Things have changed. They used to stand you in line, give you two or three shots, and off you went. Nobody asked what they were for." So said Army Col. Gaston Randolph, director of DoD's hugely controversial Anthrax Vaccine Immunization Program.
Randolph was attempting to explain why the services' effort to vaccinate the troops against deadly anthrax has generated more controversy than any previous immunization program.
"There has been a ... shift in the relationship between health care providers and patients," he noted. "No longer do you just put a patient in a doctor's office or in a shot line. We have been empowering patients with education so that they can make informed judgments about whether they want this, that, or some other kind of treatment. We see that in the military, too." He went on, "You have to tell them what they are getting and what side effects they might expect. They ask questions, and they expect answers, and rightfully so."
Col. Deneice Van Hook, chief of the Air Force Surgeon General's Prevention Division, noted, too, that perceptions about the anthrax shots are different from those of other shots.
"There is," she said, "a much higher emotional response to this vaccine. You have to understand that we are giving people an immunization that they see as a biological warfare agent. That alone scares people, and I understand that emotional response."
Understanding or not, Van Hook bluntly declared, "There is no science to support their fear."
The words of Secretary of Defense William S. Cohen: "We determined that vaccination is the safest, most reliable way to protect our service members from a potential threat that is 99 percent lethal to unprotected, untreated individuals."
Despite frequent and fervent official Pentagon reassurances of this type, the vaccination program has drawn intense fire from many quarters, including Congress. Opponents say the problem is not emotionalism or faulty perceptions but questionable medicine and heavy-handed management.
One prominent critic is Rep. Christopher Shays (R-Conn.), chairman of the House Government Reform subcommittee on national security, veterans' affairs, and international relations. His panel carried out an oversight investigation of the program and, in February, issued a report questioning both the safety and effectiveness of the shots. It argued that DoD should designate the vaccine as experimental and suspend mandatory immunizations until an improved vaccine is available.
Rep. Walter Jones (R-N.C.) of the House Armed Services Committee followed up with a letter to President Clinton, asking him to heed the recommendations and use his powers as Commander in Chief to halt the program.
Several exchanges between the Pentagon and the lawmakers followed, but the Defense Department stood firm on its vaccination program.
Another major critic is Rep. Dan Burton (RInd.), the chairman of the House Committee on Government Reform. In October, Burton announced that his committee would hold new hearings on the vaccination program. While he acknowledged that DoD has scaled back the shots because of shortages, he said it had not complied with Congressional requests for suspension.
In his announcement, Burton added, "An increasing number of individuals are suffering life-altering injuries from the vaccine."
At Burton's request, the General Accounting Office, a Congressional watchdog agency, surveyed Air National Guard and Air Force Reserve Command pilots and crew members, asking them what reactions they had to the vaccine and what effect the immunization program had on their career decisions.
GAO had mailed 1,253 questionnaires to members. By early October, the GAO issued a preliminary report to the committee on the survey on the 828 Guard members and Reservists who had responded to the survey.
The GAO reported:
AVIP gets scant support. While respondents had positive attitudes toward immunizations in general, 65 percent reported that they had little or no support for the Pentagon's anthrax program. Only 17 percent said they thought information presented on the DoD Web site was accurate. And almost nine out of 10 respondents said they probably would have safety concerns about vaccines for other biological warfare agents.
Physical reactions are underreported. Of those respondents who had taken the shots, 86 percent said they had local or systemic reactions. This percentage is higher than that reported by service officials. GAO said that some 60 percent of its respondents explained that they didn't report their reactions. Of these, almost half claimed that they feared ridicule, loss of flight status, or adverse impacts on their military or civilian careers.
The vaccinations are hurting retention. About 25 percent of respondents had switched units (most to take nonflying jobs), gone to inactive status, or quit the military within the past two years. While they cited factors such as family reasons and job opportunities among the factors, GAO said, "When asked to rank the one most important factor, the anthrax immunization was the highest." Another 18 percent of those who are still in the service said they planned to leave within six months and also cited the anthrax vaccine program as the top reason.
