FDA Announces Smallpox Vaccine Guidance for Blood Industry
2 JANUARY - FDA has issued guidance for the blood industry regarding procedures for properly qualifying potential blood donors who have recently been inoculated with the smallpox vaccine (vaccinia virus) or those who may have had other direct exposure to smallpox vaccines.
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T02-58
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December 30, 2002
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FDA has issued guidance for the blood industry regarding procedures for properly qualifying potential blood donors who have recently been inoculated with the smallpox vaccine (vaccinia virus) or those who may have had other direct exposure to smallpox vaccines.
These recommendations were developed in consultation with experts on the vaccine virus (smallpox vaccine) at the U.S. Centers for Disease Control and Prevention and the Department of Defense. They are preventive measures pertaining to non-emergency smallpox vaccination. In the event of widespread emergency vaccination due to an actual or impending smallpox outbreak, the procedures outlined in the guidance could be modified to adapt to changing risk/benefit assessments and other public health considerations.
The vaccine virus is closely related to smallpox (variola virus) and induces an immune response that is protective against smallpox. The vaccine virus has been used with great success for over 100 years to protect against smallpox.
FDA is issuing this guidance as a precautionary measure to reduce the very slight risk of blood borne exposure to the smallpox vaccine among certain small patient populations that may develop adverse reactions to the vaccine.
Those interested in the details of this guidance will find a copy of the full document at:
The What's New page at:
http://www.fda.gov/cber/whatsnew.htm
The Guidances page at:
http://www.fda.gov/cber/guidelines.htm#smpox
The Blood Guidances page at:
http://www.fda.gov/cber/blood/bldguid.htm
or directly at
http://www.fda.gov/cber/gdlns/smpoxdefquar.pdf (PDF)
http://www.fda.gov/cber/gdlns/smpoxdefquar.htm (Text)
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