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97–604 PDF 2005

S. HRG. 108–775

COMBATING THE FLU: KEEPING SENIORS ALIVE

HEARING

BEFORE THE

SPECIAL COMMITTEE ON AGING 

UNITED STATES SENATE

ONE HUNDRED EIGHTH CONGRESS

SECOND SESSION

WASHINGTON, DC

SEPTEMBER 28, 2004

Serial No. 108–45

Printed for the use of the Special Committee on Aging

(

SPECIAL COMMITTEE ON AGING 

LARRY CRAIG, Idaho, Chairman 

RICHARD SHELBY, Alabama 

SUSAN COLLINS, Maine 

MIKE ENZI, Wyoming 

GORDON SMITH, Oregon 

JAMES M. TALENT, Missouri 

PETER G. FITZGERALD, Illinois 

ORRIN G. HATCH, Utah 

ELIZABETH DOLE, North Carolina 

TED STEVENS, Alaska 

RICK SANTORUM, Pennsylvania 

JOHN B. BREAUX, Louisiana, Ranking 

Member 

HARRY REID, Nevada 

HERB KOHL, Wisconsin 

JAMES M. JEFFORDS, Vermont 

RUSSELL D. FEINGOLD, Wisconsin 

RON WYDEN, Oregon 

BLANCHE L. LINCOLN, Arkansas 

EVAN BAYH, Indiana 

THOMAS R. CARPER, Delaware 

DEBBIE STABENOW, Michigan 

LUPE WISSEL, Staff Director 

MICHELLE EASTON, Ranking Member Staff Director 

(II) 

C O N T E N T S 

Page 

Opening Statement of Senator Larry E. Craig ..................................................... 1

Statement of Senator Evan Bayh ........................................................................... 33

PANEL I 

Stephen M. Ostroff, M.D., deputy director, National Center for Infectious 

Diseases, Centers for Disease Control and Prevention, Washington, DC; 

Accompanied by: Lance Rodewald, director, Immunization Services Division, National Immunization Program, Centers for Disease Control and 

Prevention ............................................................................................................. 2

Pamela M. McInnes, DDS, MSc, deputy director, Division of Microbiology 

and Infectious Diseases, National Institute of Allergy and Infectious Diseases, Bethesda, MD ............................................................................................ 18

PANEL II 

Janet Heinrich, director, Healthcare and Public Health Issues, Government 

Accountability Office, Washington, DC .............................................................. 41

Carol M. Moehrle, district director, North Central District Health Department, Lewiston, ID .............................................................................................. 59

Howard Pien, CEO and president, Chiron Corporation, Emeryville, CA ........... 68

APPENIDX

Testimony submitted by Aventis Pasteur .............................................................. 95

(III) 

(1)

COMBATING THE FLU: KEEPING SENIORS 

ALIVE 

TUESDAY, SEPTEMBER 28, 2004 

U.S. SENATE, SPECIAL COMMITTEE ON AGING, Washington, DC. 

The committee met, pursuant to notice, at 10:04 a.m., in room 

SD–628, Dirksen Senate Office Building, Hon. Larry E. Craig 

(chairman of the committee) presiding. 

Present: Senators Craig, Bayh, and Carper. 

OPENING STATEMENT OF SENATOR LARRY E. CRAIG, 

CHAIRMAN 

The CHAIRMAN. Good morning, everyone, and welcome to today’s 

hearing, which deals with an especially appropriate topic, as we 

find ourselves in the first days of the National Adult Immunization 

Awareness Week. This year’s theme is building a path for a 

healthier tomorrow. I suppose we could say that we are here this 

morning to find out how that path is being built and where it 

leads, and just how safe is that path for today’s older Americans? 

Last year’s vaccine shortages combined with an unusually early 

flu season resulted in heightened awareness of the importance of 

immunization. With news reports of people standing in line for 

hours to be immunized, many of us questioned for the first time 

whether we can assume that everyone who needs a vaccine can obtain one. 

Today’s hearing will focus on adjustments that have been made 

to the public health system as a result of last year’s challenges. We 

will hear testimony as to what announced delay in production 

might mean for the flu season and the implications for America’s 

seniors as we move forward in pandemic preparedness planning. 

I realize that flu does not limit its attacks to the aging population exclusively. However, this potential killer certainly poses a 

high risk for this country’s seniors. Last year, 36,000 Americans 

died from exposure to flu. Approximately 90 percent of them were 

over age 65. I think there are those in the community who say this 

is a killer of our old. 

In my own state of Idaho, with the exception of one victim, all 

of those who died were over the age of 50. Another 200,000 people 

were hospitalized across the country. Influenza is a serious disease. 

We cannot underestimate the danger it poses to the seniors of 

today and the boomers of tomorrow. 

Because of this concern for our citizens, I joined with Senator 

Bayh, who I think will be with us in a few moments, and who cerVerDate 0ct 09 2002 11:45 Feb 09, 2005 Jkt 000000 PO 00000 Frm 00005 Fmt 6633 Sfmt 6633 H:\DOCS\97604.TXT SAGING1 PsN: JOYCE
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tainly was instrumental in encouraging this hearing today, I joined 

with him in introducing Senate 2038, the Flu Protection Act of 

2004. I look forward to hearing how elements of this legislation are 

currently being addressed in the public health system and by vaccine manufacturers. 

We are pleased to be joined today by experienced public health 

officers or officials including one from my home state of Idaho and 

the Government Accounting Office. We are also joined by the President and CEO of one of the few manufacturers who continue to 

provide vaccines in the United States. 

I believe many of you here are particularly interested in hearing 

more about the announcement their company made earlier this 

morning on the topic. 

We have two panels this morning. On our first panel we will 

have Dr. Ostroff, deputy director for the National Center for Infectious Disease at the Center for Disease Control and Prevention. We 

will have also Dr. Pamela McInnes, deputy director of the Division 

of Microbiology and Infectious Diseases at the National Institute of 

Allergy and Infectious Diseases. 

Our second panel, we will hear from Janet Heinrich, director of 

Healthcare and Public Health Issues at the Government Accounting Office. She will be joined with a consultant from my home 

state, or constituent I should say from my home state, Carol 

Moehrle, district director of the North Central District Health Department, located in Lewiston, ID. Finally, we will have Dr. Howard Pien, CEO and president of Chiron Corporation. 

We want to welcome all of you this morning for taking the time 

to be with us. I think you have an important and valuable message 

to America and especially to America’s seniors. So with that, Dr. 

Ostroff, we will start with you. 

STATEMENT OF STEPHEN M. OSTROFF, M.D., DEPUTY DIRECTOR, NATIONAL CENTER FOR INFECTIOUS DISEASES, CENTERS FOR DISEASE CONTROL AND PREVENTION, WASHINGTON, DC; 

ACCOMPANIED BY LANCE RODEWALD, DIRECTOR, IMMUNIZATION SERVICES DIVISION, NATIONAL IMMUNIZATION PROGRAM, CENTERS FOR DISEASE CONTROL AND PREVENTION 

Dr. OSTROFF. Thank you very much, Mr. Chairman, and let me 

thank you and this committee for their leadership on this and 

many other important public health issues. Let me also introduce 

Lance Rodewald, who is the director of our Immunization Services 

Division in the National Immunization Program, who will be here 

to answer questions. 

The CHAIRMAN. Lance, welcome to the committee. 

Dr. RODEWALD. Thank you. 

Dr. OSTROFF. Let me begin by thanking you for a very timely 

hearing since we are now entering the new influenza season. Many 

of our public health issues particularly strike older Americans, and 

therefore we look forward to working jointly with you to find solutions that impact this population. This is especially true for flu. 

CDC analysts, as you pointed out, recently published a report in 

the Journal of the American Medical Association updating data on 

3

the burden of influenza as measured by hospitalizations in the 

United States. This analysis unfortunately revised upward the annual number of hospitalizations to 200,000. 

As you mentioned, in addition we estimate that 36,000 Americans die each year from the flu, and this is just during an average 

flu year. The seeds of this bad news lie in the otherwise good news 

that today Americans live longer. Fully, 90 percent of deaths from 

complications of the flu occur in persons over the age of 65 years, 

as do about two-thirds of those hospitalizations. 

Therefore, as Americans live into their eighties, nineties, and 

even reach the century mark, the number of persons at highest 

risk for severe consequences of the flu rises too. Far too many of 

these hospitalizations and deaths are avoidable, even those that 

occur among our oldest citizens. 

The keys to prevention when it comes to flu are vaccination, vaccination, and vaccination. Let me explain. First, all senior citizens 

should be vaccinated against the flu. This vaccine clearly reduces 

the chance someone will get the flu. Even if they do get the flu, 

their chances of having serious complications are much, much 

lower. 

Second, we need to make sure that older Americans get other 

vaccines that work in concert with the flu. This is especially true 

of the pneumococcal vaccine which many people commonly refer to 

as the pneumonia vaccine. 

Third, we need to make sure that the people who spend time 

around older Americans during flu season are themselves vaccinated. When such persons themselves do not get the flu, they 

cannot spread it to others who are around them. That is why we 

target those who share the same household with, and those who 

provide services to, older Americans. 

