| OBSERVATION'S | SMALLPOX SUPPLEMENTAL FACT SHEET Investigational Vaccinia Immune Globulin (VIG) Information The smallpox vaccine is made from a live virus related to smallpox called vaccinia (not smallpox virus). The vaccine stimulates the immune system to react against the vaccinia virus, and develop immunity to it. Immunity to vaccinia also provides immunity to smallpox. For most people, live virus vaccines are safe and effective. Some people, however, are at greater risk for serious side effects from the smallpox vaccine. Vaccinia Immune Globulin (VIG) may help people who have certain serious reactions to the smallpox vaccine. VIG is an investigational new drug (IND) made from plasma from the blood of people who have immunity to smallpox. If you develop a serious reaction to the smallpox vaccine, you may be offered VIG. VIG Information !"VIG is an immune globulin made from the blood of people who have gotten the smallpox vaccine more than once (usually many times). The part of the blood (antibodies) that gives protection from vaccinia infection is taken out, purified (cleaned), and bottled. It is called the immune globulin. !"VIG is not licensed (approved) by the Food and Drug Administration (FDA). It is ģinvestigational.ī !"There are two available types of VIG: VIG-intramuscular (VIG-IM) and VIG-intravenous (VIG-IV). !"VIG might be used in cases of generalized vaccinia, eczema vaccinatum, or progressive vaccinia. How is VIG administered? VIG is given by a needle in the muscle in the arm (VIG-IM), or by a needle in a vein in the arm (VIG-IV). The type of VIG (IM vs. IV) given will depend on which is available. Side Effects !"VIG is made from human blood plasma. Products made from human blood may contain infectious agents, such as viruses, that can cause disease. To decrease the chance that such products carry viruses, plasma donors are checked for prior contact with certain viruses, the collected plasma is treated for the presence of certain viruses, which are killed and/or removed from the plasma. !"Immune globulin products like VIG may cause allergic reactions that can be mild or may be serious and cause life-threatening breathing and heart problems. If you have a serious or life-threatening reaction, medical care and drugs are available to treat you. !"People who have a problem making a certain antibody called IgA or who have had a serious allergic reaction to human antibody products before are at risk for an allergic reaction to VIG. !"Most side effects from similar products are mild and do not last for very long. You may experience back pain, chills, headache, muscle pain, joint pain, itching, weakness, fever, nausea, vomiting, abdominal cramps, flushing, tightness of the chest, sweating, changes in blood pressure, dizziness, paleness, shortness of breath, and wheezing. Rashes occur rarely. !"Some people experience pain and soreness at or near the site where VIG is given. While this is unpleasant, it is not serious and can be treated with common pain relievers. For more information, visit www.cdc.gov/smallpox, or call the CDC public response hotline at (888) 246-2675 (English), (888) 246-2857 (EspaŅol), or (866) 874-2646 (TTY) (Version 1) January 16, 2003 Page 1 of 1 |
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