Value profile for respiratory syncytial virus vaccines and monoclonal antibodies.

Respiratory syncytial virus (RSV) is the predominant cause of acute lower respiratory infection (ALRI) in young children worldwide, yet no licensed RSV vaccine exists to help prevent the millions of illnesses and hospitalizations and tens of thousands of young lives taken each year. Monoclonal antibody (mAb) prophylaxis exists for prevention of RSV in a small subset of very high-risk infants and young children, but the only currently licensed product is impractical, requiring multiple doses and expensive for the low-income settings where the RSV disease burden is greatest. A robust candidate pipeline exists to one day prevent RSV disease in infant and pediatric populations, and it focuses on two promising passive immunization approaches appropriate for low-income contexts: maternal RSV vaccines and long-acting infant mAbs. Licensure of one or more candidates is feasible over the next one to three years and, depending on final product characteristics, current economic models suggest both approaches are likely to be cost-effective. Strong coordination between maternal and child health programs and the Expanded Program on Immunization will be needed for effective, efficient, and equitable delivery of either intervention. This 'Vaccine Value Profile' (VVP) for RSV is intended to provide a high-level, holistic assessment of the information and data that are currently available to inform the potential public health, economic and societal value of pipeline vaccines and vaccine-like products. This VVP was developed by a working group of subject matter experts from academia, non-profit organizations, public private partnerships and multi-lateral organizations, and in collaboration with stakeholders from the WHO headquarters. All contributors have extensive expertise on various elements of the RSV VVP and collectively aimed to identify current research and knowledge gaps. The VVP was developed using only existing and publicly available information.

Vaccines to Prevent Meningitis: Historical Perspectives and Future Directions.

Despite advances in the development and introduction of vaccines against the major bacterial causes of meningitis, the disease and its long-term after-effects remain a problem globally. The Global Roadmap to Defeat Meningitis by 2030 aims to accelerate progress through visionary and strategic goals that place a major emphasis on preventing meningitis via vaccination. Global vaccination against Haemophilus influenzae type B (Hib) is the most advanced, such that successful and low-cost combination vaccines incorporating Hib are broadly available. More affordable pneumococcal conjugate vaccines are becoming increasingly available, although countries ineligible for donor support still face access challenges and global serotype coverage is incomplete with existing licensed vaccines. Meningococcal disease control in Africa has progressed with the successful deployment of a low-cost serogroup A conjugate vaccine, but other serogroups still cause outbreaks in regions of the world where broadly protective and affordable vaccines have not been introduced into routine immunization programs. Progress has lagged for prevention of neonatal meningitis and although maternal vaccination against the leading cause, group B streptococcus (GBS), has progressed into clinical trials, no GBS vaccine has thus far reached Phase 3 evaluation. This article examines current and future efforts to control meningitis through vaccination.

Impact and cost-effectiveness of potential interventions against infant respiratory syncytial virus (RSV) in 131 low-income and middle-income countries using a static cohort model.

OBJECTIVES: Interventions to prevent childhood respiratory syncytial virus (RSV) disease are limited and costly. New interventions are in advanced stages of development and could be available soon. This study aims to evaluate the potential impact and cost-effectiveness of two interventions to prevent childhood RSV-a maternal vaccine and a monoclonal antibody (mAb). DESIGN: Using a static population-based cohort model, we evaluate impact and cost-effectiveness of RSV interventions, from a health systems perspective. The assumed baseline efficacy and duration of protection were higher for the mAb (60%-70% efficacy, protection 6 months) compared with the maternal vaccine (40%-60% efficacy, protection 3 months). Both interventions were evaluated at US$3 and US$5 per dose for Gavi and non-Gavi countries, respectively. A range of input values were considered to explore uncertainty. SETTINGS: 131 low-income and middle-income countries. PARTICIPANTS: Pregnant women and live birth cohorts. INTERVENTIONS: Maternal vaccine given to pregnant women and mAb given to young infants. PRIMARY AND SECONDARY OUTCOME MEASURES: Disability-adjusted life years averted, severe case averted, deaths averted, incremental cost effectiveness ratios. RESULTS: Under baseline assumptions, maternal vaccine and mAbs were projected to avert 25% and 55% of RSV-related deaths among infants younger than 6 months of age, respectively. The average incremental cost-effectiveness ratio per disability-adjusted life year averted was US$1342 (range US$800-US$1866) for maternal RSV vaccine and US$431 (range US$167-US$692) for mAbs. At a 50% gross domestic product per capita threshold, maternal vaccine and mAbs were cost-effective in 60 and 118 countries, respectively. CONCLUSIONS: Both interventions are projected to be impactful and cost-effective in many countries, a finding that would be enhanced if country-specific Gavi cofinancing to eligible countries were included. mAbs, with assumed higher efficacy and duration of protection, are expected to be more cost-effective than RSV maternal vaccines at similar prices. Final product characteristics will influence this finding.

The new break-even analysis.

Changes in the economic and legislative environment have complicated the capital acquisition landscape. Hospitals and health systems should: Question the assumptions that underlie their break-even analysis. Revamp the break-even calculator. Engage in discussions about the clinical aspects of equipment and technology acquisition decisions.