When it comes to flu vaccine, the news is often good and bad at 

the same time. As you can see on the poster here, without question, 

we have made steady progress in getting flu vaccine to persons 

over the age of 65. Today, about two-thirds of these persons get an 

annual flu vaccine, but that also means that about a third of them 

do not, and that we have a ways to go to reach our Healthy People 

2010 goal of 90 percent. 

We also see a clear equity gap. African American and Hispanic 

seniors are far less likely to be vaccinated against flu than are the 

others. As for healthcare providers who are not shown on this 

graph, our surveys show us that only about one in three get an annual flu shot. So clearly, we have our work cut out for us. 

As you know, last season was especially difficult. First, it came 

on more rapidly and earlier than almost any recent flu season. Second, several locations suffered from a series of very highly publicized and tragic deaths in young children. Third, there was rising 

concern about avian influenza, or bird flu, in Asia. 

These factors drove an unprecedented demand for flu vaccine, a 

demand that could not be met, resulting in a run on remaining vaccine and coast-to-coast shortages. 

Unfortunately, last season came on the heels of several years of 

fairly mild flu activity. As a result, as seen here on this graph, in 

those years, vaccine supplies began to far exceed demand and 

many doses went unused and had to be unfortunately thrown out. 

4

So in 2003, the two primary domestic manufacturers cut back their 

production to balance the supply with the demand. At CDC, we 

have been working to reduce the chance of a similar problem this 

year. 

First, we have improved our surveillance. In addition to having 

better monitoring systems for flu itself, we are now working closely 

with the manufacturers and distributors to better monitor the vaccine supply. This way we can be more certain we know how much 

is out there, where it is, and can anticipate problems, and we have 

created a buffer stockpile of 4.5 million doses should any shortages 

arise. 

The manufacturers have also responded by increasing production 

to a record 100 million doses. As a result, the potential for similar 

problems this season is much lower. But more needs to be done. 

We would like to see more people get vaccinated against the flu. 

Shown here are some of the posters we have used in this year’s 

educational activity. This one targeting seniors and the next poster 

targeting healthcare workers. Meeting our goals will require work 

on all of our parts: policymakers, public health, the health care system, and industry. 

This is why for the past few years, we have been working 

through a coalition known as the Influenza Summit. We have also 

partnered with CMS on a project to allow standing orders for flu 

vaccine. 

Before closing, let me just touch quickly on more issue which is 

pandemic flu. Given the ongoing problems in Asia, many believe 

today we are closer to the next influenza pandemic than we have 

been in decades. These strains in Asia have already demonstrated 

two of three requirements for a pandemic. 

First, there are flu strains that have not been widely circulating 

in humans, and second, they produce very high fatality rates. All 

they now need to do is acquire the ability to easily spread from person to person. HHS has been taking steps to address this threat. 

We have expanded our monitoring systems in Asia and with WHO. 

We have assured year-round egg availability for vaccine production. We are stockpiling antiviral drugs, and we are developing and 

purchasing pilot lots of vaccines against the strains of most concern. In August, we published the draft HHS Pandemic Plan which 

is now undergoing a 60-day comment period. 

So, in summary, flu has been and will remain a very serious concern to the health and well-being of all Americans but especially 

older Americans. We look forward to working with the committee 

and with Congress to meet this challenge. 

Thank you very much and we will be happy to take questions. 

[The prepared statement of Dr. Ostroff follows:]

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The CHAIRMAN. Well, Doctor, thank you very much for that testimony. Now let us turn to Pamela McInnes, deputy director, Division of Microbiology and Infectious Diseases, National Institute of 

Allergy and Infectious Diseases. That is a great title, Pamela. Welcome to the committee. 

STATEMENT OF PAMELA M. MCINNES, DDS, MSC, DEPUTY 

DIRECTOR, DIVISION OF MICROBIOLOGY AND INFECTIOUS 

DISEASES, NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES, BETHESDA, MD 

Dr. MCINNES. It is long. Thank you, so much. Mr. Chairman, 

thank you for the opportunity to discuss with you and the committee the role of the National Institutes of Health in combating 

influenza. The National Institute of Allergy and Infectious Diseases, fondly known as NIAID, a component of the NIH, is the lead 

Federal agency for conducting, supporting, and coordinating resource on influenza and other infectious diseases. 

Influenza is a classic example of a reemerging disease. It is not 

a new disease but it continually changes. In most years, flu viruses 

that infect humans globally undergo small changes. If enough of 

these changes accumulate, the virus is able to escape the human 

immune response that resulted from prior exposure to influenza viruses or vaccination. 

These changes are the basis of well-recognized patterns of influenza disease that occur every year. One of the population groups 

at risk of the serious complications of influenza is the group over 

65 years of age. 

Only three types of influenza viruses routinely circulate amongst 

humans. However, all known influenza A subtypes are common in 

the gastrointestinal tract of wild ducks. Because the replication 

machinery of the influenza virus is prone to errors as the virus 

multiplies, avian flu viruses can emerge that may be able to jump 

species into domestic poultry, farm animals and humans. H5N1 

avian flu viruses made the jump directly from birds to humans in 

1997 in Hong Kong, but because the virus did not acquire the ability to spread from human to human, only a limited number of 

deaths occurred. 

Currently, H5N1 avian influenza virus in Vietnam and Thailand 

also have made the jump directly from bird to humans and has resulted in a 72 percent mortality rate. The fear is that the avian 

H5N1 and a commonly circulating human influenza virus might recombine resulting in the global spread of a new deadly influenza 

virus that can be spread among humans and to which the majority 

of the world will be susceptible, referred to as a pandemic strain. 

The overall goal of the NAIAD influenza program is to support 

research that leads to more effective approaches for controlling influenza. This program has two major components, both of which 

are specified in the nation’s draft Pandemic Influenza Preparedness and Response Plan. 

The first component reflects long-standing programs for interpandemic influenza, including basic research, surveillance for the 

detection of animal and bird influenza viruses with pandemic potential, and the identification, development, and evaluation of rapid 

diagnostics new antiviral drugs and vaccines. 

19

Because influenza is so easily transmitted, effective vaccines are 

essential to the control of annual flu epidemics. Although the current egg-based system used to produce licensed flu vaccines has 

been reliable, there is room for improvement. NIAID is supporting 

a number of research projects to develop flu vaccines that can be 

manufactured more rapidly and are more effective. 

Recently, NIAID supported a clinical trial in older adults of a 

new influenza vaccine produced in a cell culture system as an alternative to manufacturing the vaccine in eggs. The positive results 

of this trial suggest that this new vaccine approach could be a viable alternative to the traditional egg-based influenza vaccine. 

Although vaccination in the elderly population is very effective in 

preventing severe illness, complications and death, we know that 

elderly individuals are protected less effectively by vaccination that 

younger individuals. There is early research evidence that increased doses of vaccine in the elderly result in a higher level of 

protective antibodies against influenza virus. 

NIAID is also supporting research to determine if a novel booster 

vaccination strategy would improve the efficacy of flu vaccines in 

the elderly. 

The second component of NIAID’s influenza program is geared to 

address the emergence of influenza viruses with pandemic potential in humans. NIAID has already begun to implement this carefully planned process in response to the H5N1 avian outbreak in 

southeast Asia. 

An NIAID contract investigator used reverse genetics technology 

to generate a reference virus that has the characteristics of the 

H5N1 wild type virus but is safe for researchers and manufacturers to work with in the laboratory and in the manufacturing plant. 

NIAID has provided this reference strain to the currently licensed and activated flu vaccine manufacturers, Aventis and 

Chiron. Under contract to NIAID, both of these manufacturers are 

developing pilot lots of the inactivated H5N1 vaccine. NIAID will 

test this vaccine in people for safety and the ability to raise antibodies. It is planned that one of the groups in the studies will be 

older adults. These actions are critical steps which will help prepare the Nation to respond to a pandemic influenza outbreak. 

Mr. Chairman, thank you again for inviting me to discuss NIH’s 

efforts to address the threat of influenza. In addition to the significant toll exacted by flu each year in the United States, the risk of 

pandemic influenza is significant and the consequences could be 

very serious. 

Influenza is one among many ever-changing infectious disease 

threats confronting our nation and the world. Fortunately, much of 

what we learn from the study of one pathogen can often be applied 

to others. NIAID as the lead Federal agency for infectious diseases 

research constantly strives to improve its ability to respond to any 

infectious disease threat in concert with our colleagues at CDC and 

FDA. 

I would be pleased to answer your questions. Thank you. 

[The prepared statement of Dr. McInnes follows:]

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The CHAIRMAN. Pamela, thank you very much. But before I do 

question either of you, let me turn to my colleague Evan Bayh who 

has joined us. I had mentioned in my opening statement that Evan 

was instrumental in introducing S. 2038, the Flu Protection Act of 

1904. I joined with him as co-sponsor. 

Evan, any opening comments you would wish to make, and then 

if you want to start, you can lead off with questions. 

STATEMENT OF SENATOR EVAN BAYH 

Senator BAYH. Well, thank you very much, Mr. Chairman. Only 

to say I appreciate your leadership on this issue and I appreciate 

the time of the panelists, both on this panel and panel two. 

