Are Vaccines Safe?

Since vaccines are administered to otherwise healthy people, they are among the most rigorously tested and safest medical products on the market. It can take 10 or more years and millions of dollars to thoroughly test a new vaccine before it is licensed and made available to the public. Once on the market, continuous monitoring ensures that each dose of the vaccine is as safe as possible.

Manufacturers continually test their products and submit the results of key tests, along with samples of the product, to the Center for Biologics Evaluation and Research (CBER) at the United States Food and Drug Administration (FDA) for evaluation before the CBER will approve the release of that lot of vaccine for administration. Tests performed on the final product may include those for sterility, identity, purity, and potency to assess immunogenicity (the ability to produce an immune response) and/or immunological content, among others.

VAERS

In addition to testing of the actual vaccine, there is a system in place whereby any symptoms that people think may have been caused by a vaccine can be reported into a central program which collects this information about possible side effects. This system is called the Vaccine Adverse Events Reporting System (VAERS).

The combined effects of the post licensure testing and VAERS reporting have resulted in the quick withdrawal from the market in 1999 of RotaShield™ after it was discovered that the vaccine may have contributed to an increased risk for intussusception, or bowel obstruction, in one of every 12,000 vaccinated infants and also to the development of a safer combination diphtheria/tetanus/pertussis vaccine (DTaP).

VAERS, however, cannot be used by itself to detect safety risks associated with vaccines. It is a passive reporting system, which means that anyone can file a report in the system, including parents, relatives and family friends as well as doctors. Oftentimes, this results in reports of coincidental, not causal relationships between vaccines and a child's symptoms.

Side Effects

Side effects can occur with vaccines, as with any medication. These side effects are usually minor and most often include tenderness at the injection site and a low fever (which is actually a positive sign that the body is doing its job by reacting to the vaccine). Severe reactions to vaccines are very rare (less than one in a million shots according to the Centers for Disease Control and Prevention).

You should be sure to discuss any known allergies with your child's doctor since it is often a known allergic reaction to a vaccine component that causes a more severe reaction, such as an allergic reaction to eggs causing a possible reaction with the flu vaccine.

Learn More

• American Academy of Pediatrics
• Every Child By Two
• American Academy of Family Physicians
• American Medical Association
• Centers for Disease Control and Prevention
• The Vaccine Education Center at the Children's Hospital of Philadelphia
• Emory Vaccine Center
• Immunization Action Coalition
• Institute for Vaccine Safety at Johns Hopkins Bloomberg School of Public Health
• National Network for Immunization Information
• Parents of Kids with Infectious Diseases
• Voices for Vaccines

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