Pneumococcal Conjugate Vaccine, 15-Valent
Active immunisation for the prevention of pneumococcal disease caused by Streptococcus pneumoniae serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F and 33F) in infants, children and adolescents up to 18 years of age, including non-Indigenous and Aboriginal and Torres Strait Islander populations, those with specified medical risk conditions, and haematopoietic stem cell transplant recipients.
Access path
- Mar 2023Recommended · restricted
vs 13-valent pneumococcal conjugate vaccine (13vPCV)
- PBS listing · Restricted
From the public summary
The PBAC recommended that 15-valent pneumococcal conjugate vaccine (15vPCV, Vaxneuvance®) be a designated vaccine for the purposes of the National Health Act 1953, for the prevention of pneumococcal disease in the following paediatric populations:PSD · Mar 2023
• Non-indigenous infants and Aboriginal and Torres Strait Islander infants living in ACT, NSW, Vic and Tas: 3 doses at ages 2, 4 and 12 months (2+1 doses);PSD · Mar 2023
The submission presented a CMA using 13vPCV as the comparator. The key components and assumption used are shown in Table 7.PSD · Mar 2023
The equi-effective doses were estimated as 15vPCV 0.5 mL injection and 13vPCV 0.5 mL injection. 17PSD · Mar 2023
The submission claimed non-inferiority of 15vPCV to 13vPCV in 12 of the 13 shared serotypes, an increased immune response to serotype 3, and a superior immune 16PSD · Mar 2023
The submission described 15vPCV as non-inferior in terms of safety compared to 13vPCV. The evaluation noted that moderate and severe pain at the injection site was more frequent with 15vPCV. While the ESC agreed with the evaluation that the claim of non-inferior safety was not adequately supported, it considered it is uncertain whether this would impact on tolerability/acceptability of the vaccine.PSD · Mar 2023
The PBAC noted and welcomed the input from an organisation via the Consumer Comments facility on the PBS website. The comments from the Lung Foundation Australia described a range of benefits that the listing of 15vPCV on the NIP for paediatric populations will have on the Australian population.PSD · Mar 2023
Cost-effectiveness
Cost-minimisation analysis; no ICER calculated as the submission assessed 15vPCV as equi-effective to 13vPCV.
The submission presented a CMA using 13vPCV as the comparator. PSD · 2023
Decision context
PopulationPaediatric populations aged 6 weeks to <18 years: non-Indigenous infants and Aboriginal and Torres Strait Islander infants in ACT, NSW, Vic and Tas receiving 2+1 doses; infants with specified medical risk conditions and Aboriginal and Torres Strait Islander infants in WA, NT, SA and Qld receiving 3+1 doses; children and adolescents 12 months to 18 years newly diagnosed with specified medical risk conditions receiving 1 dose; and haematopoietic stem cell transplant recipients aged 12 months to <18 years receiving 3 doses.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Mar 2023 | Recommended · restricted | 13-valent pneumococcal conjugate vaccine (13vPCV) | — | RCT · Immunogenicity (serotype-specific IgG responses) |
Consumer voice
Lung Foundation Australia described benefits of listing 15vPCV on the NIP for paediatric populations, including providing alternative vaccine supply, reducing disease cases, and alleviating economic and social burden on parents.
The organisation considered it would provide an alternative line of supply and ensure continued access to required vaccines, reduce costs to health systems and services by reducing cases of invasive pneumococcal disease, reduce the risk of disease, disability and death associated with pneumococcal disease, and reduce the economic and social burden experienced by parents required to care for ill children. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to paediatric populations aged 6 weeks to <18 years; TGA label includes adults.