We are really here today because of some of the problems uncovered as a result of the flu season last year. We want to encourage 

those who are in at-risk populations to receive immunization and 

to really ensure that the shortage that occurred and the ensuing 

sort of mini-panic on the part of the public does not happen again. 

So Mr. Chairman, I appreciated our opportunity to work together 

and this hearing really before the advent of flu season to try and 

encourage. Basically we have one message to people at home today. 

It is go out and get immunized. Vitally important. 

I would like to begin, I just have a couple of questions, Mr. 

Chairman. You know the old adage, ‘‘fool me once, shame on you; 

fool me twice, shame on me.’’ Can any of you assure us that we 

have enough doses of vaccine to get us through this flu season after 

the shortage we experienced last year? 

Dr. OSTROFF. Well, the answer to that question is that we ultimately will not know until we are actually through the flu season. 

As I mentioned in my statement, we feel that we are in much better shape than we were last year, given that the amount of vaccine 

that is being produced far exceeds what was produced last year, 

and we know that that vaccine is now being distributed. 

Senator BAYH. Mr. Ostroff, forgive me. If everyone who we are 

recommending were to receive the vaccine, how many vaccine doses 

would that be in our country? 

Dr. OSTROFF. Well, that would be 185 million. 

Senator BAYH. How many doses are we estimating it will produce 

this year? 

Dr. OSTROFF. Currently 100 million. 

Senator BAYH. So we know that we are 85 million short of the 

number of doses needed to cover all the people we are encouraging 

to get vaccinated? 

Dr. OSTROFF. You are absolutely correct, Senator. 

Senator BAYH. That seems to me to be a little cognitive dissonance here. 

Dr. OSTROFF. The difficulty is that there is always a conflict between supply and demand, and certainly with the current production of the vaccine, the amount that is produced is the amount that 

is anticipated to be demanded by the public. 

We had several seasons in a row before last season where the 

supply far exceeded the demand and unfortunately a lot of that 

vaccine did not go into people’s arms. 

34

The CHAIRMAN. Yes. Could we put up that chart because Evan 

asked a very important question, and you brought a chart along 

that I thought was interesting. 

Dr. OSTROFF. Right. 

The CHAIRMAN. That reflected the difference here. 

Dr. OSTROFF. As you can see, for several years, there was an excess that was building up. 

Senator BAYH. Sure. That is the tension, as I understand it. 

Dr. OSTROFF. Correct. 

Senator BAYH. The companies, of course, need to keep an eye on 

the bottom line and if they have had an experience of producing too 

many doses, then obviously they have learned from that, but then 

you get a year like last where we are caught short and so the trick 

is to either have better forecasting tools or to try to assure the producers that they are not going to get left holding the bag if we have 

a year like last year. 

That is why I thought the mechanism included in our bill, Mr. 

Chairman, was the right way to approach this, to basically lend 

some certainty to the producers. I gather that instead we have 

gone down a different path of the government purchasing a fixed 

number of doses—is that correct—to try and make up any shortfalls should one occur? 

Dr. OSTROFF. That is correct. 

Senator BAYH. How many doses did the government purchase? 

Dr. RODEWALD. We have a contract for eight million doses of vaccine through the routine program, and then as an insurance policy 

in response to what happened last year, we have a contract for 4.5 

million additional doses of influenza vaccine, half of which will be 

available December 1 and half of which will be available before 

January 1. 

We think that will go a long way to help if there is unanticipated 

emergency late season demand like we had last year. I think this 

point about demand and supply is a very important one because I 

believe the best way to increase the production of vaccine is to increase the demand of vaccine, but it has to be done in a way that 

is orchestrated such that we do not outstrip the production by expanding our recommendations and thereby, pushing too much demand at one time. 

For example, the new childhood recommendation will help raise 

the demand for vaccine and ultimately we would like to weave influenza vaccination much more closely into the fabric of society. Increased demand will increase production and will not leave the 

manufacturers with a lot of unused vaccine at the end of each season. 

Senator BAYH. What was the reasoning behind choosing to purchase a fixed number as opposed to purchasing the unused numbers of doses? 

Dr. RODEWALD. I do not know the answer to the question whether it was presented as an option, but we thought that a fixed number of——

Senator BAYH. It was the option in our bill. 

Dr. RODEWALD. The fixed number was selected because we were 

able to fund this through the Vaccines for Children program, which 

35

is an entitlement program to children, and this allowed us to buy 

vaccine that we could guarantee to be distributed in December. 

Senator BAYH. I am curious, Mr.—again, we all want the same 

things here. We all want to ensure that there is enough supply to 

cover people in years that are a little, hopefully, aberrant like last 

year, and at the same time minimize the cost to the taxpayers. 

I am just curious as to why the method of selecting or trying to 

divine a fixed number to purchase was chosen over instead of ensuring the producers that we would purchase any unused quantities? 

Just curious as to why one was chosen over the other? We all 

want to choose the right course, whatever that might be. 

Dr. OSTROFF. Well, again, our ultimate goal is to make sure that 

we do not have some of the same problems that we did last year. 

We all want to make sure that there is an adequate supply of vaccine, and in response to your earlier comment, when we have a 

goal of 90 percent coverage, we all want to be able to work together 

to move toward that 90 percent or even 100 percent coverage, and 

there is no question that that is going to take a concerted effort on 

everybody’s part to encourage people to get vaccinated as well as 

to assure that there is vaccine available to be able to deliver to 

them. 

Senator BAYH. Mr. Chairman, you have been very gracious, and 

I see the red light is on, so I would like to thank the panelists 

again for your work in this area and your presence here today. 

The CHAIRMAN. Evan, thank you very much. Let me turn to another one our colleagues who has joined us, Senator Tom Carper. 

Tom, do you have any opening comments and questions of this first 

panel? 

Senator CARPER. I have a couple of questions, if I could. 

The CHAIRMAN. Please proceed. 

Senator CARPER. To our panelists, thanks very, very much for 

joining us this morning and for your good work in this effort. I am 

not sure who to direct this question to. Maybe I should direct it to 

you, Ms. McInnes, and if I am wrong, then maybe one of your colleagues will take it on. 

Could you just start off by talking to me about the nature of the 

disease itself, the diseases, the viruses that we are trying to contain here? 

Dr. MCINNES. Sure. Influenza is one of the important respiratory 

viruses. It is spread by a respiratory route. It is a disease that affects the mucosal, the lining of the respiratory tract, and it replicates when in human and it also has an unfortunate——

Senator CARPER. When you say it replicates, just explain to us. 

Dr. MCINNES. To multiply, copies itself and multiplies. 

Senator CARPER. Once it is inside of a body? 

Dr. MCINNES. Yes. 

Senator CARPER. OK. 

Dr. MCINNES. It has an unfortunate part of its disease progression where it actually, in the cells that line your nose and your epithelium and your tissues in your lungs, there are little hair-like fibers that are called cilia, and they are very important in protecting 

your body against infection, and one of the byproducts of influenza 

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piratory system that is now vulnerable to so many things in addition to influenza, and many of the deaths associated with influenza 

are started with flu and then you will have a secondary bacterial 

infection that may come in on top of that influenza infection. 

Classically, people have fevers, they have muscle aches, chills, 

sort of almost bone-cramping kinds of muscle pains can happen. 

The fever goes on for several days and then normally healthy people who have normal immune systems will mount an immune response to that and recover. 

People who do not have a normal and high functioning immune 

system very often go on and develop secondary infections and have 

a much harder time dealing with influenza as a disease. 

Senator CARPER. How does a vaccine work to combat the infection? 

Dr. MCINNES. Most of the vaccine that is used in this country is 

the inactivated vaccine, and that is a killed vaccine. 

Senator CARPER. A what? 

Dr. MCINNES. It is a killed vaccine. 

Senator CARPER. What does that mean? 

Dr. MCINNES. So we grow up the influenza virus in eggs, and 

then it is taken out of the eggs, and it is inactivated with a procedure whereby the virus is actually killed. 

So you have an inert virus and pieces of the virus in the vaccine, 

and what that does is that it stimulates the antibody response 

without itself causing an infection. So what you do is you hope that 

you have—we know very well that antibodies are a very, very important protective mechanism against the live virus, and so by vaccinating you induce an immune response with good antibodies so 

that if you encounter the virus, you then have a heightened way 

to respond to the virus and hopefully not become ill. 

Senator CARPER. The vaccine that was developed, for example, to 

fight the flu last year——

Dr. MCINNES. Yes. 

Senator CARPER [continuing]. Is it likely to work this year and 

next year and the year after that? Do we have to continue to, I 

guess, are we looking for continuous improvement in our vaccine? 

Dr. MCINNES. Flu is one of those things where every year we 

monitor for what we think may be the next viruses and, no, there 

are subtle changes that happen in these influenza viruses every 

year, and so very early in the year, we are looking at the data that 

have come out from other parts of the world and we may make recommendations to change the virus a little bit. There are three virus 

components in each annual year’s flu vaccine. Sometimes they stay 

the same. Sometimes they are changed. Sometimes just one strain 

is changed. This year actually two of the strains will be changed 

from last year’s vaccine. 

