Abrysvo (PF-06928316) / Pfizer - LARVOL DELTA

SPECIAL INVESTIGATION FOR ABRYSVO IN INDIVIDUALS AGED 60 YEARS OR OLDER (clinicaltrials.gov) - P=N/A | N=1100 | Active, not recruiting | Sponsor: Pfizer | Trial completion date: Feb 2029 ➔ Oct 2027 | Trial primary completion date: Feb 2029 ➔ Oct 2027

Trial completion date • Trial primary completion date • Infectious 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

Real-World Evidence Evaluation of Respiratory Syncytial Virus (RSV) Vaccines: Deep Dive into Vaccine Adverse Events Reporting System. (PubMed, Diseases) - "The VAERS database reported data on vaccine types, including Arexvy®, Abrysvo®, and mRESVIA® was analyzed for adverse events and vaccination errors... RSV vaccines demonstrate a generally acceptable safety profile based on post-marketing surveillance data. However, the observed increase in hospitalization rates, vaccination errors, and pregnancy-related outcomes warrants continued active surveillance and cautious interpretation."

Adverse events • HEOR • Journal • Real-world evidence • Dermatology • Fatigue • Pain • Respiratory Diseases • Respiratory Syncytial Virus Infections

Crucial Obstacles and Strategies for Human RSV Pediatric Vaccine Development. (PubMed, Viruses) - "Despite recent approvals of prefusion F (pre-F) protein-based vaccines (Arexvy, Abrysvo) for older adults and pregnant women, pediatric vaccine development faces unique challenges including enhanced respiratory disease (ERD) risks, maternal antibody interference, and immature infant immune responses...Additionally, current animal models demonstrate notable constraints in virus replication, host susceptibility, immune responses, clinical symptoms, and ERD phenomena. This review synthesizes current obstacles and innovative strategies, highlighting that the selection of multi-antigen strategies, appropriate adjuvants, and the development of more precise preclinical animal models are critical elements that will determine the efficacy and safety of future RSV vaccines."

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

Clinical and economic benefits of bivalent respiratory syncytial virus prefusion F (RSVpreF) maternal vaccine for prevention of RSV illness in infants: A cost-effectiveness analysis for Singapore. (PubMed, Vaccine) - "Year-round RSVpreF maternal vaccination would help reduce pressures on the healthcare system as well as reduce RSV's clinical and economic burden among infants in Singapore, and likely be a cost-effective program."

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

The benefits and risks of maternal RSV vaccination on mortality in South Africa: A modeling study. (PubMed, PLoS Med) - "If RSVpreF increases preterm birth risk, and if this increases neonatal mortality, then the benefit-risk analysis failed to show that the direct benefits of vaccination in reducing RSV-associated infant mortality would substantially outweigh the risks of preterm birth-associated neonatal mortality in South Africa with vaccination from 24 GA to 36 GA weeks. There was large uncertainty in the analyses due to small numbers of preterm births. With vaccination from 27 GA weeks, the benefit-risk analysis favored vaccination. RSVpreF vaccination has the potential to be safe and effective when used from the third trimester."

Journal • Respiratory Diseases • Respiratory Syncytial Virus Infections

Bivalent RSVpreF Beyond Clinical Trials: Insights from the Latest Real-World Evidence and UK Vaccine Program Implementation (RSVVW 2026) - "Sponsored by Pfizer."

Clinical • HEOR • Real-world • Real-world evidence • Respiratory Syncytial Virus Infections

Interim Safety of RSVpreF Vaccination During Pregnancy. (PubMed, JAMA) - No abstract available

Journal

Adverse Events Reported Following RSV Prefusion F Protein Vaccines Administration Among Approved Populations: A Cross-Sectional Study. (PubMed, Kans J Med) - "The higher frequency of injection site symptoms among Arexvy™ recipients may be attributable to the adjuvant included in Arexvy™ but absent in Abrysvo™. Overall, these findings indicate that both vaccines provide safe protection against RSV for older adults, with minimal side effects, in a population that previously had no vaccination option."

