Respiratory Syncytial Virus Vaccine, Recombinant Pre-Fusion F Protein

7.1 The PBAC did not recommend recombinant syncytial pre-fusion F protein vaccine (RSVpreF) for the prevention of lower respiratory tract illness (LRTI) caused by respiratory syncytial virus (RSV) in infants from birth through 6 months of age by active immunisation of pregnant women.PSD · Mar 2024

39 McRae, J.E., McHugh, L., King, C., Beard, F.H., Blyth, C.C., Danchin, M.H., Giles, M.L., Mohammed, H., Wood, N. and Macartney, K. (2023), Influenza and pertussis vaccine coverage in pregnancy in Australia, 2016–2021. Med J Aust, 218: 528- 541. https://doi.org/10.5694/mja2.51989PSD · Mar 2024

6.47 The submission presented a cost-utility analysis based on the MATISSE clinical trial, measuring outcomes in quality-adjusted life years (QALYs). This was consistent with the clinical claim of superior effectiveness. Key components of the economic evaluation are presented in Table 11. 21PSD · Mar 2024

Time horizon As the model estimates the QALY difference over a lifetime, the time horizon is technically a lifetime.PSD · Mar 2024

6.42 The submission described RSVpreF as superior in terms of effectiveness compared to placebo. The ESC agreed with the commentary that this claim was adequately supported. In the key MATISSE trial, administration of RSVpreF to pregnant women resulted in a reduction in RSV-positive MA-LRTI in infants up to 180 days after birth, corresponding to a VE of 51.3% (97.58% CI:29.4%, 66.8%), which met the statistical criterion for success for the primary …PSD · Mar 2024

Hospitalisations due to RSV were also reduced in the RSVpreF group up to 180 days after birth, giving a VE of 56.8% (99.17% CI:10.1%, 80.7%). The key areas of uncertainty include a lack of evidence for the efficacy of the vaccine in infants born prematurely, and those resulting from multiple pregnancies and non-healthy pregnancies.PSD · Mar 2024

6.3 The comments from the Immunisation Foundation of Australia described a range of benefits of the proposed vaccine stating that protecting infants from RSV would provide a healthier start to life and reduce paediatric hospital burden.PSD · Mar 2024

6.4 The Lung Foundation Australia stated that listing RSVpreF on the NIP would provide clinicians and patients with access to an effective vaccine, reduce the risk of disease, disability and death associated with RSV, and reduce costs to health system, particularly among children and immunocompromised individuals. The input stated that based on a survey of over 800 consumers, on average, Australian consumers were “very worried” about RSV.PSD · Mar 2024