A response to vaccine safety: National Childhood Vaccine Injury Act

At some point, almost every person in the United States is vaccinated. Therefore, many individuals question how vaccines are made, if they are effective, and whether they are safe.

The topic of vaccine safety became prominent during the mid 1970’s with increases in lawsuits filed on behalf of those presumably injured by the diphtheria, pertussis, tetanus (DPT) vaccine. Manufacturers were getting concerned due the increasing number of lawsuits against them, and called on Congress to act. In order to reduce liability and respond to public health concerns, Congress passed the National Childhood Vaccine Injury Act (NCVIA) in 1986. This act was influential in many ways.

The NCVIA requires all health care providers who administer vaccines containing diphtheria, tetanus, pertussis, polio, measles, mumps, rubella, hepatitis B, Haemophilus influenzae type b and varicella to provide a vaccine information statement (VIS) to the vaccine recipient, or his or her parent or legal guardian, prior to each dose. A VIS must be given with every vaccination including each dose in a multi-dose series. Each VIS contains a brief description of the disease as well as the risks and benefits of the vaccine.

The NCVIA also requires health care providers to report certain adverse events that occur following vaccination. As a result, the Vaccine Adverse Event Reporting System (VAERS) was established by CDC and FDA in 1990. VAERS is a surveillance system to monitor the adverse effects of vaccines. Rare side effects and delayed reactions may not be evident until the vaccine is administered to millions of people, and therefore possibly does not show up in initial trials when only hundreds to thousands of people are tested.

To reduce the liability of manufacturers and health care providers, under the NCVIA, the National Vaccine Injury Compensation Program (NVICP) was also created to compensate those injured by vaccines on a “no fault” basis. The program covers all routinely recommended childhood vaccinations. Settlements are based on a Vaccine Injury Table, which summarizes the adverse events caused by vaccines.

The NCVIA also established a committee from the Institute of Medicine (IOM) to review the literature on vaccine side effects. This group concluded that there are limitations in our knowledge of the risks associated with vaccines. Specifically, the IOM identified the following problems: limited understanding of biological processes that underlie adverse events, incomplete and inconsistent information from individual reports, poorly constructed research studies (not enough people enrolled for the period of time), inadequate systems to track vaccine side effects, and few experimental studies published in the medical literature. Significant progress has been made over the past few years to monitor side effects and conduct research relevant to vaccine safety.

The CDC would also like the public to know that before vaccines are even licensed by the FDA, they are tested extensively in the laboratory and with human subjects to ensure their safety. Vaccine licensing is a lengthy process that may take 10 years or longer. The FDA requires that vaccines undergo three phases of clinical trials with human subjects before they can be licensed for use in the general public. After a vaccine is licensed for public use, its safety is monitored continually.

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