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The Hunt for an Ebola Vaccine

eye on the news

The Hunt for an Ebola Vaccine

We could have one by next year, but it may not be enough to stop the virus’s deadly spread. October 28, 2014
Photo by NIAID

The effort to contain the spread of Ebola through traditional infection-control measures in West Africa may fail. The nations suffering from the outbreak are poor, and their medical infrastructures are already strained past the breaking point. Many hospitals in Liberia lack even basics like gloves, soap, and bleach. Meanwhile, the American effort to build treatment units and train medical personnel in the region has been slow to launch and will likely get going too late to make a material difference in halting the spread of the virus. In a worst-case scenario, the Centers for Disease Control has predicted, there could be 1.4 million cases in West Africa by January 2015. To date, West Africa has seen nearly 10,000 cases of Ebola, with 5,477 fatalities, according to the World Health Organization. The CDC believes that those figures may be low; there may be two to three times as many infections as reported.

The American media has been obsessively focused on whether the United States should impose a ban on travel from the most severely affected countries. The problem with that idea is that a vast humanitarian disaster in West Africa would quickly spill over into other countries not affected by the American ban. An asymptomatic virus carrier could circumvent a ban by taking a plane from Liberia to Paris, say, and then Paris to the United States. A travel ban would likely push patients underground, too, limiting public-health authorities’ ability to track and treat the disease. There is simply no “zero contagion” policy possible for the United States. The real nightmare scenario for America would be if Ebola spreads to more globally connected, developing countries with public-health systems unequipped to deal with it. That would be a disaster for the global economy. And if the disease made the jump to Central America, a humanitarian disaster could unfold on our doorstep.

If the virus continues on its current trajectory, our best hope to stop it lies in the development of a successful vaccine. Vaccines against Ebola have been tested on macaque monkeys since the 1990s. After 9/11, the U.S. began investing heavily in Ebola research, concerned about the virus’s potential as a bioweapon. Various pieces of legislation, including Project BioShield in 2004 (reauthorized in 2013), and billions of federal dollars have been focused on financing the development and stockpiling of “medical countermeasures” against likely agents of bioterrorism—including hemorrhagic fevers like Ebola and Marburg.

In 2006, Congress recognized that getting a drug or vaccine to fight bioterror threats and emerging diseases through the FDA’s drug-approval protocols would be nearly impossible. It would also be unethical: you can’t expose a patient to Ebola to test whether a drug works against it. Nor can you deny a potential cure to Ebola patients in the name of placebo-controlled trials. Congress instead created the Biomedical Advanced Research and Development Authority (BARDA), which gave the government “fast-track” authority to fund and procure promising drugs and vaccines, and let the FDA rapidly authorize their use during public-health emergencies. BARDA has funded 233 projects since its inception, including anthrax vaccines and radiation treatments, but only one concerning Ebola, so far.

Eight years later, we still don’t have any drugs or vaccines to treat Ebola. Why not? The government didn’t prioritize the development of Ebola countermeasures. Small outbreaks in Central Africa didn’t register sharply enough on the government’s radar screen. BARDA, for all its good points, doesn’t have the budget to shepherd drugs or vaccines through the FDA’s rigorous drug-approval process, which can cost hundreds of millions of dollars. And since Ebola and other emerging diseases typically hit poor countries, no viable private market exists for an Ebola vaccine.

If Uncle Sam doesn’t shell out the money to help develop and then buy an Ebola vaccine, no one else will. The Defense Threat Reduction Agency (DTRA), the only other major investor in countermeasures for early-stage research, wrapped promising drugs such as ZMAPP in red tape, and seemed more interested in publishing academic papers than in actually helping companies develop products. Not surprisingly, the government is not an effective pharmaceutical company.

Still, nothing focuses the mind of government bureaucrats like a global health crisis unfolding in real time on cable-news networks. The government and private companies are now fast-tracking vaccine-development programs. The National Institute of Allergy and Infectious Diseases at the National Institutes of Health is collaborating on developing Ebola vaccines with GlaxoSmithKline and NewLink Genetics. GSK hopes to get data from early-stage safety testing soon. If the vaccine passes, GSK intends to run a large trial with health-care workers in Ebola-affected countries by early 2015, if not sooner.

Johnson & Johnson is partnering with a Danish company to produce its own vaccine. Unlike GSK’s vaccine, J&J’s prototype requires two vaccinations, but may provide longer-lasting immunity. Even more promising, J&J has suggested that it could have 250,000 doses of its vaccine produced in 2015, a massive accomplishment (if it works). Pfizer and other companies have stepped up to partner with those firms to share production facilities.

Even if the vaccines show promise, logistics will present an enormous challenge. Researchers are trying to come up with trial designs that would meet ethical standards while also determining whether the vaccines work. That means carefully tracking everyone treated with a control or placebo to estimate infection and survival rates, another complicating factor. Both vaccines would have to be kept cold to avoid spoilage, a challenge in countries with unreliable power grids. Health authorities worry they might not be able to distribute an effective vaccine widely enough to halt Ebola’s spread in the most severely stricken regions. Only time will tell.

There is some good news. After embarrassing missteps by almost every national or international authority monitoring Ebola, government and industry are finally hitting their stride. American policymakers are learning that while you can ask government agencies to act like nimble venture-capital investors, you can’t change their cultures. Public/private ventures may be necessary to impose needed discipline and focus efforts to develop drugs and vaccines against the next outbreak of a deadly virus or the next bioterror attack. In the future, we may not have the luxury of contemplating a large disease outbreak far from our shores. The few Ebola cases in the United States so far have revealed serious shortcomings in our preparedness. Let’s hope that we learn the right lessons from Ebola today, so that we don’t have to pay a much higher price for our complacency tomorrow.

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