Current Pipeline Absent of New Vaccines for HIV, Other Infectious Diseases

New vaccines to treat some of the world’s most prevalent infectious diseases are not on the horizon, according to a study led by Duke University's Center for Policy Impact in Global Health.

A financial modeling tool showed that the current pipeline is unlikely to produce effective new vaccines for HIV, tuberculosis (TB), or malaria, which could have a significant effect on the global spread of infectious diseases, according to the researchers.

The study evaluated the current pipeline, which included 538 candidate medications for 35 neglected diseases to project the cost and probability that each product would hit the market.

"What this tells us is that the current development pipeline is not likely to give us all the pieces to fight these diseases," Gavin Yamey, director of the Center for Policy Impact in Global Health, said in a press release. "It underscores the need to substantially scale up resources and innovative development approaches to fill those gaps."

The study authors used the Portfolio-to-Impact (P2I) financial model to evaluate drugs, vaccines, diagnostics, and other technologies in various stages of development, from preclinical research to advanced clinical trials. Each candidate product was classified into one of several developmental pathways to project the cost of taking it to market. Although the P2I tool does not forecast the clinical implications or utility of the product, it does calculate the cost and likelihood of the product entering the market.

Of the products they evaluated, the study authors found that it would cost approximately $16.3 billion to move the candidates through the pipeline to launch, with three-quarters of the costs incurred within the first 5 years. Of the 128 products they expect to launch, 60% are for new diagnostic tests, while repurposed drugs comprise an additional 13%.

Despite the unlikelihood of effective new vaccines for TB, HIV, and malaria, the model predicts that approximately 85 other treatments for these conditions would reach the market, which illustrates the predominant share of research and development funding in these disease states, according to the researchers.

The study authors also identified 18 areas they deemed high-priority for which the pipeline is unlikely to produce new advances. The financial model projected that it would require an investment of anywhere from $13.6 billion to $21.8 billion over the next decade to bring these products to market, but the researchers said those costs are likely underestimated.

"The model shows us where the current pipeline is most robust and where it is lacking," Yamey said. "For global health advocates, this is a broad picture of what pieces we are likely to still be missing, and where we can direct priorities in funding and product development."