Smallpox: More fear of vaccine than of attack

But reactions actually less than projected

It is becoming increasingly apparent that fear of adverse vaccine reactions and the perception that there is little likelihood of a smallpox attack have undermined the federal immunization plan for health care workers. Though originally projected at some 500,000, only 38,000 health care workers were immunized for smallpox as of July 18, 2003.

"The fact that the participation rate is lower than some projected has been generally attributed to the low perceived threat of a smallpox attack and continuing concerns about the risk of adverse reactions to vaccination," said Julie Gerberding, MD, director of the Centers for Disease Control and Prevention (CDC).

Gerberding testified July 24, 2003, at a congressional hearing on biodefense preparedness held by the Senate Health, Education, Labor and Pensions Committee. Despite the problems, the overall incidence of adverse reactions in both civilian and military populations has actually been lower than anticipated, she said.

"The low adverse reaction rate appears to be directly attributable to the efficacy of pre-vaccination screening that has ensured those at risk for complications do not receive the vaccine," Gerberding said.

"The occurrence of possible vaccine related heart problems, however, did surface as a possible adverse event that required further restricting the possible use of the smallpox vaccine in those at risk for heart disease," she explained.

The original plan called for vaccinations to be given to volunteers in two stages. In the second stage, which now appears to be somewhat in limbo, the plan was to expand the program to as many as 10 million additional health workers and other emergency response personnel.

With the program now stalled, there are discussions about revising the original goals and reconsidering the second stage. A recent report by the General Accounting Office (GAO) cites widespread concern about "insufficient resources to support the program and about liability protection.

Many potential volunteers are concerned about health risks to themselves and their co-workers, families, and patients and about compensation for adverse events and lost income."

50,000 HCWs may be enough

According to the GAO, the CDC has reconsidered the initial targets and said that as few as 50,000 vaccinated health workers nationwide would provide sufficient response capacity. "[The] CDC and some of the jurisdictions have indicated that as the program unfolds and they learn more, they are less concerned about achieving their initial targets and are considering revising them," the GAO report states.

"However, if the estimates are reduced for the numbers and types of vaccinated health workers in smallpox response teams, the CDC would need to provide guidance to ensure that smaller or fewer teams are organized and distributed in a manner that will provide adequate response capacity — that is, the capacity to effectively investigate an outbreak, care for patients, and vaccinate members of the public," the report adds.

According to Gerberding’s Senate testimony, participation in the vaccination program has varied widely across the country. As a result, some states essentially remain nonimmunized and others have cadres of vaccinated workers in numerous hospitals. In 10 states (TX, FL, TN, OH, CA, MN, NE, NC, MO, LA), more than 1,000 health care workers have been vaccinated. Is education an issue? Gerberding said the CDC has conducted 74 training and education sessions, reaching 1.8 million health care workers.

The liability issues may be solved to some degree by the Smallpox Emergency Personnel Protection Act of 2003, which established a no-fault program to provide benefits and/or compensation to health care workers and emergency responders injured as the result of the administration of smallpox vaccine.

Though Congress approved the compensation bill, the Bush administration has not published the additional data specifying how much money someone will receive for various types of injuries.

"We are increasingly concerned about the delay," Senate committee members Sens. Ted Kennedy (D-MA) and Chris Dodd (D-CT) stated in a letter to Health and Human Services Secretary Tommy Thompson. "Too many first responders, aware of the possibility of side effects, are refusing to participate in this very-high-priority vaccination program."

Preparedness beyond vaccination

But Gerberding stressed that vaccination is only one element of overall smallpox preparedness. Other areas of progress she cited in her testimony include:

• All states and four designated cities have developed detailed pre-event and post-event smallpox response plans.

• Public health teams now are organized nationwide to respond to a suspected smallpox outbreak within six hours.

• A national information system has been implemented that can support smallpox and other emergency vaccination administration needs. It advances preparedness to know who needs to be vaccinated, to monitor vaccine take results, and track adverse vaccination events. The system produces information that decision makers and response teams need to support the protection of the population from communicable diseases in an emergency setting.

• Clinical and public health laboratories have improved their ability to detect and diagnose rash illness within 24 hours of presentation. Twenty-three laboratories nationwide have the training and reagents to screen for smallpox and differentiate it from other pox-related diseases (e.g., chickenpox and monkey pox).

• Current vaccine supplies and projected production continue to meet the goal of having sufficient smallpox vaccine for every American in the event of an emergency.

• More than 290,000 doses of vaccine are currently deployed, with vaccine available in every state and four major cities (New York City, Chicago, Los Angeles, and Washington, DC).

(Editor’s note: The GAO report Smallpox Vaccination: Implementation of National Program Faces Challenges can be found at: http://www.gao.gov/new.items/d03578.pdf.)