Mrna-1273

7.1 The PBAC deferred making a recommendation for the National Immunisation Program (NIP) listing of the mRNA-1273 platform (Spikevax®) vaccines, for prevention of coronavirus disease 2019 (COVID-19) caused by SARS CoV-2 virus in four populations of adults as requested by the sponsor. The PBAC deferred making a recommendation due to the TGA evaluation of Spikevax LP.8.1. being delayed and the TGA Delegate’s Overview not being available.PSD · Mar 2026

This represents a restricted group in comparison to current arrangements under the National COVID-19 Vaccination Program (NCVP). The PBAC considered that Spikevax was superior to no vaccine in terms of effectiveness with an acceptable safety profile, although the magnitude and duration of benefit were uncertain.PSD · Mar 2026

6.91 The submission presented a modelled economic evaluation of Spikevax compared with no vaccine for the prevention of COVID-19. Relative reduction in COVID-19 infections and hospitalisations is derived from a large observational study of mRNA-1273 (Spikevax) targeting the KP.2 SARS-CoV2 variant (Wilson et al 202520).PSD · Mar 2026

Consistent with the claim of superior effectiveness and inferior safety to no vaccine, the economic evaluation was a cost-effectiveness / cost-utility analysis.PSD · Mar 2026

• Spikevax is superior compared to no updated vaccine in reducing the number of COVID-19 infections, COVID-19 related medical attendance, hospitalisation, ICU admission and mortality, and improving immunogenicity. Spikevax is well tolerated with an acceptable safety profile. Spikevax is inferior compared to no updated vaccine in terms of safety. TGA-approved near market comparator:PSD · Mar 2026

• Spikevax is at least non-inferior to Comirnaty in reducing the number of COVID-19 infections, COVID-19 related hospitalisation and mortality, and improving immunogenicity.PSD · Mar 2026