Introduction

Vaccines are routinely administered to healthy individuals, primarily infants, with the expectation that they will be protected from certain preventable diseases that often result in severe complications such as pneumonia, infection, meningitis, and sometimes death. Reporting any adverse events that occur after administration of a vaccine is important and provides valuable information needed to help regulatory agencies ensure that vaccines are safe.

Background

Although vaccines are considered relatively safe, just as with any drug, vaccines have been associated with adverse events. In 1986,the National Childhood Vaccine Injury Act (NCVIA) was enacted and required healthcare professionals and vaccine manufacturers to report to the US Department of Health and Human Services (HHS) specific adverse events that occurred after the administration of routinely recommended vaccines. The Vaccine Adverse Event Reporting System (VAERS) was established based on this act in 1990. The US Food and Drug Administration (FDA) in conjunction with the Centers for Disease Control and Prevention (CDC) created the VAERS as a tool to collect data on adverse events following the administration of a vaccine to evaluate safety. This does not determine causality, however; some adverse events are considered coincidental, while others are actually caused by the vaccine.

There has been a tremendous increase in the last few decades in the number of lawsuits brought against manufacturers of vaccines claiming that vaccinations cause a variety of mental and physical illnesses. This has resulted in a large increase in reporting in VAERS and possibly contributed to a distorted image of actual vaccine-related injuries.

Issue

Does the increase in adverse events reported in the VAERS after vaccine-related litigation misrepresent vaccine-caused injuries?

Rule

The increase in adverse events reported in the VAERS after vaccine-related litigation misrepresents vaccine-caused injuries, if:

  1. Reports are proven to be false cases of vaccine-caused injuries.

Analysis

Although NCVIA requires physicians and vaccine manufacturers to report serious health problems following administration of vaccines, adverse event reports filed each year in the VAERS show less than 15% resulting in life-threatening illnesses, death, or other serious outcome. Being that VAERS is open to the public and voluntary, a vaccine-related report can be filed by anyone, including physicians, parents, patients, and vaccine providers.

Under-reporting

Often, data is limited due to incomplete reports and under-reporting of adverse events. Evidence of this is shown in a surveillance report conducted by the CDC over a 10-year period (1999-2001). During that time, only 128,717 reports, primarily from vaccine manufacturers, were entered into the VAERS, compared to more than 1.9 billion vaccines administered.

Over-reporting

The issue of over-reporting adverse events occurs more frequently following vaccine-related legal proceedings. A study conducted by the American Academy of Pediatrics in 2006 aimed to prove that vaccine-related litigation increased the number of possible vaccine-related adverse event reports entered into the VAERS. Thirteen years of data was analyzed and showed that a large percentage of reports was made following court proceedings regarding possible vaccine injury. For example, in 2000, records mentioning thimerosal (controversially linked to autism) went from 0% to 87% following litigation.

Conclusion

Over-reporting in the VAERS database of potential vaccine-related adverse events occurs more frequently following vaccine‑related litigation. Due to the fact that reports submitted to the VAERS are not verifiable, it is not possible to determine causal relationships between vaccines and certain adverse events. Therefore, this type of reporting results in a possible misrepresentation of vaccine-related injuries.

For more information on this issue, contact the Kulkarni Law Firm.