Mike Leavitt, Secretary of Health and Human Services


Washington, DC


March 6, 2006

Remarks Prepared for Delivery at the National Immunization Conference

It is a delight to be here with you today.

State and local health professionals are among our Nation’s foremost public servants. I saw how essential you are during the Salt Lake Olympics.

You heal, you protect, you prevent. You not only treat diseases that are already raging, you also prevent them from becoming infernos in the first place.

Because of you, people all across the country are living longer, healthier lives. Because of you, seniors have less to fear from the annual flu and children avoid being touched by terrible diseases.

It is easy to forget how far we’ve come. Longer life spans are common. Many diseases are treatable. Miracle cures are almost mundane.

But it was not always this way.

Scarcely a century ago, life expectancies were thirty years less than they are today—men could expect to live to about 46 years old, women about 48. In 1900, I would have been considered an old man. Today, I’m simply middle-aged—though that’s old enough!

In 1900, the two leading causes of death were infectious diseases—pneumonia, and tuberculosis. Today, the leading causes of death are cancer and heart disease. (This year, for the first time in more than 70 years, annual cancer rates in the United States fell.)

Vaccines—and their dedicated application by people like you—are one of the reasons for these stunning achievements in public health. Vaccination campaigns have virtually eliminated common diseases of 1900, such as diphtheria, tetanus, and polio.

These miracles continue to happen today. Rubella was recently eliminated from the United States. Vaccines against measles and mumps are now in widespread use.

Biotechnology is making it possible to bring even more diseases under control. For instance, effective vaccines have been created against:

  • Rotavirus, which causes severe diarrhea among children, and
  • Many forms of bacterial meningitis.

Vaccines are even being developed against certain cancers. For example, researchers are developing a vaccine against the human papillomavirus, which can lead to genital cancers.

Those new vaccines make it possible to put prevention into practice. But they are also more costly than earlier vaccines. I recognize that that has created concerns among those who provide them.

The question of financing is ripe for discussion, but not yet ready for decision. But I can assure you that it is an issue we will continue to pay attention to.

Vaccines are critical in the fight against many diseases, including the annual flu. Vaccines—and you, the people who will provide them—are also going to be essential if a pandemic flu should arise again.

Viruses are constantly evolving, adapting, and attacking. And the influenza virus has a high rate of mutation compared with humans, animals, and even other viruses.

This highlights the importance of real-time surveillance and rapid access to viruses.

We already have a process in place, working with international partners to create “seed viruses,” or reference strains, of candidate viruses that are used in vaccine manufacturing. We have already made a vaccine to an H5N1 virus. NIH has tested it in people and we know we can provide an immune response that is predictive of protection, albeit at a very high vaccine dose. We are now working on improving this response.

We have also manufactured nearly 8 million doses of this vaccine for our stockpile.

The H5N1 virus has continued to drift (evolve) over the past 18 months. We continue to monitor its evolution. We will have seed viruses reflecting this drift that can be quickly available for vaccine testing and production.

For example, since the H5N1 has drifted considerably from the 2004 version isolated in Southeast Asia, the CDC has developed another seed virus similar to the virus currently circulating in parts of Asia, Europe, and Africa. HHS will proceed with the development of pilot lots for clinical testing of this virus. We will continue this approach as different versions of H5N1 virus or other viruses with pandemic potential appear.

There have been ten pandemics of influenza in the last three hundred years. There have been three in the last century.

The influenza pandemic that swept the Nation in 1918 was catastrophic. It touched countless towns and communities all across the country.

I became curious about the impact of the Great Pandemic in my hometown of Cedar City, Utah, and so I spent time going back though the newspapers and the records of when it struck.

One of those who kept records was the town doctor. His name was L. W. MacFarlane, but everyone called him Dr. Mac. He was the consummate country doctor and naturally served as the chairman of the town’s public health committee.

Dr. MacFarlane wrote, “Quite a group had gone from Cedar City to attend [the] conference and State Fair in Salt Lake. They returned home bringing unexpected gifts with them. By the time they got back to Cedar City, Mr. and Mrs. Don Coppin and their son Billy, Mrs. James E. Anderson and their daughter Ethel, and Miss Mell Corlett were definitely sick with the flu. Before many days had passed, influenza was sweeping like a fire through Cedar City and breaking out in the surrounding communities.”

A Mrs. George Foster was the first victim of the influenza. The newspaper said that she left a husband and a “little motherless child.” As others were stricken, authorities rushed to contain its spread.

The mayor of Cedar City issued an official proclamation, ordering several stringent measures.

Public gatherings were prohibited. Those with symptoms of influenza were to be isolated. So were their caretakers. Those who went out on the streets or in public places had to wear gauze masks, although exceptions were made for individuals who were “actually engaged in eating or in a barber chair.”

However, the proclamation did not always have its intended effect.

As Dr. MacFarlane noted, “The wearing of the masks was annoying to everyone, but it was particularly galling to those members of the community addicted to chewing tobacco. One elderly member of this fraternity is recalled whose mask was tied on, sure enough, but hung around his neck, leaving his nose and mouth well uncovered, and served only to rescue whatever tobacco juice had failed to clear his chin.”

Despite all efforts to contain it, pandemic influenza continued to spread through Cedar City.

Similar stories were told all across the country. For instance, here in Georgia, the pandemic afflicted more than 20,000 people, and caused more than 500 deaths in just three terrible weeks (October 19th through November 9).

You in the public health community understand the threat of pandemic flu. But this is about much more than the public health community.

Entire communities need to be engaged. That’s why I’ve been traveling across the country holding summits on pandemic preparedness.

Preparedness means political leaders, employers, school leaders, healthcare leaders and the media need to be informed, engaged, and activated.

