More questions raised about smallpox vaccinations

As the Institute of Medicine (IOM) called on the Centers for Disease Control (CDC) to address major concerns about the nation’s planned smallpox vaccination program and reports circulated that states were not as ready to start Phase 1 vaccinations, two major unions representing health care workers asked for a delay and said they could not recommend that their members volunteer to be vaccinated until major issues were resolved.

In a Jan. 17 Letter Report to the CDC, the IOM’s smallpox study committee said the CDC should continue pursuing opportunities to deliberate and analyze outstanding issues and concerns to ensure that the campaign is carried out as safely as possible. The committee urged the CDC to address remaining concerns about the program, such as how people who are vaccinated will be compensated for medical expenses and other losses that might be incurred through vaccination, to the extent allowed by the rapid time frame, and to spell out more clearly both the risks and benefits for vaccine recipients.

The committee said that broader vaccination of health care workers should begin only after adequate evaluation of the immunization of the first round recipients has occurred.

"While we recognize that CDC has been asked to initiate the immunization campaign rapidly, it’s important to remember that recipients of the vaccine are voluntarily assuming its risks for the greater public good," said committee chairman Brian Strom, professor and chair of the department of biostatistics and epidemiology of the University of Pennsylvania School of Medicine in Philadelphia.

"We agree with President Bush and the CDC that safety is paramount, and we support efforts to minimize those risks. Learning from experience, making midcourse corrections on every aspect of the program, and maintaining constant communication with the public are integral to developing the safest program possible," he added.

In its report, the committee called on the CDC to:

  • highlight the unique nature of the smallpox vaccination program as a public health component of a national bioterrorism preparedness policy, focusing on delivery of clear, consistent, science-based information;
  • proceed cautiously, allowing continuous opportunity for adequate and thoughtful deliberation, analysis, and evaluation, and embarking on Phase 2 only after adequate evaluation of Phase 1 has occurred;
  • use a wide range of methods for proactive communication, training, and education, and customize it to reach diverse audiences, including potential vaccinees, all health care providers, and the general public;
  • designate one credible, trusted scientist as key national spokesperson for the campaign and sharpen and expand communication plans and strategies to ensure rapid, transparent, and sustained contact with the media through implementation.

Compensation the biggest issue

It appears that the biggest stumbling block is likely to be the issue of compensation for those who have an adverse reaction to the vaccine.

The IOM committee said the CDC should address compensation questions because "the currently stated plans for compensation for adverse reactions could seriously affect achievement of the stated goal of the program — to increase the nation’s bioterrorism preparedness. A number of hospitals have said that they will not participate in the pre-event vaccination program until these issues have been resolved. The committee believes that resolution of the adverse reaction compensation issues is important for the informed consent process. . . . Implications of the pre-event vaccination program for issues related to health insurance, disability insurance, and life insurance should also be considered."

Limits to compensation

While the Homeland Security Act of 2002 provides a federal mechanism to compensate vaccinees who are injured due to negligent manufacture or administration of the smallpox vaccine, the committee said, it does not provide reimbursement to vaccinees for costs associated with participating in the program where there is no negligence.

Those costs could include administrative leave (with possible loss of salary) to avoid accidental infection of vulnerable patients in their workplace; lost income due to time away from work when recuperating from adverse reactions that occur, and unreimbursed medical expenses associated with treating adverse reactions that occur despite non-negligent manufacture and administration of the vaccine.

The committee also cautioned "with concern" that there may be some people, such as patients and family members, who are infected accidentally by contact with a vaccinee, despite efforts to care for the vaccination site appropriately.

It called for the administration to pursue "bold and creative" solutions to provide compensation for those who are injured.

Unions raise questions

The question of adverse reactions and compensation was uppermost when the Service Employees International Union (SEIU) and the American Federation of State, County, and Municipal Employees (AFSCME), both in Washington, DC, called on the Bush administration to make changes before starting the vaccination program.

