December 17, 2004

Congress seeks to stimulate market for bioagent vaccines

Government Executive
By Chris Strohm

Legislation will be introduced early next year as part of an ongoing effort to stimulate private sector development of medical vaccines and countermeasures to protect against biological pathogens, officials said Wednesday.

Congressional officials plan to introduce legislation for Project Bioshield II in February, said Chuck Ludlam, counsel to Sen. Joe Lieberman, D-Conn., ranking member of the Senate Governmental Affairs Committee.

"It will be the most ambitious, aggressive set of legislation on the development of drugs for infectious diseases ever introduced, or even contemplated," Ludlaw said Wednesday at a forum in Washington sponsored by Equity International.

Government and industry officials at the forum said the nation is woefully unprepared for a biological attack, despite the growing awareness of bioterrorism threats.

"We are totally unprepared medically for one of these attacks," Ludlaw said.
Last July, President Bush signed into law Project Bioshield, which is a $6 billion program to create and expand the nation's stockpile of vaccines and treatments to combat potential bioterrorism agents.

Ludlaw said the program is "a step in the right direction," but what it encompasses "is not remotely enough." Bioshield II will probably have 30 titles, he said, adding that a draft of the legislation should be completed by the end of this week.

Although there has been speculation that the Homeland Security Department will be given lead responsibility for Bioshield II, Ludlaw expects Congress to leave the program in the hands of the Health and Human Services Department.

Jerome Hauer, former HHS acting assistant secretary for the office of public health emergency preparedness, agreed with Ludlaw's assessment that Project Bioshield has not achieved its potential.

"Bioshield I was a good start; there's no question about it," Hauer said. "It was intended to engage the industry [and] to stimulate the industry. ... But it appears to have had just the opposite effect for many of the pharmaceutical companies."
Hauer said his former office, which is now run by Stewart Simonson, is not responsive to industry and not moving fast enough. He believes Bioshield should stay with HHS, but be moved to a new office.

Hauer is joining Fleishman-Hillard as a senior vice president for government relations. He also is a consultant for BioPort Corporation of Lansing, Mich., which produces the military's anthrax vaccine.

"Three years after Sept. 11, we have added virtually no new countermeasures to the national pharmaceutical stockpile with the exception of smallpox vaccine, a larger cadre of antibiotics and maybe some modest increases in the botulinum and antitoxin stockpile," Hauer said. "By and large, we have seen nothing in the way of addition of new chemical antidotes."

HHS did not provide comment by press time.

Industry efforts to develop vaccines have been stifled due to liability concerns, costs, difficulties producing enough vaccine and questions over how vaccines would be distributed, said Stephen Morse, director of the Center for Public Health Preparedness at Columbia University.

"While the number of threats continues to increase and become more dynamic, the vaccine industry has been shrinking in recent years," Morse said.

Air Force Col. Joseph Palma, director of the Defense Department's chemical and biological defense program, agreed. He said the government has not found an appropriate way to offer incentives to the pharmaceutical industry for producing vaccines. He added, however, that private corporations also need to "think very carefully about how they're going to support the national effort."

Ludlaw believes Project Bioshield II will have support in Congress. But he said the legislation's fate depends on whether the administration gets behind it.

"If the president leads, we can enact all of this," Ludlaw said. "If he doesn't, we will enact none of it."

Pentagon Looks to Declare Anthrax Risk Emergency, Resume Mandatory Vaccinations

By David Ruppe
Global Security Newswire

WASHINGTON — A senior Republican congressman is investigating a U.S. Defense Department claim that an emergency exists requiring it to resume mandatory military anthrax vaccinations, which were blocked by a federal judge in October (see GSN, Nov. 11).

Deputy Defense Secretary Paul Wolfowitz in a letter last Friday asked Health and Human Services Secretary Tommy Thompson to declare a state of emergency with the aim of resuming anthrax vaccinations, apparently without first informing the soldiers to be vaccinated of the risks of side effects and obtaining their consent.

In making his request, Wolfowitz cited “a classified November 2004 Intelligence Community assessment” of a threat to U.S. forces in South Korea and the U.S. Central Command region, which includes Iraq and stretches from the horn of Africa to Central Asia.

“I have determined there is a significant potential for a military emergency involving heightened risk to United States military forces of attack with anthrax. … This heightened risk has been and continues to be the basis for the DOD program of vaccinating personnel serving in areas of the Central Command and Korea,” he wrote.

The military suspended the vaccinations after a U.S. District Court judge ruled in October that a prior Food and Drug Administration approval for the drug’s use against inhalation anthrax was invalid, that the drug therefore remained experimental for that purpose, and so troops should be given it only with informed consent.

