Materiały źródłowe

• #1 Predicted effectiveness of vaccines and extended half-life monoclonal antibodies against RSV hospitalizations in children

  https://pmc.ncbi.nlm.nih.gov/articles/PMC9612629/

  Several vaccines and extended half-life monoclonal antibodies (mAbs) against respiratory syncytial virus (RSV) have shown promise in clinical trials. […] Our results suggest that maternal immunization and long-lasting mAbs are likely to be highly effective in preventing RSV hospitalizations in infants under 6 months of age, averting more than half of RSV hospitalizations in neonates. […] With high coverage, maternal immunization and long-lasting mAbs are predicted to offer comparable protection against RSV hospitalizations in the most vulnerable population, those under 6 months of age. […] Our results suggest that long-lasting mAbs will have high effectiveness against RSV hospitalizations in infants under 6 months of age. […] Live-attenuated vaccines are estimated to be the most effective immunization strategy in children under 5 years of age. […] Our findings highlight the substantial public health impact that upcoming RSV prevention strategies may provide.

• #2 Use of Respiratory Syncytial Virus Vaccines in Older Adults: Recommendations of the Advisory Committee on Immunization Practices — United States, 2023 | MMWR

  https://www.cdc.gov/mmwr/volumes/72/wr/mm7229a4.htm

  Respiratory syncytial virus (RSV) causes substantial morbidity and mortality in older adults. In May 2023, the Food and Drug Administration approved the first two vaccines for prevention of RSV lower respiratory tract disease (LRTD) for use in adults aged 60 years. […] For both vaccine products, vaccination with a single RSV vaccine dose demonstrated moderate to high efficacy in preventing symptomatic RSV-associated LRTD among adults aged 60 years. On June 21, 2023, the Advisory Committee on Immunization Practices recommended that persons aged 60 years may receive a single dose of RSV vaccine, using shared clinical decision-making. […] RSV vaccines have demonstrated moderate to high efficacy in preventing RSV-associated lower respiratory tract disease and have the potential to prevent substantial morbidity and mortality among older adults; postmarketing surveillance will direct future guidance.

• #3 A Statistical Model to Predict Protection Against Infant Respiratory Syncytial Virus Disease Through Maternal Immunization

  https://www.mdpi.com/2076-393X/12/12/1351

  A maternal immunization approach whereby pregnant women are immunized can boost the level of protective RSV-neutralizing IgG antibodies that mothers naturally transfer across the placenta to their fetuses to prevent infant RSV disease through at least the first six months of life. […] Our model shows that integrating the lower respiratory tract disease risk based on infant airway diameter and associated airway resistance is critical to appropriately model predicted infant VE. The VE predictions by our models, which preceded maternal RSV prefusion F vaccine efficacy trial primary readouts, closely align with the VE outcomes of these field studies. […] The model predicts that RSV infection rates in infants of unimmunized mothers peak at 4–5 months of age, which is substantially higher and later than the peak in the rate of RSV disease, which is projected to peak at 1–2 months of age in those same infants.

• #4 A Statistical Model to Predict Protection Against Infant Respiratory Syncytial Virus Disease Through Maternal Immunization

  https://www.mdpi.com/2076-393X/12/12/1351

  Maternal RSV vaccine-elicited increases in neutralizing antibody titers were shown to improve the outcome for infants by delaying or reducing the incidence of RSV infection and disease, respectively. The delay in peak RSV infection beyond 6 months of age is clinically important, as an infant’s immune system has matured by this time, their airways are bigger, and thus the infant can better cope with infections. […] The model underscores the critical role of maternal antibodies in safeguarding infants against RSV-associated disease and has potential use in modeling the clinical trial outcomes of other respiratory disease vaccines where maternal antibodies play a role in the protection of newborns.

• #5 RSV Vaccines Projected to Protect Infants and Seniors This Season | International Vaccine Access Center

  https://publichealth.jhu.edu/ivac/2025/rsv-vaccines-projected-to-protect-infants-and-seniors-this-season

  Vaccines RSV vaccine and other interventions could help avert 17 percent of hospitalization caused by RSV this season. […] Based on the latest projections from the RSV Scenario Modeling Hub, between July 2024 and June 2025, these interventions are expected to avert thousands of cases of severe disease that would require hospitalization, relieving some of the pressure on a health system already burdened by higher-than-usual numbers of pertussis and Mycoplasma pneumonia and seasonal epidemics of COVID-19 and influenza. […] The most optimistic scenario, assuming early infant protection and limited waning of protection among seniors, projects that RSV interventions could avert 17% (29,300) of RSV hospitalizations, including a reduction of 31% (14,300) in hospitalizations among infants and 22% (13,000) among seniors.

