FDA’s Role in Protecting Your Child’s Health Through Safe and Effective Vaccines. Norman W. Baylor, PhD Director, Office of Vaccines Research and Review Center for Biologics Evaluation and Research U.S. Food and Drug Administration. Why Vaccines Are Important for Children.
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Norman W. Baylor, PhD
Director, Office of Vaccines Research and Review
Center for Biologics Evaluation and Research
U.S. Food and Drug Administration
Vaccines protect against serious infectious diseases and save lives.
The devastating effects of diseases such as polio, pertussis (whooping cough), rubella (German Measles) and Haemophilus influenzae type b (Hib) are now rare due to vaccines.
Infant deaths due to these diseases have essentially disappeared in the United States.
Viruses and bacteria that cause vaccine-preventable diseases and death still exist and can be passed on to people who are not immunized.
Safe: “Relative freedom from harmful effect… when prudently administered, taking into account the character of the product in relation to the condition of the recipient at the time.”
Pure: “Relative freedom from extraneous matter in the finished product,…”
Potent: “Specific ability of the product … to effect a given result.”
Vaccines must be manufactured consistently according to current Good Manufacturing Practices.
FDA takes vaccine safety very seriously throughout the vaccine life cycle
for the population
for a patient
in terms of
A vaccine is made-up of various ingredients and each ingredient present in a vaccine is there for a specific reason. Different ingredients have different roles in a vaccine, and vaccines licensed for use in the United States are demonstrated to be safe and effective before they are used by the public.
FDA’s work continues after approval:
FDA employees are parents, aunts, uncles, and grandparents and we have complete confidence in FDA-approved vaccines for our own families. The public can be assured that FDA is diligent in ensuring that the vaccines licensed for use in the United States are shown to be safe and effective.
By phone, toll-free:
On the web: www.fda.gov/BiologicsBloodVaccines/default.htm