Abrysvo (PF-06928316) / Pfizer - LARVOL DELTA

RSVVaccine: Safety, Tolerability and Immunogenicity of a Maternal Respiratory Syncytial Virus (RSV) Vaccine (MKK900) in Healthy Adult Women (clinicaltrials.gov) - P1 | N=120 | Not yet recruiting | Sponsor: MAXVAX Biotechnology Limited Liability Company

New P1 trial • Respiratory Diseases • Respiratory Syncytial Virus Infections

Self-reported reactogenicity of RSV vaccines among older adults: a post-licensure study within a large integrated healthcare system in Southern California. (PubMed, Vaccine) - "The most common reactions after RSV vaccines were local pain, fatigue, myalgia, and headache. GSK vaccine recipients containing the AS01E adjuvant reported reactions more frequently than Pfizer vaccine recipients. Consistent with pre-licensure safety data, most symptoms were transient and did not require medical care."

Journal • Fatigue • Infectious Disease • Musculoskeletal Pain • Novel Coronavirus Disease • Pain • Respiratory Syncytial Virus Infections

Health and Economic Impact of Seasonal Maternal Vaccination With Bivalent Respiratory Syncytial Virus Prefusion F Vaccine in Belgium. (PubMed, Pediatr Infect Dis J) - "The bivalent RSVpreF vaccine, administered in line with the recommendations of the Superior Health Council, is a dominant option compared with no immunization."

HEOR • Journal • Infectious Disease • Pediatrics • Respiratory Diseases • Respiratory Syncytial Virus Infections

Examining Rates of and Disparities in Receipt of the ABRYSVO Vaccine for Respiratory Syncytial Virus among Pregnant Patients Greater than 32 Weeks of Gestation (PAS 2026) - No abstract available

Clinical • Respiratory Diseases • Respiratory Syncytial Virus Infections

Safety monitoring of health outcomes following RSVPreF3 + AS01 and RSVPreF vaccination among Medicare beneficiaries aged 65 years and older in the United States, 2023-2024. (PubMed, Vaccine) - "Findings from this study suggest no increased risk of these health outcomes following RSV vaccination. These results contribute to the larger U.S. federal government vaccine safety monitoring efforts and further supports regulatory decision-making regarding RSV vaccines administered to U.S. adults aged 65 years and older."

HEOR • Journal • Medicare • Reimbursement • US reimbursement • Atrial Fibrillation • Cardiovascular • Cerebral Hemorrhage • CNS Disorders • Hematological Disorders • Multiple Sclerosis • Respiratory Diseases • Respiratory Syncytial Virus Infections

Bivalent RSV prefusion F vaccination elicits effective neutralization of contemporary and monoclonal antibody-resistant RSV strains. (PubMed, NPJ Vaccines) - "Monoclonal Ab-resistant mutant strains (MARMs) displaying in vitro resistance to nirsevimab, clesrovimab, and palivizumab (up to 300,000-fold resistance over the parental strain) were also evaluated. RSVpreF immune sera effectively neutralized both the panel of global clinical isolates and all MARMs tested. These findings demonstrate that the bivalent RSVpreF polyclonal response maintains robust neutralizing activity against circulating RSV A and B strains, including those that escape RSV F mAbs, and provides broad protective immunity against RSV."

Journal • Respiratory Diseases • Respiratory Syncytial Virus Infections

CosTaR: Concurrent Versus Sequential Administration of Tdap and RSV Vaccines in Pregnancy (clinicaltrials.gov) - P4 | N=60 | Recruiting | Sponsor: Canadian Immunization Research Network | Trial primary completion date: Jan 2026 ➔ May 2026

Trial primary completion date • Infectious Disease • Pertussis • Respiratory Diseases • Respiratory Syncytial Virus Infections • Tetanus

PIPELINE-RSV-France (clinicaltrialsregister.eu) - P2/3 | N=2000 | Not yet recruiting | Sponsor: Centre Hospitalier Annecy Genevois

New P2/3 trial • Infectious Disease • Pulmonary Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections

Impact of nirsevimab and maternal Abrysvo immunisation on socio-economic disparities in RSV SARI incidence in Lyon, France, 20182025 (ESCMID Global 2026) - No abstract available

ECONOMIC IMPACT OF RSV MATERNAL IMMUNIZATION [RSVPREF] IN THE DOMINICAN REPUBLIC: A COST-UTILITY ANALYSIS (ISPOR 2026) - "At PAHO-referenced prices, RSVpreF maternal vaccination was a cost-effective strategy for the Dominican health care system. The intervention could substantially prevent RSV-related morbidity, improve infant health outcomes, and lower healthcare costs."

