CDC system monitors smallpox vaccine side effects

Last Updated: 2003-02-06 16:44:57 -0400 (Reuters Health)

By Alison McCook

NEW YORK (Reuters Health) - The US government has established a system to track all civilians who receive the smallpox vaccine and record who develops any side effects as a result, the Centers for Disease Control and Prevention (CDC) said Thursday.

This tracking system is designed to serve as the "gold standard" of monitoring programs for vaccine safety, CDC director Dr. Julie Gerberding told reporters during a press conference.

A total of 687 non-military health workers had been vaccinated against smallpox as of Wednesday, Gerberding said. The CDC has also shipped more than 200,000 doses of the vaccine to 40 states and counties across the US, she said.

The CDC has received no reports of serious side effects among civilians.

According to the Department of Defense (DOD), as of January 31st, almost 4,000 military health workers had received the vaccine, as had tens of thousands of operational forces.

Jim Turner, a spokesperson for the DOD, confirmed in an interview with Reuters Health that two Army soldiers recently developed illnesses that appear to have resulted from their previous vaccinations. Both have now fully recovered, Turner said.

In one case, a 23-year-old male was diagnosed with the brain condition encephalitis in a military hospital overseas eight days after receiving the vaccine. Although it is not clear whether the vaccination caused the soldier's encephalitis, the timing of the condition is suspicious, according to the DOD.

In another case, a 30-year-old male developed a rash 10 days after receiving the smallpox vaccine, likely another result of the vaccine.

The smallpox vaccine contains a live virus related to smallpox that builds immunity to the disease. However, experts have raised concerns about the vaccine's side effects, which can include a scarring rash, high fever, and encephalitis, a swelling of the brain that can kill.

The current vaccination effort is designed to "ensure our capacity to respond to a smallpox attack, should one occur," Gerberding said. Specifically, it involves vaccinating the people who would be the first to respond to and investigate any cases of smallpox and the health workers who would treat smallpox patients, CDC officials report in the February 6th issue of Morbidity and Mortality Weekly Report.

As part of the new monitoring system for vaccine side effects, each person who receives the smallpox vaccine will receive a unique number, which health workers will enter into an electronic tracking system to enable public health officials to record who develops what side effects to the vaccine.

Officials will collect information from approximately 10,000 vaccine recipients via telephone surveys conducted 10 and 21 days after they are given the vaccine.

The CDC also plans to track anyone who becomes ill from contact with a person who received the smallpox vaccine.

SOURCE: Morbidity and Mortality Weekly Report 2003;52:88-89,99.

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