The Defense Department appears unwilling to provide the vaccinations to soldiers with informed consent, apparently out of concern a voluntary vaccination program would result in refusals, increasing U.S. military vulnerability to an attack.

In a letter last night obtained by Global Security Newswire, Representative Christopher Shays (R-Conn.) asked the Central Intelligence Agency to provide him with the intelligence assessment cited by Wolfowitz and a briefing on the perceived danger.

“The basis for any determination of emergency use of a biological warfare countermeasure should be as clear as possible to those who take the vaccine and to their elected representatives,” wrote Shays, who chairs the House Subcommittee on National Security, Emerging Threats, and International Relations of the Committee on Government Reform.

Shays also sent a letter to Thompson, asking whether his agency views Wolfowitz’s letter as a valid emergency determination under statutory requirements. The Federal Food, Drug and Cosmetic Act “explicitly requires” a determination by the defense secretary and publication of such a determination in the Federal Register for emergency use, along with the concurrence of the Health and Human Services Department, he wrote.

The Defense Department request “presents a number of unique, potentially troubling legal and procedural issues,” he wrote.

Shays furthermore urged Health and Human Services to review Wolfowitz’s request “deliberately and openly … with maximum public input to avoid even the implication HHS will rubber stamp or give unquestioning, and underserved, deference to DOD determinations on medical matters.”

“Hundreds of military personnel have suffered adverse reactions to the vaccine,” he wrote.

The military has maintained the drug is relatively safe and effective against inhalation anthrax and that the Food and Drug Administration rule was legitimate.

Defense Department Strategy Uncertain

Observers say they are uncertain what Wolfowitz was trying to accomplish with his letter, noting as Shays did that federal law requires the defense secretary to determine a state of emergency and to publish the determination in the Federal Register prior to emergency use of an unapproved vaccine.

The emergency-use provision was contained in the Project Bioshield Act of 2004 passed by Congress in July and this appears to be its first invocation.

Furthermore, another U.S. law requires the military to obtain a presidential waiver to resume the anthrax vaccinations without informed consent, in light of the judicial ruling on the status of the vaccine, and whether there is an emergency or not, said John Michels, a partner in the Chicago office of McGuireWoods LLP representing plaintiffs in a lawsuit that pushed for the injunction.

“We are not exactly clear on the meaning of the Wolfowitz letter,” Michaels said.

The law “says you can’t use investigational drugs without the consent of the soldier or a presidential waiver. That’s the bottom line right there,” he said.

U.S. officials appear unwilling to pursue a presidential waiver.

Officials with the Health and Human Services and Defense departments had not returned requests for comment by press time.

December 15, 2004

Defense seeks emergency authority to resume anthrax vaccinations

By Chris Strohm

The Defense Department has asked the Health and Human Services Department for emergency authority to resume its anthrax vaccination program for military personnel, Government Executive has learned.

Deputy Defense Secretary Paul Wolfowitz issued a Dec. 10 memo asking HHS Secretary Tommy Thompson to declare an emergency in order to justify using the vaccine for protection against inhaled anthrax. The military's anthrax vaccination program was suspended in late October by a federal judge in response to a lawsuit filed by six anonymous plaintiffs. The lawsuit argued that the vaccine was not proven to protect against inhaled anthrax, and led to health problems.

In the memo, Wolfowitz said he has "determined there is a significant potential for a military emergency involving a heightened risk to United States military forces of attack with anthrax."

"In making this determination," Wolfowitz added, "I have considered a classified November 2004 Intelligence Community assessment of the anthrax threat. This heightened risk has been and continues to be the basis for the DoD program of vaccinating personnel serving in the areas of the Central Command and Korea."

Central Command is responsible for operations in Iraq and Afghanistan. More than 1.2 million troops have been inoculated under the anthrax vaccination program since 1998.

A HHS spokesman was unaware of the request and had no comment. The Defense Department did not provide comment by press time.

Judge Emmet Sullivan of the U.S. District Court for the District of Columbia ruled Oct. 27 that the military must stop administering the BioThrax vaccine, also known as Anthrax Vaccine Adsorbed, to service members. The vaccine is produced by BioPort Corp. of Lansing, Mich.

The Food and Drug Administration previously issued a final rule and order in December 2003 that licensed the vaccine as safe and effective for anthrax, regardless of the route of exposure. The judge, however, vacated that final rule and order, saying FDA did not follow proper procedures to determine whether the vaccine is safe and effective against inhaled anthrax.