Senator CARPER. All right. To your colleagues and to you, Ms. 

McInnes, what would be your take-away for us as we walk out of 

this hearing knowing that we are going out and face the challenges 

the world poses for us and our country? What would you want to 

be our take-away from this hearing? If we remember nothing else, 

what would you want us to remember? 

Dr. OSTROFF. My message as we sit here on September 28, is 

that we need to roll up our sleeves. We need to roll up our sleeves 

37

and all work together to build the vaccine supply and we need to 

roll up our sleeves and get vaccinated. Now is the time to get started. 

Senator CARPER. All right. 

Dr. RODEWALD. Influenza vaccination is the safest and most effective way to protect not only yourself from influenza disease but 

also your loved ones from influenza disease. 

Senator CARPER. All right. Thanks. Ms. McInnes? 

Dr. MCINNES. I think those are wonderful. 

Senator CARPER. Were you born in Delaware? Is that a Delaware 

accent I hear or is that Idaho or is that Indiana? 

Dr. MCINNES. Actually, no, I was born in a very small town in 

South Africa. 

Senator CARPER. No kidding. I thought you might be. How did 

you end up here? 

Dr. MCINNES. I married an American. 

Senator CARPER. So did I. [Laughter.] 

That is good. We are glad you are here. We are glad you are all 

here. Thank you very much for your testimony and for your help. 

Thank you. 

The CHAIRMAN. Well, let me ask some questions because I think 

the thing that is most profound, and I think both of my colleagues 

and I realize this, that this is a killer of elderly Americans. It 

ought to be viewed like that, and I would wish that older Americans would view it, that as they age, they develop a higher risk and 

the statistics are just black and white when it comes to that issue. 

Doctor, you stated that the majority of influenza strains that 

CDC has characterized this year are well matched to the vaccine 

that has been produced for the coming season. What is the possibility that an unmatched strain could still appear? 

Dr. OSTROFF. Well, Senator, in response to that question, the one 

thing that we always know about flu is that it can be very unpredictable. So predicting what might happen during the coming flu 

season is always an imperfect science: when the flu season will 

really get started, where it will occur first in the country, and 

which strain is going to be causing the majority of disease. 

The CHAIRMAN. When that begins to appear, what do you do? 

Dr. OSTROFF. Well, we work year-round monitoring for cases of 

influenza. We used to just do it starting on October 1 and then we 

would continue to monitor through May 1, but we’ve now been 

moving towards year-round monitoring because we recognize that 

even up here in the temperate part of North America there is the 

occasional case of flu that occurs during an unusual time of the 

year, so we need to know about that. 

We need to know what the strain is that is causing the disease 

and be prepared to respond to that. So we are constantly in this 

country monitoring for influenza, and we are looking for just the 

circumstances that you mentioned is the problem that we have is 

that we need to let the manufacturers know so far in advance 

which strains we predict are going to be circulating six to eight to 

nine months later, so that they can go through the entire manufacturing process and end up with enough vaccine in the fall to be 

able to vaccinate. 

38

The CHAIRMAN. From the time you discover or let us say you or 

a discovery occurs that you have got a different form and you notify 

the manufacturer, how long does it take for a vaccine to be able 

to get to the street? 

Dr. OSTROFF. Well, the short answer to that is it depends, and 

so there is no single answer. It depends when during the season 

that strain is recognized in relation to where the manufacturers 

happen to be in the manufacturing process. 

In general, it will take a good four to six months to make those 

types of changes given the current system for vaccine production in 

this country. However, I will point out that our predictive capacity 

is much, much better than it used to be because the monitoring 

systems, not only here in North America, but also especially in 

Asia, are much, much better than they used to be, and so the predictions in virtually all years, and I say virtually because nothing 

is 100 percent, between what strains should go into the vaccine and 

what actually circulates have been extremely good essentially every 

year. Last year, unfortunately, was one of the anomalies. 

The CHAIRMAN. What is—I guess let me put it this way—how do 

we deal with only 38 percent of our health care providers receiving 

flu vaccinations? I mean the connectivity between a healthcare provider and his or her client, the senior citizen? 

How do we address that? 

Dr. OSTROFF. Well, I must confess all of us have been perplexed 

about why we have such difficulty getting that number higher. I 

certainly get my flu vaccine every year and have done so for years. 

I am a healthcare provider and it is the appropriate thing to do, 

not only to protect myself so that I do not have lost work time, but 

in particular, to protect those around me that I care for, who are 

at higher risk of developing the complications. 

I myself find it in inexcusable that a healthcare worker would 

not heed that message and do something to protect their patients 

in that way. We know, I think from experience, that the more opportunities that there are, and the easier that we make it for 

healthcare workers to get the vaccine, the more likely they are to 

actually accept it. So having organized vaccination campaigns in 

healthcare facilities, particularly acute healthcare facilities, nursing homes, et cetera, is the way to boost coverage. 

The CHAIRMAN. How many states have developed contingency 

plans in light of the whole influenza issue; do you know? 

Dr. OSTROFF. It depends what you mean by contingency plans 

and I will ask Dr. Rodewald to amplify my answer. We have been 

encouraging all states to develop plans to deal with shortages, yes. 

The CHAIRMAN. By that, I mean obviously if we get into a shortage environment and you have a limiting factor out there being the 

availability of vaccines——

Dr. OSTROFF. Right. 

The CHAIRMAN [continuing]. How do we deal with that more frail 

or fragile or susceptible population, and what is being done in that 

regard if we get caught once again? 

Dr. OSTROFF. Right. Go ahead. 

Dr. RODEWALD. We have asked all the states to develop contingency plans in order to handle vaccination and vaccine shortages 

39

and the states respond in their grant applications to CDC for how 

they are going to do this. 

The CHAIRMAN. How many have done this to date? 

Dr. RODEWALD. I do not know the exact number, but I think pretty much all of the states have plans for how they will handle a 

shortage, but I think the other part of the equation is to recognize 

that about 95 percent of this vaccine goes out through the private 

sector, and so close collaboration between the private sector distributors for the vaccine and the vaccine manufacturers in the Public Health Department and providers is essential, so we are working with the top 20 distributors to monitor how the vaccine is going 

out and in the case of a shortage what we will end up encouraging 

to have happen is that the distributors will send some vaccine to 

all the providers so that all the vaccinators can be working as best 

they can rather than giving a few providers a lot of vaccine, and 

some providers no vaccines. 

So I think working collaboratively with the private sector has 

been a key to this, and the lessons for how to meter out this vaccine were learned in the childhood program where we have had to 

deal with shortages over the past two to three years, and metering 

out vaccine has been one of the more successful strategies there. 

The CHAIRMAN. All of us are concerned about shortages or availability to a vulnerable population. So let me ask this of all of you 

because this is a question where we probe a bit. Media reports of 

influenza caused deaths seemed last year to be a significant factor 

in the shortage because with that alarm sent off, people rushed 

out. How can the media cover the seriousness of this issue without 

causing undue panic because clearly it is my opinion that the seriousness of it has to be understood or we should try to have it understood? 

Dr. OSTROFF. My answer to that would be to report responsibly 

both information on flu as well as what people can do to reduce 

their risk. You want to avoid having a large cohort of individuals 

that did not heed the message to get flu vaccine at a time when 

the flu vaccine was widely available, and then at the last minute 

have a large deluge of individuals who then have to shop around 

looking for a place that has remaining vaccine. 

The CHAIRMAN. Sure. 

Dr. OSTROFF. This is the time to start getting your flu vaccine. 

The other important message is that not everybody has to get the 

vaccine at the same time. So we strongly encourage that people 

should be vaccinated well into the influenza season and one should 

never think that it is too late to get vaccinated. 

The CHAIRMAN. Pamela, any additional comment to that? 

Dr. MCINNES. No, I think if any message could go out about 

heeding what happened last year and not waiting until too late 

would be very, very welcome. 

Dr. OSTROFF. Then one other message that I would get out there. 

The CHAIRMAN. Yes. 

Dr. OSTROFF. There is still a widespread belief that you can get 

the flu from getting the vaccine. As was pointed out, this is not the 

case. So we should not have anyone out there that has any concerns about developing the flu after getting the vaccine. 

40

The CHAIRMAN. Well, that is a great lead-in to my next question, 

and the question is of you, Dr. McInnes, the available literature in 

this area raises the question of vaccine effectiveness for older people. It concerns me that the population in greatest need responds 

more poorly to the available vaccines, and I have heard it said in 

elderly populations that I know, ‘‘Well, I don’t know that I want 

that, it might cause me to get it,’’ type of thing. Can you tell us 

more about new vaccines being produced that are especially for the 

elderly? 

Dr. MCINNES. Yes, I think we know very clearly that the more 

antibody you can stimulate with the vaccine, the better will be your 

chances of not becoming ill from influenza. You may become infected, but the disease may not be as severe, and we know the biggest impact from flu vaccine in the elderly is to prevent serious disease, hospitalizations, and death. 

