections

Respiratory Syncytial Virus-Associated Health Care Utilization in the Pivotal Phase 3 Trial RSV Vaccine Efficacy Study In Older Adults Immunized Against RSV Disease (RENOIR) (IDWeek 2023) - No abstract available

Clinical • HEOR • P3 data • Infectious Disease • Respiratory Syncytial Virus Infections

Clinical Profile of Acute Respiratory Illness (ARI) Events in the Phase 3 Trial The RSV Vaccine Efficacy Study iN Older Adults Immunized against RSV Disease (RENOIR) (IDWeek 2023) - No abstract available

Clinical • P3 data • Infectious Disease • Respiratory Syncytial Virus Infections

Vaccine-Preventable Hospitalisations from Seasonal Respiratory Diseases: What Is Their True Value? (PubMed, Vaccines (Basel)) - "This paper estimates the number of hospitalisations that current vaccines against influenza, pneumococcal disease (PD), COVID-19, and a hypothetical Respiratory Syncytial Virus (RSV) vaccine, could prevent in the winter among older adults in England...However, the value of hospital beds freed up by vaccination is likely to be 1.1-2 times larger (£48-93 million for flu, PD and RSV; £1.4-2.8 billion for COVID-19) when quantified in opportunity cost terms. Considering opportunity costs is key to ensuring maximum value is obtained from preventative budgets, as reference costing may significantly underestimate the true value of vaccines."

Journal • Infectious Disease • Influenza • Novel Coronavirus Disease • Pneumococcal Infections • Respiratory Diseases • Respiratory Syncytial Virus Infections

Rational Design of a Highly Immunogenic Prefusion-Stabilized F Glycoprotein Antigen for a Respiratory Syncytial Virus Vaccine. (PubMed, Sci Transl Med) - "No RSV vaccine is currently available...Through in vitro and in vivo characterization studies, we identified F constructs that are more stable in the prefusion conformation and elicit ~10-fold higher serum neutralizing titers in cotton rats than DS-Cav1. The stabilizing mutations of the lead construct (847) were introduced onto F glycoprotein backbones of strains representing the dominant circulating genotypes of the two major RSV subgroups, A and B. Immunization of cotton rats with a bivalent vaccine formulation of these antigens conferred complete protection against RSV challenge, with no evidence of disease enhancement. The resulting bivalent RSV prefusion F investigational vaccine has recently been shown to be efficacious against RSV disease in two pivotal phase 3 efficacy trials, one for passive protection of infants by immunization of pregnant women and the second for active protection of older adults by direct immunization."

Journal • Geriatric Disorders • Respiratory Diseases • Respiratory Syncytial Virus Infections • CAV1

"Pfizer ready to launch RSV vaccines for older adults, pregnant women in US, Europe https://t.co/pFC48eSZXl" (@Reuters)

Clinical • Launch Europe • Launch US • Respiratory Syncytial Virus Infections

Rates of Medically Attended RSV Among US Adults: A Systematic Review and Meta-analysis. (PubMed, Open Forum Infect Dis) - "The true burden of RSV has been underestimated and is significant among older adults and individuals with chronic medical conditions. A highly effective adult RSV vaccine would have substantial public health impact."

Journal • Retrospective data • Review • Respiratory Diseases • Respiratory Syncytial Virus Infections

Vaccine Efficacy in Adults in a Respiratory Syncytial Virus Challenge Study. (PubMed, N Engl J Med) - P2a | "RSVpreF vaccine was effective against symptomatic RSV infection and viral shedding. No evident safety concerns were identified. These findings provide support for further evaluation of RSVpreF vaccine in a phase 3 efficacy study. (Funded by Pfizer; EudraCT number, 2020-003887-21; ClinicalTrials.gov number, NCT04785612.)."

Journal • Infectious Disease • Pain • Respiratory Diseases • Respiratory Syncytial Virus Infections

A Study to Evaluate the Safety and Immunogenicity of an Adjuvanted RSV Vaccine in Healthy Older Adults (clinicaltrials.gov) - P2; N=304; Terminated; Sponsor: Pfizer; Completed ➔ Terminated; Suspended pending amendment

Clinical • Trial termination • Infectious Disease • Respiratory Diseases