"Unless and until FDA properly classifies AVA as a safe and effective drug for its intended use, an injunction shall remain in effect prohibiting [the military's] use of AVA on the basis that the vaccine is either a drug unapproved for its intended use or an investigational new drug," Sullivan wrote. "Accordingly, the involuntary anthrax vaccination program, as applied to all persons, is rendered illegal absent informed consent or a presidential waiver."

The chief lawyer for the lawsuit called DoD's request for emergency authority "legally ineffective."

"This is just another attempt to betray the members of the military and circumvent the now judicially determined problems with the vaccine," said Mark Zaid, managing partner of Krieger & Zaid in Washington.

He cited a provision under Project BioShield stating that only the defense secretary has the authority to determine if there is an emergency, as opposed to the deputy defense secretary. Even then, Zaid claimed, the military must seek consent from military personnel or a presidential waiver in order to resume the vaccination program.

"Neither DoD or HHS has the authority to grant a waiver. It has to be the president," Zaid said.

"Just because they declare a military emergency doesn't allow resumption of the program. It is a step toward it but it doesn't allow resumption," he added. "This changes nothing but raises a tremendous amount of questions that Congress ... should immediately demand answers for."

BioPort spokeswoman Kim Brennen Root said her company considers the BioThrax vaccine as fully licensed and validated by the FDA.

"Our license is in place regardless of the route of exposure," she said. "I don't think it's the judgment of any of the appropriate agencies that this is an investigational vaccine."

She said the emergency request from DoD is a mechanism that can be used to resume the military's vaccination program.

Emergent BioSolutions Inc., the parent company of BioPort, recently announced the acquisition of a 150,000-square-foot facility in Frederick, Md, which will be used as an additional vaccine manufacturing site. Brennen Root said the facility is being designed to produce multiple vaccines. The company is waiting, however, for contracts before it begins production at the center.

HHS announced in November that it plans to buy 5 million doses of the BioThrax vaccine for civilian inoculations. Brennan Root said the company expects a contract for actual work to be let early next year.

HHS also awarded another contract in November worth almost $880 million to VaxGen Inc. of California to produce 75 million doses of a new type of anthrax vaccine.

December 8, 2004

FDA asked to regulate advertising of anthrax vaccine

By Chris Strohm
GOV Exec

Two lawyers have asked the Food and Drug Administration to prevent the Defense Department and a private contractor from advertising that the government's anthrax vaccine is fully licensed.

The lawyers claimed the Pentagon and BioPort Corporation of Michigan should be prevented from saying the anthrax vaccine -- BioThrax -- is an FDA-licensed product. Mark Zaid, managing partner of Krieger & Zaid in Washington, and John Michels, a partner in the Chicago law firm of McGuireWoods, said the FDA is required to take such action in response to a recent court ruling.

Zaid and Michels represent six anonymous plaintiffs who filed a lawsuit against the military's anthrax vaccine program.

A federal judge decided Oct. 27 that the military must stop administering BioThrax, also known as Anthrax Vaccine Adsorbed, to service members.

Judge Emmet Sullivan of the U.S. District Court for the District of Columbia ruled that the vaccine was not properly licensed for protecting against inhaled anthrax.

"Unless and until FDA properly classifies AVA as a safe and effective drug for its intended use, an injunction shall remain in effect prohibiting [the military's] use of AVA on the basis that the vaccine is either a drug unapproved for its intended use, or an investigational new drug," Sullivan wrote.

The FDA previously issued a final rule and order in December 2003 saying the anthrax vaccine was licensed and safe and effective for the prevention of anthrax disease, regardless of the route of exposure. The judge, however, vacated that final rule and order in his ruling and told the FDA to get more public input and to reevaluate the vaccine.

Zaid and Michels sent a letter to the FDA last week stating that BioPort and the Defense Department continue to advertise that the anthrax vaccine is fully licensed for use against inhaled anthrax, despite the recent court ruling.

"The FDA is legally obligated per its statutory mandate to enforce the court's ruling and prevent the marketing of unlicensed vaccines," the lawyers wrote. "Yet, the FDA is permitting BioPort and others to openly advertise the AVA as a licensed vaccine for use against inhalation anthrax."

The letter added: "The FDA must take immediate and aggressive steps to ensure BioPort, its paid proxies and the Department of Defense accurately characterize AVA as an unlicensed and investigational vaccine for purpose of inhalational exposure."

FDA spokeswoman Lenore Gelb said the judge's ruling is "under review" and the agency is evaluating whether to reopen the public comment period for the anthrax vaccine. She said the FDA has no intention of directing BioPort or the Defense Department to alter their marketing materials for the vaccine, however, because the agency still considers AVA to be a fully licensed vaccine. Gelb declined to comment further.