We still get people who are vaccinated who become infected with 

influenza, but one hopes that they have a more mild form of the 

disease. Clearly, the efficacy of the vaccine in terms of preventing 

any disease in the elderly is lower than in younger adults. We have 

very nice data to show that if you increase the amount of the components of the flu vaccine, you can stimulate more antibody in the 

elderly, and this is now a strong focus of ours in collaboration with 

the manufacturers to look at alternative formulations of vaccine 

that perhaps need to be twofold, threefold, fourfold in concentration 

compared to what is currently delivered now. So that is something 

that I think is quite practical and will probably have a good payoff. 

The effect of adjuvants, which enhance the response, have been 

somewhat disappointing with regard to influenza vaccine in general, not just in the elderly. There is also the question on whether 

one might need to give a booster dose of vaccine to the elderly, and 

so instead of a one-dose regimen, could you do a two-dose regimen. 

So both of those strategies are being explored currently. 

The CHAIRMAN. I appreciate that, but we are still dealing with 

the complication of getting the first vaccination. 

Dr. MCINNES. Absolutely. 

The CHAIRMAN. Let alone a second vaccination. 

Dr. MCINNES. Absolutely. 

The CHAIRMAN. Yes. If you have to choose the most promising 

area of research, what are you most excited about? What shows the 

greater promise at this point? 

Dr. MCINNES. In terms of influenza, we are very excited about, 

in fact, three areas, one of which is this tantalizing data about the 

ability to mount an improved immune response in the elderly by 

concentrating the vaccine, and that is something we will explore 

very aggressively. 

The live attenuated influenza vaccines which are on the market 

now and last year were out for the first time, unfortunately do not 

look that promising for the elderly. The response does not look that 

promising, but shows great promise in the pediatric population 

which might help alleviate some of the vaccine availability issue. 

More of the inactivated vaccine could be available for the other 

populations. 

Then third, in terms of new technologies, both in how we manufacture vaccines that might increase the amount of vaccine that is 

41

available, the speed of our ability to make vaccines by being able 

to engineer the starting viruses will be probably critical, not only 

in producing inter-pandemic vaccines, but certainly in being able to 

respond to a pandemic situation. 

The CHAIRMAN. Well, we thank you all very much, and Dr. 

Ostroff, we are going to let you have the last word, and ask you 

to repeat. The most important part of your message to the public 

today was? 

Dr. OSTROFF. Roll up your sleeves and get vaccinated. 

The CHAIRMAN. Repeat that, please, and louder. 

Dr. OSTROFF. Roll up your sleeves and get vaccinated, and I will 

add that hopefully we can encourage all Members of Congress that 

fit into one of those high-risk groups to help us do that. 

The CHAIRMAN. I thank you all very much for being here. 

Dr. OSTROFF. Thank you, Senator. 

Dr. MCINNES. Thank you. 

The CHAIRMAN. I will ask our second panel to please come forward. Well, again, welcome to our committee. As I said earlier, our 

second panel, is comprised of Janet Heinrich, Director of 

Healthcare and Public Health Issues at the Government Accounting Office. I am also pleased to welcome Carol Moehrle, one of my 

constituents from Idaho, District Director for the North Central 

District Health Department, located out of Lewiston, ID, in the 

north end of our state. Last, and I think very importantly for this 

committee and for our public to hear, from Dr. Howard Pien, CEO 

and President of Chiron? 

Dr. PIEN. Perfect. 

The CHAIRMAN. Chiron Corporation. So again, to all of you welcome. Janet, would you please proceed? 

STATEMENT OF JANET HEINRICH, DIRECTOR, HEALTHCARE 

AND PUBLIC HEALTH ISSUES, GOVERNMENT ACCOUNTABILITY OFFICE, WASHINGTON, DC 

Ms. HEINRICH. Mr. Chairman, it is a pleasure to be here today 

as you discuss issues regarding the annual production and distribution of flu vaccine and preparedness for an influenza pandemic. 

Each year, influenza viruses are associated with deaths and hospitalizations, as we have heard, especially for persons age 65 and 

over. 

The best way to prevent influenza is to be vaccinated each year. 

In the past, this country experienced periods when the demand for 

flu vaccine exceeded supply. There has also been increased concern 

about the prospect of an influenza pandemic which many experts 

believe to be inevitable. 

Experts have raised concerns about the ability of our public 

health system to detect and respond to emerging infectious diseases such as pandemic flu. You have asked us to comment on 

these issues based on our previous work. 

I will discuss issues related to supply, demand, distribution of flu 

vaccine, and review the pandemic plan recently released. For the 

current flu season, CDC is recommending that about 185 million 

people receive vaccine. It is generally widely available in the fall, 

and in the past about two-thirds of flu shots were administered in 

healthcare settings such as doctors’ offices and clinics. 

42

About a third were given in other locations such as stores or 

community settings. Most vaccine distribution and administration 

are accomplished within the private sector, with relatively small 

amounts being purchased by CDC or by state and local health departments. 

Ensuring an adequate and timely supply of vaccine is a difficult 

task that has become more challenging with only a few manufacturers. Problems at one or more companies can upset the fall delivery of and flu vaccine cause unnecessary fluctuations in who has 

ready access to the vaccine. 

Matching supply and demand is also a challenge. For example, 

in 2000–2001, when a substantial portion of flu vaccine was distributed much later than usual because of manufacturing problems, 

temporary shortages were followed by decreased demand as more 

vaccine became available later. 

Last year’s shortages, as we have heard, were attributed to an 

unexpected severe flu season and concerns about the deaths of children. 

Our work has also found that there is no mechanism in place to 

ensure distribution of flu vaccine to high risk individuals before 

others when there is a short supply. For example, when the supply 

was not sufficient in the fall of 2000, focusing distribution on high 

risk individuals was difficult because all types of providers served 

at least some high risk individuals. Some physicians and public 

health officials were upset when the local grocery store was offering flu shots to anyone when they, the healthcare providers, were 

unable to obtain vaccine for their high-risk patients. 

While CDC has taken some steps to recommend targeting vaccine when there are shortages, the situation is no different today. 

In regards to pandemic planning, the new plan describes Federal 

roles and responsibilities in responding to a pandemic and provides 

guidance to state and local health departments. Although the draft 

plan is comprehensive in scope, it leaves some important decisions 

about the purchase, distribution, and administration of vaccines 

unresolved. 

Consequently, states are left to make their own decisions, potentially compromising the timing and adequacy of a response to a 

pandemic. For example, the draft plan does not establish a definitive Federal role in the purchase and distribution of vaccine. Instead, different options are discussed. 

The plan delegates to the states responsibility for distribution of 

vaccine. Among the current state plans, and there are only a few 

of those, we found no consistency in terms of their procurement 

and distribution of vaccine and the relative role of the Federal Government. 

In addition, the plan does not identify priority groups to receive 

initial doses of vaccine. According to HHS officials, prioritization 

would be an iterative process and will be tied to vaccine availability in the progression of the pandemic. While recognizing that 

there is a need for flexibility, state officials have consistently told 

us that a lack of detailed guidance makes it difficult for states to 

plan. 

In conclusion, ensuring an adequate and timely supply of vaccine 

to protect seniors and others from flu-related complications conVerDate 0ct 09 2002 11:45 Feb 09, 2005 Jkt 000000 PO 00000 Frm 00046 Fmt 6633 Sfmt 6633 H:\DOCS\97604.TXT SAGING1 PsN: JOYCE
43

tinues to be a challenge. Despite efforts by CDC and others, there 

remains no system to ensure that persons at high risk for complications receive flu vaccine first. 

These vaccine supply and distribution problems may become especially acute in a pandemic. The absence of more detail in such 

issues as purchase and distribution creates uncertainty for the 

states with implications for adequate preparedness for a pandemic. 

That is my statement. I am happy to answer any questions. 

[The prepared statement of Ms. Heinrich follows:]

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The CHAIRMAN. Janet, thank you very much. Now let us turn to 

you, Carol. Please proceed. 

STATEMENT OF CAROL M. MOEHRLE, DISTRICT DIRECTOR, 

NORTH CENTRAL DISTRICT HEALTH DEPARTMENT, 

LEWISTON, ID 

Ms. MOEHRLE. Thank you. Good morning, Mr. Chair. It is my 

pleasure to address you today with the prospective of a local public 

health department as it relates to flu vaccinations and the elderly. 

I am also honored to represent the National Association of County 

and City Health Officials, NACCHO, our national organization representing the nation’s nearly 3,000 local health departments. 

As we all know, the old adage, says, ‘‘It’s at the local level where 

the rubber meets the road,’’ when we talk about flu vaccine, it is 

also the local level where that needle finally meets the arm of each 

of those receiving that vaccine. 

I am particularly proud to share with you some of our collaboration that our health district has been doing with the Idaho Commission on Aging. Our health district, along with two others in the 

state, have joined with the Commission on Aging to develop outreach to our senior citizens in our most rural areas of Idaho. 

The public health districts are providing information and oftentimes flu vaccine clinics at the senior meal sites in these rural 

areas. The commission is helping us by identifying certain homebound seniors that are not able to attend these flu clinics and we 

are sending a public health nurse into those homes to give those 

seniors their vaccine. 

