Launch of Highly Efficacious HIV, Tuberculosis, and Malaria Vaccines Unlikely, Study Says

With ambitious targets for ending the HIV and other infectious disease epidemics, prevention efforts are crucial for gaining hold of the diseases. However, the vaccines needed to combat these infectious diseases are not likely to be developed, according to a new study.

Analyzing vaccine candidates and other products in the research and development pipeline, researchers determined that the current pipeline is unlikely to produce highly effective vaccines for HIV, tuberculosis, or malaria, which could be important for controlling the spread of these diseases.

The reason, according to the researchers, is lack of funding. Since 2008, annual funding for product development for these diseases has been $3 billion. However, this figure is at least $1.5 billion to $2.8 billion short of what’s needed.

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“Closing this large financial gap will require a major effort to mobilize new resources from across the public, philanthropic, and private sectors,” wrote the researchers. “High-income governments have been the most important source to date for financing product development for neglected diseases, but they are arguably under-investing in such research given the very large health, social, and economic returns to investment.”

To determine future results based on current funding, the researchers conducted a pipeline portfolio review of 538 candidate products for 35 neglected diseases to estimate the costs of moving each product through the pipeline and the likelihood of a product launching. Products included drugs, vaccines, diagnostics, and multipurpose prevention technologies. Stages of development ranged from preclinical trials to phase 3 trials.

Researchers observed that 3 diseases dominated the pipeline: malaria (109 candidates), HIV/AIDS (99 candidates), and tuberculosis (98 candidates).

A cost analysis showed that, in order to move all 538 candidates through the pipeline, it would cost approximately $16.3 billion over 10 to 12 years. More than half (55%) of the cost would be attributable to phase 3 trials, one-third (33%) would be for phase 2 trials, 9% would be for preclinical development, and 4% would be for phase 1 trials. Vaccines would account for more than half of the cost (55%).

The researchers estimated that 128 products would make it to launch, two-thirds of which would be for HIV, tuberculosis, and malaria. However, launches of vaccines for the 3 diseases would be unlikely, according to the researchers.

The researchers also identified 18 high-priority “missing” products—products that are unlikely to be launched that are of particular need. These products include highly efficacious vaccines against HIV, tuberculosis, malaria, and hepatitis C. The total cost for launching these 18 products ranges from $13.6 billion to $21.8 billion over 10 to 12 years, depending on the complexity of the products.

“The model shows us where the current pipeline is most robust and where it is lacking,” Gavin Yamey, professor of global health and public policy and director of the Center for Policy Impact in Global Health, Duke Global Health Institute, said in a statement. “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.”

Reference:

Young Ruth, Bekele T, Gunn A, et al. Developing new technologies for neglectied diseases: a pipeline portfolio review and cost model [published August 22, 2018]. Gates Open Res. doi: 10.12688/gatesopenres.12817.2.