Kids' Vaccinations : Vaccines and the Law

by Food and Drug Administration (FDA)

(Page 4 of 4)

For children, the vaccine has been shown to be safe and effective and can be administered at the same time as the measles, mumps and rubella vaccine. (The MMR vaccine is given at 12 to 15 months and again between 4 and 6 years or before junior high or middle school.) Public health officials hope that being able to give the chickenpox vaccine along with an already schedulated vaccine will encourage vaccination.

A new vaccine approved by FDA in September 1998 protects children against rotavirus, the most common cause of severe diarrhea and dehydration in infants and toddlers. According to the DHHS, rotavirus kills an estimated 870,000 children annually, and hospitalizes about 55,000 infants and children.

The government recommended schedule for this oral vaccine is 2, 4, and 6 months. This vaccine may be given concurrently with other vaccines, but it is not recommended for children over 6 months old.

Despite occasional serious reactions from vaccines, for the vast majority of children, benefits of immunity greatly outweigh the risks.

Before any vaccine is licensed by FDA, it has been tested and evaluated thoroughly both in the laboratory and in clinical trials. Besides reviewing scientific studies on vaccines before licensing them, the agency is involved in basic research leading to the development of new and safer products. The acellular pertussis vaccine, for example, was developed in part based on research by FDA scientists.

Agency scientists have developed methods to test vaccines in the laboratory before using them on children. They have also developed accurate methods for testing those children to see if they have appropriate immune responses to new vaccines.

FDA continues to encourage the timely inoculation of all children in this country against childhood diseases, and to make sure those vaccines are as safe and effective as possible.

Vaccines and the Law

In 1986, Congress passed the National Childhood Vaccine Injury Act to help ensure vaccine safety and availability, and to compensate people injured by vaccination.

The act established the National Vaccine Injury Compensation Program to compensate those who suffer certain vaccine-related injuries or death. The act also required health-care providers and manufacturers of specified vaccines to report certain serious adverse reactions they encounter. FDA and CDC keep track of these reports through the Vaccine Adverse Event Reporting System, or VAERS.

VAERS tracks serious vaccine reactions, not common fevers and soreness from shots. Serious reactions include death, life-threatening illness, hospitalization, and disability resulting from a vaccine. Patient identity is kept confidential.

Monthly reports from VAERS are sent to FDA's Center for Biologics Evaluation and Research, which evaluates possible safety issues. Anyone may file a report. To receive a VAERS reporting form, call (1-800) 822-7967.

From its beginning to September 1993, VAERS received more than 20,000 reports. Though it helps in assessing the number of adverse reactions to vaccines nationwide, VAERS is a "passive" system that relies on reporting from health-care professionals and others. For instance, VAERS does not directly compare the incidence of disease among recently vaccinated people with disease among people who have not been vaccinated.

The National Vaccine Injury Compensation Program protects doctors and manufacturers from lawsuits while providing compensation for those injured from vaccines. It's designed to be easier and faster than traditional legal remedies for medical injuries.

Individuals claiming more than $1,000 in expenses from vaccine injury may be eligible for as much as $250,000 compensation. Any death from a vaccine is awarded the highest amount in compensation.

Some injuries may be compensated without proof that the vaccine was at fault. These are spelled out in a vaccine injury table. Most injuries must occur within hours or days of a vaccine to be considered a result of the shot. For more information about what injuries may be compensated, call (1-800) 338-2382.

About the Author

www.fda.gov
FDA is A United States government body that oversees medical devices, including contact lenses, intraocular lenses, excimer lasers and eyedrops. In the US, these products must be approved by the FDA before they can be marketed.