President Bush is mobilizing the nation to prepare:

  • $7.1 billion in emergency funds
  • Vaccines
  • Local planning
  • International/domestic monitoring

We are preparing a series of planning checklists to help guide preparation efforts, to organize our national thinking and to bring consistency to our efforts.

Five checklists have been released so far, for:

  • State and local governments
  • Businesses
  • Individuals and families
  • Faith-based and community organizations, and
  • Home health care organizations.

Other checklists will follow.

There is a big difference between having a plan and being prepared. Being prepared means:

  • Exercising the plan
  • Refining the plan, and
  • Exercising it again.

Exercises and checklists will reveal weaknesses. But we cannot be afraid to have our weaknesses revealed. By finding and fixing them, we can become strong, prepared to meet the threat of a pandemic.

Our national plan includes:

  • Monitoring
  • Antivirals, and
  • Vaccines.

The most important part is a network of plans tied together by our use of common checklists, the coordinated distribution of countermeasures, and shared science.

For the United States to become a nation prepared:

  • Every federal agency
  • Every state
  • Every tribe
  • Every city
  • Every county
  • Every business
  • Every school and college
  • Every hospital and clinic
  • Every church, and
  • Every household

Needs a plan. And we need to exercise it.

We’ve made a lot of progress in pandemic preparation.

But we still have a way to go.

For instance, vaccines will be essential should a pandemic come.

But the cold, hard truth is that the capacity doesn’t exist within the United States to produce vaccines with sufficient speed and quantity to reach every American. That condition exists all over the world.

This needs to change.

The President and I have met with manufacturers to find ways to revive our domestic vaccine capacity.

Our focus has been on influenza vaccine. But it has become clear to me that the issues of supply and innovation are applicable to all other vaccine production and immunization programs.

Vaccines must be there when we need them. But that is not always the case. Recent disruptions in the supply of annual flu vaccine and frustrations in vaccine distribution have reinforced the need for us to work with vaccine makers to do better.

So, with both annual influenza and a potential pandemic in mind, we need to vigorously pursue the promise of cell-based vaccine production to augment the more cumbersome egg-based vaccine that we rely on today.

When you are growing vaccine in these specialized eggs, you have a rate-limiting factor.

You would need billions of eggs standing by. If you are growing the virus in cells, you can quickly expand quantities available when necessary.

This is a technology that is being used for other vaccines and we should apply this to flu vaccines.

Reviving that capacity will also help us do a better job protecting against the annual flu.

A cell-based technology for producing flu vaccine will provide the capability to quickly expand available quantities of vaccine when necessary, and so will save the lives of millions of people for generations to come. It will give us a better capacity to develop vaccines, not only against pandemic flu, but also against the annual flu.

We also need to aggressively explore the potential role of adjuvants and new delivery systems to maximize our supply. And we must get our best scientific minds focused on developing the influenza vaccine of the future, one that is broadly protective against a wide variety of influenza viruses.

Such a vaccine would change the way we approach annual influenza and would greatly diminish the threat of a pandemic. Together, those investments in research and developments of technology have great potential to make public health history. The annual flu as we know it, and dread it, will have been taken off the table, saving thousands of lives each year.

These investments in vaccine capacity will also allow us to provide influenza vaccine to more people each year. To better prevent the annual flu, the Advisory Committee on Immunization Practices recently expanded its recommendations for influenza vaccine. Now all children between 6 months and 5 years old should be vaccinated against influenza.

Influenza killed 153 children during the 2003-2004 flu season.

Electronic records will increase our ability to use vaccines effectively.

With electronic records, parents, school nurses, and health care providers would have information about children’s vaccinations at their fingertips. Parents would no longer have to do hopeless searches. Kids would no longer be stuck with unnecessary shots.

Electronic records of vaccinations might also be essential during a national emergency such as another attack of anthrax, a pandemic, or the aftermath of a hurricane.

I saw that need in New Orleans.

The Katrina After Action Reports have called for the development of a lean electronic health record that could be easily accessed by first responders in an emergency.

This would not be a full hospital electronic health record. Rather, it would hold a standardized set of a number of crucial elements that would be needed in an emergency situation.

The development of such electronic health records fits well into the progress already underway at HHS to fulfill the President’s charge of ensuring that most Americans have electronic health records within the next ten years.

Through the American Health Information Community (AHIC), we are already working with the private sector to build a common framework for implementing a nationwide electronic health records system. We will also work though AHIC to achieve the goal of creating emergency electronic health records.

Electronic health records will also be useful when a vaccine requires more than one dose for protection.

During a crisis, there will be a need for an efficient and effective system to tell not only who has been vaccinated and who has not, but also who needs another dose to complete the series. Such an electronic system will also allow the rapid assessment of the effectiveness and safety of the vaccine.

Many have been inoculated against those diseases, but they might not know, or might not remember, if their vaccinations were still good. But with electronic records, they would.

In a sense, electronic records are sort of an adjuvant to vaccines—they cannot substitute for them, but they can strengthen their effectiveness immeasurably.

Coupling the new tools of electronic information to new vaccine technology will help us avoid common diseases, prepare against emerging threats, and give each of us the confidence that we are reaching all of those who need to be reached. It will help people all across the country live longer, healthier lives.

It has been more than 200 years since Edward Jenner’s first experimental vaccination against smallpox. That first inoculation began a medical revolution that continues to this day.

The history of immunization represents the best of preventive medicine. I believe that the possibilities are even greater in the future. I believe that, together, we can use the power of new treatments and new technologies to prevent ancient scourges and defeat emerging threats.

Thank you.

Last revised: March 6, 2006