BioPort did not return telephone calls for comment.

Zaid and Michels noted that BioPort recently dedicated a new facility in Maryland for producing 100 million anthrax vaccine doses when it becomes fully operational in two years.

"If BioPort wishes to continue to ignore the current legal climate concerning the status of the AVA, it does so at its own commercial risk," they concluded in the letter. "However, so long as the FDA continues to fail to exercise its authority to oversee the manufacturing and marketing of biological products, it seems clear that BioPort and others will take advantage of the FDA's dereliction of its duties."

December 6, 2004

Vaccine role in gulf illness proposed for more study

By Deborah Funk
Times staff writer

Vaccines, particularly anthrax vaccine, should be further studied to determine if they contributed to illnesses suffered by tens of thousands of 1991 Persian Gulf War veterans, according to a panel that helps guide research for the Department of Veterans Affairs.

The Research Advisory Committee on Gulf War Veterans’ Illnesses thus far has focused largely on toxins, such as nerve agents and pesticides, which can cause neurological damage. But other factors could play a role, including vaccines, it said in a report released Nov. 12.

Studies have shown higher rates of illnesses among veterans who reported getting vaccines, but determining links between anthrax and botulinum toxoid vaccines and illness in U.S. veterans is tough to do because the shots often were not recorded.
“A number of potential problems with the anthrax vaccine have been suggested, including problems with quality control during the manufacturing process, changes in the manufacturing process that may have resulted in increased levels of active antigen” and the use of unapproved additives to boost a person’s immune response, the report said.

;Among other things, the VA advisory committee report points to a study that found an “excess of symptoms” among people who said they received vaccinations to prepare for the 1991 Gulf War but never deployed.

The committee recommends the VA work with the Centers for Disease Control and Prevention and the National Institutes of Health, which are conducting or overseeing studies of anthrax vaccine in an effort to track people for at least five years after they take it. They should look for symptoms similar to those suffered by Gulf War veterans, including memory and reasoning problems, the report said.

The VA also should study ailments and symptoms of veterans who received anthrax vaccine as part of the military’s mandatory program in recent years, and compare those to veterans who did not get the shots, according to the report.

Spacing out the shots may get harder look

by Deborah Funk
Army Times

Services usually ‘overvaccinate’ now, doctors say

A group of civilian medical experts says multiple simultaneous vaccinations are safe, but nevertheless advises the Pentagon to look for ways to reduce the number of shots given to troops at one time.

The goal should be to “minimize discomfort” to troops and prevent possible lost work time and unnecessary vaccination while still protecting the force against diseases, the Armed Forces Epidemiological Board said in a April 2004 memo to senior health officials in the Defense Department and the services.

The board recommends spreading vaccinations out over time during initial entry training and subsequent service, and investigating whether someone has immunity against a particular disease before vaccinating.

“What we see consistently is overvaccination,” said Dr. Stephen Ostroff, president of the board and assistant surgeon general of the U.S. Public Health Service. “We don’t see solid, scientific, well-documented information that suggests there’s any particular reason you can’t give multiple vaccinations. However, we need to take a hard look at what we’re doing because [vaccines] may not be needed by that particular individual.”

In mapping out specific approaches, service officials will have to consider how many people are immune to a disease against which they might vaccinate; the costs and logistics of selective versus universal vaccination; and the risk of missing vaccinating someone who may be susceptible to a particular disease, the memo said.
While decades of experience show no serious or long-term health problems from vaccinating against more than one disease at the same time, there is evidence of short-term soreness and illness that resolve on their own but increase with multiple simultaneous vaccinations and may lead to missed work time, according to the board’s memo.

One way to avoid this for recruits, the board said, would be to administer shots for flu, measles, mumps, rubella and other kinds of vaccines that would have “immediate potential” for keeping people healthy at the beginning of training, then giving the remaining required shots closer to the end of boot camp.

To avoid unnecessary shots, the services could screen blood to check for immunity against disease troops may have encountered naturally or may have been inoculated against during childhood, such as chickenpox or hepatitis B.

The board said vaccination against diseases that are a threat only in certain geographic areas, such as yellow fever, could be limited to people who are likely to travel to those areas of the world. The Air Force, for example, has reduced its use of yellow fever vaccine by 81 percent after requiring vaccination based on risk of exposure, the board noted.

Beyond basic training, the services should more closely track which vaccinations troops have received, to include presuming that those who graduated from boot camp got the standard vaccines given during that period.

National Guard and reserve members also should be required to bring vaccination records with them when they are mobilized or assessed for medical readiness, the board said.

These groups are more likely to require updated vaccinations than other troops, so more frequent medical readiness reviews could help cut the number of vaccines they must be given at one time.