HEOR • Infectious Disease • Influenza • Respiratory Diseases • Respiratory Syncytial Virus Infections

Real-world evidence on RSV vaccine uptake, effectiveness, and safety in older adults: a systematic review and meta-analysis. (PubMed, Lancet Reg Health Eur) - "Following vaccination, Guillain-Barré syndrome (GBS) was reported in two studies with between 5.2 and 6.5 cases per one million doses for RSVPreF3+AS01 (Arexvy, GSK) vaccines and between 9.0 and 18.2 cases per one million doses for RSVpreF (Abrysvo, Pfizer) vaccines...Our study showed a favourable safety profile and high effectiveness of the RSV vaccines, highlighting the value of wide implementation of these vaccines. There was no funding for the study."

HEOR • Journal • Real-world evidence • Retrospective data • Geriatric Disorders • Infectious Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections

Cost-Effectiveness Analysis of Bivalent Respiratory Syncytial Virus Prefusion F (RSVpreF) Maternal Vaccine for the Prevention of RSV Illness Among Infants in Hong Kong. (PubMed, Int J Infect Dis) - "Year-round RSVpreF maternal vaccination would substantially reduce RSV's clinical and economic burden among infants in Hong Kong and would be a cost-effective program."

HEOR • Journal • Infectious Disease • Pulmonary Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections

Bivalent RSVpreF Subunit Vaccine Safety and Immunogenicity in Seropositive 2-<18 Year Olds. (PubMed, Vaccines (Basel)) - "RSV-A and RSV-B neutralizing titer geometric mean fold rises from before to 1 month after vaccination with RSVpreF 60 and 120 µg, which were 17.7-20.6 and 42.8-39.8, respectively, in 2-<5 year olds, and 19.0-23.5 and 20.3-20.3, respectively, in 5-<18 year olds. RSVpreF was safe, well tolerated, and elicited immune responses in RSV-seropositive 2-<18-year-old participants, supporting further clinical development in this pediatric population, including those with chronic conditions."

Journal • Pediatrics • Respiratory Diseases • Respiratory Syncytial Virus Infections

Maternal perspectives on the RSV vaccine (Abrysvo): a thematic analysis of survey findings from the first season of implementation in England and Scotland. (PubMed, Arch Dis Child) - "Uptake of the maternal vaccine was influenced by barriers to access, informational gaps and perceived safety concerns. Improved vaccine delivery, enhanced awareness and personalised antenatal counselling are essential to increase vaccine uptake. There is an urgent need to address structural inaccessibility and provide tailored antenatal education to address informational gaps. Ongoing qualitative research is crucial to guide targeted public health interventions ahead of future RSV seasons."

Journal • Infectious Disease • Pediatrics • Pulmonary Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections

Prevention of respiratory syncytial virus in children (PubMed, Ugeskr Laeger) - "Until now, prevention relied on palivizumab for high-risk infants, limited by high costs and monthly injections. This review describes new preventive options including maternal vaccination (Abrysvo) and monoclonal antibodies (nirsevimab, clesrovimab). From October 2025, Denmark introduced a seasonal maternal vaccination, expected to substantially reduce RSV-related hospitalisations. Additionally, monoclonal antibodies are recommended for premature and high-risk infants."

Journal • Respiratory Diseases • Respiratory Syncytial Virus Infections

Real World Efficacy/Effectiveness and Immunogenicity of Maternal RSVpreF Vaccination: A Living Systematic Review and Meta-Analysis (RSVVW 2026) - "Included studies and meta-analyses are publicly released through the Safe in Pregnancy & Safe in Children hub as evidence accrues. This LSR-MA provides a comprehensive synthesis of the expanding evidence on maternal RSVpreF VE, supporting timely interpretation of emerging real-world data with robust methodological quality."

Real-world • Real-world effectiveness • Real-world evidence • Retrospective data • Review • Respiratory Diseases • Respiratory Syncytial Virus Infections

Real-world Abrysvo Vaccine Effectiveness (VE) against Respiratory Syncytial Virus (RSV)-Associated Cardiac Hospitalizations and Emergency Department Admissions without Acute Respiratory Infection (RSVVW 2026) - "Effectiveness against RSV-related non-ARI cardiac hospitalization/ED visits was 74% (29─91) across two seasons, and 79% (26–94) and 71% (-58─95) in the first and second seasons after vaccination, respectively (Table 2). These findings suggest that Abrysvo effectively reduced RSV-associated cardiac hospitalization/ED visits without an ARI diagnosis and may help mitigate cardiac morbidity in older adults beyond clinically apparent acute respiratory infection."