• #6 RSV Vaccines Projected to Protect Infants and Seniors This Season | International Vaccine Access Center

  https://publichealth.jhu.edu/ivac/2025/rsv-vaccines-projected-to-protect-infants-and-seniors-this-season

  RSV interventions, including vaccination and the widespread use of monoclonal antibodies for infants, are thus an important tool to reduce disease burden and free up hospital resources to treat other seasonal respiratory illnesses. […] In only 2 years since these products were approved, we are expecting to see them prevent a third of hospitalizations that would have otherwise occurred due to RSV this season. These interventions have immense potential to reduce RSV associated burden even more with increased uptake and optimized timing.

• #7 Use of Respiratory Syncytial Virus Vaccines in Older Adults: Recommendations of the Advisory Committee on Immunization Practices — United States, 2023 | MMWR

  https://www.cdc.gov/mmwr/volumes/72/wr/mm7229a4.htm

  Vaccination with a single dose of the GSK or Pfizer RSV vaccines demonstrated moderate to high efficacy in preventing symptomatic RSV-associated LRTD over two consecutive RSV seasons among adults aged 60 years. […] Although trials were underpowered to estimate efficacy against RSV-associated hospitalization and death, prevention of LRTD, including medically attended LRTD, suggests that vaccination might prevent considerable morbidity from RSV disease among adults aged 60 years.

• #8 RSV Vaccine Shows High Effectiveness Against Hospitalization in Older Adults

  https://www.ajmc.com/view/rsv-vaccine-shows-high-effectiveness-against-hospitalization-in-older-adults

  The first real-world study highlights benefits for adults aged 60 years and older who receive the respiratory syncytial virus (RSV) vaccine. […] A study found the RSV vaccine to be 75% effective in preventing hospitalizations due to RSV-associated illness. […] This study evaluated RSV vaccine effectiveness (VE) against RSV-associated hospitalization among adults aged 60 years and older during the first season of use. […] Overall, the RSV vaccine was found to be 75% effective (95% CI, 50-87) in preventing RSV-associated hospitalizations among adults aged 60 years and older. […] Among adults aged 75 years and older, VE was 76% (95% CI, 40-91). […] Despite these limitations, the researchers believe the study shows the RSV vaccine provides significant protection against hospitalization for older adults. […] Evaluation of RSV VE in future seasons is important to confirm these findings and further examine VE among subgroups and by time since vaccination, wrote the researchers.

• #9 Use of Respiratory Syncytial Virus Vaccines in Adults Aged ≥60 Years: Updated Recommendations of the Advisory Committee on Immunization Practices — United States, 2024 | MMWR

  https://www.cdc.gov/mmwr/volumes/73/wr/mm7332e1.htm

  On June 26, 2024, ACIP voted to update these recommendations as follows: all adults aged 75 years and adults aged 6074 years who are at increased risk for severe RSV disease should receive a single dose of RSV vaccine. […] These updated recommendations are intended to maximize RSV vaccination coverage among persons most likely to benefit, by clarifying who is at highest risk and by reducing implementation barriers associated with the previous shared clinical decision-making recommendation. […] On June 26, 2024, ACIP recommended a single dose of any FDA-approved RSV vaccine for all adults aged 75 years and for adults aged 6074 years who are at increased risk for severe RSV disease. […] The challenges of shared clinical decision-making, along with the updated evidence on balance of benefits and risks, led ACIP in June 2024 to make an age-based recommendation for adults aged 75 years and a risk-based recommendation for those aged 6074 years. […] Based on currently available evidence, ACIP concluded that the benefits of RSV vaccination did not clearly outweigh the potential harms in adults aged 6074 years without risk factors for severe RSV disease.

