Leapfrogging the Cold Chain: Why Gates is Big Into Microneedles

Millennium Development Goal 8 (MDG 8) calls for pharmaceutical companies to work in cooperation with the global health and development groups, country governments, and government agencies to make essential drugs affordable and sustainable for least-developed countries. According to the U.N. Development Group (UNDG), “Access is defined as having medicines continuously available and affordable at public or private health facilities.”

Providing continuous access to essential medicines is a global health and development challenge where innovation is key. Especially where the critical cold chain is concerned—i.e., ensuring that vaccines and other medicines can be kept refrigerated until they reach patients.

We’ve covered the importance of the cold supply chain before at IP, particularly as it pertains to last-mile health delivery in rural areas. This is an area of global health and development that is faced with ongoing challenges, including weak healthcare systems, lack of community health workers, and failing or non-existent infrastructure.

Plenty of nonprofits are addressing these challenges, not the least of which is the Gates Foundation, which often backs some of most innovative and exciting projects in global health. For the past couple of years, one such area of interest for Gates has been supporting the development and increased use of microneedles for vaccine and medicine delivery.

The Gates Foundation recently awarded Vaxess Technologies Inc. two grants for a total of $6 million supporting its “proprietary technology platform for sustained transdermal delivery of vaccines and immunotherapies,” called MIMIX.

The first grant of roughly $3 million is a Phase I Grand Challenges grant, and funds the continuing development of Vaxess’s microneedle patch vaccines. This includes the preclinical development and production of a thermostable inactivated polio vaccine (IPV) microneedle patch. If successful, the patch will not only simplify dosing and administration of the vaccine, but it will also lower costs and break imposing cold chain constraints.

The second grant of approximately $3 million is directed toward the preclinical development of a “resorbable microneedle patch for the delivery of a live attenuated MR (measles rubella) vaccine.” The grant will also allow Vaxess to formulate a thermostable MR vaccine, manufacture microneedle patches, and establish preclinical proof-of-concept models to support clinical trials in the future.

I know, vaccine supply chains aren’t as exciting as, say, vaccine discovery, and the subject of supply chains in general is rather boring. But boring doesn’t mean less important.

Vaccine wastage is a considerable and often overlooked problem in the global health landscape. In 2012, Intellectual Ventures Lab examined global vaccine wastage and discovered that around 40 percent of the oral polio vaccine (OPV) is wasted each year, either due to destruction from heat and ultra-violet light exposure or mishandling. Put in monetary terms, the lab stated that around 2 billion doses of OPV are purchased each year at around $0.14 per dose for a total cost of approximately $270 million. The 40 percent wastage rate means that global polio vaccine campaigns are collectively throwing away around $108 million.

Microneedles are just one solution to curb wastage and improve the storage and handling of vaccines and essential medicines. Gates has been beating the microneedle drum since around 2009 when it awarded a $100,000 grant to TransDerm for its dry polymer patch to increase malaria vaccine access. If the use of microneedles can effectively leapfrog the cold supply chain and do so sustainably and cost effectively, I imagine Gates will have a hand in the further development of multiple microneedle applications for some time to come.