[Congressional Record (Bound Edition), Volume 148 (2002), Part 8]
[Senate]
[Pages 11100-11101]
[From the U.S. Government Publishing Office, www.gpo.gov]




                                VACCINES

  Mr. FRIST. Madam President, I rise for a few minutes to discuss in 
morning business an issue that involves essentially every American 
today, and that is an issue regarding the shortage of vaccines. Every 
day, thousands and thousands of parents take their children to 
physicians' offices all across this great country, not because their 
children are sick or in response to an acute illness, but because they 
understand the importance of preventing a potential illness.
  They want, and they rightfully expect, their children will be able to 
receive vaccines needed to prevent illnesses that range from 
tuberculosis to measles to mumps to rubella to chicken pox. Yet--and I 
tell this to my colleagues and to people listening across the country--
the fact is that many of these parents are being turned away with their 
children still vulnerable to some of these very destructive and often 
deadly diseases. Five vaccines that prevent eight childhood diseases 
have been in short supply in the United States since last summer.
  Thankfully, there have been no major outbreaks among American 
children. We thankfully have been vigilant about vaccinations in this 
country in recent years, and our population on the whole has built up a 
strong immunity. But we have a short supply of vaccines today. The 
longer these vaccine shortages continue, the more vulnerable our 
children become.
  If we do not take prudent steps today in Congress to address these 
current and recurring vaccine shortages, it is almost certain--from a 
public health standpoint, from what we know today--that American 
children will experience an outbreak of diseases that we have the 
tools, we have the ability, we have the medicines to prevent.
  Is it possible to have these destructive diseases appear in this day 
and time? The answer is yes, and these vaccines that are in short 
supply today in our country are necessary to prevent such outbreaks 
that have occurred in other industrialized nations.
  If we look at Japan, for example, vaccination rates for whooping 
cough dropped from the 80-percent rate in 1974, to 10 percent in 1976--
from 80 percent to 10 percent over a 2-year period. This caused a 
dramatic rise in the incidence of the disease from 400 cases and no 
deaths, to 13,000 cases and 41 deaths within 5 years.
  The vaccine for pertussis, which is whooping cough, diphtheria and 
tetanus is one of the five vaccines in short supply. The others are for 
tetanus, measles, mumps, rubella, chicken pox and pneumococcal disease, 
which can lead to pneumonia, bacteremia--that is bacteria floating in 
your blood that can give you fever and make you ill--and meningitis, 
which is inflammation of the structures that surround the brain.
  These vaccines for our children are in short supply. The Centers for 
Disease Control and Prevention, the CDC, reports that new supplies of 
these vaccines will be available soon. That is good news. Two of the 
vaccines that are now in short supply will be available later this 
summer, two more by the end of the year, and the last one in the fall, 
we believe--maybe a little bit later.
  That is welcome news. But the underlying, fundamental problems that 
have caused the current shortage--and past shortages--if not addressed, 
will cause another shortage in the future. Vaccine shortages will occur 
year after year, time after time, if we do not act. Now is the time to 
address the fundamental problems underlying these shortages.
  Today, there are only four manufacturers producing vaccines for 
America's children. Of those four, only two are American companies. New 
companies that may want to produce vaccines are confronted with this 
dual risk of increasing liability and at the same time questionable 
return on investment. When you put those two together, there are fewer 
and fewer manufacturers, and that is contributing to this shortage.
  The remaining vaccine manufacturers are upgrading and expanding 
production facilities. Again, that is good news. Even if we have a 
flood in the supply of vaccines to take care of current shortages, it 
will be only a matter of time when we have another drought for these 
lifesaving vaccines. We must address the underlying, fundamental 
reasons for these recurring vaccines shortages. We have to do that in a 
thoughtful and comprehensive way based on what we know are the 
realities in terms of production and usage. It is the job of the Senate 
to set this framework in place.
  In March, I introduced the Improved Vaccine Affordability and 
Availability Act. This act does a number of things. In essence, it 
requires the Federal Government to build and maintain a 6-month supply 
of prioritized vaccines that we and our public health and our medical 
communities agree are necessary to prevent these preventable diseases.
  This would stabilize the supplies over time and help us to be better 
prepared in those years in which vaccine production cannot meet the 
demand at that point in time. It would also expand the funding 
available for State and local efforts to boost immunization rates. You 
can have the vaccine and know that the vaccine prevents disease, but 
unless you actually apply that vaccine to our children it is not going 
to do much good. This increased vaccination effort will focus on adults 
and children who are underserved or who are at high risk of contracting 
vaccine-preventable diseases.
  Perhaps the most important provisions in this bill are modifications 
to help restore balance to a program called the Vaccine Injury 
Compensation Program. This program was created about 20 years ago, in 
the mid-1980s, to rapidly compensate those who suffer serious side 
effects from vaccines that we recommend, from a public health 
perspective, our children receive. It has been very successful. This 
program also reduces the burden of litigation for doctors and nurses 
who administer the vaccines, as well as for manufacturers.
  Until a few years ago, the program seemed to work very well. But now 
factors threaten it from working so well and will cause an impediment 
to the supply of vaccines over time. Let me briefly explain.
  We have had a rush of new law suits, which are threatening our 
vaccine supplies. The Vaccine Injury Compensation Program is literally 
being overwhelmed today with new cases. Many of those are broadly 
without merit. As a result of the program's 240-day decision deadline, 
State and Federal courts

