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Smallpox I:<span style="mso-spacerun: yes">  </span>Public Vaccinations Raise ConcernsFrom Monday, December 16, 2002 issue.

Smallpox I:  Public Vaccinations Raise Concerns

Experts have raised a variety of medical questions and protests in the wake of U.S. President George W. Bush’s announcement Friday that smallpox vaccine will be offered to emergency responders and, on a voluntary basis, eventually to every U.S. resident, the Washington Post reported today (see GSN, Dec. 13).

“The risk of the vaccine is higher than the risk of us having a case of smallpox,” said Carlos del Rio, chief of medicine at Grady Hospital in Atlanta.  Widespread, pre-emptive smallpox inoculations are comparable to nationwide appendix removal due to fears of appendicitis, del Rio said.

Randall Larsen, director of the ANSER Institute for Homeland Security, applauded Bush’s decision to immunize up to 10 million emergency responders but criticized the public immunization policy.

“I do not think it should be available to the general public any more than a person can walk into a pharmacy and say, ‘Give me some penicillin and tetracycline,’” Larsen said.  “My concern is if a bunch of people go out and start taking it and you have this cute little fifth-grader that dies, it will be on the tube 24-7.  Then people will stop taking it, including first responders and military personnel,” he added.

Other health officials said the smallpox vaccine plan represents a skewed perception of health risks in the United States.

“I’d like the president to have an influenza vaccine campaign that’s comparable,” said William Shaffner, chairman of preventive medicine at Vanderbilt University Medical Center.  “There’s a disease that kills 10,000 to 20,000 citizens of the United States each year,” he added.

Some White House health officials said it is not clear to them how Bush established the public immunization policy (see GSN, Dec. 12).  Top U.S. biological terrorism adviser D.A. Henderson said he was not aware of the policy until a Friday press conference.

“The president was trying to be responsive to (requests from the public) but at the same time making it clear that based on the current level of threat, there is no reason to recommend the general public to be vaccinated,” said Jerome Hauer, director of the U.S. Office of Public Health Preparedness (Ceci Connolly, Washington Post, Dec. 15).

While polls have indicated that a majority of U.S. residents want to receive the smallpox vaccine, federal officials are going out of their way to emphasize that the government is not recommending immunization.

“I want to restate and underscore that it is not the recommendation of the president or of the Department of Health and Human Services” that the general public receive the vaccine, Health Secretary Tommy Thompson said (M.A.J. McKenna, Atlanta Journal-Constitution, Dec. 15).

Publicizing Dangers

Some officials said the public is insufficiently informed about the potential dangers of the vaccine.  The U.S. Health Department has debuted a Web site — www.smallpox.gov — to offer more information and answer questions.

For every 1 million people immunized, one or two people are expected to die, 14 to 52 people are expected to experience potentially fatal side effects and up to 1,000 people would probably suffer serious — but not life threatening — reactions, according to Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases.

In recent clinical trials of Dryvax — the brand of smallpox vaccine that is to be used in the first wave of emergency responder vaccinations (see GSN, May 16) — “as many as 50 percent of individuals experienced some degree of muscle aches and fatigue, and approximately 10 percent experienced fever,” Fauci said.  “Indeed, about one-third of the vaccine’s [recipients] had symptoms that were significant enough to have them change or alter their normal daily activities for a day or longer,” he added (see GSN, Dec. 10).

If a smallpox outbreak was detected today, a similar but still-unlicensed vaccine made by pharmaceutical company Aventis Pasteur would be used to immunize the general public, Fauci said (see GSN, Oct. 10; State Department release, Dec. 14).

Who Is Getting It

In the next year, people could be vaccinated by participating in a clinical trial.  U.S. officials might also allow people who “feel strongly that they want to have access to the vaccine” to be immunized, according to Julie Gerberding, director of the Centers for Disease Control and Prevention.  In addition, the State Department plans to offer vaccine to personnel stationed in the Middle East, according to the department’s medical director Cedric Dumont.  As part of an effort to vaccinate 500,000 military personnel, defense officials have begun immunizing some in Maryland, said William Winkenwerder, assistant defense secretary for health affairs.

Vaccine recipients — including up to 500,000 domestic health and emergency workers to be immunized at state-run clinics beginning in January — will receive careful attention and specific instructions on how to take care of the inoculation sites on their arms, Gerberding said.

“Already we have trained several thousand clinicians and public health officials in several hours of training in how to organize and conduct the clinics, how to monitor the side effects, how to safely store the vaccine and securely store the vaccine, and all of the other logistic elements necessary to make this program go safely,” she said.

Health officials plan to build two types of smallpox response teams, Gerberding said.  One type, known as public health response teams, will consist of “public health officials, doctors with special knowledge about skin conditions and smallpox, [and] the disease detectives who will help understand the cause and the source of an exposure,” she added.

The other type, health care delivery system response teams, will be responsible for treating smallpox cases once they reach medical facilities and will include both medical personnel and other staff who work in intensive care units, Gerberding said.

Response Strategies

U.S. health officials do not necessarily plan to react to a smallpox outbreak with a “ring vaccination” strategy, according to Tom Ridge, Bush’s nominee to head the new Homeland Security Department.

Current preparations should allow a range of opportunities, and “the response of the country would depend on the circumstances surrounding the detection of smallpox, whether it’s a singular case, an isolated case, or multiple cases,” Ridge said.  Medical workers’ first reaction to a smallpox case, however, is to locate infected people and immunize the people with whom they are in contact.  A decision on further ring vaccinations or a general immunization effort would only come after that, Gerberding said.

Meanwhile, the United States is increasing stocks of vaccinia immune globulin, which could be used to treat the side effects of the vaccine, particularly in a mass vaccination campaign, according to officials (see GSN, Nov. 12).  U.S. officials now have about 2,000 doses of the globulin, known as VIG, and they expect to have 30,000 by summer, Fauci said.  About 100 doses of VIG are needed for every 1 million immunizations, and the United States currently has enough to deal with 27 million inoculations (State Department release, Dec. 14).

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