Provider Information

At some point, most patients will encounter the need for vaccination. Many people question how vaccines are made, if they are effective and whether they are safe. They seek answers to these questions from a wide variety of sources including family, friends, health care providers, the Internet, television and medical literature. The information they receive is complex and, at times, inaccurate or misleading. Therefore, health professionals have a responsibility to provide accurate, understandable information and to handle vaccine safety concerns appropriately.

The National Childhood Vaccine Injury Act (NCVIA) requires all health care providers who administer vaccines to discuss the potential risks and benefits of immunization. Additionally, federal law requires all health care providers who administer vaccines in the United States to provide Vaccine Information Statements (VISs) to vaccine recipients (or their parent/guardian) prior to each dose being administered. VISs are developed by Centers for Disease Control and Prevention (CDC) and contain information on the disease as well as the risks and benefits associated with immunization. These documents, and others, can be obtained from the National Immunization Program (NIP) through the CDC Information Contact Center at 1-800-232-4636 or from the NIP's VIS website.

Revised Label for Gardasil Vaccine due to Reports of Syncope

The Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER) revised the label for Gardasil, a vaccine to protect against cervical, vulvar and vaginal cancers caused by Human Papillomavirus (HPV) types 16 and 18 and genital warts caused by HPV types 6 and 11. The revised label includes new information in the Warnings and Precautions section noting that individuals who faint sometimes have tonic-clonic (jerking) movements and seizure-like activity.

Find iInformation about this change on FDA’s web site.

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