Small number may react to smallpox vaccine

ATLANTA -- Smallpox shots may have triggered a painful heart inflammation in a very small number of emergency workers vaccinated after Sept. 11, researchers say.

A study in Wednesday's Journal of the American Medical Association showed a higher rate of heart inflammation cases than ever documented before in people who got smallpox vaccinations.

"I think that was completely not anticipated," said Dr. Inger Damon, an author of the study.

Overall, however, the vaccine appears to carry an extremely small risk of serious side effects, researchers reported after looking at nearly 700,000 civilians and soldiers who received vaccinations after Sept. 11.

The United States ended routine childhood vaccination against smallpox in 1971, and the World Health Organization reported the disease was eradicated in 1980. But about 15 months after the Sept. 11 attacks, the U.S. government ordered certain military personnel vaccinated and recommended shots for front-line health care workers.

The smallpox vaccine, Dryvax, made by Wyeth Laboratories, has long been suspected of triggering neurological complications, including encephalitis, in rare cases. But Dryvax was not associated with heart problems until 2003, when three adults died suddenly of heart attacks. As a precaution, health officials advised people with heart disease to skip the vaccination.

One of the studies published Wednesday looked at emergency responders, a group made up largely of female health-care workers ages 40 to 64.

Researchers counted 100 possible cases of serious side effects in 37,901 people who got the shots from January to October 2003. Among the 100 were 21 cases of non-fatal heart inflammation and six heart attacks, two of which were fatal.

Researchers said they cannot tell if the heart attacks were caused by the vaccine. They said the number of heart attacks was not out of line with what would be expected in a patient population of that size and age range.

But the rates of inflammation were higher than those seen in previous studies. Further research may help determine whether these cases were triggered by the vaccine, said Damon, chief of the poxvirus program at the Atlanta-based federal Centers for Disease Control and Prevention.

The patients with heart inflammation suffered such symptoms as shortness of breath and chest pain, and some were hospitalized.

Health officials continue to advise patients with heart disease to skip the vaccination.

In a second study in the journal, researchers looked at neurological problems in 665,000 people vaccinated through the Pentagon and the Health and Human Services Department. Three cases of encephalitis were reported - a number that would be expected in any group of that size.

"If widespread vaccination ends up being warranted for some reason, we can be somewhat reassured," said Dr. James Sejvar of the CDC, lead author of the second study.

Adverse Events Associated With Smallpox Vaccination in the United States, January-October 2003 Christine G. Casey, MD; John K. Iskander, MD, MPH; Martha H. Roper, MD, MPH; Eric E. Mast, MD, MPH; Xiao-Jun Wen, MD; Thomas J. Török, MD, MPH; Louisa E. Chapman, MD, MSPH; David L. Swerdlow, MD; Juliette Morgan, MD; James D. Heffelfinger, MD, MPH; Charles Vitek, MD, MPH; Susan E. Reef, MD; La Mar Hasbrouck, MD, MPH; Inger Damon, MD, PhD; Linda Neff, PhD; Claudia Vellozzi, MD, MPH; Mary McCauley, MTSC; Raymond A. Strikas, MD; Gina Mootrey, DO, MPH

JAMA. 2005;294:2734-2743.

Context On January 24, 2003, the US Department of Health and Human Services (DHHS) implemented a preparedness program in which smallpox (vaccinia) vaccine was administered to federal, state, and local volunteers who might be first responders during a bioterrorism event.

Objective To describe results from the comprehensive DHHS smallpox vaccine safety monitoring and response system.

Design, Setting, and Participants Descriptive study of adverse event reports from the DHHS smallpox vaccine safety monitoring and response system received between January 24 and October 31, 2003, through the Vaccine Adverse Event Reporting System (VAERS) and the Centers for Disease Control and Prevention. A total of 37 901 volunteers in 55 jurisdictions received at least 1 dose of smallpox vaccine.

Main Outcome Measures Number of vaccinations administered and description of adverse events and reporting rates.

Results A total of 38 885 smallpox vaccinations were administered, with a take rate of 92%. VAERS received 822 reports of adverse events following smallpox vaccination (overall reporting rate, 217 per 10 000 vaccinees). A total of 590 adverse events (72%) were reported within 14 days of vaccination. Nonserious adverse events (n = 722) included multiple signs and symptoms of mild and self-limited local reactions. One hundred adverse events (12%) were designated as serious, resulting in 85 hospitalizations, 2 permanent disabilities, 10 life-threatening illnesses, and 3 deaths. Among the serious adverse events, 21 cases were classified as myocarditis and/or pericarditis and 10 as ischemic cardiac events that were not anticipated based on historical data. Two cases of generalized vaccinia and 1 case of postvaccinial encephalitis were detected. No preventable life-threatening adverse reactions, contact transmissions, or adverse reactions that required treatment with vaccinia immune globulin were identified. Serious adverse events were more common among older revaccinees than younger first-time vaccinees.

Conclusions Rigorous smallpox vaccine safety screening, educational programs, and older vaccinees may have contributed to low rates of preventable life-threatening adverse reactions. Other rare, clinically significant, or unexpected cardiac adverse events were detected by timely review of VAERS data and intensive clinical case investigation.

Author Affiliations: Smallpox Vaccine Adverse Event Monitoring and Response Activity, Epidemiology and Surveillance Division, National Immunization Program, Centers for Disease Control and Prevention (CDC), Atlanta, Ga (Drs Casey, Iskander, Roper, Mast, Wen, Török, Chapman, Swerdlow, Morgan, Heffelfinger, Vitek, Reef, Hasbrouck, Neff, Strikas, and Mootrey); Division of Viral and Rickettsial Diseases, National Center for Infectious Diseases, Coordinating Center for Infectious Diseases (Dr Damon), Office of Preparedness and Emergency Response (Drs Neff and Vellozzi), and Office of the Associate Director for Science (Ms McCauley), National Immunization Program, CDC, Atlanta, Ga; and Logistics Health Inc, La Crosse, Wis (Dr Vellozzi). Drs Casey, Iskander, Roper, Mast, Wen, Török, Swerdlow, Morgan, Heffelfinger, Vitek, Hasbrouck, Neff, and Strikas are now affiliated with different divisions within the CDC.

We are all targets so why aren't we ALL given vaccinations?

The program was limited to first responders. They also anticipated adverse effects.

I'll tell you why, it is a scare tactic. We are living in an age of who can scare the most money out of the government.

Why don't you try to use that cynicism on the victims of Katrina, Rita, the earthquake in Kashmir and its neighbors and the tsunami almost a year ago. You did not respond to my question of trusting the Russians with their samples of smallpox. You also ignore Al Qaeda desire to kill us.

We are not all targets. Big cities have the greatest mortality for the buck. Try reading Mackubin Thomas Owens at National Review. If you are Al Qaeda with limited resources, where do you strike except big cities?

When someone says they want to kill me, I will give them the benefit of the doubt that they don't just want to scare me. If they do more than scare me, it's too late.

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