Smallpox vaccinee deaths raise concerns about heart link
Does smallpox vaccine lead to inflammation?
Two deaths and six other heart-related problems among civilian smallpox vaccinees added to uncertainty as hospitals added more restrictions to the already lackluster vaccination program. One military vaccinee also died of cardiac arrest five days after vaccination.
The vaccine may be causing "mild pericarditis" or inflammation of the heart lining, or myocarditis, inflammation of the heart, said officials of the Centers for Disease Control and Prevention (CDC). But because the serious heart-related events occurred in people with pre-existing heart conditions and cardiac risk factors, CDC was uncertain about the relationship between myocardial infarction or ischemic heart disease and the vaccine.
While an investigation into the cases continued, the Advisory Committee on Immunization Practices (ACIP) recommended that those with heart conditions or three or more known cardiac risk factors, such as hypertension, high cholesterol, and smoking, should not receive the vaccine.
States continued their vaccination programs, adding prescreening questions that were expected to screen out as many as 6.8% of health care workers. About 26,000 health care workers had been vaccinated as of March 21, only about 5% of the 500,000 once envisioned by CDC and the U.S. Department of Health and Human Services (HHS). Meanwhile, Congress continued to work on a compensation program in the hopes of encouraging more health care workers to volunteer for vaccination. (See CDC screening worksheet for smallpox.)
"It points to the need for truly adequate prescreening," says Cheryl Peterson, RN, senior policy fellow with the American Nurses Association, who lauded the CDC for the agency’s quick response to the cases. But she added, "Are there other diseases like this that we need to be thinking about that might be impacted by this vaccine?"
On March 23, a Maryland nurse in her 50s suffered a heart attack and died in nearby Arlington, VA. She had a history of heart disease and had been vaccinated five days before her heart attack, public health authorities reported. "Right now, we don’t believe it was a factor," said Lucy Caldwell, spokeswoman for the Northern Virginia division of the Virginia Department of Health. "We know it wasn’t the primary factor."
A 57-year-old Florida nurse suffered a heart attack 17 days after vaccination. She had had a history of hypertension and a previous cardiac catheterization.
The CDC had previously reported heart ailments among vaccinees, but had not concluded that the vaccine was a cause. One other patient suffered a heart attack; there were two cases of angina, or chest pain, and two of myocardial or pericardial inflammation. For example, four days after vaccination, a 60-year-old man suffered from chest pain while exercising. He was discharged after a two-day hospital stay. In another case, two days after vaccination, a 45-year-old woman suffered from chest pain and was found to have viral myocarditis, or inflammation of the heart. The condition was considered to be associated with the influenzalike illness she had suffered about two weeks before vaccination.
The Department of Defense (DOD) reported that one 55-year-old member of the National Guard died of cardiac arrest five days after vaccination. He had no evidence of pericarditis or myocarditis. Additionally, 10 military vaccinees developed 10 cases of myocarditis or pericarditis. Some health experts emphasized the number of serious cardiac events — heart attacks and deaths — is within the normal range for those age groups. The CDC convened cardiology and immunology experts to evaluate the cases, and ACIP considered the impact on the vaccination program.
"While everyone is working very hard to sort out what the relationship is with the vaccine, the prudent thing seems to be to broaden the contraindications to the vaccine until we have more information," says Jane Siegel, MD, a professor of pediatrics at the University of Texas Southwestern Medical Center in Dallas. Siegel is co-chair of the Healthcare Infection Control Practices Advisory Committee and a member of the ACIP group that is monitoring vaccine safety. "Work in this area is moving as fast as it possibly could," she says. "It’s very difficult to sort out what’s related to the vaccine and what is not."
Meanwhile, an Institute of Medicine (IOM) panel issued a report urging the CDC to carefully evaluate the program before expanding it to other health care workers and first responders. ACIP member Paul Offit, MD, chief of infectious diseases at The Children’s Hospital of Philadelphia, also argued for halting the vaccinations until the issue of heart inflammation could be fully investigated. "We have a vaccine that does work post-exposure, and we have a lot of people out there who may have heart conditions but don’t know it," he said. "To me, that just makes sense."
The new contraindications may lead some hospitals to halt their vaccination programs, predicted ACIP chair John Modlin, MD, professor of pediatrics and medicine at Dartmouth Medical School in Lebanon, NH.
But when she announced the efforts to investigate the heart-related adverse events, CDC director Julie L. Gerberding, MD, stressed that the vaccination program must go on.
"Safety really is important. It’s a priority for this program. And we are going to continue the program with that in mind, as we help prepare a nation for a potential bioterrorism event," she said.
In a bright spot for the vaccination program, one fear has not materialized: As of March 14, there were no cases of secondary transmission of vaccinia in civilian hospitals. The DOD reported five cases of secondary transmission from its vaccination program, which involved more than 250,000 vaccinees.
A compensation program proposed by HHS moved through Congress as a part of a broader bioterrorism package. HHS Secretary Tommy Thompson also announced a $1.4 billion funding program to support bioterrorism preparedness in states — money that could be used to reimburse hospitals and state health departments for costs related to the smallpox vaccination program.
The IOM panel expressed concerns that lack of adequate funding might hamper efforts to expand the vaccination program, and that the cost of the vaccination program already was leading to a shift in resources away from other public health activities, such as childhood immunizations. The IOM once again stressed the need for a compensation program. Critics have charged that the administration’s proposal doesn’t go far enough. "We don’t believe the cap on the compensation is appropriate," says Peterson. "It has no prescreening provisions in it. It really doesn’t meet the concerns we’ve been raising."
Edward Richards, JD, MPH, a Louisiana law professor who has studied smallpox vaccine legal issues, notes that not all cases of secondary transmission would be covered and not all medical expenses would be paid. "The fund proposed by this bill is very restrictive and may not go far enough to address the concerns of health care providers and their institutions," says Richards, who is director of the program in law, science, and public health at the Louisiana State University School of Law in Baton Rouge.
The compensation program, patterned after a benefits program for police officers and firefighters who are injured on the job, would provide:
- $262,100 to anyone who dies or has a permanent and total disability caused by the vaccine. This would be in addition to any other death benefits available to the individual.
- Two-thirds of lost wages after the fifth day away from work, up to a maximum of $50,000. This benefit would be secondary to any workers’ compensation or disability insurance benefits.
- Out-of-pocket medical expenses related to the vaccine for other than minor injuries. This benefit would be secondary to any health insurance benefit that might be available to the individual.
- Compensation to third parties who contract vaccinia from public health and medical response team workers who have been vaccinated.
- Retroactive coverage for health care workers who have been vaccinated since Jan. 24.
(Editor’s note: Updated information on smallpox vaccination is available at www.bt.cdc.gov/agent/smallpox/index.asp.)
Two deaths and six other heart-related problems among civilian smallpox vaccinees added to uncertainty as hospitals added more restrictions to the already lackluster vaccination program. One military vaccinee also died of cardiac arrest five days after vaccination.You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
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