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Maine Puts Smallpox Vaccination On Hold

Mar 31, 2003 | Portland Press Herald

The director of Maine's Bureau of Health on Sunday suspended the state's first smallpox vaccination clinic for hospital workers because of new concerns about possible fatal side effects of the immunization. The clinic had been scheduled for today.

Dr. Dora Anne Mills said she suspended the state's vaccination program until authorities learn more about three deaths in other states that may be related to the vaccine. Today's clinic for hospital workers had been scheduled at Maine Medical Center.

Mills said the deaths appear to be heart attacks. Because about 350,000 military personnel and about 25,000 civilians have been vaccinated since February, the three deaths might have nothing to do with the vaccinations. Heart disease is the leading cause of death in the United States, so the deaths could be a coincidence.

But about a dozen people who have received the vaccinations developed inflammation in their hearts or heart lining, and that is almost certainly related to the vaccine. It has long been known that the vaccine causes swelling on the skin in the area where it is administered, so vaccine-related inflammation is not unexpected.

"One naturally wonders whether the three people who died might have had inflammation of the coronary arteries and hence a heart attack, a fatal heart attack. We don't know but we'll have more information soon, based on autopsy results," Mills said. "In the absence of a disease outbreak, I think we have to be very cautious in whom we vaccinate and under what circumstances."

On Friday, an advisory council at the Centers for Disease Control and Prevention recommended that people who have at least three risk factors for heart disease, such as smoking, high blood pressure and diabetes, not get the shot.

Mills said that depending on what the autopsies determine, "and on how many other people come down with this heart inflammation, this could mean simply adding more contraindications to who receives the vaccine, or it may simply mean a complete postponement of the program of the entire program."

Mills said the Bush administration's smallpox vaccination program called for public health workers to be vaccinated first, and that 39 people in Maine, mostly Bureau of Health employees, have gotten the shots. None developed any serious side effects.

But a much larger group first responders is scheduled to get the vaccinations next.

"There are a lot of men in their 50s among the first responders," Mills said. "And men in their 50s have risk for heart disease."

All three people who died from heart attacks had risk factors for heart disease.

Initially, public health authorities expected that 10 to 15 people out of every million who got immunized would develop serious complications and that two out of every million would die.

Mills noted that the last full risk studies of the vaccine were performed in 1968. "The tests for diagnosing heart inflammation are much more sophisticated now," she said.

She also said that the vaccine that is being administered has been in a freezer for about 30 years.

"Who knows what happens over time?" she said. "This is a live virus. If you have a synthetic protein that's stable and you put it in the freezer for 30 years, it probably isn't going to change much, but this is a live virus, this is a live organism you're putting in the freezer for 30 years."

California, Illinois, New York and Vermont also have temporarily suspended their vaccination programs.

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