The statistical significance of this survey is somewhat murky. Some defenders of the anthrax program have noted that the GAO survey was based on a relatively small sample. In its report, the GAO notes that this was only a pretest of the questionnaire and that they had only 828 respondents, of whom only 42 percent (about 348) had actually had any shots. Moreover, all of the respondents were self-selected and therefore could not be said to comprise a truly random sample.
The debate over the program has found its way to the Internet as well. "One of the biggest lessons we have learned," said Randolph, "is that you should never underestimate the power of the Internet to inform and misinform. It used to be that protesters made posters, put on marches, and maybe ran ads in newspapers with limited audiences. Now, they can go worldwide, and in an instant, the information is available to millions."
To defend the program, AVIP opened its own Web site (www. anthrax.osd.mil). It presents what it believes are the facts about the disease and the vaccine and provides links to other government and private sources of information.
Officials often direct USAF members to a site called "Virtual Flight Surgeons Inc." at www.aviationmedicine.com. The site is run by civilians, Randolph said, but some are in the reserves as well. When a number of ANG and AFRC pilots refused vaccination for fear it would lead to their being grounded from their airlines jobs, the group went out to the airlines, interviewing not only people in operations but the medical directors.
The flight surgeons give a balanced discussion of the vaccine but conclude that flight crew members have nothing to fear either in their military status or civilian jobs.
Lt. Col. Susan Northrup, chief of operational medicine in the USAF Surgeon General's office, said she often refers skeptical crew members to the site for reassurance. She added, "I'm a flight surgeon myself, and we have not seen reaction rates any higher than with any other vaccine. By and large, our pilots are taking these and doing just fine."
Randolph concedes the services underestimated the anxiety that rated members would have about the vaccinations.
"Pilots and other people on flight crews have very special health requirements," he said. "The absence of being ill is very important to them. ... We probably should have recognized early on that, as with other health issues, fliers were going to have some unique concerns."
Northrup agreed. She said, "If you worried about whether something that you were required to take might affect your being allowed to do what you love to do, you'd probably raise questions, too. They also are concerned about whether they can support their families. But I have not heard of any individuals who have had their civilian airline jobs threatened."
Few Real Refusals
Resistance to the vaccinations has attracted widespread press coverage, but officials note that only a relative handful of members actually had refused the injections. As of August, they said, there had been a total of 441 refusals, including 129 in the Air Force. Most refusers have received nonjudicial punishment, said Randolph. A limited number have gone to court-martial, most of them in the Marines, but the majority have been administratively separated, he said.
"The feeling is that this is basically a refusal of an order," said Randolph, "and each case is handled separately by the local commander."
Van Hook suggested, too, that not all those who raise questions actually refuse the shots. According to her, "There are lots of folks who initially say, 'I'm not going to take the immunization,' but when we go through a full one-on-one education program, they realize there is nothing to fear and go ahead and take the shots. So we don't want to call those people refusers."
The extent of adverse physical reactions to the vaccine itself also has been exaggerated, the officials said.
"They have been very similar to other vaccines in terms of the reactions you would commonly expect," said Randolph. "It's closest to that for tetanus, and of course, millions and millions of people have had tetanus shots. I'm talking about redness, a little pain at the injection site, swelling, and other things such as that."
He went on, "In terms of systemic reactions, the shots seem to be consistent with other vaccines as well. But, again, we are talking about minor reactions that are self-limiting and don't require hospitalization or loss of work time. Generally, you take an over-the-counter pain medication and you're just fine. There have been no deaths and no long-term chronic or life-threatening illness."
Two Million Doses
Van Hook gave a breakdown of the reported reactions for all services. As of September, she said, the services had immunized 487,098 people, injecting 1,947,053 doses of vaccine. Over the period, 1,152 reactions have been reported and reviewed by an expert civilian panel. It determined that 592 were "certainly or probably" caused by the anthrax vaccine.
Of the 592 reactions linked to the vaccine, Van Hook said, 469 were classed as minor, meaning the members didn't lose any duty time or have to be hospitalized. Another 114 members did lose some duty time, most of them because of reactions at the injection site. Others had manifestations such as rashes, flu-like symptoms, intestinal problems, and itchiness.
