The Centers for Disease Control and Prevention (CDC) began shipping smallpox vaccine to some states on January 22, launching the first phase of a federal program to vaccinate a half million US health care workers. The vaccine is being offered on a voluntary basis to those who would be the most likely to respond to a terrorist attack with smallpox—emergency department personnel and people working on special smallpox response teams.
Under the program, which was announced by President Bush in December, states could begin inoculating volunteers on January 24. Another 10 million people, including additional health care workers and emergency medical personnel, firefighters, and police, will be offered the vaccine during phase 2 of the program. Mandatory immunization of 500 000 military personnel was already under way last December.
QUESTIONS ABOUT COMPENSATION
The effort remained on schedule despite pointed questions raised days earlier in a report by an expert panel convened by the Institute of Medicine (IOM) at the request of the CDC and unions representing thousands of health care workers. (The Institute of Medicine's report, Review of the Centers for Disease Control and Prevention's Smallpox Vaccination Program Implementation is available on-line at http://www.nap.edu/catalog/10601.html.)
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The smallpox vaccine contains live vaccinia, which—like smallpox (variola)—is a member of the Orthopoxvirus family. It is administered with a bifurcated needle, which is dipped into the vaccine solution and used to prick the skin several times. (Photo credit: Fred Murphy, PhD/Silvia Whitfield, CDC [left side], and CDC [right side])
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High on the list of concerns was the program's lack of provisions for compensating individuals for medical expenses or lost wages if they are harmed by the vaccine. Without such measures in place, compensation would be left to employers, insurers, and state worker's compensation plans.
Currently, under the provisions of the Homeland Security Act, the government, vaccine manufacturers, and the institutions and individuals who administer the smallpox vaccine are protected from liability; individuals harmed by the vaccine would have to sue the federal government and prove negligence to receive compensation. One of the unions, the Service Employees International Union, said it will advise the 750 000 health care workers who are among its members not to participate in the vaccination program unless the Bush administration addresses the compensation issue.
Based on past experience with the smallpox vaccine, for every 1 million people immunized, between 14 and 52 individuals vaccinated for the first time could experience serious and potentially life-threatening complications and 1 or 2 could die.
Additional concerns involve the cost of screening out individuals who should not be vaccinated because they are particularly susceptible to the vaccine's potential adverse effects, such as people with eczema, individuals with weakened immunity such as cancer patients and organ transplantation recipients, and others. Screening efforts should also determine whether potential vaccinees could pose a risk to others—for example, if they live with and could inadvertently infect someone with a condition that makes them vulnerable to the live vaccinia used in the vaccine.
Department of Health and Human Services Secretary Tommy Thompson said that he was working with the White House and key senators to compensate such individuals for medical expenses, lost wages, and other costs they might incur from being vaccinated.
EXPERT PANEL URGES MORE DELIBERATION BY GOVERNMENT
The IOM panel also urged the government to "proceed cautiously, allowing continuous opportunity for adequate and thoughtful deliberation, analysis, and evaluation." Phase 2 of the program should begin only after the first phase of the program could be evaluated, and the CDC should use active surveillance of vaccinees regarding adverse effects, the group said.
However, CDC officials said it would not be necessary to pause between the two phases because the agency had established a data safety monitoring board to assess the program on an ongoing basis.
"There is a very active adverse-event monitoring program in place already," said Walter Orenstein, MD, director of the CDC National Immunization Program during a press briefing. "In fact, because we are the ones who control the therapies for a number of these adverse events, we believe a lot of them will be reported to us for that reason, as well."
"The priority is getting these response teams vaccinated," said CDC Director Julie L. Gerberding, MD, MPH. "We'll go forward with the larger group"—the second wave of vaccinations—"as preparations evolve," she said. What that will mean in practice is that some states will likely proceed with the broader ranges of groups—firefighters, police, emergency medical personnel, and additional health care workers—while others are still inoculating the smallpox response team members.
As of January 22, CDC shipped kits (containing enough vaccine and the two-pronged bifurcated needles used to administer the vaccine for 21 600 public health and health care workers) to Connecticut, Nebraska, Vermont, and Los Angeles County. As of that date, 20 states have requested nearly 100 000 doses of the vaccine.
However, a number of hospitals across the country are declining to participate in the program for now, citing concerns such as the vaccine's potential adverse effects, worker's compensation issues, and the possibility of inadvertant exposure of vulnerable individuals to vaccinia shed by vaccinated volunteers.
Sen Edward Kennedy, (D, Mass), planned to offer an amendment to a spending package currently under debate that would allocate $750 million for a smallpox vaccine compensation fund and provide $850 million to help states, facing severe budget shortfalls, run their inoculation programs.
The CDC maintains a Web site with up-to-date information for medical professionals regarding the vaccine itself, the method of vaccination, contraindications for vaccination, and normal and adverse reactions to the vaccine at http://www.bt.cdc.gov/training/smallpoxvaccine/reactions/default.htm.
| The Smallpox Vaccine
- Contains live vaccinia, a member of the Orthopoxvirus family, which includes smallpox (variola), cowpox, others.
- Offers a high level of immunity for 3 to 5 years; protection after primary vaccination begins to fade after 5 years and is probably negligible after 20 years.
- When given within 2-3 days after exposure to smallpox, can result in protection against the disease. May prevent death when given as late as 4 to 5 days after exposure.
- Causes (based on historical data) potentially life-threatening reactions in an estimated 14 to 52 people per million who receive the vaccine.
Source: Centers for Disease Control and Prevention
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