Vaccines

A vaccine is a preparation used to prevent contraction of a particular disease by triggering an immune response to that disease. Because of the large number of deadly diseases that have been eliminated through the proliferation of effective vaccines, vaccination is generally viewed as one of the greatest public health achievements during the 20th century. However, risks are associated with using all immunobiologics, and no vaccine is 100% safe or effective.

Key issues in the global vaccine market today include product safety, supply shortages, the use of vaccines to prevent pandemics and address bioterrorism, and innovations in vaccine delivery systems.

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, and tetanus (DPT) vaccine. To respond to public health concerns, Congress passed the National Childhood Vaccine Injury Act (NCVIA) in 1986, which in turn led to the creation of the National Vaccine Program Office (NVPO) within the Department of Health and Human Services (DHHS). NCVIA requires that all healthcare providers who administer vaccines containing diphtheria, tetanus, pertussis, polio, measles, mumps, rubella, hepatitis B, Haemophilus influenzae type b and varicella provide a Vaccine Information Statement (VIS) to the vaccine recipient, their parent or legal guardian prior to each dose. Each VIS contains a brief description of the disease as well as the risks and benefits of the vaccine. The NCVIA also mandated that all healthcare providers report certain adverse events that occur following vaccination. As a result, the Vaccine Adverse Event Reporting System (VAERS) and Vaccine Safety Datalink Project (VSD) were established in 1990. VAERS provides a mechanism for the collection and analysis of adverse events associated with vaccines currently licensed in the U.S.; VSD involved forming partnerships with four large health maintenance organizations (HMOs) to continually monitor vaccine safety. The National Vaccine Injury Compensation Program, which was also created by NCVIA, compensates those individuals who have been injured by vaccines on a no-fault basis. On a global basis, the World Health Organization (WHO) is actively involved in ensuring the quality of vaccines.