The Novartis plant is not the first example of BARDA's efforts paying off. During the 2009-10 flu season, when the H1N1 swine flu struck suddenly and without warning in the U.S., a new vaccine was created, packaged and distributed in a record time of six months, making it available during the second surge of that flu threat. Fortunately, the second surge was milder than the first and the vaccine was not as crucially needed as it could have been. But the experience demonstrated that in an emergency, flu vaccine can now be developed and produced in time to meet an unforeseen threat.
The work to improve response to influenza continues in several government agencies. The National Institute of Allergy and Infectious Diseases (NIAID), which is a part of the National Institutes of Health, under the Department of Health and Human Services, has been leading an effort to develop new and better flu vaccines for more than eight years.
In 2005, when GlaxoSmithKline wanted to produce a vaccine not yet approved for manufacture in the U.S., NIAID staff worked with the company to gain accelerated approval for Fluarix, the branded vaccine that is used widely in the U.S. today. In 2014, an additional component will be added to Fluarix vaccine, giving people immunity to four, rather than three flu subtypes.
The ultimate goal for vaccine research and development is a universal one-shot-for-life vaccine that protects most people against a wide range of flu variants. Previous funding from BARDA and NIAID may have brought that goal within reach. Five vaccine candidates that confer broad immunity against flu have advanced to the first phase of human trials. These candidates were developed by a group within NIAID that is working with the pharmaceutical manufacturer, MedImmune, under a Cooperative Research and Development Agreement.
Efforts such as these will help hold down health care costs. Seasonal flu imposes an $87.1 billion annual economic burden on the U.S., as estimated in a study by researchers at the CDC. Though the results of government-business cooperative efforts may not be reported on the nightly news, we, as a nation, already reap the rewards of such investments that improve the quality of health care while reducing the economic impact of yearly flu.
But seasonal flu, as tragic and expensive as it can be, is only part of the challenge facing public health agencies. The steps that agencies like BARDA and other divisions within HHS take also protect us from the threat of a novel flu strain that could strike suddenly with devastating impact. The worst-case scenario is a 1918-like flu. In that year there were 500,000 flu-related deaths in the U.S. and as many as 50 million people died worldwide. The potential for a repeat of a flu epidemic of such deadly proportions is the nightmare of many health care professionals. But antiviral development isn't their only concern.
Even among the healthiest people, a common side-effect of an influenza infection is a secondary or opportunistic bacterial infection that develops when the body's resistance is lowered from fighting the flu. These infections can be equally or more life-threatening than the original virus.
Since the late 1940s, antibiotics have been used to battle bacterial infections, but because of the overuse of antibiotics and natural evolutionary processes, the bugs are developing immunity to the antibiotics at an alarmingly rapid rate.