Analysis of Neglected Tropical Disease Drug and Vaccine Development Pipelines to Predict Issuance of FDA Priority Review Vouchers over the Next Decade
Prediction model used to calculate the total number of expected PRVs, as well as the average annual rate of how many PRVs will be awarded. The model assumes a 100% success rate for approval by FDA of products already approved abroad. (The analysis adjusted for situations where one product approval would deem another ineligible. For example, SM14, a recombinant/purified protein vaccine, is currently under development for both schistosomiasis and fascioliasis. If it were to be approved for schistosomiasis, it would make approval for the indication of use against fascioliasis ineligible. Therefore, SM14 was counted as one product for the purposes of predicting the number of PRVs.) Similarly, the model assumes each individual product in development will yield one product. For malaria vaccines, for example, this may not be the case as many believe that these parts would be combined into one product before licensure. See study limitations for further explanation.