May 29, 2003 (CIDRAP News) The Institute of Medicine (IOM) has again recommended a pause for evaluation of the federal smallpox vaccination program before it is expanded to more health workers and to emergency responders.
A break is needed to allow time to evaluate safety issues, to assess which additional personnel should be vaccinated, and to revise educational materials for new groups of potential vaccinees, the IOM Committee on Smallpox Vaccination Program Implementation says in the report, published this week.
"A break in the course of the vaccination program may help prevent vaccinating potentially large numbers of additional volunteers (e.g., health care workers, traditional first responders, and others) less safely than in the first phase of vaccinations, without adequate time to implement or update safeguards (e.g., screening, training, and education) that would be appropriate to new types of vaccinees and their contacts," the report states.
About 36,000 public health and healthcare workers who volunteered to serve on smallpox response teams have been vaccinated since the program began last January. The second phase of the program is supposed to include many more health workers, plus emergency workers such as police and firefighters. The Centers for Disease Control and Prevention (CDC) has told states they can start vaccinating those groups as soon as they are ready.
The CDC asked the IOM last fall for ongoing advice on the vaccination program. In its first report, just before the program began in January, the IOM committee recommended a pause for evaluation of safety issues after the first round of immunizations. A second report, in March, called on the CDC to proceed cautiously whether it takes a formal break in the program or not.
In the new report, the committee says the safety measures in the program have worked well so far. "The program has progressed with deliberation and caution," it states. "The screening of potential vaccinees may have played a role in preventing several of the historically expected moderate-to-severe adverse events" such as eczema vaccinatum and progressive vaccinia. The committee also says that reports of cardiac events in vaccinees reached the CDC quickly, and the agency promptly responded by modifying its screening procedures.
Despite this record, safety is one of three reasons for calling a pause in the program, the IOM says. "It is important to ascertain whether or not the vaccine played a role in the cardiac events, and rule out any other reasons for concern before vaccination is expanded to other populations," the report says. Also, by April 29, only 34% of vaccinees had been included in the active surveillance program for adverse events.
Second, the committee says, a break in the program would give CDC and the states time to tailor "vaccination plans, data systems, and materials" to new groups of potential vaccinees. Many states have cited a need to revise educational materials to suit new groups, the panel says.
Finally, the committee recommends taking time to assess the program's implications for overall smallpox preparedness, which includes determining "what level of pre-event vaccination is needed, and what personnel should be vaccinated to play specified roles in smallpox response." It is "imperative" to determine what level of pre-event vaccination is needed, the panel states.
The CDC is not planning an official time-out in the program, but a "natural pause" will occur this summer as the agency evaluates state applications for the next round of funding for the program, CDC spokesman Curtis Allen told CIDRAP News today.
States have until July 1 to submit applications for a new round of public health preparedness grants, including funds for smallpox immunization, Allen noted. "They're due to CDC on July 1 and it'll take at least 30 days to turn them around," he said. He predicted that most states will wait to hear from the CDC before continuing with their vaccination campaigns. Further, many state programs are already more or less on hold, since relatively few vaccinations have been reported in recent weeks, Allen said.
The IOM says that suspending the program could cause "a loss of momentum, and perhaps vulnerability" in the event of a smallpox outbreak. But because the smallpox threat level apparently has not changed, the panel believes the benefits of a pause outweigh the risks.
The report also advises the CDC to clarify several statements made in its recent instructions to states on applying for the new round of public health preparedness funding.
Table of contents page for IOM report
Jan 21, 2003, CIDRAP news story on the first IOM report on the smallpox vaccination program
May 14, 2003, CIDRAP News story on CDC guidance to states for applying for 2003-04 public health preparedness funds