[[Page 11101]]

are increasingly becoming the forum for expensive litigation. And many 
of the meritorious claims and justified claims are not being decided in 
a timely way.
  One pending lawsuit is for $30 billion in damages--$30 billion. If 
you look at the whole value today of the global vaccine market, the 
total value is only $5 billion. This one lawsuit is six times the 
global market for vaccines.
  This climate of legal uncertainty has contributed to an exodus of 
manufacturers from being in the business at all and also from being in 
the business here in the U.S. We have seen a subsequent rise in the 
price of vaccines. Since the 1980s, the number of vaccine manufacturers 
has dwindled from 12 down to 4. In some cases, only a single 
manufacturer is producing some of our most critical vaccines. The 
Improved Vaccine Affordability and Availability Act--S. 2053--restores 
balance to the Vaccine Injury Compensation Program. It would help 
compensate those with serious health side affects from vaccines while 
at the same time ensuring that unwarranted litigation does not further 
destabilize our vaccine supply.
  The development and widespread use of vaccines indeed has been one of 
the most successful public health initiatives in our history. We have 
reduced the incidence of diseases, such as measles, mumps, and polio, 
and we have even eradicated smallpox--which over a period of time has 
killed somewhere between 300 million to 500 million people in the 20th 
century alone. Smallpox as a disease does not exist.
  The decision before us is whether or not to build on the successes 
that we have achieved in vaccines in the 21st century. I speak not only 
of vaccines that already exist--the vaccines for our children that are 
in short supply--but also as we look at the role of future vaccines 
needed to address bioterrorism--when we know we don't have the vaccine 
for the Ebola virus today. We have inadequate vaccines for three of the 
seven agents that are classified by our intelligence agencies as 
critical and for which we are at risk. Some day we will have a vaccine, 
I believe, that will hopefully cure Alzheimer's disease.
  What we are looking for is a platform--a comprehensive approach for 
all vaccine development.
  The Improved Vaccine Affordability and Availability Act will help us 
to expand the vaccine market. It will stabilize our vaccine supply, and 
it will improve access to vaccines.
  When parents take their children to the doctor, they will not be 
turned away because of a shortage of supply of these vaccines.
  Earlier this month the Improved Vaccine Affordability and 
Availability Act gained additional momentum when the Advisory 
Commission for Childhood Vaccines--the group that advises the Secretary 
of Health and Human Services on improving the Vaccine Injury 
Compensation Program--voted on June 6 in favor of most of the 
provisions in our bill, S. 2053.
  I thank the members of the Advisory Commission for Childhood 
Vaccines, or ACCV, for acting so quickly on a matter of such 
importance, and also for lending their expertise to this debate. 
Further, I thank them and express my appreciation for their suggestions 
in how we can modify some of the provisions in the bill.
  I urge my colleagues to look at this particular bill and I look 
forward to working with my colleagues as we move forward in considering 
the ACCV recommendations.
  The need to act is urgent. We simply cannot afford to wait until 
tragedy strikes, or to surrender the gains we have made over the last 
50 years in reducing and preventing childhood diseases through 
vaccination. I urge my colleagues to join Senator Hutchison and Senator 
Bunning in cosponsoring S. 2053, and to work with us to pass this 
critical legislation this year.
  The ACTING PRESIDENT pro tempore. The Senator from Alabama.
  Mr. SESSIONS. Thank you, Madam President.

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