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National Vaccine Advisory Committee

Washington, D.C.
September 15, 2010

Thank you for the warm welcome. I am delighted to be here.

Thank you, Bruce, for your kind introduction and for your leadership at the helm of the National Vaccine Program. It is not easy to coordinate among the many agencies involved in vaccine and immunization across our federal government, but you have done it with clear vision and a steady hand.

Over the last year and a half, I have relied on: Dr. Gellin, Assistant Secretary Howard Koh, Assistant Secretary Nicole Lurie, Dr. Anthony Fauci at the NIH, Dr. Robin Robinson with BARDA, and Dr. Tom Frieden at the Centers for Disease Control and Prevention.

And countless others across the Department have worked together to make sure the American people have access to the safe, effective vaccines they need.

I know that the National Vaccine Advisory Committee has played a big part in that effort. Your work here and across the field continues to push the science and policy forward to reach people in need.

Today, many Americans may not give much thought to the immunizations they or their children receive. That’s a testament to just how dramatically vaccination has transformed the public health landscape over the last century.

Diseases like measles, smallpox, and polio once stirred fear in every parent’s heart. They could bring entire communities to a standstill. The cost and loss were immeasurable.

Just 100 years ago, childhood mortality was at 20 percent. But decades of steady, patient, and sometimes thankless work and investment have changed all that. Once-devastating diseases have been thoroughly eradicated. Millions of lives have been saved and our nation transformed.

It is perhaps the greatest public health achievement of the 20th century. And now the work goes on to build on that legacy, find new discoveries, and develop better tools.

Each of you has stepped up to share your experience and expertise in this effort. And I cannot tell you how valuable that participation is to this Department and to our nation.

So, to our Chairman, Dr. Gus Birkhead, and every one of you on the Advisory Committee: Thank you for your service.

Dr. Gellin keeps me up to speed about your work: I read your reports, and I follow the progress of your working groups. Your insight and analysis continue to inform our decision-making process, every step of the way.

When I turn to Dr. Koh or Dr. Gellin for an update on our vaccine program, or when the White House turns to us for the latest on our nationwide immunization strategy, I know that our policies are sound. And when it is time to act, I am confident that our plans reflect the best input of experts on the ground and in the labs taking on these challenges every day.

That was never more that more clear than during last year’s H1N1 flu pandemic.

We pushed our system to its limits to develop and produce a safe H1N1 vaccine in record time.

And the National Vaccine Advisory Committee – along with the rest of the department, CDC, FDA, NIH, and BARDA – stepped up. You established a strong, sophisticated, and transparent apparatus to quickly evaluate the new vaccine’s safety, with very reassuring results – a confirmation of the strong safety record we’ve consistently seen for flu vaccines including the H1N1 vaccine.

And we could not have done it without your rapid response, keen oversight and unwavering focus.

Yet, despite our tireless work last year, we still reached our production peak three weeks after the peak of flu season. Too often we needed greater capacity, and more flexibility when it just wasn’t available to produce the quantity with the speed that we needed.

The Department has looked closely at these challenges in a recent comprehensive analysis of our nation’s entire medical countermeasure enterprise – vaccines as well as antivirals, antibiotics, and medical equipment.

This first of its kind review, conducted with the President’s support, revealed that the pipeline we rely on to provide those critical countermeasures is full of leaks, choke points, and dead ends. And in an age of new threats where delays cost lives, we simply aren’t developing and manufacturing new countermeasures fast enough.

At a moment when the most dangerous threat may be something we’ve never seen before, we don’t have the flexibility to adapt.

And so, in the coming years, the Department of Health and Human Services will direct nearly $2 billion in preparedness funds to help us build a countermeasures enterprise with the solid base of discovery, robust regulatory science capacity with clear development pathways, and the agile manufacturing that’s necessary if we’re going to be able to more quickly respond to any threat at any time.

Specifically we intend to work closely with developers to establish facilities capable of providing core product development and manufacturing services. And to meet constantly evolving demands and prepare for the next pandemic, we’ll expand domestic surge capacity using new flexible manufacturing technologies.

