Recommendations issued on development of drugs for vaccine side effects.

2004 MAR 31 - (NewsRx.com & NewsRx.net) -- The U.S. Food and Drug Administration has issued draft guidance for the development of drugs to treat the side effects of vaccination against smallpox with vaccinia virus.

The need for drugs to treat the side effects of this vaccine became acute after the terrorist attacks on September 11, 2001. Routine vaccination for smallpox in the United States had ended in the 1970s, when the disease stopped occurring naturally, but the potential threat that variola virus would be used as a weapon of terrorism has raised the possibility that a large-scale vaccination could be necessary in an emergency. Because the use of this vaccine may cause complications in some individuals, the FDA wants to help commercial and research sponsors plan and design appropriate studies for the development of drugs to treat such adverse events.

"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. [This] guidance should reduce the cost and uncertainty of developing medicines that will harden our defenses against one of the most dangerous bioterrorism agents."

According to experts, the currently available live vaccinia virus vaccine, when given before exposure to variola virus, substantially protects most people against smallpox for at least several years. In addition, if given within a few days after initial variola exposure, the vaccine may prevent or lessen the impact of smallpox infection.

The vaccinia virus vaccine, however, can potentially cause serious complications. Groups at increased risk of developing smallpox vaccine complications include immuno-suppressed people (such ...