Volume 4, No. 6, June 2006
Abstract of the Month
Varicella Prophylaxis for high risk persons (including pregnancy): VariZIG replaces VZIG
On October 27, 2004, the Advisory Committee on Immunization Practices (ACIP) was informed by the only U.S.-licensed manufacturer of varicella zoster immune globulin (VZIG) (Massachusetts Public Health Biologic Laboratories, Boston, Massachusetts) that the company had discontinued production of VZIG. The supply of the licensed VZIG product is now nearly depleted. In February 2006, an investigational (not licensed) VZIG product, VariZIG™ (Cangene Corporation, Winnipeg, Canada) became available under an investigational new drug application (IND) submitted to the Food and Drug Administration (FDA).* This product can be requested from the sole authorized U.S. distributor, FFF Enterprises (Temecula, California), for patients who have been exposed to varicella and who are at increased risk for severe disease and complications.
The investigational VariZIG, similar to licensed VZIG, is a purified human immune globulin preparation made from plasma containing high levels of anti-varicella antibodies (immunoglobulin class G [IgG]). Unlike the previous product, the investigational product is lyophilized. When properly reconstituted, VariZIG is approximately a 5% solution of IgG that can be administered intramuscularly. As with any product used under IND, patients must be informed of potential risks and benefits and must give informed consent before receiving the product.
Indications for Use of Investigational VariZIG
Patients without evidence of immunity to varicella (i.e., without history of disease or age-appropriate vaccination) who are at high risk for severe disease and complications, who have been exposed to varicella, and from whom informed consent has been obtained, are eligible to receive the IND application product under an expanded access protocol. The patient groups recommended by ACIP to receive VariZIG include the following:
- Pregnant women.
- Immunocompromised patients.
- Neonates whose mothers have signs and symptoms of varicella around the time of delivery (i.e., 5 days before to 2 days after).
- Premature infants born at >28 weeks of gestation who are exposed during the neonatal period and whose mothers do not have evidence of immunity.
- Premature infants born at <28 weeks of gestation or who weigh <1,000 g at birth and were exposed during the neonatal period, regardless of maternal history of varicella disease or vaccination.
Varicella vaccine was recommended in 1999 for postexposure prophylaxis of other persons without evidence of varicella immunity and who have no contraindications to vaccination (2). The vaccine should be administered preferably within 96 hours and possibly up to 120 hours postexposure. If illness occurs, with or without postexposure vaccination, antiviral treatment (e.g., acyclovir) can be considered for adolescents and adults.
OB/GYN CCC Editorial comment: Rosalyn Singleton MD
Varicella Prophylaxis for high risk persons: VariZIG replaces VZIG
Varicella Zoster Immune Globulin (VZIG) is no longer available. A similar product, VariZIG™ (Cangene) is available under an investigational new drug application ( IND) with the FDA. VariZIG™ can be used for patients without evidence of varicella immunity who have been exposed to chicken pox and are at high risk for severe disease and complications, including: immunocompromised patients, neonates whose mothers have chicken pox around the time of deliver, certain premature infants in the neonatal period, and pregnant women. These groups have contraindications to Varicella vaccine.
VariZIG must be given within 96 hours of exposure. A protocol under the IND has been approved by a Central IRB which allows use of VariZIG on a case by case basis using the Central IRB approval as long as your institution and local IRB allow that. Providers who identify a patient can call FFF Enterprises 800-843-7477 for the necessary forms. FFF will send VariZIG by next day air. This MMWR contains the full VariZIG information: http://www.cdc.gov/mmwr/preview/mmwrhtml/mm55e224a1.htm?s_cid=mm55e224_e
Rosalyn Singleton MD
Immunization Consultant
Alaska Native Tribal Health Consortium
ris2@cdc.gov
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OB/GYN
Dr. Neil Murphy is the Obstetrics and Gynecology Chief Clinical Consultant (OB/GYN C.C.C.). Dr. Murphy is very interested in establishing a dialogue and/or networking with anyone involved in women's health or maternal child health, especially as it applies to Native or indigenous peoples around the world. Please don't hesitate to contact him by e-mail or phone at 907-729-3154.
