Cardiac screening further slows smallpox program

Some hospitals await updates on cardiac risks

Smallpox vaccinations slowed while some hospitals completed or halted their programs and others re-screened employees for cardiac contraindications.

Yet concerns over cardiac problems did not stop some states from moving forward with Phase 2, which involves vaccinating first-responders such as firefighters and paramedics. As of April 10, the Centers for Disease Control and Prevention (CDC) reported that 32,644 health care workers had received vaccines nationwide.

There were 49 moderate to severe vaccine-related adverse events, including 10 cases of myocarditis or pericarditis — inflammation of the heart or the lining of the heart. The CDC reported 37 other severe events, including five myocardial infarctions and six reports of angina, which occurred after vaccination but have not been conclusively linked to the vaccine. Two of the five patients who had myocardial infarction died.

Despite the cardiac concerns, CDC had some good news to report: No health care workers developed eczema vaccinatum or progressive vaccinia, serious conditions previously associated with the vaccine.

"That suggests that our screening has been very successful. We did not vaccinate individuals who had underlying skin conditions or immune deficiencies," says Jane Siegel, MD, a professor of pediatrics at the University of Texas (UT) Southwestern Medical Center in Dallas and co-chair of the Healthcare Infection Control Practices Advisory Committee.

And none of about 20,000 military health care workers and 30,000 civilian health care workers transmitted vaccinia to patients. "The one thing I think we’ve learned is that it’s safe for recently vaccinated health care workers to continue to have patient contact as long as they use the semipermeable dressing, have site checks before work, and change the dressing as necessary," she says.

Siegel, who is on the vaccine safety group and a liaison member of the Advisory Committee on Immunization Practices, says the advisory panel will analyze the experience of health care worker vaccination before making recommendations about Phase 2 vaccination. Identifying new cardiac risk factors, CDC advised those with heart conditions or three or more known cardiac risk factors, such as hypertension, high cholesterol, and smoking, not to receive the vaccine.

Some states all but shut down their smallpox clinics, but others moved forward to expand the program. Florida health officials announced that they would use remaining stocks of vaccine to start Phase 2 on May 1. Florida vaccinated about 3,600 health care workers with six potentially vaccine-related adverse events, including one nurse who died from a heart attack. That case is still being investigated and may not be linked to the vaccine.

"For us, it’s never been a numbers game. It’s about capacity — throughout the state making sure we have enough people to respond should we [suffer a bioterrorism attack]," said John O. Agwunobi, MD, MBA, secretary of the Florida Department of Health in Tallahassee.

Some hospitals had already completed their vaccinations when the new cardiac recommendations came out. Others quickly added new screening questions and found a sudden drop in the number of volunteers. At UT Southwestern Medical Center, the number of volunteers declined from 60 to 30, as some employees chose not to have the vaccine.

But there were no serious adverse events, and only two employees missed work for just one day each, Siegel says. "I’m pleased with how things went in my hospital. We do have a team of people who are protected."

For some hospitals, the cardiac cases led to an alteration of plans. "We’re on hold," said James Garb, MD, director of occupational health and safety at the Baystate Health System in Springfield, MA. The cardiac concerns arose just a day before public health officials had scheduled to begin vaccination. Garb postponed the vaccines, and plans to re-screen employees. But he is taking a cautious approach.

"Until there’s a little more clarity and assurance, we’re going to sit tight," he says.