• #10 The Potential Public Health Impact of the Adjuvanted Respiratory Syncytial Virus Prefusion F Protein Vaccine Among Older Adults in Italy

  https://www.mdpi.com/2076-393X/13/3/212

  Currently, no RSV disease-specific treatment has been approved for adults aged 60 y or more. The GSK AS01E-adjuvanted RSV preFusion protein 3 OA (adjuvanted RSVPreF3 OA) vaccine has shown efficacy in preventing RSV infection and RSV-associated lower respiratory tract disease (LRTD) in adults aged 60 y or more. […] The adjuvanted RSVPreF3 OA vaccine became the world’s first vaccine approved for the prevention of LRTD due to RSV in adults aged 60 y or over in the US in May 2023 and in the European Union in June 2023. […] Preventive interventions such as RSV vaccination in adults at high risk and those aged 75 y or over could offer not only potential clinical benefits by reducing disease burden but also possible economic benefits by reducing healthcare and social costs. […] The objective of the present study was to assess the public health impact (e.g., reductions in RSV-related cases, hospitalizations, and other outcomes) of a vaccination program using the adjuvanted RSVPreF3 OA vaccine in the two populations in which its use is currently recommended in Italy, the population aged ≥75 y and the HR population aged ≥60 y, over a 3-year time horizon (corresponding to three consecutive RSV seasons). […] The results of the present analysis indicate that vaccinating the population of adults aged ≥75 y and the HR population aged ≥60 y could potentially reduce RSV-related cases, healthcare resource use, deaths, and direct costs over a 3-year period (corresponding to three RSV seasons).

• #11 The benefits and risks of maternal RSV vaccination on mortality in South Africa: a modelling study | medRxiv

  https://www.medrxiv.org/content/10.1101/2025.02.14.25321914v1

  Maternal respiratory syncytial virus (RSV) vaccine, RSV prefusion F protein vaccine (RSVpreF (Abrysvo)), was found to be safe and efficacious in its phase III trial. However, post-hoc stratified analyses identified an excess of preterm births in the intervention arm in two upper middle-income countries, most prominently in South Africa. This study weighs the potential benefits and risks in mortality associated with maternal RSV vaccination in South Africa, assuming the increased risk of preterm births observed in the trial was caused by vaccination. […] The benefit model estimated that vaccination would reduce RSV-associated infant deaths by 31 (95% Credible Interval (Crl): 27, 35) per 100,000 live births born to vaccinated mothers in South Africa. The risk model suggested that neonatal deaths would increase by 44 (95%CrI: 43, 210) with vaccination at 24-36 GA weeks, totaling 1.4 (95%CrI: 1.4, 7.0) excess neonatal deaths for every infant RSV death prevented.

• #12 The benefits and risks of maternal RSV vaccination on mortality in South Africa: a modelling study | medRxiv

  https://www.medrxiv.org/content/10.1101/2025.02.14.25321914v1

  If RSVpreF increases preterm birth risk, and if this increases neonatal mortality, then the benefit-risk analysis did not 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 weeks. There was large uncertainty in the analyses due to small numbers of preterm births. With vaccination from the third trimester, the benefit-risk analysis favoured vaccination.

• #13 Cost-Effectiveness of an RSVpreF Vaccine for Prevention of Respiratory Syncytial Virus Outcomes in Infants – NCBI Bookshelf

  https://www.ncbi.nlm.nih.gov/books/NBK596748/

  From CADTHs search of the economic literature, 4 economic studies were identified that assessed the cost-effectiveness of respiratory syncytial virus (RSV) immunization during pregnancy in high-income countries, including 1 study set in Nunavik, Quebec. Only 1 of these studies specifically considered the product of interest (RSVpreF), and only in a scenario analysis. […] In the 4 identified studies that evaluated the cost-effectiveness of RSV immunization during pregnancy, the outcomes predicted by the models focused on those related to infants. There is a lack of evidence on outcomes thus cost-effectiveness for the persons who are pregnant. […] The results from the 4 studies varied considerably. RSV immunization during pregnancy ranged from being more effective and associated with lower total costs (dominant) to more than $200,000 per quality-adjusted life-year gained when compared with no intervention. The results depended on the modelled region, efficacy, pricing, and severity of the RSV season.

