Can a crippled HHS react in time to a killer virus?

While Congress is preoccupied with the shortcomings of Obamacare and the mangled launch of Healthcare.gov, another disaster is brewing that deserves the immediate attention of Congress, especially those members who supported reauthorization of the Pandemic and All-Hazards Preparedness Act earlier this year.

A new and deadly avian influenza virus named H7N9 emerged in China early this year and demonstrated an alarming ability to jump the species barrier and infect humans. When it does, the infected person typically comes down with a severe form of pneumonia that leads, to multiple organ failure. So far, H7N9 has killed one out of three victims.

By October 2013, the World Health Organization (WHO) reported 137 laboratory-confirmed cases of H7N9 flu, including 45 deaths. Although incidence of new cases declined during the warmer months mid-year, ominously, four new cases were reported in recent weeks as cooler weather returned.

The H7N9 virus, like similar influenza viruses, is a disease whose natural hosts are birds, including ducks and chickens. But in conditions of close contact, like those in much of China’s rural countryside its live bird markets, it can and does spread to humans.

Scientists are watching closely to determine if this rapidly-mutating virus will develop an ability to pass directly from human-to-human in a sustained manner. This has not happened yet with H7N9, nor has it been detected in the United States, but the Centers For Disease Control (CDC) already has cited the “pandemic potential” of the virus to spread rapidly across the globe should human-to-human transmission develop.

The good news is that China has developed a vaccine. Chinese scientists reportedly used reverse genetics and genetic reassortment to achieve their success. Concern remains, however, about whether China will be able to produce vaccine quickly enough to meet a likely massive demand as cold weather ushers in the 2013-2014 flu season. In late October 2013, a spokesman for the vaccine team said manufacturers would need at least another six months to conduct pilot tests, human trials, and obtain drug approvals.

Meanwhile, even though H7N9 has not appeared in the U.S. as of mid-September 2013, the National Institute of Allergy and Infectious Diseases launched clinical trials at nine sites of a U.S. candidate vaccine, called an investigational vaccine. Despite the pandemic threat posed by the H7N9 virus, these studies are not expected to conclude until December 2014.

In light of the deadly threat from this new and not fully understood virus, it might be expected that the Department of Health and Human Services (HHS) would be moving aggressively to fund vaccine production as expeditiously as possible. But, according to a report issued by Biomedical Advanced Research and Development Authority (BARDA), the HHS approach is laid-back one. That is, even though vaccine clinical trials are underway, the decision to conduct a “large-scale vaccine manufacturing campaign” depends on HHS’s assessment of the “risk of emergence of sustained human-to-human transmission.” In other words, once HHS decides an H7N9 pandemic is imminent, only then it will decide about ramping up vaccine production.

With HHS Secretary Kathleen Sebelius otherwise occupied trying to explain the HealthCare.gov disaster to Congress, it may be understandable that a mere flu pandemic, with the potential to sicken and kill millions around the world, has slipped a place or two on her priorities list.

Flu season is just around the corner, and an H7N9 pandemic may be as well. For Americans to be protected, HHS must stop dithering and, at a minimum, use the previously allocated $110 million to place initial vaccine production orders. While that may afford only a fraction of what is ultimately needed to protect all of America, having a stockpile for select groups, such as our troops and first responders, is a critical first step that should not be ignored or further delayed.

On at least one count, though, the American public can be somewhat reassured. For various reasons, including its rapidly mutating genome, the H7N9 virus is probably not a good candidate for a biological warfare agent. That doesn’t mean that countries like China, North Korea, and Russia, with their advanced biological warfare programs, aren’t conducting offensive weapon research on H7N9 — they probably are.

The H7N9 threat is very real, and the CDC did not mince words in its assessment of the danger. Congress must ensure BARDA gets that message before it is too late.