Hepatitis B Vaccine Safety Hearing

Public health, including vaccine safety, is critically important to this Subcommittee.

Our Subcommittee, which is today exercising its oversight responsibility for the Department of Human Health & Services, is committed to ensuring that our national immunization policies and programs are functioning properly. The Centers for Disease Control & Prevention (CDC) and the Food & Drug Administration are the federal agencies primarily responsible for immunization policy and safety and will be sharing their expertise with us later this morning.

There is no doubt that immunizations have greatly improved the public health in our country. Smallpox has been eradicated and cases of polio, tetanus, and diphtheria are rare. Theses are great victories for our public health system.

Unfortunately, however, and, tragically, the history of immunization shows that sometimes vaccinations injure a child instead of inoculating them. That is why Congress created the Vaccine Injury Compensation Program in 1986, to compensate those who have been harmed by a vaccine.

My colleague the Ranking Member of our full Committee, the gentlemen from California, Mr. Waxman and my brother, a former Member of Congress worked to successfully enact that law. Oversight of that law and program are important Congressional responsibilities. This will be the first oversight hearing held in 13 years on these issues.

The purpose of this law was to protect vaccine manufacturers and also to compensate children injured from a vaccine. I do have some concerns about whether the Compensation fund is working the way Congress intended. The Department of Health &Human Services has issued new rules making it harder to be compensated, so that while there is over $1 billion in the fund, only a fraction of that was awarded last year.

The vaccine experience in the early 1980s also demonstrates that when a pattern of injuries from a vaccine emerges, that vaccine can be made safer. The crisis in public confidence in the Diphtheria, tetanus, pertussis (DPT) vaccine that led to creating the compensation law also resulted in manufacturers creating a safer vaccine. Today, the "whole-cell" vaccine that caused the controversy is coming off the market and has been replaced by a safer, "acellular" vaccine.

Today we have convened individuals from a variety of government, academic, professional and citizen groups in an effort to provide a structured opportunity for the Members of this Subcommittee to ask questions about the federal government’s Hepatitis B vaccination policy and its impact on public health.

I want to make clear at the outset that the purpose of this hearing is not to scare parents away from immunizing their children.

The purpose of this hearing IS to examine the effectiveness of the 1986 law, to learn more about how the federal agencies administer their immunization policy and then how they monitor and analyze the safety of the Hepatitis B vaccine, and to review the evidence of adverse reactions to the vaccine.

Hepatitis B virus is certainly a serious disease. We will here from witnesses today who have experienced the terrible effects of this disease. In 1996, the CDC reported 10,637 new cases of Hepatitis B, 279 of who were below age 14. The CDC estimates that four to five thousand people die a year from Hepatitis B related liver disease.

To combat this disease, the CDC issued guidelines in 1991 recommending that every infant receive the Hepatitis B vaccine. In 1995, the CDC recommended the routine vaccination of teenagers

The FDA first licensed a plasma-derived hepatitis B vaccine in 1981. In 1986, the FDA licensed the first "recombinant" Hepatitis B vaccine, meaning the vaccine is the first genetically engineered vaccine.

Based on the CDC recommendations, 42 states mandate that children be vaccinated before entering kindergarten.

20 million children a year now receive some type of required vaccine. Almost 90% of all children in this country are now immunized.

When a parent takes their child in for a vaccine, they are supposed to be given an information sheet outlining the risks and benefits of the vaccine. While almost all of the states mandating childhood vaccinations allow exemptions, the information sheet does not tell parents that these exemptions exist.

Recent news reports have questioned the safety of hepatitis B vaccines and have suggested an association between the vaccine and multiple sclerosis and other autoimmune disorders. Our job here today is not to "prove" whether or not this vaccine "causes" illnesses or deaths. Instead, we have created a forum for asking questions about what scientific evidence does exist and whether further studies should be completed.

Specifically, I would like this hearing to examine the following issues:

First, what is being done to study the adverse reactions reported in the Vaccine Adverse Event Reporting System (VAERS)?

Second, do the benefits of administering the vaccine to infants outweigh the risks?

Third, what process does the CDC employ to make a recommendation for a vaccine? What role do pharmaceutical companies play in that process? Do conflicts of interest exist?

Fourth, what disclosure is required before the vaccine is given? Is it adequate?

With this outline in mind, I want to recognize the ranking minority member of the Subcommittee.