And for the most critical countermeasures, we will give FDA the support it needs to engage in highly interactive review and applied research from early in the development process.

We will also provide strategic support to small companies with big ideas that have little hope of making huge profits, but huge potential to improve our public health.

And we’ll reduce the time it takes to get flu vaccines to people in need by producing vaccine seed strains that can grow better and by modernizing potency and sterility testing methods.

We are trying to build a modern, flexible public health system prepared and equipped to respond quickly and effectively to any threats that arise.

And that also means working with our partners in state and local government and in the private sector to develop robust plans to distribute and administer countermeasures when it becomes necessary.

Of course, that challenge reaches far beyond the obstacles faced by developers, producers, and providers. It starts and ends with the American people.

While we have made great strides, many are still not getting the vaccines they need to effectively prevent disease and stay healthy.

But that is beginning to change and together, we need to make sure people know about it.

In just nine days the Affordable Care Act’s prevention benefits will become effective, which means that for the first time Medicare and private health plans will offer flu vaccine and other critical vaccine coverage – without co-pays or deductibles. Uninsured children will continue to be covered under the federal Vaccines for Children program.

These powerful prevention benefits and others available under the new law are outlined in a new document available at healthcare.gov. If you haven’t seen it yet, I encourage you to check it out and get all the details.

But more than that, I also want to ask you today, to spread the word: Please share this information with your colleagues, with doctors and nurses, with educators and public health directors.

By eliminating cost as a barrier to vaccination, we are offering security and relief to countless Americans who, when faced with rising co-pays and deductibles, may have considered going without a key vaccine – hoping for the best while fearing the worst.

No longer will a new mom and dad have to wonder if they can afford the whooping cough vaccine to protect themselves and avoid spreading this dangerous germ to their baby -- especially now, as we have seen increases of this condition around the country.

No longer will people who struggle with chronic health conditions like asthma have to choose between paying rent and getting the flu shot they need to protect themselves from potentially serious complications.

It’s about peace of mind, but it’s also a long-term investment in a stronger, more sustainable health care system.

Next year, an estimated 31 million people in new employer plans and 10 million people in new individual plans will benefit from these new prevention provisions under the Affordable Care Act.

By 2013, the number of people in employer plans who will benefit from those provisions is expected to rise to 78 million, for a total potential of 88 million Americans whose prevention coverage will improve due to the new policy.

Yet, right now too few doctors and too few patients know about the new benefits. In order for that investment to succeed, our nation has to take advantage of it.

We need everyone to recognize vaccines as a cornerstone of prevention: By getting vaccines to more people we can have a profound impact by stopping disease, saving lives and lowering costs for everyone.

Now, the elimination of cost as a barrier to vaccination comes at a key moment: This is the first year in which health officials are recommending every American older than six months of age get a flu shot. And we anticipate that there will be ample supply.

Internally, as you heard yesterday from Dr. Koh, we have been exploring ways to leverage all the Department’s resources to ensure more Americans than ever before are vaccinated this season – especially vulnerable populations like pregnant women and older Americans.

We see this as the first year of a long-term process to improve protection against seasonal influenza.

Once again Flu.gov will serve as a one-stop shop throughout the flu season, coordinating outreach and providing news and resources for doctors, parents, public officials, and community leaders.

Last year, we benefitted from very successful partnerships at every level of government from the president on down. We are working to replicate that collaboration this year and will be reaching out to other agencies and departments in the days and months ahead.

I encourage you to spread the word, and contribute your thoughts and expertise as we finalize the Healthy People 2020 plan and develop targets for measuring our progress in immunization.

Together, we are responding to today’s most urgent crises, but in the process we’re also making a long-term investment in meeting what Jonas Salk called our greatest responsibility: “To be good ancestors.”

We are providing real relief for people today and making progress that will benefit generations to follow. With your leadership, we truly are building a stronger health care system and a healthier America.