Malaria vaccine may not eliminate need to combat counterfeit medicines

The recent announcement of a first-generation malaria vaccine is truly historic. The promise of widespread prevention rather than just treatment is cause for excitement and relief. But as monumental as this vaccine is, endemic diseases are rarely taken down by a single silver bullet. We must also increase efforts to deal with the problem of counterfeit medicines and treatments.

Malaria has plagued humankind across the globe since the Ice Age, playing a significant role in the rise and fall of cities and civilizations over the millennia. Contrary to popular belief, these effects have not been isolated to the Global South. In fact, the Centers for Disease Control and Prevention (CDC) was founded in 1946 to prevent malaria from further decimating the United States. It has only been in recent decades that malaria has become a disease mainly of the Global South. 

Despite malaria being both detectable and treatable, it remains a significant global health problem. According to the World Health Organization (WHO), an estimated 229 million cases of malaria and 409,000 deaths occurred worldwide in 2019, with 94 percent of cases and deaths occurring in the WHO African Region. Children under five years old account for 67 percent of deaths. Malaria and the costs of treatment trap families in a cycle of illness, suffering and poverty. All in all, it is estimated that malaria reduces GDP growth in some malaria-endemic countries by 1.3 percent per year. 

There are multiple strains of malaria, and the parasite is capable of evolving and growing resistant to treatments, so individuals can contract malaria more than once in a lifetime. This has complicated the development of a vaccine. 

First created in 1987 with pilot trials beginning over two decades later, the recently announced vaccine has been a long time coming and is now the first vaccine to be developed for a human parasite. Naturally, many experts are celebrating this milestone, with the WHO’s director general stating that the vaccine “changes the course of public health history” and the WHO’s regional director for Africa noting that the vaccine “offers a glimmer of hope for the continent which shoulders the heaviest burden of the disease.”

But the emergence of this vaccine could make the problem of counterfeit medicine more troubling than it already is in sub-Saharan Africa. The most commonly used definition of counterfeit medicines was put forth by the WHO in 2017, defining them as substandard, falsified and unregistered/unlicensed, with each type playing its own distinct role. While higher-income countries offer a more lucrative market for counterfeiters, they also have the most advanced technologies and regulatory bodies in place for combating them, leaving the poorest, most vulnerable populations to suffer the most. It has recently been estimated that one in 10 products circulating in low- and middle-income countries is either substandard or fake.

Counterfeiters prey on lower-income countries due to the unfortunate confluence of struggling economies, weak technical capacity, limited regulatory oversight, a lack of punitive action, a preponderance of poor consumer and health-worker knowledge about product authenticity, a large, unregulated private sector for purchasing drugs and high burden of disease. The high prevalence of malaria in much of sub-Saharan Africa generates a constant, high demand for antimalarials, such that anywhere between 72,000 and 267,000 deaths every year are the result of fraudulent antimalarials. And, now that a vaccine is being advocated for widespread use, counterfeit vaccines will likely emerge, just as has already been witnessed recently with COVID-19 vaccines and treatments.

A multi-pronged approach lying at the intersection of technology and policy may be needed. As far as technology has come in recent decades, significant drug testing gaps remain, particularly in low-resource settings. A technological solution capable of detecting poor-quality medicines without destroying them, allowing for repeated verification at multiple points in time and place, could also be valuable.

On the policy front, there is a growing consensus about the need for an internationally uniform system for tracking and tracing legitimate pharmaceuticals, creation and maintenance of electronic pedigrees to improve supply chain regulation and surveillance efforts to catch counterfeiters.

But the vaccine, even if counterfeiting can be overcome, does not make other preventive measures, such as sleeping under insecticide-treated bed nets, any less important. The vaccine itself requires a reasonably complex regimen of four doses administered between five and 24 months of age, three of which sync up with other childhood vaccines, and one of which requires a separate trip. The vaccine has modest efficacy, reducing the risk of contracting malaria by 40 percent and reducing hospitalization rates by 30 percent, and efficacy drops to nearly zero by the fourth year.

The newly announced malaria vaccine could be a critical tool to combat the tremendous socioeconomic burden malaria causes. But global achievements in reducing malaria cases and deaths in the past decades, especially in sub-Saharan Africa, where billions of dollars have been spent on creating sustainable malaria-control programs, may be in danger of significant reversal if the problem of counterfeiting continues.

Samantha McBirney is an engineer at the nonpartisan, nonprofit RAND Corporation, where she has been studying counterfeit anti-malarial drugs in Africa. Krishna B. Kumar directs international research at RAND and the Pardee Initiative for Global Human Progress at the Pardee RAND Graduate School, where Todd Richmond directs the Technology and Narrative Lab.