LAUSR

OBJECTIVE To assess the public health impact and economic value of booster vaccination with the Pfizer-BioNTech COVID-19 Vaccine, Bivalent in the United States. METHODS A combined cohort Markov decision tree model estimated the cost-effectiveness and budget impact of booster vaccination compared to no booster vaccination in individuals aged ≥5 years. Analyses prospectively assessed three scenarios (base case, low, high) defined based upon the emergence (or not) of subvariants, using list prices. Age-stratified parameters were informed by literature. The cost-effectiveness analysis estimated cases, hospitalizations and deaths averted, Life Years (LYs) and Quality Adjusted Life Years (QALYs) gained, the incremental cost-effectiveness ratio (ICER), the net monetary benefit (NMB), and the Return on Investment (ROI). The budget impact analyses used the perspective of a hypothetical 1-million-member plan. Sensitivity analyses explored parameter uncertainty. Conservatively, indirect effects and broad societal benefits were not considered. RESULTS The base case predicted that, compared to no booster vaccination, the Pfizer-BioNTech COVID-19 Vaccine, Bivalent could result in ∼3.7 million fewer symptomatic cases, 162 thousand fewer hospitalizations, 45 thousand fewer deaths, 373 thousand fewer discounted QALYs lost, and was cost-saving. Using a conservative value of $50,000 for 1 LY, every $1 invested yielded estimated $4.67 benefits. Unit costs, health outcomes and effectiveness had the greatest impact on results. At $50,000 per QALY gained, the booster generated a 34.2 billion NMB and probabilistic sensitivity analyses indicated a 92% chance of being cost-saving and 98% of being cost-effective. The bivalent was cost-saving or highly cost-effective in high and low scenarios. In a hypothetical 1-million-member health plan population, the vaccine was predicted to be a budget-efficient solution for payers. CONCLUSIONS Booster vaccination with the Pfizer-BioNTech COVID-19 Vaccine, Bivalent for the US population aged ≥5 years could generate notable public health impact and be cost-saving based on the findings of our base case analyses.