U.S. Army Says Pneumonia Data Shows No Link to Vaccines

By David Ruppe
Global Security Newswire

WASHINGTON — The U.S. Army Surgeon General’s office said last week that its data indicates no causal relationship between the serious pneumonia suffered by 19 U.S. soldiers in Southwest Asia and the smallpox and anthrax vaccines they received.

That conclusion, however, has been questioned by some experts who said that assessing causes of some cases is better done from medical analyses, rather than through a statistical analysis based on only 19 pieces of data.

The data, presented on three charts provided to Global Security Newswire last week, indicates that most of the soldiers did not receive their anthrax and smallpox vaccinations shortly before they were hospitalized for serious pneumonia-like symptoms.

Instead, it shows the 19 troops, two of whom died, were hospitalized between one and 30 weeks after receiving their smallpox vaccination and between 10 and more than 40 weeks after their first anthrax vaccination — with no apparent clustering of data around a particular time period.

The Army data also shows an apparently even distribution of illness onsets from the time the soldiers received their sixth and final anthrax booster shot.

“The pneumonia cases were evenly distributed after vaccination, which is what you’d expect if there was no cause-and-effect relationship, if they were just dispersed by chance, and that’s in fact what we see,” said Col. John Grabenstein, deputy director for military vaccines for the Army’s surgeon general.

Grabenstein, an epidemiologist and pharmacist by training, said investigators might suspect the vaccinations as a cause if there was a cluster of data showing hospitalization within a month of vaccination.

Grabenstein said the data, combined with information suggesting people vaccinated for anthrax and smallpox were no more likely to be hospitalized with pneumonia than unvaccinated people, has led military investigators to rule out the possibility that the vaccinations caused the unusually serious cases of pneumonia.

“The fact that pneumonia admissions were statistically equivalent between unvaccinated people, people who got anthrax only, people who got smallpox only, people who got both vaccines were statistically equivalent, is the second reason,” he said.

The Army has said that, altogether, about 100 soldiers in the region have contracted pneumonia since U.S. forces invaded Iraq last March and that such an infection rate is not out of the ordinary. However, some experts said that while hospital admissions for pneumonia are not uncommon, serious cases requiring ventilator support for young and healthy adults are unusual.

“How often do you have a young healthy gunfighter get on the ventilator? That’s definitely less common,” said Craig Smith, medical director of the Phoebe Center for Infectious Diseases in Georgia.

The Army surgeon general this summer dispatched epidemiological consultation teams to the region and to Germany to investigate the possible causes or contributing factors to the illnesses, including whether the anthrax or smallpox vaccines played a role. 

Grabenstein previously has said investigators have generally ruled out the vaccines as a cause, but had not provided data indicating whether there was a telltale pattern of hospitalization following the vaccinations for the 19 cases.

Meryl Nass, a practicing physician and prominent critic of the military’s use of the anthrax vaccine, challenged Grabenstein’s conclusions. 

She said it could be a mistake to assume that vaccine-caused illnesses would occur at generally the same time following a vaccination. Sickness from a vaccine could possibly weaken an immune system, making the patient more susceptible to an autoimmune illness that could strike at a random time with symptoms possibly manifesting weeks after that.

“The fact that these vaccines can have a profound effect on the immune system, thus potentially increasing the susceptibility of vaccinated individuals to a myriad of other diseases, is the issue here,” she said.

“The problem with these autoimmune illnesses is that the initial pathology may start right after the vaccination, but by the time you are developing symptoms that are severe enough to take you to a doctor and get you diagnosed, a lot of time may go by,” she said.

Nass cited a New England Journal of Medicine article published last week that referenced a study she said showed “people start getting sick at point A, but at the time they really show up with most of these autoimmune illnesses, it’s months or years later.”

She also questioned Grabenstein’s conclusion that pneumonia hospitalization rates did not differ significantly for vaccinated and unvaccinated people, presenting statistics she said were obtained indirectly from Grabenstein’s office that contradict the conclusion.

Grabenstein contended that if the vaccinations were causing the illnesses, there would likely be a cluster of hospitalizations within a month of the vaccination.

“After a month, things become quite unlikely. There just aren’t many things … that have an association after a month,” he said.

Grabenstein challenged the idea that a vaccine might weaken an immune system and make the recipient more susceptible to infection.

 He cited an Institute of Medicine report published last year that he said showed “there is no evidence of this kind of association with military vaccines.”

The study concludes that there is no risk that multiple immunizations commonly given to infants could overwhelm their immune systems and make them more susceptible to infection.

The report says “the epidemiological evidence … favors rejection of a causal relationship between multiple immunizations and increased risk for infections.”

According to Grabenstein, “As a general phenomenon, the human body expects to encounter things in the environment that stimulate the immune system, that stimulate the immune defense, and a vaccination is, you know, having one of those immune responses intentionally rather than just at random, and unraveling, is just not a legitimate concern.”

Smith of the Phoebe Center said he agrees with Grabenstein that the data appears to indicate no link between the vaccines and 19 sick soldiers.

“If you are going to associate it with the vaccination itself, you are going to have to show some kind of temporal relationship. And right now, they have kind of a “scattergram” that doesn’t look like it has any pattern to it,” he said.

Smith cautioned, however, that 19 cases may not be a large enough statistical sample for identifying a meaningful pattern.

“The caveat always in epidemiology is, well that’s because you only did 200,000 patients. If you did two million patients, then that scattergram might develop into a pattern,” he said.

Smith also agreed with Grabenstein’s view that it is unlikely the vaccines might have damaged the immune systems of the 19 servicemen, making them more susceptible to infection and pneumonia weeks later. 

With the case of the smallpox vaccine, which uses a live virus, a patient might be more susceptible to contracting a respiratory infection for a short time while building up immunity, he said.

“But, to the point of damaging their immune system over the short term or long term or making them highly susceptible to other infections over the short term or long term, that hasn’t been proven out, and that’s from the [Institute of Medicine] report, from experience and from a lot of other things you can read about,” he said.

“Every time you take a breath, drink a glass of water, it’s got all kinds of antigens and things that will affect your body. So if you go kind of from just a country doctor approach, why would one thing tend to knock everything out? It just wouldn’t make sense,” he said.

Nass said the safety of administering the anthrax vaccine at the same time as other vaccines remains in question.

She cited a disclosure by a senior British defense official this month that British health authorities as late as 1999 advised against administering the anthrax vaccine with others.

“The vaccine should be used alone. There is no evidence for the safe use in combination with other vaccines or medicinal products,” the British Medicines Control Agency had advised.

In 1998, the British Ministry of Defense had required that the vaccine be given alone and in 2001 issued guidance stating, “Ideally, anthrax vaccine should be given separately from other immunizations,” citing live vaccines in particular.

The British Committee on Safety of Medicines, however, conducted a review of available studies and reconsidered the advice, concluding that “none of the human and animal data available to members of the committee in respect of U.K. and U.S. anthrax vaccines warranted the advice that the vaccine should be used alone.”

It advised against mixing the vaccine with others, though, and said the shot should be not given on the same limb at the same time as other vaccines.

Grabenstein cited a March 2002 Institute of Medicine report, to which he contributed data, that found no evidence that vaccine recipients “face an increased risk of experiencing life-threatening or permanently disabling adverse events immediately after receiving” the vaccine.

It further found no “convincing evidence that vaccine recipients face elevated risk of developing adverse health effects over the longer term,” but added, “although data are limited in this regard.”

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