Remarks as prepared for the 2008 World Vaccine Congress

Good morning. Thanks for that warm introduction. I’m delighted to have the chance to speak to you about what we’re doing at the Department of Health and Human Services to improve health here in the United States and around the world.

Vaccines, along with clean water and modern sanitation, are one of the most important ways to improve and extend lives.

Power of disease

Diseases hold the power to reshape societies.

Thucydides chronicled the plague that hastened the end of Athens’s golden age. In 430 B.C., a pestilence, perhaps the bubonic plague, smallpox, typhus, or even Ebola, killed about a quarter of the city’s population. The plague helped Athens lose the Peloponnesian War, paving the way for Rome’s eventual rise.

The Black Death of 14^th century Europe killed between a quarter and a third of Europe’s population — as many as 34 million people.

And over the last three hundred years, there have been ten influenza pandemics. Three occurred over the last century. Two of them, 1857 and 1968, were relatively minor events. But the pandemic of 1918 was catastrophic. It killed more than a half a million Americans.

If a similar one were to occur today, we would find ourselves with 90 million people sick with the flu, 45 million in need of medical attention, and 2 million people dead.

Power of public health

But something else significant has happened over the last century: modern public health. And modern public health has been able to reshape societies more profoundly than disease.

Beginning in the nineteenth century and galloping through the twentieth, scientists began to discover the real causes of diseases that had bedeviled mankind and reshaped societies over and over since time immemorial. More important, they also began to devise effective ways to combat them — and ultimately eliminate many common, unfortunate facts of life. They pioneered public health milestones like:

• Modern sanitation eliminated the spread of diseases like cholera and typhoid.
• Food safety reduced outbreaks of milk sickness and listeria.
• Antibiotics curtailed scourges like syphilis and turned once fatal injuries into relatively minor events.
• And vaccines have all but eradicated whole hosts of diseases: rabies, measles, mumps, rubella, yellow fever, tuberculosis, tetanus, chicken pox, the flu, and many more. Smallpox was actually eliminated. Many so-called childhood diseases are now vaccine-preventable diseases.

Modern public health has improved human health and longevity better than anyone in the past could have imagined.

Unfortunately, there are those who are starting to take these past successes for granted. Some assume that since we have controlled so many diseases, we can cease in our vigilance.

So in countries like Afghanistan, some people aren’t receiving vaccines against polio because of mistrust in the purpose of the vaccines. Unsurprisingly, we continue to see outbreaks of polio.

Here in the United States, some parents are declining to have their children vaccinated against diseases like measles because of fear against the side-effects of vaccines. Unsurprisingly, we’re starting to see small outbreaks of measles. 

Commitment to ensuring vaccine safety

When vaccine-preventable diseases are prevalent, people are concerned about the diseases. They’re more inclined to want to be vaccinated. Conversely, when diseases are less prominent, people grow complacent. But we can’t be complacent. That’s why, for example, the Centers for Disease Control and Prevention is currently celebrating National Infant Immunization Week.  Over the course of this week, hundreds of communities around the country along with sixty countries around the world are promoting the importance of protecting infants from vaccine-preventable diseases.

We also cannot be complacent in our efforts to improve the vaccines we are using to fend off disease.

For example, we are looking at how to use insights from basic science to develop vaccines with an improved safety profile — as we did in the development of the acellular pertussis vaccine.

We also want to improve our understanding of who may be most at risk of vaccine adverse events and what we can do to prevent them from occurring.

The Centers for Disease Control and Prevention is also studying the population dynamics to discover those who may respond poorly to vaccines and why that is.

And given the important and effective role vaccines have played in public health crises of the past, we expect them to play a large part in our current and future efforts to protect the public health against threats like pandemic influenza or anthrax.

Administration commitment to preparedness

So President Bush and Secretary Leavitt have placed a high priority on establishing an effective framework to prepare against those future public health threats. Needless to say, the role of vaccine technology and development is a significant one. Here is how we’ve come to our current position on vaccines:

Six years ago, we proposed a plan that led to the Public Health Security and Bioterrorism Preparedness and Response Act of 2002. The Act expanded our abilities to respond to any disaster, combat bioterrorism, and protect the food supply.

The Act improved the ability for private groups to respond in emergencies. It also let us extend deadlines for affected groups to submit data and reports to HHS.

Four years ago, President Bush signed the Project Bioshield Act, a comprehensive effort with help from the Department of Homeland Security to develop and make available modern, effective drugs and vaccines to protect against chemical, biological, radiological, or nuclear threats to national security.

Project Bioshield made it significantly simpler for us to use those countermeasures in an emergency by allowing the Food and Drug Administration to grant Emergency Use Authorizations for unapproved drugs, biologics, and medical devices.

In 2005, President Bush issued the National Strategy for Pandemic Influenza. Under this strategy, we began to develop domestic capacity to produce vaccines and other countermeasures and domestic stockpiles of vaccines and antivirals in preparation for a pandemic.

We worked with Congress to enact the Public Readiness and Emergency Response Act of 2005 — also known as the PREP Act. Under the PREP Act, the Secretary may offer immunity from lawsuit and liability to manufacturers, distributors, program planners, health care professionals, and others, for tort claims — except for willful misconduct that leads to death or serious injury — that arise in connection with the administration and use of any countermeasure named in the Secretary’s declaration.

