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FDA favors drug development for smallpox vaccination side effects

Emergency Management Alert, March 15, 2004

The Food and Drug Administration (FDA) has issued guidance for the development of drugs to treat side effects of the smallpox vaccine.

Smallpox, which is incurable and often fatal, is a potential bioterrorism agent. Vaccination may prevent smallpox. However, the vaccine may cause serious complications. Groups at increased risk of developing smallpox vaccine complications include immuno-suppressed people (such as persons with HIV/AIDs, organ transplant recipients, and patients on cancer chemotherapy), pregnant women, people with a history of eczema and other chronic skin diseases, and possibly individuals with cardiac disease.

The following are some effects of the vaccine: 

• Generalized rash 
• Eye infection  
• Severe eczema or other skin diseases
• Inflammation of the brain 
• Inflammation of the heart and surrounding tissues
• Infection of the fetus

The FDA wants to help commercial and research sponsors plan and design appropriate studies for the development of drugs to treat adverse effects.

"Bioterrorism is one of the most profound new public health threats facing the U.S.," said FDA Commissioner Mark B. McClellan, MD, PhD, "and our agency intends to identify all possible steps to help minimize or eliminate the potential risks of bioterrorism to Americans. Today's guidance should reduce the cost and uncertainty of developing medicines that will harden our defenses against one of the most dangerous bioterrorism agents."

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