Vaccine Safety

Are vaccines safe?
Most vaccines cause some side effects, but they are usually minor and short-lived, like low-grade fever and soreness at the injection site. Serious vaccine reactions-causing disability, hospitalization, or death-are extremely rare but they can happen. Like any medicine, vaccines carry a small risk of serious harm, such as severe allergic reactions. But experts point out that the risk of being harmed by a vaccine is much lower that the risk that comes with the infectious disease.

Are vaccines tested and monitored for safety?
Yes. Before vaccines are licensed, the FDA requires they be extensively tested to ensure safety. This process can take 10 years or longer. Once a vaccine is in use, the CDC and FDA monitor its side effects through the Vaccine Adverse Event Reporting System (VAERS). Any hint of a problem with a vaccine prompts further investigations by the CDC and FDA. If researchers find a vaccine may be causing a side effect, the CDC and FDA will initiate actions appropriate to the nature of the problem. This may include the changing of vaccine labels or packaging, distributing safety alerts, inspecting manufacturers' facilities and records, withdrawing recommendations for the use of the vaccine, or revoking the vaccine's license. For more information about VAERS, click here or call the toll-free VAERS information line at 1-800-822-7967.

For a quick reference sheet on key vaccine safety elements, an explanation of VAERS, and "what happens when rare, adverse events are detected?",consult the Surveillance and Vaccine Safety Fact Sheet.

Vaccine Safety: A Continuing, Thorough Process
There have been recent policy changes to improve vaccine safety, including ACIP's (Advisory Committee on Immunization Practices) recommendation to change the use of oral polio vaccine (OPV) to inactivated polio virus (IPV). OPV had been highly effective in controlling naturally occurring polio outbreaks, preventing thousands of cases of paralysis a year. But as a live virus, it mutated in extremely rare cases to cause polio itself. IPV eliminated this risk and was appropriate once epidemic polio was controlled.

Thimerosal, a mercury-containing preservative in vaccines, used to prevent bacteria from contaminating multi-dose vials of vaccines, has been nearly eliminated from vaccines because of growing scientific concerns about the possible effects of mercury on the nervous system. This was done even though there are no convincing data that show harm because of thimerosal in vaccines.

Manufacturers conduct stringent tests to make sure that vaccines are safe. The most important clinical trial for the recently licensed vaccine Prevnar involved nearly 40,000 people equally divided between those who received the vaccine and those who did not. Prevnar was approved to prevent invasive pneumococcal diseases, such as meningitis.

Steps to Take When You Vaccinate:
The following guidelines will serve as a tool to promote vaccine safety by communicating important information to you health care provider before immunization occurs.

1. Review the Vaccine Information Sheets (VIS's) that explain the potential risks of each vaccine. Health practitioners are required by law to provide them.
2. Ask your doctor which post-vaccination symptoms are normal and which warrant medical attention. Inquire whether certain reactions can be controlled, such as taking acetaminophen before a vaccination to prevent a fever.
3. Inform your doctor if you, your child, or a sibling has ever had a bad reaction to previous vaccinations or their components.
4. Tell the health care provider if the child has any known allergies to medication or food, such as allergies to eggs, gelatin, or baker's yeast.
5. Inform the health care provider if your child has problems with their immune system (immunosuppression disease), has HIV infection, or is undergoing steroid treatment.
6. Let the doctor know if currently your child has symptoms of a moderate to severe illness, with or without a fever.
7. Inform the health care provider if your child has received any blood products in the last year, like a transfusion or gamma globulin.
8. Adolescent and adult women should tell the doctor if they are pregnant or trying to become pregnant.
9. Research information from reliable sources, such as CDC and The Immunization Action Coalition. Some groups with names that sound official may actually be anti-vaccine networks.
   

For More Information:

The National Vaccine Program Office

FDA's Vaccine Adverse Event Reporting System

National Immunization Program

National Immunization Hotline
1-800-CDC-INFO (1-800-232-4636)

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