April 16-19, 2004

The Washington Fax

U.S. preparedness response capabilities still lacking, George Washington University's Hauer says
The nation's ability to respond in the event of either a naturally occurring or terrorist-related disease outbreak has a number of "holes" that must be tackled and include the need for a cadre of mobilization-ready personnel, George Washington University Response to Emergencies and Disasters Institute Director Jerome Hauer stated. The former acting Department of Health and Human Services assistant secretary for public health emergency preparedness led a discussion of preparedness plans at the Partnership for Anthrax Vaccine Education's first meeting in Washington, D.C. He urged partnership members to increase pressure on congressional appropriators, while pointing out areas where there has been significant improvement over the last two years. Each state now has at least one laboratory that can handle select agents and the country has significant antibiotic stockpiles.

Newsday

FDA Seeks Rules Change to Address Side Effects
As a precaution against a possible terrorist attack with the deadly smallpox virus, the federal government wants to loosen its usual drug safety reviews to speed approval of medications to treat serious side effects of the smallpox vaccine. To date, the government has approved no drugs for complications from the vaccine. Under new FDA guidelines, beginning May 4, the agency would expedite approval of such drugs, with no more than six months spent evaluating them. Among those at increased risk of developing smallpox vaccine complications are chemotherapy patients, pregnant women, people with eczema, organ transplant recipients, HIV/AIDS patients and possibly those with heart disease. Drugs eligible for the shortcut approval process would target serious vaccine side effects like heart and brain inflammations, dangerous rashes and eye infections. Under the current smallpox vaccination program, both military and civilians who would respond to a bioterrorism attack are being vaccinated. As of March 31, 39,398 civilians had received the vaccine. About 620,000 members of the military have been vaccinated. Between January 2003 and February of this year, the U.S. Centers for Disease Control and Prevention counted 98 serious adverse events and 725 non-serious adverse events in civilians who received the vaccine. Three people have died of heart attacks after being vaccinated although they had other risk factors. Under the FDA's published guidelines, pharmaceutical companies could either develop new drugs to treat vaccine side effects or explore innovative uses for older ones already proven safe.

The Washington Post

Government Considers New Smallpox Vaccine
Government officials are contemplating buying massive quantities of a new type of smallpox vaccine to supplement the national stockpile already assembled in the aftermath of the Sept. 11, 2001, attacks. Scientists believe that unlike any of the vaccines now available, the new vaccine may be effective in protecting against the deadly infectious disease without the risk of serious -- and occasionally lethal -- side effects. Efforts to develop the new vaccine, underway for several years, have taken on an air of urgency after safety concerns stalled a 2003 campaign to vaccinate millions of health care professionals and emergency workers who might be first to respond to a biological attack. Those concerns were underscored on Tuesday, when the vaccine that makes up the bulk of the U.S. stockpile was possibly linked to cases of heart inflammation. Scientists are increasingly optimistic about the prospects for the experimental vaccine, called Modified Vaccinia Ankara, or MVA. Some government officials say MVA has shown such promise that it could do far more than merely fill the gaps left by other vaccines, and that it may become the nation's primary means of defense against a smallpox attack. Unlike Dryvax, which was used effectively during a global eradication campaign during the 1970s, MVA has never been put to the test during an outbreak. The current stockpile consists of three vaccines, including Dryvax from the government's decades-old stockpile. The second was donated from the stockpiles of Aventis Pasteur, the French vaccine maker. The third, made by Acambis PLC, is an update of Dryvax using modern production techniques. MVA is also alive when it's injected, but it doesn't replicate well in humans so researchers believe that it's much less likely to cause side effects. The vaccine was first discovered in Turkey, and was later given to more than 100,000 people in Germany. The vaccine is scheduled to enter human trials in the United States within weeks, using samples from two competing companies. One of those companies, Acambis, has already produced an updated version of Dryvax called ACAM2000, some 200 million doses of which have been purchased in the past few years by the government. The company stopped adding volunteers to a study on ACAM2000 this week, however, after at least one person exhibited swelling in the heart. Acambis officials declined to comment on their MVA program. The other company is the Danish firm Bavarian Nordic AS. Bavarian Nordic and Acambis are not the only companies hoping to produce the vaccine of the future, and MVA isn't the only contender for that title. In the long term, experts say that a genetically engineered vaccine may be the solution. In the shorter term, the California-based biotechnology firm VaxGen Inc. reported this week that its vaccine, known as LC16m8, protected rabbits and mice against a pox virus just as well as Dryvax after only one dose. Scientists have yet to determine how many doses of MVA are needed to induce immunity.

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