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Vaccines: FDA Guide Tells You What You Need to Know

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As parents and caregivers fill out a multitude of forms at the start of the school year, they may have questions about some requirements, including the vaccine schedule.

According to Marion Gruber, Ph.D., director of the Office of Vaccines Research and Review at the Food and Drug Administration (FDA), vaccines are integral to get children off to a healthy start.

"Parents should know that vaccines protect children from many serious illnesses from infectious diseases. The risk of being harmed by vaccines is much smaller than the risk of serious illness from infectious diseases," she says.

Gruber emphasizes that most side effects of vaccines are usually minor and short-lived. For example, a child may feel soreness at the injection site or experience a mild fever. Serious vaccine reactions are extremely rare, but they can happen.

FDA’s online resource, Vaccines for Children, A Guide for Parents and Caregivers, describes in more detail the types of routinely administered vaccines available for children, and answers many of the questions posed by parents and caregivers.

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Reducing Childhood Disease

Vaccines have contributed to a significant reduction in many childhood infectious diseases, such as diphtheria, measles, and Haemophilus influenzae type b (Hib). Some infectious diseases, such as polio and smallpox, have been eliminated in the United States because of vaccines. It is now relatively rare for American children to experience the devastating and often deadly effects of diseases that can be prevented by vaccines.

Because immunization programs of the 20th century were so successful, many of today’s parents have never seen many vaccine-preventable diseases and do not understand that the diseases could actually reemerge. If individuals choose not to vaccinate themselves or their children, some diseases that are now rare or nonexistent in this country may resurface, Gruber says.

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Steps to Take When Your Child Is Vaccinated

Review the vaccine information sheets

These sheets explain both the benefits and risks of a vaccine. Healthcare professionals are required by law to provide them.

Talk to your healthcare professional about the benefits and risks of vaccines.

Learn the facts about the benefits and risks of vaccines, along with the potential consequences of not vaccinating against diseases. Some parents and caregivers are surprised to learn that children can be harmed or die of measles, diphtheria, pertussis, and other vaccine-preventable diseases.

Before vaccination, inform your healthcare professional of these conditions.

This might include being sick or having a history of certain allergic or other adverse reactions to previous vaccinations or their components. For example, eggs are used to produce many influenza (flu) vaccines; therefore, it is important to inform your healthcare professional if your child is severely allergic to eggs.

The packaging of some vaccines that are supplied in vials or prefilled syringes may contain natural rubber latex, which may cause allergic reactions in latex-sensitive individuals. Let your healthcare professional know about an allergy to latex. It is also extremely important to discuss with your healthcare professional which vaccines should or should not be given to children who have a weakened immune system.

Report adverse reactions

Adverse reactions and other problems related to vaccines should be reported to the Vaccine Adverse Event Reporting System, which is maintained by FDA and the Centers for Disease Control and Prevention (CDC). For a copy of the vaccine reporting form, call 1-800-822-7967, or report online to www.vaers.hhs.gov

This article appears on FDA's Consumer Updates page, which features the latest on all FDA-regulated products.

August 11, 2015

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