The U.S. is currently suffering from an unprecedented outbreak of Highly Pathogenic Avian Influenza (HPAI), and poultry farmers across the nation, not to mention egg consumers, are paying the price. But higher egg prices could soon be the least of our worries if the virus were to spread to humans. The Centers for Disease Control and Prevention (CDC) warned last month that it “considers these newly-identified HPAI H5 viruses as having the potential to cause severe disease in humans.”

During the last pandemic influenza (pan flu) outbreak in the U.S., H1N1 in 2009-2010, the CDC estimated there were between 43 and 89 million cases in our country, leading to as many as 403,000 hospitalizations and 18,300 deaths. That outbreak, according to the World Health Organization (WHO), was “relatively mild.” They added that “such good fortune is no precedent.”

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The prospect of HPAI spreading to humans recently drew the attention of bipartisan leaders on the House Energy & Commerce Committee, who wrote letters to the Government Accountability Office (GAO) and Health & Human Services (HHS) asking about the administration’s emergency preparedness in response to HPAI, including efforts to develop vaccines against the viruses. It’s an important question — and the answer is far from reassuring.

Vaccines and other medical countermeasures (MCMs) to respond to a pandemic influenza outbreak largely depend on federal funding for research, development, manufacturing and scale-up. This is done through a public-private partnership under the Biomedical Advanced Research and Development Authority’s (BARDA) pan flu program, which contracts with the private sector to develop and manufacture pan flu countermeasures.

This partnership is currently in jeopardy due to a substantial decline in federal support. Influenza vaccine manufacturers are uncertain about the government’s commitment and cannot on their own sustain the capacities to respond in the event of a pandemic. From 2006 to 2013, there was robust funding for pandemic influenza preparedness, with $5.6 billion to implement the first two years of HHS’s Pandemic Influenza Plan and an emergency supplemental appropriation of $6.15 billion for the H1N1 pandemic. But these funds are now exhausted, and in recent years BARDA’s pan flu program has received only a tiny fraction of the previous level: $115 million in 2014 and $72 million this year. At that level, according to HHS, “BARDA will not be able to fund activities on newly awarded stockpile contracts that are required to maintain the existing stockpile program critical for a swift and nimble pandemic response.”

Moreover, there are no existing vaccines in the stockpile that could be used to respond should H5N8, the most prevalent strain of HPAI, mutate and infect humans. Federal commitment to the research, development, and stockpiling of countermeasures for potential pandemic flu strains is critical to ensure we can respond to an outbreak. As it stands now, any outbreak in humans would require a supplemental appropriation from Congress, and this may come far too late. Vaccine production is a complex process that cannot be turned on and off like a spigot; generating adequate supplies for a large-scale response takes months, necessitating ongoing investments rather than emergency funding after a crisis.

The U.S. government must strengthen its commitment to pandemic influenza preparedness. Congress can help achieve this by appropriating robust multiyear funding for BARDA’s pan flu program. This would support the research and development of flu vaccines, therapeutics and diagnostics, the testing and evaluation of our national preparedness and replenishment of the stockpiles.

Further, the administration should provide increased transparency to industry partners regarding future budget allocations. This would allow manufacturers to plan accordingly in terms of resources and production capacity. A good place to begin would be in the five-year MCM budget plan, a version of which was recently released by HHS. More detail about the pan flu funding would provide much-needed clarity to BARDA’s private sector partners.

Counting on good luck is not a preparedness strategy. The Ebola crisis last year further underscored the importance of investing in a preparedness plan for outbreaks before they happen. As congressional appropriators and administration officials continue planning for fiscal year 2016, we should all hope they bear in mind that lesson.

 

Greenwood is president and CEO of the Biotechnology Industry Organization (BIO).