Few Serious Side Effects Seen Among 100,000 Military Smallpox Vaccinees

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Few Serious Side Effects Seen Among 100,000 Military Smallpox Vaccinees

By Alicia Ault

WASHINGTON (Reuters Health) Feb 13 - The U.S. military reported Thursday that there have been just three serious, life-threatening events among the more than 100,000 troops and medical personnel who have received the smallpox vaccine since December.

One-to-five percent of those vaccinated have had milder side effects, such as fever, malaise, and rash, said Col. John Grabenstein, deputy director for Military Vaccines, who presented the latest data to an Institute of Medicine (IOM) committee reviewing the safety and progress of the federal government's smallpox vaccination program.

"I think our experience is very much like what's going to be seen in the general population," Col. Grabenstein told reporters.

Two Army soldiers came down with encephalitis within a week to 12 days of receiving a smallpox vaccination. The cases have not been definitely linked to the vaccine, but it's likely responsible, said Grabenstein. Both men were hospitalized for several days, one in Georgia and the other in Germany. But Grabenstein said that both recovered fully and were back on active duty with no apparent long-term consequences.

In the third serious reaction, an Air Force member was hospitalized after going to an emergency room with chest pain and was diagnosed with myocarditis. The airman was discharged after two days, and has had no evidence of long-term problems, Grabenstein said.

There have been no deaths, and no one has accidentally infected a contact with the vaccinia virus used in the vaccine, he said.

Rashes, affecting 12 of every 1,000 people immunized, have been the main side effect. The rashes have gone away in most instances, but in 7 cases, physicians weren't sure if the rash was a sign of vaccinia infection. Grabenstein said the Centers for Disease Control and Prevention (CDC) is reviewing the cases, but that the military is almost certain these seven people were not infected.

Only about 3% of those vaccinated lost any work, and that averaged one day, he said.

Depending on the location, 10% to -40% of those eligible for vaccination have been turned down, because they, or a household contact, had a disease or condition that increased the risk of side effects or vaccinia infection.

The military experience is being closely monitored by the CDC and state and local health authorities, who are in the process of vaccinating an estimated 500,000 public health and hospital workers.

Joe Henderson, CDC associate director of terrorism preparedness and response, told the IOM panel that the agency has shipped 267,100 doses, and that 1,043 public health and hospital workers have been vaccinated. There have been no reports of serious or life-threatening side effects.

Though the numbers vaccinated seem low, Henderson said he was "not surprised." Vaccination programs are designed to "go slow," he said. But, Henderson acknowledged that some states have been hesitant to start until the federal government or state authorities determine how injured vaccinees will be compensated.

Michigan has said it will definitely not start vaccinations until the issue is resolved. A number of other states are also on the fence, he said.

Some hospitals have opted out of the program, as have some health workers, said Henderson. The CDC is still collecting data on why institutions or individuals are refusing, he said, speculating that economic issues and negative media coverage both played a role.

Henderson predicted a "substantial increase over the next two to three weeks," in immunizations, as the first states begin a second wave, and more states get started.

New Jersey smallpox vaccination program coordinator Eddy Bresnitz said that 150 state workers and hospital employees have been vaccinated, with no serious side effects. Most volunteers were nurses and other public health workers. More than 50% of the hospitals have agreed to participate, but 15% have given no response at all yet, he said.

Bresnitz said he wasn't concerned. "At the end of the day, I believe we're going to have enough people," he said, adding, "Whatever number we get, we're going to be better off than we were."

Georgia director of public health Kathleen Toomey told the IOM panel that the state has vaccinated 68 people, mostly public health officials, and will immunize three more today. Most hospitals are agreeing to participate, though some, like Atlanta's Grady Memorial, are waiting, she said, noting that Grady has many patients at risk for vaccinia infection.

Many public health officials have complained that the smallpox effort is detracting from other important prevention and disease control efforts. IOM panelists asked Bresnitz and Toomey if they were strapped by the vaccination program.

Bresnitz said New Jersey is managing, but Toomey had a different story. "We're really stretched thin," she said, adding that she is spending "90% of my time on homeland security."

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