Smallpox inoculation plan must go forward, says CDC chief

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Jan 21, 2003 (CIDRAP News) – Julie Gerberding, MD, director of the Centers for Disease Control and Prevention (CDC), says the national smallpox vaccination program for hospital and public health workers must go forward despite the new recommendation from the Institute of Medicine (IOM) to proceed slowly and cautiously.

The vaccination program is driven by national security considerations, Gerberding said in a press briefing Jan 17. "The urgency and the need for efficient action comes from the fact that we are in fact in a dangerous world, where a terrorist attack with smallpox is possible. We have to be prepared so that we can protect the American people," she said.

"This is a high priority for all of us in the system and we intend to make the program happen on time," she added. She said the CDC will begin shipping vaccine this week to 11 states, which have requested a total of more than 50,000 doses.

Under a plan announced by President Bush Dec 13, voluntary vaccination of smallpox response teams in hospitals and public health agencies is expected to begin within a few days. This initial round of vaccinations is likely to include about 500,000 people; a second phase is expected to reach as many as 10 million additional healthcare and emergency-response workers.

Gerberding held the late-afternoon briefing in response to the IOM report (see related story), which advises the CDC to carefully study the safety record of the first phase of vaccinations before starting the second phase. The IOM also said the CDC should work to resolve the murky question of compensation for those who suffer adverse reactions to the vaccine, among other recommendations. The CDC asked the IOM last fall for advice on how to implement the vaccination campaign.

As noted in the IOM report, the Homeland Security Act provides a mechanism for compensating people who are injured by the vaccine as a result of negligence in manufacturing or administering it, but the act does not deal with adverse reactions unrelated to negligence. State workers' compensation programs may help vaccinees who suffer harm or lose work time because of the vaccine, but it is unclear how far those programs will go.

Gerberding commented, "We are looking at ways to work with all of the involved parties to address issues related to compensation, and . . . workers' compensation is part of the mechanism we have to address compensation. Even though the states may vary in the kinds of coverage or the programs that are available, we are certainly not going to delay this program because of concerns about compensation."

In announcing that states have requested vaccine, she said, "We will be initiating the fist shipments of vaccine to the requesting jurisdictions as early as Tuesday [Jan 21], after the Monday federal holiday, and we think that's a good sign—that, clearly, states intend to utilize this vaccine and their programs are getting into a state of readiness where we'll be able to go forward and do what we need to do, which is to get this show on the road."

But she refused to disclose which states have requested smallpox vaccine, saying it's up to the states to announce their own plans. "CDC never preempts states," she said.

Gerberding was asked repeatedly about hospitals and hospital systems around the country that have decided not to participate in the vaccination program. She said the CDC expected that some hospitals and healthcare workers wouldn't participate. "Our conversations with state health offices reassure us that we will have the level of preparedness we need to be able to do what this stage 1 program is all about, and that is to be sure that we can initiate a mass vaccination program to protect our country if we needed to. . . . We have over 3,000 hospitals already who have agreed to participate in this program. So I think we're on target."

She also said the CDC does not see a "groundswell" of requests to delay or stop the program. "Our experience in working with our partners in the state and local health agencies is that people really understand that this is an important aspect of preparedness" and are "extremely responsive" to the CDC request to participate, she insisted.

In response to a reporter who spoke of signs that doctors are starting to oppose the plan, Gerberding said the goal of the program is not "to ensure that every hospital in the country has vaccinated employees. The goal is to ensure that we have the public health response teams that can go out and assess initial cases and that we have healthcare personnel in a facility in the jurisdiction that would be able to take care of the first cases. . . . We still remain confident that we have the level of preparedness we need."

The IOM report recommends that the CDC conduct active surveillance for adverse events during the first phase of the program and not rely on the Vaccine Adverse Events Reporting System, a "passive" system. In response to questions, Walter Orenstein, director of the CDC's National Immunization Program, said the CDC already has an active surveillance program. "There is a very active adverse-event monitoring program in place already, relying on hospital workers who are inspecting each of these sites on a daily basis for workers to continue to be vaccinated," he said. He added that the CDC is likely to hear about adverse events in any case because it controls the treatments for them. "But we will look at the issue of the adverse-event monitoring."

When they were asked whether the CDC would take time to evaluate the first phase of the vaccination program before starting the second phase, Gerberding and Orenstein didn't give a clear answer. "I think we will be continually evaluating this effort," said Orenstein.

Gerberding commented, "The priority is to get the response teams vaccinated. Individual jurisdictions may have the initiation of the immunization program for the broader groups when they're ready to do it. So this is not 'Do stage 1 and then do stage 2' simultaneously across the nation. There's going to be some variability here and you need to expect that, because we'll go forward with the larger group as preparations evolve."

Another IOM recommendation was that the CDC evaluate whether a committee set up to evaluate the safety of the smallpox vaccine, called the Data and Safety Monitoring Board, is too closely tied to the CDC. The board needs to be independent to be credible, the IOM said. But Gerberding defended the existing arrangement, saying, "We're looking at the IOM report and whether we need to make any changes in our decision, but I think this is a very legitimate approach to data safety monitoring."

In response to IOM recommendations about careful screening of potential vaccinees and thorough education programs for healthcare workers and the public, Gerberding recited a long list of steps the CDC has taken along those lines.

See also:

Transcript of the CDC press briefing
http://www.cdc.gov/media/transcripts/t030117.htm

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