By Laurie Garrett
Foreign Policy – 16 January 2018
On Feb. 27, 2017, the World Health Organization (WHO) named a dozen bacteria as major global health threats, underscoring the surge in antibiotic resistance and paucity of vaccines that, combined, now render incurable the infections caused by those germs.
There is plenty to fret about on the microbial front at the moment: Several scary strains of flu are circulating, and Australia’s winter 2017 flu season was one of the country’s deadliest in recent years. Any hope of protecting the world, generally, against the resurgence of old microbes, as well as the emergence of new ones — man-made biological menaces, for example — hinges on resolving the breakdown in the manufacturing of vaccines and moving the best, most applicable pharmaceutical innovations into the commercial pipeline for affordable access.
Ever since the 2014 Ebola epidemic in West Africa claimed 11,000 lives, global health experts, including those at Doctors Without Borders, have insisted on WHO reforms and an overhaul of the ways governments respond to outbreaks. But topping the list of needed changes is the speed with which the pharmaceutical industry develops new vaccines to guard against everything from Zika virus and tuberculosis to Ebola and drug-resistant bacteria.
But the reality is that … the world faces an even bigger problem: shortages and completely diminished stores of older but highly effective vaccines and a shrinking pool of manufacturers that can produce them.
This search for new protections against infection captured attention at the World Economic Forum in Davos, Switzerland, in January 2017 and at the G-20 summit later in July. It’s certainly appealing to imagine that pharmaceutical innovation fueled by Wall Street investments could lead to the quick creation of technological solutions to ward off outbreaks. But the reality is that, as 2018 begins, the world faces an even bigger problem: shortages and completely diminished stores of older but highly effective vaccines and a shrinking pool of manufacturers that can produce them.
In an average year between 2011 and 2015, data submitted to WHO and UNICEF showed that one-third of 194 countries ran out of a vaccine for a month or longer. Nearly 13 million infants received no vaccines at all in 2016, and by 2017 supplies of vaccines that target yellow fever, hepatitis B, cholera, meningitis C, diphtheria, whooping cough, tetanus, hepatitis A, and tuberculosis were critically low. And these shortages are acute in both poor and rich countries, with 77 percent of European nations telling WHO in 2015 that they had depleted supplies. By September 2017, Switzerland was experiencing shortages of 16 essential vaccines, prompting Daniel Desgrandchamps, an infectious diseases expert at the University of Geneva, to say, “This isn’t a Swiss problem — it’s an international problem.… I can’t remember a situation like this in my 30 years of professional life as a vaccination expert.”
The global pharmaceutical market is worth more than $1 trillion a year, but the vaccines portion of it is trivial, amounting to merely $24 billion — or about 2.4 percent. Yet the tried-and-true ways of targeting viruses and bacteria to prevent infection garner less industry interest. Though low profit margins, despite high demand, have long blocked the vaccine pipeline, the situation is worsening and now has impact on new product development. Few solutions have been suggested, but one country — Brazil — was able to handle a potentially catastrophic shortage better than any other because it manufactures its own vaccines in a unique public-private arrangement that fulfills the country’s constitutional requirement of providing health care for all of its citizens. The government sets production priorities and purchases from local pharmaceutical manufacturers, avoiding the unreliable international market.
In 2016, outbreaks of two mosquito-spread viruses — yellow fever and Zika — exploded in Angola and Brazil, respectively. The yellow fever outbreak spread to nearby Democratic Republic of the Congo as the entire world supply of yellow fever vaccine dwindled dangerously toward zero.
The irony is that the vaccine is almost 100 percent effective and a full dose protects patients for life. But the drug had become so cheap — by 2008, it cost a mere 60 cents for each vaccine — that few companies were interested in making it. With tens of millions of African lives at stake, WHO took a big gamble, diluting donated vaccines from countries such as Brazil — which donated 18 million doses — by 5 to 1 and hoping they would still work. Briefly, by January 2017, the epidemic seemed to be under control. But then it began to sweep across Brazil and the region, with cases popping up in the states of São Paulo and Rio de Janeiro. As the disease continued to spread, placing the global supply under further strain, stockpiles at the U.S. Centers for Disease Control and Prevention (CDC) disappeared. The CDC now estimates that its supplies won’t be replenished until the end of 2018, perhaps not until 2019.
The Zika epidemic and vaccine invention offer a cautionary tale of how these contradicting interests culminate in a less-than-desirable scenario. Before Zika first surfaced in Brazil in 2015 and then spread across the Americas, it had been too obscure to draw pharmaceutical industry interest. But once it hit Puerto Rico and Florida, the industry raced to create a vaccine, and the manufacturer Sanofi developed one that seemed safe and almost completely effective. Officials sighed in relief. But in 2017, when an epidemic in the wealthy United States failed to materialize, Sanofi shut down its Zika vaccine program. And as the year closed, another manufacturer, Merck, failed to apply to the U.S. Food and Drug Administration for approval of its Ebola vaccine — a product supported by strong clinical data — even after signing a $5 million advance purchase commitment with Gavi, the global vaccine alliance.
The challenge for 2018 will be finding a way to keep the pharmaceutical pipeline flowing, both for vaccines against 20th-century threats such as measles and cholera and for 21st-century challenges including SARS, MERS, new forms of deadly influenza, and the unknown microbes lurking out there. Many things have been tried: creating pots of gold for guaranteed bulk purchases, improving global shipping and delivery systems to better target limited supplies, and promoting the entry of vaccine manufacturers from emerging economies. These measures have acted like fingers in a dike, holding back a flood of further market failures. But Doctors Without Borders and many global health leaders fear that nothing less than a change to the capitalist underpinnings of the pharmaceutical industry will resolve the vaccine crisis — a step so extreme that only Brazil and a handful of left-leaning nations have dared put in practice.
Garrett is a Pulitzer Prize-winning writer and global health policy analyst.