"It is wrong for President Bush to ask health care workers to participate in a vaccination program that is not safe," said SEIU president Andrew Stern in a message to his members. "The vaccination program should be delayed until the concerns raised in the IOM report have been properly addressed. If workers or patients get sick as a result of this vaccine, they’ll be lucky if they receive a get-well card from Washington."

The union represents doctors, nurses, paramedics, and other health care workers across the country.

And in a letter to President Bush, AFSCME president Gerald McEntee wrote, "We have grave concerns that the smallpox vaccination program is being implemented without a comprehensive program to educate, medically screen, monitor and treat vaccine recipients, and to educate and treat affected family members, co-workers, and patients. Furthermore, the smallpox vaccination program fails to provide compensation to those who will suffer adverse effects from the vaccination exposure to the vaccinia virus. The program also fails to implement the use of safety-designed needles to protect those administering the smallpox vaccine, and provides no safeguards to prevent employers from improperly coercing employees to receive the vaccine.

"The absence of a federally funded, comprehensive approach to the civilian vaccination program is in stark contrast to the more thorough program developed by the Department of Defense for military personnel. Both military and civilian responders are part of the front-line defense against an attack on the United States. Those asked to risk their health, likelihood, and even their lives must be protected from receiving a vaccine where contraindicated and must be compensated for adverse affects resulting from vaccination."

Stern also called attention to steps taken with the military vaccination program, saying civilian volunteers should receive the same screening and protections as the military, which has screened out some 30% of its members because of contraindications. The unions say the government should pay for medical tests that could screen out risk factors such as pregnancy, eczema, and weakened immune systems.

Meanwhile, the Los Angeles Times reported that as the president’s vaccination program was due to get started, its survey of 20 states indicated that the number of frontline health care workers expected to voluntarily be vaccinated had dropped dramatically, and some states reported being months away from starting their programs.

Communication gaps

The newspaper said that several key misunderstandings between state and federal officials exist on issues as basic as when vaccine supplies will be delivered to states.

"All the states have taken enormous steps . . . in an incredibly short period of time," Julie Gerberding, MD, MPH, CDC director, told the Times. "Overall we’re very pleased and impressed."

Many plans described by state health officials differ markedly, especially in size and timing, from the program laid out by the administration, the Times said. State officials cited a variety of reasons including lack of additional liability protection for hospitals, absence of guaranteed compensation for vaccinated health care workers who lose time on the job, a growing sense that a smallpox attack is not imminent, and a deeper understanding of the vaccine’s risks.

Several state officials indicated to the Times that they would not begin vaccinating emergency response team members until mid-February or later. Others said they did not know when their programs would begin because they were waiting for direction from the CDC and notification of when they would receive vaccine.

But CDC officials said they were waiting to hear from the states and Ms. Gerberding said the agency would ship vaccine to states ready to receive it. "We want states to begin the program as soon as they can safely do it," she said.

While some state officials indicated a belief that the federal government wanted the first phase completed within 30 days, Ms. Gerberding pointed out that was yet another misunderstanding, because "there is no end date for this program."

State officials expressed concern about the number of health care workers changing their minds about volunteering to be vaccinated.

Because studies in the 1960s indicated that one or two people in every 1 million vaccinated would die and many others will suffer serious complications, health care workers reportedly want to make sure they will be compensated if their reaction to the vaccine causes them to miss work for a time or leaves them with large medical bills.

Vaccinated workers and the hospitals in which they work also are said to want reassurance that they will not be sued if they unintentionally infect vulnerable hospital patients with the smallpox virus.

In her interview with the Times, Ms. Gerberding downplayed the reports of people dropping out of the program. "We need to get away from this notion of a number," she said, referring to government estimates of 450,000 frontline healthcare workers to be vaccinated. "We knew full well that we did not need to vaccinate that many people," but overestimated to be sure there would be enough vaccine available.

(Download information from www.smallpox.gov; www.cdc.gov; and www.iom.edu.)