Vidyya Medical News Service
Volume 5 Issue 221 Published - 14:00 UTC 08:00 EST 9-Aug-2003 Next Update - 14:00 UTC 08:00 EST 10-Aug-2003
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Vaccines and how they work
Understanding how vaccines work requires some appreciation of the cells and other factors that play a role in the acquisition of immunity.  more

Scientific studies of vaccines
Scientific studies are conducted throughout the many stages of vaccine research, development, licensure and general use. Results of studies on the prevalence and burden on society of a particular disease help manufacturers and advisory committees decide whether developing a particular vaccine would be useful to the public. Market and social research conducted prior to the development of a vaccine helps manufacturers determine a vaccine’s potential profitability. Laboratory studies help researchers and manufacturers to develop quality, safe vaccines that provide protection against infectious disease. Scientific research helps federal agencies evaluate whether a vaccine is safe and effective enough to be licensed for use by the general public. Surveillance studies conducted following a vaccine’s licensure and its widespread use provide ongoing assessment for manufacturers, government agencies, state and local health departments, independent agencies and the public of the vaccine’s safety and effectiveness. Such studies also provide evidence to the public of the safety, value and importance of vaccines for themselves, their families and their communities. more


Federal regulation, surveillance and evaluation of vaccines
The regulation of vaccines begins with the extremely lengthy and rigorous process of vaccine licensure. The Center for Biologics Evaluation and Research (CBER) of the Food and Drug Administration (FDA) is the United States agency that is responsible for regulating and licensing vaccines. CBER reviews applications for licensure of vaccines, biologicals and blood products as well as evaluates the establishments that produce these products, enforces compliance with FDA standards and conducts post-marketing product surveillance.  more

Physicians, public health officials and individuals share an interest in understanding the health and safety implications associated with vaccine usage. Vaccines play an significant role in protecting both individuals and the community at large from infectious diseases. In the absence of such protection, diseases such as measles, mumps, polio and hepatitis can cause injury and death. In the absence of a vaccine against tetanus, out of every 100,000 persons in the US infected with the tetanus-causing bacterium, 30,000 would die. Similarly, if there was no diphtheria vaccine, 5,000 out of every 100,000 infected children would die on an annual basis. In contrast, out of every 100,000 people who smoke one pack of cigarettes a day, 300 deaths would be expected each year.  more

Vaccine safety issues
The following diseases have been linked either anecdotally or through research to vaccines: Autism, inflammatory bowel disease, multiple immunizations, bovine spongiform encephalopathy, thimerosal, diabetes, multiple sclerosis, and shaken baby syndrome (sbs).  more

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