Adverse events • Journal • Observational data • Infectious Disease • Musculoskeletal Diseases • Respiratory Diseases • Respiratory Syncytial Virus Infections

Safety, Tolerability, and Immunogenicity of RSVpreF Vaccine in Pregnant Individuals Living with HIV. (PubMed, Vaccines (Basel)) - P3 | " These results support maternal RSVpreF vaccination among those living with stable HIV for preventing RSV-LRTI in HEU infants. (NCT06325657)."

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

B-Raf kinase blockade protects airway epithelial cells against respiratory syncytial virus infection and modulates interferon responses. (PubMed, ERJ Open Res) - "Collectively, our data indicate that B-Raf kinase is involved in RSV replication, interferon-stimulated gene induction, and type I and III interferon release in airway epithelial cells following infection. We propose that repurposing dabrafenib as a host-directed antiviral against RSV may be valuable in reducing disease pathogenesis associated with RSV infection."

Journal • Infectious Disease • Pneumonia • Pulmonary Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections • BRAF • IFIT1

How do Recent Population-Level RSVpreF Vaccine-Impact Results from the United Kingdom Relate to Previously Reported Vaccine Effectiveness Results? (PubMed, Infect Dis Ther) - "These early results indicate that the extent of expected population-level impact achieved can be reliably predicted from VE studies and national coverage data. Bivalent RSVpreF use can have a substantial public health and economic impact by reducing RSV-related hospitalizations, as seen in this initial UK vaccination program. Protection of older adults from severe RSV disease is off to a promising start and implementation efforts to boost vaccine uptake should be a priority for health care workers, public health practitioners, and policymakers."

Journal • Respiratory Diseases • Respiratory Syncytial Virus Infections

Evaluating ABRYSVO Maternal Vaccine Effectiveness Among Infants (clinicaltrials.gov) - P=N/A | N=39456 | Active, not recruiting | Sponsor: Pfizer | Not yet recruiting ➔ Active, not recruiting

Enrollment closed • Respiratory Diseases • Respiratory Syncytial Virus Infections

Effectiveness of Immunization in Preventing Severe Acute Respiratory Infection RSV (clinicaltrials.gov) - P=N/A | N=1097 | Not yet recruiting | Sponsor: Bogotá District Health Secretariat

New trial • Infectious Disease • Pulmonary Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections

Assessing the risk of Guillain-Barré syndrome in older adults after bivalent RSV pre-F vaccination in England. (PubMed, Nat Commun) - "Final results were consistent, with the self-controlled case-series estimating a relative incidence of 3.34 (95% CI: 2.12-5.28) and an attributable risk of 23 (95% CI: 17-26) cases per million doses. Here, we show a small risk of GBS following RSV vaccination with the bivalent pre-F in England's older adults' programme, but this is at a level that is far exceeded by the vaccine benefits."

Journal • Respiratory Diseases • Respiratory Syncytial Virus Infections

RSV Vaccines: Targeting Prefusion F and G Proteins from Structural Design to Clinical Application. (PubMed, Vaccines (Basel)) - " Approved vaccines such as Abrysvo and Arexvy utilize structural engineering to stabilize the prefusion conformation of the F protein (PreF), thereby exposing neutralizing epitopes. Subunit vaccine candidates such as DS-Cav1 and DT-PreF enhance stability through disulfide bonds and dityrosine linkages, while ADV110 targets the conserved domain of the G protein to elicit cross-strain immunity. Virus-like particle (VLP) vaccines like IVX-A12 combine RSV and human metapneumovirus antigens to provide broad-spectrum immunity. However, challenges exist, including maintaining PreF stability, overcoming immunosenescence in the elderly, and addressing safety concerns like Guillain-Barré syndrome (GBS). Future RSV vaccine development should center on combined PreF-G protein vaccines, VLP technology, and optimizing cold-chain logistics to improve global accessibility and overcome existing challenges, thereby providing more effective prevention and control of RSV infections."

