“Running the Gauntlet”: Formidable challenges in advancing neglected tropical diseases vaccines from development through licensure, and a “Call to Action”

Abstract

Translational science for new biotechnologies (e.g. drugs, vaccines, devices, or diagnostics) depend on the development of a robust ‘business case’. This is driven by complex scientific, technical, logistical, financial and operational elements to determine the feasibility and probability of traversing the “valleys of death” leading to licensure. The potential results in terms of profitability and financial realization, called ‘product value proposition’ play a crucial role in establishing incentives for investment during and after development. With this review, our goal is to summarize the challenges in taking vaccines against neglected tropical diseases (NTDs) from development through licensure and provide a perspective that these vaccines can have measurable public health and economic profitability and market success. Understanding these processes and its challenges would open the opportunity to accelerate and advance these essential NTD vaccines through the last mile towards licensure and for the delivery to afflicted populations in low- and middle-income countries.

30 years of parasitology research analysed by text mining

“…Vaccine development is one such area, and so we note here the value and importance of vaccine development in a time when drug resistance remains a concern. A ‘Call to Action’ on vaccine development was recently issued for NTDs (Bottazzi and Hotez, 2019). The failure to identify topics such as vaccines as major themes or terms in these analyses is simply the outcome of scale; other themes simply had many more publications supporting them.…”

Global COVID-19 Efforts as the Platform to Achieving the Sustainable Development Goals

“…For example, adult vaccinations for COVID-19 could be linked to scale-up for other adult vaccines, including influenza. As new vaccines for schistosomiasis and Chagas disease enter advanced development, there may be opportunities to link these as well [ 30 ]. Outside of vaccines, we will need to look at bundling COVID-19 vaccines with mass treatments for malaria, tuberculosis, and HIV/AIDS, as well as large-scale programs for neglected tropical diseases.…”

Enlisting the mRNA Vaccine Platform to Combat Parasitic Infections

“…Similarly, for malaria, tremendous gains have been achieved through the administration of antimalarial drugs and insecticide-treated bed nets, but a vaccine will still be required to go the last mile for this ancient scourge. We urgently need a new generation of vaccines for high-prevalence parasitic infections, such as malaria, leishmaniasis, Chagas disease, hookworm infection, and schistosomiasis [14]. However, there are only a handful of licensed vaccines against parasites available and, with the exception of the malaria vaccine, Mosquirix (RTS, S), which was approved by the European Medicine Agency (EMA) in 2015 and is just now being introduced in three African nations [15], all are for veterinary applications [16].…”

“…Vaccine development for parasitic infections is often hindered by limitations of production and/or inadequate immune responses [20]. There is also the expense associated with traditional vaccine platforms, which might not be linked to a traditional return on investment [14].…”