This joint effort is to increase the flu vaccination rate amongst 

those very fragile, very elderly in our state of Idaho. However 

skilled we are at locating these high-risk individuals and administering the vaccine, we cannot achieve optimal protection for our 

communities unless the vaccines are available to us. 

The nation’s local public health departments have experienced 

distribution issues in four out of five of the last flu seasons. We do 

not yet know what challenges await this year, but we are hopeful 

that maybe we will not have to be as worried as we have been in 

the past. 

In the five counties that my health district covers in north Idaho, 

we are already hearing flu concerns, and receiving questions, and 

dozens of phone calls each week from citizens wanting to know 

about the flu vaccine for this year. Will there be shortages? Will 

there be an ample amount? 

I spoke with one elderly woman just recently who was quite distressed. She insisted that she get her vaccine first. She is elderly, 

has frail health concerns, and wanted to receive it before the lines 

start forming that oftentimes do in the clinics. 

She was worried also about the safety of the vaccine given the 

most recent media telling us about some of the vaccine being recalled. She wanted to know if we had the good vaccine or the bad 

vaccine? 

I reassured her that even though we were hoping that we would 

have ample doses, we were convinced that we would have enough 

to serve the population, and all the doses that we had were safe 

doses of vaccine. She did not leave that call very settled. She was 

60

quite disturbed still that I would not just let her have her vaccine 

today when she called and that I could not give her more reassurance that she wanted. 

Those are some of the calls that we are already receiving. It is 

clear to me that many elderly residents, do not trust the ability of 

the public health system to deliver the vaccine when they need it, 

where they need it. 

We have a lot of work to do to rebuild that trust because of the 

last few years and the issues that have happened. Idaho also experienced a flu shortage last year, as many of the health departments 

in our nation did. 

We didn’t receive the full amount of vaccine as that we ordered. 

We knew that we would run out. So we early on started prioritizing 

who the vaccine would be given to, and we used the CDC’s guidelines for the high risk population. Many of the people that we customarily give flu vaccine to were quite disturbed and panicked that 

they were not among the highest risk that we were giving the vaccine to. 

There was much emotion, confusion and even some anger in our 

communities that they could not receive this. Some people were so 

upset that they offered to pay more just so they could get a dose 

of vaccine. 

During some of the clinics that we held, we were actually turning 

some people away that were not qualified in the high risk categories, only to find out that they showed up for the next clinic 

with made-up diseases so that they would then be able to receive 

their vaccine. 

This pains me greatly that we have placed people in a situation 

where they have to lie about their health concerns in order to be 

amongst that high risk population when we have people that want 

to do the responsible thing to receive their flu vaccine. 

It also demonstrates some of the most critical concerns we have 

about the supply. We do not believe that anyone has a clear understanding of the reason for the supply and distribution problems 

that we have seen in the recent years. 

Every entity that gives flu shots, whether it is the large chain 

stores, the physicians or public health, we all order the vaccine 

from the same distributors and wholesalers. There does not seem 

to be a discernable rhyme or reason why some who place orders receive it early and in a full amount while others receive partial shipments sporadically throughout the flu season. 

Two years ago, a local nursing home called me at the health department and said, ‘‘It is flu season, I have no vaccine.’’ This was 

very concerning, a nursing home to call and not have received vaccine yet. I made more calls to other nursing homes and our senior 

living centers in our five counties, and lo and behold, we had others, other nursing homes that did not have flu vaccine. 

We called a meeting with our local medical community. We had 

physicians and healthcare providers arrive and voluntarily turned 

over doses of vaccine to Public Health so we could redistribute to 

the most at-risk, our elderly seniors in those living centers. 

The cooperative spirit that we had with our medical community 

helped us to address this distribution problem successfully, but on 

the contrary, we had two large chain stores that had received their 

61

full amount of vaccine early on. When asked to come to the table, 

they said that they were continuing to give the vaccine to anyone 

who walked through their stores and could not spare to give this 

to the public health when we thought it needed to be distributed 

elsewhere. 

In times of shortage, we all need to be working together with the 

same guidelines and the same rules as we use the vaccine very responsibly. Public Health urges stronger Federal leadership to bring 

all the parties together to find ways to rationalize the current chaotic distribution system, and to collaborate to assure optimal distribution of all the flu vaccine. 

If a nightmare of a flu pandemic ever arrives, we believe that the 

Federal Government will need to step in to take a strong hand in 

vaccine distribution because only optimal distribution will be essential to stemming outbreaks and to saving lives. 

Senator Craig, thank you for holding this hearing and for your 

support of public health. I will stand for questions. 

[The prepared statement of Ms. Moehrle follows:]

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The CHAIRMAN. Carol, thank you very much. Now let us turn to 

Howard Pien, president and CEO of Chiron Corporation. Howard, 

please proceed. 

STATEMENT OF HOWARD PIEN, CEO AND PRESIDENT, CHIRON 

CORPORATION, EMERYVILLE, CA 

Mr. PIEN. Mr. Chairman, thank you for the opportunity to appear at this hearing. Today I would like to focus on three key messages. First, Chiron reiterates our expectation that we can deliver 

between 46 and 48 million doses of flu vaccine this season as we 

previously announced. We expect to make an announcement on our 

shipment plans in the next few days. We profoundly regret that we 

have caused uncertainties in this year’s flu vaccine supply. However, in considering all of the dimensions of our responsibility as 

a vaccine supplier, we ultimately place the heaviest weight on the 

preservation of the trust of Americans that when they get the flu 

shot, the product is safe. 

This is the reason that we have been deliberate, thorough and 

extremely careful. The issues we encountered this year do highlight 

some of the important and valuable principles. 

First, the system in place to test flu vaccine does work. The problem was identified before release of a single dose of the vaccine to 

the public. So to Ms. Moehrle’s comment and phone call that she 

got, there is no bad vaccine. There is not going to be a recall because we will not release a single dose of the vaccine, until we are 

certain that the quality issues have been put to bed. 

But we also learned that when there is unexpected disruption in 

supply, timely and transparent communication is most important. 

We have benefited enormously from the guidance and the advice of 

the men and women serving the public health interest at the FDA, 

the CDC, and the other parts of Health and Human Services. 

We pledge always to be open in our communication and to help 

ensure that there are concerted efforts to coordinate communication to the public at large. Without that kind of communication, 

there is every risk of misinformation, possible panic, and erosion of 

public confidence in vaccines. 

My second message today is that while significant advances have 

been made in increasing immunization rates in older Americans, 

greater enhancements are possible, particularly for individuals between 50 and 64 years of age and healthy adults in close contact 

with people at high risk. The threat of flu to public health makes 

the enhancement of vaccination rates one of the clearest and most 

accessible ways to improve the health of Americans, and we applaud this committee in holding this hearing. 

Progress has been made in raising flu coverage rates, but as Dr. 

Ostroff pointed out, we still have a long way to go. Only 65 percent 

of the high-risk population over 65 are immunized. It is estimated 

that only 34 percent of those between the age of 50 and 64 have 

received vaccine, and the immunization of healthcare workers is 

less than 40 percent as we heard. 

Chiron believes that the following are paramount in importance 

to expand the rate of immunization. Education is critical. Public/

private partnerships, such as that of National Influenza Vaccine 

Summit, need to undertake substantial and innovative efforts to 

69

raise flu immunization coverage rates in any individuals over the 

age of 50 as well as their contacts. We can and we should reduce 

the disparities between geographic areas and between racial and 

ethnic groups. 

Also, vitally important is a recommendation for universal immunization. Expanding today’s recommendations to cover more than 

the 60 percent of the population currently covered will enhance our 

pandemic readiness as a nation. The Canadian province of Ontario 

has already done this and so can the United States. 

Finally, we need better incentives for immunization when it 

comes to flu and its terrible complications, the best medicine is preventive medicine. Therefore the best health economic policy is for 

the CMS to continue to encourage physicians to actively immunize 

against flu by setting adequate administration fees and reimbursement rates. 

My third message is that over the past year, collaboration between the public sector and industry has led to significant progress 

in both flu vaccine supply and pandemic preparedness. It is imperative that these efforts are sustained because they have led to improvements already and we should maintain the momentum. 

Here are some of the examples: 

The CDC has worked with flu vaccine manufacturers to establish 

a reserve of over four million doses to be delivered at the end of 

the flu season. Chiron will deliver two million doses to this buffer 

stock. 

The National Institute of Allergy and Infectious Disease with the 

leadership that we have grown to expect from the NIH has supported the production and testing of candidate vaccines against 

pandemic strains of avian flu that was described by Dr. McInnes. 

Chiron is manufacturing pilot lots of H5N1 and H9N2 vaccine to 

enable NIH’s evaluation. 

A draft pandemic influenza preparedness and response plan was 

recently published by the National Vaccine Program Office. The 

document will stimulate discussion and set priorities to enhance 

our preparedness including distribution against the pandemic 

threat. Chiron pledges to contribute to this important discussion. 