Journal • Review • Infectious Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections • CAV1

RSV Vaccination Programme for Older Adults: A Scotland-Wide Study on RSVpreF Vaccine Safety. (PubMed, Vaccines (Basel)) - "Study results indicated a good safety profile of the RSV vaccine for older eligible adults aged 75 to 79 years, although a small increased risk of GBS was identified in both analyses. Excess risk levels of GBS from vaccination align with other studies."

Journal • Acute Coronary Syndrome • Acute Kidney Injury • Cardiovascular • Congestive Heart Failure • Heart Failure • Infectious Disease • Myocardial Infarction • Renal Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections

Evaluating ABRYSVO Maternal Vaccine Effectiveness Among Infants (clinicaltrials.gov) - P=N/A | N=39456 | Not yet recruiting | Sponsor: Pfizer

New trial • Real-world evidence • Respiratory Diseases • Respiratory Syncytial Virus Infections

DAN-RSV: Vaccine Effectiveness of a Bivalent RSV Prefusion F Protein-Based Vaccine for Preventing RSV Hospitalizations in Adults (clinicaltrials.gov) - P4 | N=690000 | Recruiting | Sponsor: Tor Biering-Sørensen | Active, not recruiting ➔ Recruiting | N=130000 ➔ 690000 | Trial completion date: Aug 2027 ➔ Aug 2028 | Trial primary completion date: May 2027 ➔ May 2028

Enrollment change • Enrollment open • Trial completion date • Trial primary completion date • Respiratory Syncytial Virus Infections

PISSARRO: A Study to Evaluate the Safety and Immunogenicity of RSVpreF Coadministered With Herpes Zoster Vaccine in Adults (clinicaltrials.gov) - P3 | N=526 | Completed | Sponsor: Pfizer | Active, not recruiting ➔ Completed

Trial completion • Herpes Zoster • Respiratory Diseases • Respiratory Syncytial Virus Infections • Varicella Zoster

BORLAND: Evaluating the Benefits of RSV Maternal Vaccination Using a Scottish National Dataset (clinicaltrials.gov) - P=N/A | N=1 | Not yet recruiting | Sponsor: Pfizer

New trial • Infectious Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections

Expert Consensus Statement on the Disease Burden and Vaccination for Respiratory Syncytial Virus (RSV) Infection in Adults. (PubMed, Tuberc Respir Dis (Seoul)) - "As of 2025, three RSV vaccines (Arexvy, Abrysvo, mRESVIA) have FDA approval; only Arexvy is approved in Korea for older adults...In the absence of effective antivirals, vaccination is a key preventive strategy. Expanding vaccination uptake, improving awareness, and integrating RSV vaccines into national immunization programs could substantially reduce RSV-related morbidity and mortality."

Journal • Asthma • Bronchiectasis • Chronic Obstructive Pulmonary Disease • Immunology • Infectious Disease • Pneumonia • Pulmonary Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections

PIPELINE-RSV-F: Prevention of RSV Infection in Infants by Administering Nirsevimab to Infants, With or Without Maternal RSV Vaccination (clinicaltrials.gov) - P3 | N=1000 | Not yet recruiting | Sponsor: Centre Hospitalier Annecy Genevois

New P3 trial • Infectious Disease • 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 | Not yet recruiting ➔ Recruiting

Enrollment open • Infectious Disease • Pertussis • Respiratory Diseases • Respiratory Syncytial Virus Infections • Tetanus

Cost-Effectiveness of Bivalent Respiratory Syncytial Virus Stabilized Prefusion F Subunit Vaccine (RSVpreF) Among Older Adults in Ireland (ISPOR-EU 2025) - "ICERs were all near or below the typical €45,000/QALY willingness-to-pay threshold. While all strategies evaluated would reduce the clinical and economic burden of RSV among older adults in Ireland, findings suggest RSVpreF vaccination for all aged ≥65y would have the greatest impact on the burden of RSV."

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