"Only 10 were actually hospitalized," said Van Hook, "and all were due to allergic inflammatory reactions at the injection site."
She added, however, "There have been several studies that seem to indicate that females are more apt to have reactions than males, but we really don't know what's causing that. That gender difference is one of the things we have asked the Center for Disease Control to investigate."
Overall, however, the reports so far have come as a welcome surprise to officials. Van Hook said, "Actually, the adverse reaction rate is lower than we would have anticipated with most vaccines. It's very low and the serious adverse reaction rate is extremely low with this vaccine."
In recent months, the controversy over the vaccine has cooled a little. The Pentagon's efforts to put out more information may be one reason, but it also could be because there has been a slowdown in the vaccination program itself.
The problem is in the supply of the vaccine. The services rely on a single provider, BioPort Corp. of Michigan. The firm has been expanding and, during the process, has halted production.
"Until they receive approval for their newly renovated vaccine facility from the Food and Drug Administration," said Randolph, "we have a finite amount of stockpiled vaccine that was produced earlier. So we have had to slow down the program."
According to a July 17 policy letter signed by Rudy de Leon, the deputy secretary of defense, those deployed for at least 30 days to the high-risk theaters of Southwest Asia and Korea will continue to be vaccinated. Vaccinations for personnel deploying to these areas should begin prior to arrival in theater and are authorized to begin up to 45 days prior to deployment.
"We're vaccinating only people who are forward deployed in the two high-threat areas of Southwest Asia and Korea," Randolph said.
While the shortage will interrupt the vaccination schedule for other members, officials say those who already have begun the series of shots won't have to start over.
Van Hook said current service guidelines say members who have had only one shot given more than two years ago will have to restart the series. Those who have had two can pick up where they left off.
That guideline is consistent with other immunizations, she said. "Say, for example, that we start a woman out on hepatitis B vaccine, which requires three shots, and she gets pregnant," said Van Hook. "We delay immunization until after she is through with her pregnancy, but we don't restart the series."
When the program resumes its former pace, officials said, all members will receive an initial series of six shots over 18 months, followed by an annual booster. At the moment, the booster shots have been suspended except for members headed into high-risk areas.
Back on Schedule
If all goes well, the services should have no trouble getting back on schedule by early 2001. Randolph said, "We have enough to get us through about spring of next year with the current slow-down rules. We estimate that somewhere between January and the end of March, we'll have that FDA approval of the newly renovated vaccine suite and we'll have more vaccine."
Even though it cannot release more vaccine at the moment, BioPort continues to produce it. "As part of the FDA approval process, they have to produce new vaccine in the renovated facility," said Randolph. "Three lots have to come out successfully. So approval also would be approval of three lots of vaccine and each lot has about 200,000 doses in it."
All this assumes there are no major hitches in the approval schedule, however. Against the possibility of further problems, AVIP has contingency plans that include developing additional sources of the vaccine.
The program's critics have questioned its safety and effectiveness. One recurring allegation is that the shots were responsible for the maladies commonly termed Gulf War Illness. That charge was fueled in 1994 by Congressional testimony from the Army's Surgeon General Lt. Gen. Ronald R. Blanck. He said that the "anthrax vaccine should continue to be considered as a potential cause for the undiagnosed illnesses in Persian Gulf military personnel." Blanck later retracted the statement and said there is no link between the shots and the problems reported by Desert Storm veterans, but it is still a live issue.
The decision to halt production of the vaccine also was taken by some critics as evidence that the shots are risky. But Randolph insists it was not FDA that ordered the interruption in delivery of the shots. "Early on," he said, "we realized that the original facility would not be large enough to handle the volume of production we needed and approved an expansion of what then was [Michigan Biologics Product Institute]. It is the renovation, which requires new FDA approvals, that has caused the vaccine shortage."
When stocks allow the services to resume their normal shot schedules, debate over the vaccine may heat up again, but officials close to the immunization program have no doubts about its importance or safety. Said Van Hook, "I've had four of the shots myself. I didn't have any reaction other than that associated with a little lump in my arm. If there were enough vaccine, I would give it to my child today."
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