Vaccine Safety : Reactions, Part 2

by Food and Drug Administration (FDA)

(Page 4 of 4)

Alleged Associations

Some have looked to vaccines to explain a host of serious conditions that we don't fully understand, including sudden infant death syndrome (SIDS), multiple sclerosis, diabetes, and autism. There have been a number of epidemiological studies of these possible associations, and experts say there is no good scientific evidence at this time showing that vaccines cause these diseases or conditions.

"Physicians give vaccines to children at multiple time points during their development and a lot can happen during that time," says Midthun. She stresses that both the FDA and the CDC take concerns of parents seriously. After careful review of all available information, neither agency has found that existing data support any link between the measles, mumps, and rubella (MMR) vaccines and autism, a hypothesis that has received considerable publicity over the last year.

The CDC and the NIH recently contracted with the Institute of Medicine, part of the National Academy of Sciences, to establish the Immunization Safety Review Committee. The independent committee is charged with evaluating nine vaccine safety topics over a three-year span. The possible association of the MMR vaccine and autism was the first topic.

On April 23, 2001, the Immunization Safety Review Committee reported its finding that the current evidence does not favor the hypothesis that there is a link between MMR and autism, and that no changes should be made in the current policy of administering the MMR vaccine. The committee could not rule out the possibility that the MMR vaccine might be linked to autism in some sub-population, and recommended that targeted research in this area be conducted. To date, there is no indication as to whether there is any such subpopulation, or what the genetic makeup or other characteristics of such a subpopulation would be, Egan says.

"It's important that policy decisions about vaccine safety be based on science," says Martin G. Myers, M.D., director of the U.S. Department of Health and Human Service's National Vaccine Program Office. As vaccine safety research continues, Myers says, we can't afford to lose sight of what life was like before immunization. Vaccination is the reason we don't see the suffering, disability, and death from whooping cough, measles, polio and other infectious diseases like we used to.

"Vaccines are very safe," Myers adds, "but nothing is without risk." Not vaccinating against certain diseases means choosing another type of risk, he says. Myers recalls treating an infant with seizures from tetanus so strong they shook the baby's whole body. These types of seizures and many deaths are preventable by vaccination. And Myers still has an audiotape from the early eighties of a child hacking and gasping for air because of whooping cough. "The child's mother asked me to play it for parents who might be undecided about getting vaccinated." He's also played the tape for medical students and residents. "It doesn't take long before somebody in the room asks me to please turn it off."

National Vaccine Injury Compensation Program

The National Vaccine Injury Compensation Program became effective in 1988. The program is a federal "no-fault" system designed to compensate those individuals, or families of individuals, who have been injured by childhood vaccines. A claim may be made for any injury or death thought to be the result of a vaccine covered under the program. The program is administered jointly by the U.S. Department of Health and Human Services, the U.S. Court of Federal Claims, and the U.S. Department of Justice. For more information, call 1-800-338-2382, or visit www.bhpr.hrsa.gov/vicp.

Steps to Take When You Vaccinate

1. Review the vaccine information sheets that explain the potential risks of each vaccine. Health practitioners are required by law to provide them.

2. Talk to your doctor about whether certain reactions to vaccines can be controlled. For example, fever may be prevented or reduced by taking acetaminophen before or after vaccination.

3. Tell your doctor if you, your child, or a sibling has ever had a bad reaction to a vaccine.

4. Ask your doctor about conditions under which you or your child should not be vaccinated. This might include being sick or having a history of certain allergic or other adverse reactions to previous vaccinations or their components, such as allergies to eggs, which are used to grow influenza vaccines.

5. Report unexpected events after vaccinations to your doctor and to the Vaccine Adverse Event Reporting System (VAERS) at 1-800-822-7967.

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.