Our recommendation on pandemic readiness has already been incorporated in our written testimony. Briefly, the tenets are: 

Educating the public to increase the uptake of flu vaccine in the 

aged and their contacts and caregivers; 

Increasing research and development to enable higher certainty 

of sufficient pandemic vaccine supply; 

Proactively removing the obstacles in pandemic vaccine production including indemnification to the suppliers and well-defined 

government purchase, contractual arrangements and distribution 

plans. 

Finally, and perhaps most importantly, sustaining the political 

will to address the threat that flu represents to America’s health 

beyond this flu season and beyond this congressional session. 

In summary, on behalf of Chiron Corporation, I respectfully submit the following thoughts: 

First, Chiron expects to deliver between 46 to 48 million doses 

of the vaccine this season. Second, increasing the willingness of the 

public to be immunized this season and in the future is critical. 

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Public-private partnerships are the best mechanisms for maintaining the momentum. Third, the public sector and the industry have 

the opportunity in the next Congress to build on progress that has 

already occurred this year in both vaccine supply and in pandemic 

preparedness. We should seize on that spirit of collaboration with 

zeal. 

Thank you, Mr. Chairman, for the opportunity to represent 

Chiron’s views. 

[The prepared statement of Mr. Pien follows:]

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The CHAIRMAN. Howard, thank you very much, and again to all 

of you I appreciate your presence here. I have several questions for 

each of you. Janet, in regard to the gaps in the draft plan that you 

have mentioned, which areas do you believe or area is most important to address? 

Ms. HEINRICH. There are several, and it really is settling the 

issues of: is it the private sector or the public sector that will be 

purchasing the vaccine, who will be distributing it, how, and then 

the issue of prioritizing the populations that will be at risk knowing that there is going to be a short supply is absolutely critical. 

The CHAIRMAN. Yes. Of those areas that you have identified or 

expressed concern about, which would be the easiest to fix? 

Ms. HEINRICH. I think that the discussions have been ongoing 

about the public-private sector purchase and distribution, and I 

know from health departments, state and local, there really is an 

interest in having a Federal Government system in place or that 

could be used to distribute the scarce vaccine. 

It would seem to me that with the growing cooperation between 

manufacturers and the public sector that that would be the area 

that probably could be determined. 

The CHAIRMAN. Then let me ask this question. Do you believe 

then that CDC should dictate which population should be 

prioritized and make decisions for states on how they distribute 

and administer vaccines? 

Ms. HEINRICH. I do not think that approach would be welcomed 

by the states or the localities. There has to be dialog. There has 

to be conversation, and what we are hearing, though, is that the 

states want guidance, and in terms of setting priority populations, 

there needs to be a discussion among all the stakeholders about 

which populations would receive the vaccine. 

The CHAIRMAN. Well, Carol, with that question, we will turn 

right to you, and let me ask the same question of you. In your relationship or the relationship of states to CDC and how we make 

these priorities, what would some of your recommendations be? 

Ms. MOEHRLE. The priority I think that I would have personally 

would be the distribution issue. 

The CHAIRMAN. Yes. 

Ms. MOEHRLE. There needs to be some bigger oversight of where 

that vaccine goes first or to make sure that those administering 

vaccine to the highest risk, wherever that population is, has their 

vaccine. The distribution seems to be an issue that is of most concern at the local level. 

The CHAIRMAN. Yes. It is disturbing to me that large chain store 

might have it and you do not. 

Ms. MOEHRLE. Or physicians do not. 

The CHAIRMAN. Or physicians do not. 

Ms. MOEHRLE. Or nursing homes do not. Yes, where those high 

risk are. 

The CHAIRMAN. I mean that is obviously tremendously frustrating for the public to call in and say, ‘‘I need help or I need to 

be vaccinated,’’ you say, ‘‘I cannot,’’ and Wal-Mart is saying, ‘‘I 

can.’’ That is an interesting juxtapose here. 

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Do local providers usually order their entire supply from one 

manufacturer or do they spread the risk and order from more than 

one; do you know? 

Ms. MOEHRLE. From my perspective and what we do at the 

health districts in Idaho, we usually order from more than one. Because of the variations over the past years, where we get a partial 

shipment from the manufacturer or our distributor, at different 

times during the season, if we order from several companies or 

both companies, we sometimes get a larger shipment right up 

front, so we do not have to wait till the end to receive those doses. 

Most of us in Idaho order from several or from both companies. 

The CHAIRMAN. Any reaction to what Howard has mentioned 

today as it relates to supply? 

Ms. MOEHRLE. We are hopeful this supply will be there. I also 

appreciated his comments about getting the message to the media, 

that everything is safe, they didn’t take the chance. They are making sure that things are safe before our public receives that dose. 

The CHAIRMAN. That phone call that you got from that one elderly person, bad versus good? 

Ms. MOEHRLE. Right. I think there is a negative sentiment out 

there——

The CHAIRMAN. Yes. 

Ms. MOEHRLE [continuing]. In our communities, and then we 

need to do some real hard media work to make sure that they understand how safe that vaccine truly is. 

The CHAIRMAN. Yes, I think that is very important. I think you 

are to be commended for your partnership efforts to expand your 

outreach efforts in addition to the program you have mentioned. 

Where are the hard-to-reach senior citizens most? In the ruralist 

of populations? 

Ms. MOEHRLE. Well, I am from very rural, as you know. The ones 

that we see——

The CHAIRMAN. Actually we call that urban in Idaho. 

Ms. MOEHRLE. Urban, yeah. [Laughter.] 

I think it is frontier in a lot of areas. 

The CHAIRMAN. I think you are right. 

Ms. MOEHRLE. Some of them it is a transportation issue, which 

you know in Idaho, they just cannot get to their physician or their 

clinic in a timely manner. So by having some of our nurses go out 

to them is very helpful. I think we have definite populations in our 

cities that do not take advantage of the vaccine either, and it is a 

personal choice sometimes as well as an option for them not to be 

able to travel, but we are trying real hard. 

This was a pilot in our rural areas, specifically, to see if we could 

increase the flu availability to those that are in those very, very 

rural areas. 

The CHAIRMAN. How much authority does a local health department have to reallocate vaccine supply when shortages occur? 

Ms. MOEHRLE. Authority—partnerships, different. We have lots 

of partners in our communities and are respected highly with our 

medical partners, and I think that is why we have seen the willingness for them to actually turn over doses to the public health district to reallocate where they are needed most. 

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I am sure that partnership is different state to state and jurisdiction to jurisdiction. 

The CHAIRMAN. Are you suggesting this is all largely done on a 

voluntary basis then——

Ms. MOEHRLE. Totally voluntary. 

The CHAIRMAN [continuing]. Or collaborative voluntary basis? 

Ms. MOEHRLE. Exactly. Totally voluntary, based upon the respect 

in the partnership. 

The CHAIRMAN. It works? 

Ms. MOEHRLE. It has worked well in Idaho. 

The CHAIRMAN. Well, again, thank you very much for being with 

us today, greatly appreciated. 

Howard, again, thank you for being with us. Will you delay in 

shipment the Fluvirin; is it? 

Mr. PIEN. Fluvirin. 

The CHAIRMAN. Fluvirin vaccine composed—let me see. Now I 

understand what I am trying to say here. Will this delayed shipment compromise the ability of older Americans to obtain the influenza vaccine this year; do you think? 

Mr. PIEN. We expect not. As you had heard from a gentleman 

representing the CDC, there are guidelines and recommendations 

out of there that says that vaccination, even as late as December, 

will do good. We expect that in the next few days we can make our 

distribution plans and shipment plans, in which case the majority 

of the doses that I spoke of, 46 to 48 million doses, will be shipped 

in the month of October. Most Americans do get vaccines in the 

month of October and November. 

I should say one more word about supply. This is only our second 

year as a supplier of flu vaccine to the United States. Nonetheless, 

last year, our first year, we increased the output by 50 percent. 

This year if our expectation proves true, as we currently expect 

that it would turn true, 46 to 48 million doses, that would raise the 

supply by yet another 20 or so percent. 

Therefore, for the total industry, we expect this season we will 

have about 20 to 25 percent more doses in the United States. So 

while indeed there are reasons to be concerned about the pandemic 

situation, as to whether or not enough vaccines will be made, the 

truth of the matter is that, and a lot of work needs to be done 

there, as we have already testified, but in the so-called normal flu 

season, we certainly believe that a commitment of manufacturers 

to step up to the plate and make more products are clear and 

present and well demonstrated. 

The CHAIRMAN. Has a delay occurred in the delivery of Fluvirin 

to the U.S. market previously and what guarantees do we have 

that Chiron will not have a similar situation again next year? I say 

that because it is obvious that you are a major player in the market. 

Mr. PIEN. I have said already in my testimony, we are greatly 

pained by any disruption and uncertainty that we may have 

caused. We hope that in due course and in the next few days when 

we make an announcement, that that issue would no longer be. 

But let me just say that since a year ago, we began to make the 

investment to the tune of about $100 million for this year and next 

to upgrade our manufacturing capacity, to obtain more equipment 

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and machinery, to train our workforce even better, to increase the 

state-of-the-art capacities of managing the process of making flu 

vaccines. 