• #14 Cost-Effectiveness of an RSVpreF Vaccine for Prevention of Respiratory Syncytial Virus Outcomes in Infants – NCBI Bookshelf

  https://www.ncbi.nlm.nih.gov/books/NBK596748/

  When compared to no intervention, the cost-effectiveness of immunization during pregnancy ranged from dominant (more effective and less costly) to more than $200,000 per QALY gained, depending on the modelled region, efficacy, pricing, and severity of the RSV season. […] When compared with seasonal RSV prophylaxis with long-acting mAbs such as nirsevimab, year-round immunization during pregnancy was not considered cost-effective when the price per dose was the same as that of the long-acting mAb. Immunization during pregnancy was estimated to become cost-effective when its acquisition cost per dose was 2 to 5 times lower than that of the long-acting mAb. […] Most studies did not incorporate efficacy data from immunization during pregnancy trials, and only 1 study included data specific to the product RSVpreF in a scenario analysis. Given the between-study variation in assumed immunization during pregnancy efficacy, immunization during pregnancy acquisition costs, QALY measures, mortality assumptions, and setting, substantial uncertainty remains regarding the cost-effectiveness of immunization during pregnancy with RSVpreF in Canada.

• #15

  https://www.gov.uk/government/publications/rsv-immunisation-programme-jcvi-advice-7-june-2023/respiratory-syncytial-virus-rsv-immunisation-programme-for-infants-and-older-adults-jcvi-full-statement-11-september-2023

  JCVI has been monitoring products in development for the prevention of respiratory syncytial virus (RSV) disease for several years. […] JCVI advised that a RSV immunisation programme that is cost effective should be developed for both infants and older adults. […] The committee notes a seasonal, seasonal with catch-up or year-round passive immunisation (monoclonal antibody) programme for newborns could be cost effective over a range of potential prices that combine the cost of the product and its administration. […] The committee notes a seasonal or year-round maternal active immunisation programme could be cost effective over a range of potential prices that combine the cost of the product and its administration. […] JCVI advises that both products are suitable for a universal programme to protect neonates and infants from RSV.

• #16

  https://www.gov.uk/government/publications/rsv-immunisation-programme-jcvi-advice-7-june-2023/respiratory-syncytial-virus-rsv-immunisation-programme-for-infants-and-older-adults-jcvi-full-statement-11-september-2023

  JCVI advises a programme for older adults aged 75 years old and above. JCVI currently favours a one-off campaign as the strategy for this programme with the initial offer covering several age cohorts and then a routine programme for those turning 75 years old, with its delivery and implementation to be determined through further consultation between NHS England, DHSC, UKHSA and the devolved administrations. […] In summary, JCVI advises that a RSV immunisation programme, that is cost effective, should be developed for both infants and older adults.

• #17 Developing a prediction model to estimate the true burden of respiratory syncytial virus (RSV) in hospitalised children in Western Australia | Scientific Reports

  https://www.nature.com/articles/s41598-021-04080-3

  Respiratory syncytial virus (RSV) is a leading cause of childhood morbidity, however there is no systematic testing in children hospitalised with respiratory symptoms. […] Our model showed good predictive accuracy (AUROC: 0.87). The respective sensitivity, specificity, positive predictive value and negative predictive values were 58.4%, 92.2%, 68.6% and 88.3%. […] Findings from our study suggest that the true burden of RSV may be 30-57% higher than current estimates. […] Our study aimed to improve the estimates of RSV incidence which are needed to help advocate for vaccine programs and provide essential baseline data to evaluate vaccine impact studies. […] Our prediction model was based on readily available patient characteristics and may be useful for identifying hospitalised children likely to test positive for RSV.

• #18 Developing a prediction model to estimate the true burden of respiratory syncytial virus (RSV) in hospitalised children in Western Australia | Scientific Reports

  https://www.nature.com/articles/s41598-021-04080-3

  Our analysis confirmed that children who are younger at admission (3 months) are at increased risk of RSV positivity, which is consistent with other studies. […] Given the higher burden of RSV-associated hospitalisation among the young infant age group, future vaccine programmes could target them as priority beneficiaries. […] Our study has some limitations. Firstly, our results are based on hospitalisation data linked to laboratory records with specimen collection within 48 h of hospital admission. Therefore, we are limiting our prediction model to more severe RSV cases associated with hospitalisation and therefore our model does not estimate the broader community incidence of RSV. […] We have successfully developed a prediction model using population-based data to estimate the true burden of RSV in hospitalised children in WA with good predictive performance and internal validation. Findings from our study indicate that the true burden of RSV is up to 30-57% higher than figures based solely on laboratory detection data in young children.

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