FDA: A Parents’ Guide to Kids’ Vaccines

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The FDA has unveiled a “A Parents’ Guide to Kids’ Vaccines” on its website. The website outlines several key areas: Vaccines for Children – A Guide for Parents and Caregivers; Benefits and Risks; Types of Routinely Administered Vaccines for Children; Steps to Take When Your Child is Vaccinated; Routinely Administered Vaccines for Children; and Parents and Caregivers are Asking. We have previously covered vaccine issues before.

From the FDA’s website:

Vaccines for Children – A Guide for Parents and Caregivers; Benefits and Risks

FDA: 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 due to effective vaccines. It is now rare for children in the United States to experience the devastating and often deadly effects of these diseases that were once common in the United States and other countries with high vaccination coverage.

The vast majority of vaccines are given to healthy babies, children and adults; therefore, it is critical that vaccines be demonstrated to be safe and effective. Ensuring the safety and effectiveness of vaccines is one of the Food and Drug Administration’s (FDA) top priorities. The Center for Biologics Evaluation and Research (CBER) is the center within FDA that has regulatory oversight of vaccines in the United States assuring the availability of safe and effective 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 the potential for them to re-emerge. If too many individuals choose not to vaccinate themselves or their children, some diseases that are now rare or non-existent in this country may resurface.

Benefits and Risks

FDA: A vaccine is a medication.  Like any medicine, vaccines have benefits and risks, and although highly effective, no vaccine is 100 percent effective in preventing disease or 100 percent safe in all individuals. Most side effects of vaccines are usually minor and short-lived. For example, a person may feel soreness at the injection site or experience a mild fever. Serious vaccine reactions are extremely rare, but they can happen.

“Parents should know that the risk of being harmed by a vaccine is significantly smaller than the risk of serious illness that comes with infectious diseases,” says Marion Gruber, Ph.D., director of the Office of Vaccines Research and Review in CBER. “Vaccination is a very important step to get children off to a healthy start.”

For more information on potential adverse events or reactions, talk with your healthcare provider, and many vaccines also have FDA-approved labeling for the patient that can be a resource of information. It is important to discuss with your healthcare provider any prior reactions to vaccines and any adverse reactions following vaccination.

Types of Routinely Administered Vaccines for Children

FDA: Vaccines work by preparing the body’s immune system for future attacks by a certain disease, caused by either viruses or bacteria. Vaccines contain weakened bacteria or viruses, or parts of bacteria or viruses, and mimic these disease-causing agents (which are called antigens). As a result of vaccination, the body’s immune system thinks the antigens from the vaccine are foreign and shouldn’t be in the body, but the antigens don’t cause disease in the person receiving the vaccine. After receiving the vaccine, if the virus or bacteria that cause the real disease then enters the body in the future, the immune system is prepared and responds quickly and forcefully to attack the disease-causing agent to prevent the person from getting sick. Vaccines are frequently given by injection (a shot), but some are given by mouth and one is sprayed into the nose.

Steps to Take When Your Child is Vaccinated

FDA: Review the vaccine information sheets
These sheets explain both the benefits and risks of a vaccine. Healthcare providers are required by law to provide them.

Talk to your healthcare provider 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.

Conditions to make your healthcare provider aware of before vaccination
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 grow many influenza (flu) vaccines; therefore, it is important to inform the healthcare provider if a 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; therefore, an allergy to latex is helpful to inform healthcare providers of beforehand.

It is also particularly important to discuss with your healthcare provider which vaccines should or should not be given to children who have weakened immune systems.

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

Routinely Administered Vaccines for Children

FDA:
Some of the most commonly administered vaccines are briefly discussed below. A complete list of licensed vaccines in the United States and additional information, such as prescribing information and patient labeling are available at http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm093833.htm.

Parents and Caregivers are Asking.

FDA: Should I be worried about the increasing number of vaccines recommended for children?

No. Because of advances in science and manufacturing, it is easier than in the past to be sure that vaccines are highly pure.  Vaccines represent only a minor stimulation of the infant immune system compared to the large number of potentially dangerous bacteria and viruses babies routinely encounter: starting immediately after a baby is born; thousands of different bacteria begin to live on the skin and the lining of the nose, throat, and intestines. The baby’s immune system rapidly launches immune responses to these bacteria that prevent them from invading the blood stream.

Are the ingredients that are used to make vaccines safe?

Yes.  Each ingredient in a vaccine is included for a reason.  Before FDA determines that a vaccine is safe and effective and licenses it for use by the public in the United States, the vaccine is carefully evaluated by FDA scientists and doctors, taking into account the ingredients that make up the entire vaccine.

Are vaccines linked to autism?

No, the scientific evidence does not support a link between vaccination and autism or other developmental disorders.


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