Last year, we issued a PREP Act declaration for reference strains and vaccines from H5N1, H7, and H9 influenza strains. The Department is considering other potential PREP Act declarations and continuing to think through how to plan for and issue declarations.

And in December 2006, Congress passed the Pandemic and All-Hazards Preparedness Act. This Act established a new Assistant Secretary for Preparedness and Response at HHS and gave the Assistant Secretary authority for the advanced development and acquisition of medical countermeasures through the Biomedical Advanced Research and Development Authority, complementing Project BioShield efforts.

BARDA

Dr. Robin Robinson, who’s speaking here tomorrow morning, was actually just appointed director of BARDA.

At BARDA, Dr. Robinson is working to provide an integrated, systematic approach to the development and purchase of the necessary vaccines, drugs, therapies, and diagnostic tools for public health medical emergencies like bioterrorist attacks and pandemic influenza.

We’ve already seen how BARDA can help us prepare against public heath threats. As we began to prepare against pandemic influenza a few years ago, BARDA’s method of appropriate, early government involvement increased the profitability of influenza vaccine production in a number of ways. BARDA helped create new pathways to speed and facilitate the development and approval of new drugs. It increased access to new technologies. It built new regulatory review capacity. And it stimulated R&D by billions of dollars.

The initiatives BARDA spawned have increased and strengthened manufacturing infrastructure and international production capacity. They have fostered innovative approaches to new technologies. BARDA also spurred the development, licensing, and purchasing of alternative vaccine delivery technologies.

As we uncover new threats to the public health and work to adopt an all-hazards approach, BARDA is enabling us — and you — to ensure that the American people can purchase new, safe, and effective countermeasures.

Vaccine Research Center

There are a number of other ways through which we are leveraging vaccine technology against public health threats.

For example, the National Institutes of Health funds basic science research on pathogens that may lead to new vaccine candidates, technologies, or platforms.

NIH also runs the Vaccine Research Center, which operates like a biotechnology company. It even has manufacturing capacity for pilot scale lots, enhancing NIH’s role in facilitating vaccine development.

While the Vaccine Research Center was first established to develop an AIDS vaccine, we have expanded the Center’s scope to include biodefense as well as emerging infectious diseases.

The Vaccine Research Center works against these threats in three ways:

• First, by scientifically designing and rationally developing effective vaccine candidates.
• Second, by evaluating the candidates and optimizing the immune responses they provoke.
• Third, by advancing promising candidates into human trials.

Through these methods, the Vaccine Research Center has worked with small companies to facilitate the early stage development and proof of concept for vaccines against West Nile, SARS, and Ebola.

Among its other successes, the Vaccine Research Center developed and produced the first pilot lot of an experimental DNA vaccine for H5N1 that is now in clinical trials.

And the Vaccine Research Center and NIH helped develop and license the first H5N1 pre-pandemic vaccine.

The advantage the Vaccine Research Center offers industry is how it shares the risks inherent in vaccine development — a particularly important attribute when it comes to developing vaccines for diseases that commonly afflict poorer areas of the world.

International partnering

Fighting disease around the world is important because as we’re now learning, the more globalized the world becomes, the more the jungles of Thailand or the bird flyways of China become our backyard. Diseases like SARS and avian influenza have shown us that while problems start locally, infecting only a handful of individuals, they can quickly become global problems.

However, our ability to treat or mitigate emerging infectious diseases, developing pandemics, and even bioterrorism possibilities is limited due to a scarcity of global vaccine and therapeutic production capacity.

It takes about $1 billion in investment and about ten years to develop a new vaccine, demonstrate its safety and effectiveness, and comply with regulations just to bring it to market in the United States.

But while a vaccine’s market may span the entire world, if a particular disease is currently present only in a poor country, there’s little incentive for a company to go to the expense of developing a vaccine.

In addition, there are so many different diseases and bioterrorism agents, it’s virtually impossible for any country or company to fund programs to research and develop all the countermeasures we might need.

Historically, American taxpayers have borne most of the burden for funding the development and acquisition of medical countermeasures. So other countries frequently ask us to share supplies from our Strategic National Stockpile.

On its own, however, American taxpayers cannot afford to assume responsibility for the safety of the whole world.

So we’re looking for new ways to work with other nations to develop a sustainable global infrastructure for medical countermeasures.

For example, we have been working with Canada, the U.K., France, Germany, Italy, Japan, Mexico, the European Union, and the World Health Organization within the framework of the Global Health Security Initiative. Through this initiative, which began in 2001, we’re working toward shared solutions to the problems of bioterrorism, pandemic influenza, and other global health threats.

We expect that this multilateral engagement will encourage these countries to improve international vaccine and therapeutic manufacturing capacity. It will hopefully also result in increased international, regional, and domestic stockpiles, as well as the development and implementation of common response operations and drug utilization policies.

By working with foreign partners openly, transparently, and collaboratively, we believe we can secure our people’s health as well as strengthen global health security. 

Conclusion

Over the past few decades, we have confronted a wide variety of threats, emergencies, and disasters. We have learned a great deal about what response efforts work and don’t work. One thing we do know is that we need adequate countermeasures like vaccines.

As we move forward in preparing against public health threats, I am confident that we can count on the vaccine industry to work with us to build the resilience to handle any challenges that may emerge. For, looking at history, we’re going to need that resilience if we want to shape society — rather than letting crises shape society — going forward. Thank you.