It is our deep and unerring commitment that we are going to do 

better and be a reliable and consistent supplier. 

The CHAIRMAN. Well, Howard, your presence here today probably 

answers this question because you have heard it said—I have 

asked the question as a result of what Carol has mentioned—but 

out in the public, we have heard about people asking for the good 

vaccine and their lack of confidence in the availability, and you 

have expressed it very clearly as it relates to the safety of the vaccine. 

I think for all to hear, it would not be bad to say it again. 

Mr. PIEN. Thank you, Senator. Let me just go back a little bit 

on what happened in this situation. The flu vaccine, as you heard, 

is a different product every year. 

The CHAIRMAN. That is right. 

Mr. PIEN. To reflect the different patterns. 

The CHAIRMAN. In saying that, tell us what the shelf life is of 

a flu vaccine? 

Mr. PIEN. Theoretically, it could be longer than one season, but 

as the virus mutates or drifts every year, the product is actually 

different every year. 

The CHAIRMAN. Obsolete. 

Mr. PIEN. Obsolete. Reflecting the fact that the resistant pattern, 

mutation pattern has changed. Now, it turns out of course that flu 

vaccine is made up of three strains, so actually it is not one product 

that is different every year, but three products that are different 

every year. For that reason, the manufacturing process is complex, 

and for that reason, there has to be robust consistent routine testing procedures to ensure that the product that is made is indeed 

safe. 

In our situation, we detected some small number of batches of 

the products that we made appeared to have had contaminated, 

and the testing procedure and protocol calls for a program that has 

three components. The first one of which is to retest all of the products that we have made. The second thing is to identify all of the 

possible hypotheses as to why there might be contamination. The 

third is to do all of the experiments to rule out all of the alternative explanations such that we lock in on a root cause, as it is 

called in the trade. Root cause is what we now have come to, and 

we are doing the documentation literally on thousands of pieces of 

data and submitting in our final write-up of those testing results 

to the regulatory authorities, and have the discussion with the regulatory authorities on what it is that we have looked at what we 

had encountered early on these testing anomalies. 

That is why it takes all this time, and that is why I think it is 

critically important that Americans understand that there is a 

huge amount of routine testing protocols and procedures and system in place to ensure that there is not going to be any unsafe 

product that is released. 

The CHAIRMAN. I appreciate your walking us through that. I 

think the average person does not even begin to comprehend the 

complication and the sophistication of arriving at that, if you will, 

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new designer vaccine literally every year that fits the circumstance 

and the mutation of the change of the virus we are dealing 

with.Thank you. 

Your testimony cites the importance of public-private partnerships in addressing the important policy issues surrounding influenza and pandemic planning. Can you provide for the committee 

some of your thoughts with regard to priorities that should be considered? 

Mr. PIEN. We really think that the most important thing is before the pandemic arrives, that we increase the uptake for flu vaccine during the normal season. I think as that happens, the manufacturers are able to make more and more investments and increase their manufacturing capacity. I think that is the first and 

most important point. 

The CHAIRMAN. Capacity in other words? 

Mr. PIEN. Capacity to make more products. I think there are several obstacles that are along the way before all of these investments are going to take shape, that is in the overall system. One 

obstacle is indemnification or coverage from an insurance standpoint. Another one is to define very clearly with the guidance of the 

Centers for Disease Control and the FDA on how a pandemic vaccine can be made in a short period of time, and once it is made, 

how the product will be purchased and therefore how it will be distributed. 

I think that to wait until the pandemic is upon us, will be too 

late. The reaction time will be too short. There are new technologies that we have heard descriptions of from NIH and the one 

that is most promising is called cell culture, which mean that you 

can make vaccines without a reliance on eggs. Right now it takes 

5 months to make vaccines because of the big amount of time it 

takes to get the eggs and to grow the seeds in the eggs, so that you 

can harvest the vaccine. 

There is the potential that a cell culture vaccine can reduce the 

reaction time from what is about 5 months now to maybe 2 

months, and those kinds of research and development programs 

need to take place. Chiron is one of the companies that is in this 

field, and we hope that in a short period of time, we will have 

things to report on the progress in that area. 

The CHAIRMAN. Well, you just mentioned indemnity, liability, 

compensation programs that are necessary to establish in advance 

of a pandemic. If these programs are not in place, will Chiron be 

able to initiate production of the kind that we see necessary for the 

pandemic flu vaccine? 

Mr. PIEN. Senator, the fact is that we are committed in this field. 

But our commitment right now is to come up with this new product 

that I have just described, cell culture product that reduces the 

amount of the manufacturing time to something that is more acceptable. That will cost to something in the range of $100 million 

of R&D investment. 

Beyond that, we have to make a capital investment. We need to 

make sure that we have the facilities and the machinery and 

equipment that will make this new generation of cell culture product. That round number is another $100 to $200 million worth of 

investment. 

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Now, we are committed to coming up with a new product. If we 

do not come up with a new product, then all of the questions about 

incremental investment is theoretical. But certainly, as we get to 

the point of being able to say with some high degree of certainty 

that a cell culture product is in our hands, we can actually get registration, and get FDA approval, then it comes a time to make the 

next chunk of significant commitment, and that is the time we 

hope that would mature much of this policy discussion and advance 

many of the policy issues that we have submitted in our testimony. 

Once again, we think that with political will and with the leadership that certainly this committee represents, what you have just 

asked me, we would never have to confront. 

The CHAIRMAN. Well, I hope that is the case. You heard Carol 

express the frustration of local health officials that a seemingly 

random order in which vaccine deliveries occur. Can you shed some 

light on this for us and how does this distribution process work for 

you all? 

Mr. PIEN. I am not sure that I have a clear answer. Let me give 

you the background on why. We are still young at being a supplier 

in the United States. What we do is we work through seven national distributors. We do not ship the products ourselves directly, 

except in the case of CDC, CDC’s safety stock stockpile, as well as 

CDC’s order, which is actually a competitive tender. 

So with CDC, we do ship directly, but otherwise, we rely on the 

distributors. It is the distributors that end up shipping the products to physician’s offices, to the public health clinics, or to the retail outlets. 

The CHAIRMAN. I see. 

Mr. PIEN. Generally, based on our relatively young experience, 

we believe that we are getting the vaccines to the physicians’ offices and I am distraught to hear that we are not getting it to important pockets in different parts of the country. It is possible that 

there may have to be special consideration as to how we satisfy the 

needs in areas that are not served well by the distributors. But I 

would have to submit to you in later testimony as to what our 

thoughts are. It is outside my range of expertise. 

The CHAIRMAN. Well, thank you. Before I close out this panel, 

are there any additional comments that anyone of you would like 

to make? Janet? 

Ms. HEINRICH. I just wanted to say something more about the 

distribution——

The CHAIRMAN. Yes. 

Ms. HEINRICH [continuing]. Of vaccine going to physicians’ offices, clinics, health departments, and healthcare providers. We 

know that the 65 and over population primarily gets their immunizations through healthcare providers. But we also have heard that 

because of the distribution through intermediaries, that vaccines do 

not always go to healthcare providers first. 

In fact, it was interesting, in today’s Post, in the Health section, 

there was a little ad about finding a flu shot, and they talk about 

the Maxim Health System, and how that is where to go, and they 

are in fact supplying the Coscos and the large stores. So I just 

want to reemphasize that distribution is currently a concern. 

The CHAIRMAN. Carol, anything additional you would to make? 

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Ms. MOEHRLE. From a public health perspective where we do 

prevention, flu vaccine is one of the most common-sense things we 

can do for our citizens is help them realize what a preventive nature that vaccine does in helping us stem outbreaks and death 

from something that is preventable like the flu. 

So, the push to get the vaccine, for people to roll up their sleeve 

is a great public health message. We are here to protect the public, 

so anytime that we can get more of that vaccine at the local level 

where those people are, we need to let them know where those clinics are and who is there to help protect them. Most of the citizens 

that have a primary care physician, that is where they get their 

vaccine. For those that cannot access that, we need other clinic options for them. 

The CHAIRMAN. Thank you. Howard. 

Mr. PIEN. I would just say even on the distribution issue that we 

have identified and discussed, CDC in its characteristic way of 

wanting to contribute has been conducting conference calls on a 

weekly basis with ourselves and our distributors. As you heard in 

the earlier testimony, I think that while this is true, that there is 

more to be done. The men and women in public health service really need to be congratulated for the great advance and deep dedication that has already exhibited. This is not an issue that can be 

addressed overnight. 

It requires persistence and resolve and leadership that will ultimately lead to a much more salubrious condition than what we 

have today. 

The CHAIRMAN. Well, I thank you all, both our first and second 

panelists, for being with us today. We will monitor this closely and 

hope that not only in shaping public policy, this kind of record 

helps. We think it does, but also importantly, it again expands the 

exposure to our citizens of the need to get vaccinated. It is obviously critical, especially in certain vulnerable populations, and this 

committee tries to be an advocate of a particular one. 

We do appreciate it very much. The committee will stand adjourned. Thank you. 

[Whereupon, at 11:37 a.m., the committee was adjourned.] 

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