Clinical • Real-world • Real-world evidence • Heart Failure • Infectious Disease • Influenza • Novel Coronavirus Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections

Effectiveness of Bivalent RSV Prefusion F Protein–based Vaccine for Preventing RSV and Cardiorespiratory Hospitalizations in Older Adults: The DAN-RSV Trial (RSVVW 2026) - "The incidence of serious adverse events was similar in the two groups. Among adults 60 years of age or older, the RSVpreF vaccine reduced the incidence of hospitalization for RSV-related respiratory tract disease as compared with no vaccine."

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

Protocol for a multi-country networK evaluation of the effectiveness and impact of mAternal RSV vaccination on sHort and Long-term RSV Outcomes among infants and children: The KAHLO study (RSVVW 2026) - "The KAHLO study will quantify individual and population-level benefits of maternal RSVpreF on infant short- and long-term outcomes, including sequelae from wheeze and asthma. The platform has the potential for expansion to other settings."

Clinical • Asthma • Immunology • Infectious Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections

Public Health and Economic Impact of Complementary Strategy (RSVpreF Vaccine/Nirsevimab) VS. Nirsevimab Alone in the Prevention of RSV Infections in the Italian Infant Population (RSVVW 2026) - "However, the complementary strategy would provide greater coverage, prevent more hospitalizations, and yield lower total costs than nirsevimab alone. Increased RSVpreF coverage would further enhance economic and public health benefits, resulting in fewer cases and lower economic impact."

Clinical • HEOR • Infectious Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections

Advancing Infant Protection Against Respiratory Syncytial Virus: Clinical Impact of Passive Immunisation Strategies (RSVVW 2026) - "Pooled analyses confirm ~80% effectiveness of nirsevimab in preventing RSV-associated hospital or ICU admissions...Merck's clesrovimab (MK-1654) recently showed an ≈84% reduction in infant RSV hospitalizations through 5 months in a Phase 2/3 trial, with no new safety signals. With these new tools, routine monthly palivizumab (used for decades in high-risk infants) is being phased out in favor of once-per-season antibodies or maternal vaccines...Current evidence demonstrates high efficacy. Ongoing surveillance is needed to monitor rare outcomes, but these interventions represent powerful new tools for infant RSV prevention."

Clinical • Infectious Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections

Preliminary Evidence of Reduced RSV Infection in Maternal RSVpreF Recipients in the MATISSE Infant Efficacy Trial (RSVVW 2026) - P3 | "This preliminary evidence of infection reduction in maternal participants presents a possible future area for study of potential additional benefits of maternal vaccination. (NCT04424316)"

Clinical • Infectious Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections

Safety, Tolerability, and Immunogenicity of Respiratory Syncytial Virus Prefusion F Vaccine (RSVpreF) in Pregnant Individuals Living With HIV (RSVVW 2026) - P3 | "These results support maternal RSVpreF vaccination in individuals living with HIV for prevention of RSV-LRTI in HEU infants. (NCT06325657)."

Clinical • Human Immunodeficiency Virus • Hypertension • Infectious Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections

Effectiveness of maternal RSVpreF vaccination against RSV in hospitalised infants ≤6 months: preliminary results from a multicentre test-negative design study in Australia, 2025 (STREETON Study) (RSVVW 2026) - "These real-world findings demonstrate high VE of RSVpreF vaccination in pregnancy against hospitalisation due to RSV-LRTD and RSV-ARI in infants ≤6 months in the first year following introduction. Future analyses with larger sample sizes will evaluate VE within key subgroups and stratifications important for informing vaccine policy and provide more granularity of VE by infant age."

Clinical • Respiratory Diseases • Respiratory Syncytial Virus Infections

Real-world Abrysvo Vaccine Effectiveness (VE) against Respiratory Syncytial Virus (RSV)-related Acute Respiratory Illness (ARI) Hospitalizations and Emergency Department Admissions over Two RSV Season (RSVVW 2026) - "Waning was pronounced among immunocompromised individuals. These results expand on prior data by evaluating endpoints through two seasons and by RSV subtype."

Clinical • Real-world • Real-world evidence • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections