In The Arena Ebola Is Bad. But the Flu Is Worse.

Kendall Hoyt is assistant professor at the Geisel School of Medicine at Dartmouth and author of Long Shot; Vaccines for National Defense.

As we stare with horror at the ravages of Ebola, it is easy to overlook an old familiar foe: the flu. Ebola has claimed fewer than 4,000 lives globally to date, none in the United States. Flu claims between 250,000 and 500,000 lives every year, including over 20,000 in the United States—far more American lives than Ebola will ever claim.

Ebola is no joke: The Centers for Disease Control project 1.4 million cases of the disease worldwide by January in a worst-case scenario. But by comparison, the 1918 pandemic killed an estimated 50 to 100 million worldwide. The United States simply cannot afford to be complacent about flu preparedness.


Getting ready for the flu is a complex endeavor, relying on surveillance, detection, communication and detailed response plans. The United States has been fine-tuning its response plans since it first released a national flu pandemic strategy in 2005. The linchpin of the strategy is timely access to an effective flu vaccine.

And that’s where the trouble lies. Ten years ago this week, the United States lost nearly half its flu vaccine supply overnight when British regulators detected contamination at a manufacturing facility. U.S. flu planners, who had been eyeing the reemergence of a deadly form of bird flu (H5N1), were deeply shaken. If the manufacturing base was too frail to service seasonal flu, how would it respond to a pandemic?

We soon found out. When swine flu (H1N1) struck in 2009, vaccine production lagged the outbreak by three to five months. In even a mild pandemic, time lost is measured in human lives. More than 2,000 U.S. deaths could have been prevented if a vaccine had been available just one month earlier.

These production delays and supply disruptions were a tragic consequence of our dependence on an elaborate, outdated system that grows vaccine virus in chicken eggs. We put all our eggs in one basket, so to speak. And we paid a price for it.

Galvanized by these experiences, a collection of federal agencies led by the Biomedical Advanced Research and Development Authority set out to transform the industry. “More, better, faster” vaccines is the mantra, and BARDA is making real progress . Domestic production capacity has grown from 61 million doses in 2004 to 500 million doses today. There are four new companies producing for the U.S. market. The FDA has approved eight new flu vaccines, including some next-generation vaccines made with cell-culture and recombinant techniques.

Thanks to a decade of federal investments in vaccine technologies and manufacturing capabilities, the flu industry has undergone a revolution. However, unless we take additional steps to protect these investments, we may be no better off when the next pandemic hits.

These next-generation vaccines are strategically important in a pandemic. Unlike egg-based vaccines, they are not vulnerable to bird flu viruses, and they can be scaled up on short notice in an emergency.

In 2013, the FDA also licensed its first adjuvenated flu vaccine. Adjuvants, which boost our immune response to vaccines, are another important pandemic tool primarily because they allow a fixed supply of viral material to be stretched across a greater number of people.

These new technologies and capabilities confer tremendous benefit on society. A timely and effective pandemic vaccine will reduce medical costs, improve worker productivity, save lives and bolster national security. As the African Ebola outbreak demonstrates, access to effective medical countermeasures can mean the difference between containment and chaos.

Unfortunately, next-generation flu vaccines have gained little traction in the marketplace. Flu producers carry significant legacy investments in egg-based production and compete in a largely commoditized market. The business case is weak for higher-priced “boutique” vaccines unless those vaccines offer significant clinical benefit relative to egg-based alternatives.

Some analysts have suggested that next-generation technologies can boost productivity and free up facilities for other manufacturing activities. Others remain skeptical that productivity gains will carry the day. This includes Gordon Douglas, former president of Merck Vaccines and board member of Protein Sciences, which makes Flublock, the only approved recombinant flu vaccine, who told me in a phone interview: “Clinically, Flublock looks like all other flu vaccines on the market. And when you are trying to sell your vaccine through CVS or Walgreens, price wins. ”

Federal investments in alternative flu technologies are on shaky ground today. Flublock has struggled to gain market share, accounting for less than 1 percent of flu vaccine sales. Meanwhile, Novartis, which makes the only FDA-approved cell-based flu vaccine, has been trying to sell its flu business. If the market fails to embrace these new technologies, we will lose hard-won gains in the race against flu.

BARDA is hoping to circumvent this problem by developing a universal flu vaccine that would target most seasonal and pandemic flu strains. A universal flu vaccine is considered the holy grail of flu vaccine research. It would take the guesswork out of strain selection and eliminate the need for seasonal flu shots. It would represent a quantum leap in the flu vaccine market and could provide an economically sustainable solution pandemic preparedness. But even if a universal vaccine proves viable, it could take 10 to 15 years to reach the market. We can’t afford to wait that long.

There are at least three actions we should consider in the near term. First, subsidize manufacturing runs for strategically important products and processes. BARDA already does this to some extent through three public private partnerships with pharmaceutical companies that operate the Centers for Innovation in Advanced Development and Manufacturing. Second, offer tax breaks to companies willing to develop medical technologies and manufacturing capabilities that serve the national interest. Third, structure advance purchase agreements that will engage large, experienced manufacturers and encourage them to make continuous improvements to their products and manufacturing processes.

After a decade of progress in the fight against flu, there is much to celebrate, but now also much to worry us. Some will argue that the U.S. government is notoriously bad at “picking winners” and that we should let market forces prevail. Prior to 2004, however, there was little to choose from. The only thing worse than being unprepared for the next pandemic would be to realize with hindsight that we let so much potential slip away.