Background: Increasing prices of newly licensed vaccines increase the fiscal burden for government programs. Pricing decisions by vaccine manufacturers are proprietary. However, it is possible to estimate contract prices that would cover research and development costs and still allow manufacturers to obtain a profit consistent with other types of capital investment.
Objectives: To estimate contract prices for non-influenza vaccines for 2000-2008 and compare those prices with observed federal contract prices.
Methods: Multiple data sources (interviews with vaccine developers and manufacturers; FDA documents; clinicaltrials.gov; industry data on vaccine failures and successes; stock market data) were used to inform a novel model of pre-licensure vaccine development and post-licensure manufacture and uptake. These informed a probabilistic model designed to estimate contract prices for pneumococcal conjugate vaccine (PCV), human papillomavirus vaccine (HPV), rotavirus-Merck (rota-M), rotavirus-GSK (rota-G), meningococcal conjugate vaccine (MCV), Tdap-Sanofi (Tdap-S), and Tdap-GSK (Tdap-G). The model anticipated a 10% return within 10 years in the market, accounting for expected number of doses sold and rising costs of manufacturing over time.
Results: For 5 vaccines, estimated contract prices were significantly less than observed prices: PCV (estimated $15.43 [95% CI: $14.25, $19.08] vs observed $45.99); HPV ($43.66 [$39.46, $56.65] vs $96.15); rota-G ($35.08 [$32.72, $42.39] vs $82.25); rota-M ($21.04 [$19.46, $25.91] vs $55.05); MCV ($47.57 [$41.27, $67.05] vs $68.00). For 2 vaccines, estimated contract prices were significantly greater than observed prices: Tdap-S (estimated $48.78 [$42.48, $68.26] vs observed $30.75) and Tdap-G ($47.38 [$41.08, $66.86] vs $28.75).
Conclusions: The model consistently under-estimated contract prices as compared with observed prices for vaccines that with 1 US-licensed manufacturer. For the one vaccine (Tdap) with 2 manufacturers who entered the market simultaneously, the model over-estimated the contract price versus the observed price. Estimates of more vaccine contract prices need to be made before a pattern can be firmly established.