“DoD procedures should minimize just-in-time delivery of preparatory countermeasures,” the board wrote.

The Air Force has adopted many of the board’s suggestions. For example, it stores shot records electronically and checks blood for existing immunity. Vaccinations are spread out as training schedules allow, and vaccinations needed for specific geographic regions are held off until just before deployment, according to Lt. Col. (Dr.) Michael Snedecor, chief of preventive medicine for the Air Force surgeon general.

The Navy is looking at how it might reduce vaccinations among Navy and Marine Corps trainees while still keeping them healthy and ready, said Capt. Edward Kilbane, director of preventive medicine and occupational health in the Navy’s Bureau of Medicine and Surgery.

The Navy has done studies of recruits’ immunity to diseases like chickenpox and hepatitis B to see if those vaccinations were needed, and is also developing ways to screen health histories to avoid repeating vaccinations people may have received prior to joining the Navy.

The Army tries to spread out vaccinations when possible, and its clinics de-emphasize measles-mumps-rubella and polio vaccines after initial entry training.
Army officials also say they are paying closer attention to individual health records to reduce the number of shots given prior to deployment when possible.

Too many vaccines, too quickly?

Air Force Times
By Deborah Funk

Concurrent inoculations increase your risk of getting sick, some say. Now, scientists are taking a look

Army Spc. Tyran Duncan no longer needs a machine to draw breath, but his hands can’t grip tightly and he wears braces on his legs to help him walk.

Duncan, 20, who was temporarily medically retired Nov. 24, hasn’t completely recovered from the Guillain-Barré syndrome that struck him two years ago, a few weeks after he received numerous military-related vaccinations.

But at least he’s not completely paralyzed anymore.

He believes the vaccinations caused his health problems, but since he received multiple shots, one after another, he has no idea which vaccine or vaccines may be to blame. He hasn’t received any vaccinations since and may not ever again — not even for the flu or for trips abroad.

“He wouldn’t know which shots not to have,” said his grandmother, Faye Harville, who shares her home in Tennessee with Duncan. “He couldn’t pursue a life where he might be able to travel with a job.”

A long military tradition

From the ragtag Continental Army that fought for George Washington to the dust-covered grunts in Iraq and Afghanistan today, American troops have been given vaccines to protect them against diseases their leaders say threaten their health and the military’s readiness.

In the Revolutionary War, troops were inoculated with live smallpox. After the Spanish-American War, typhoid vaccine was introduced. By World War II, U.S. troops got multiple jabs, often at the same time, a practice that continues today.

Medical experts say numerous simultaneous shots generally are safe, and studies in young children who get multiple shots have not proved otherwise.

“You are bombarded with far more ... immunologic challenges in your environment than you’d ever encounter from a vaccine,” said immunology expert Dr. Paul Offit of The Children’s Hospital in Philadelphia. “If you really want to get scared, just take a nasal swab. … It’s teeming with bacteria, and you’re making an immune response.”

Available data also show no patterns of long-lasting bad side effects in adults who get two or more shots together, but such studies are more limited than those in childhood populations and derived largely from military practice and civilian travel medicine clinics.

Still, “This is a long-standing practice,” Dr. Stephen Ostroff, president of the Armed Forces Epidemiological Board, said of multiple simultaneous vaccinations. “There is virtually no data to say there is a problem with this.”
“You conclude that at least there is no evidence that it is detrimental,” added retired Army Lt. Gen. Ronald Blanck, who was the Army surgeon general when the Pentagon announced in 1997 it would vaccinate all U.S. service members against anthrax — a program that was halted in late October after a federal judge ruled it illegal.

But while most experts say numerous vaccinations on the same day is safe, the military acknowledges that it is partnering with the Centers for Disease Control and Prevention to more closely study whether vaccines are linked to illnesses and, if so, in what combinations and in which people.

Lethal side effects

Vaccines, like any drug, can trigger bad reactions. So when someone receives more than one vaccination and suffers a side effect, finding answers can be difficult.
Bawana Perry believes a combination of vaccines played a role in the death of her sister.

Pfc. Arwana Lattimore-Oliver joined the Army Reserve in 1991, re-enlisted and was serving at Fort Riley, Kan., in March 1998. In April 1998, she got at least three shots, for yellow fever, typhoid, and diphtheria and tetanus, on the same day. Later that month, she got a hepatitis shot.

In September, she went to the hospital with vomiting and low heart rate, according to a source familiar with her medical records.

Her condition worsened over the following months, robbing her of her vision and sense of touch, her balance, and ability to walk or even feed herself. She also contracted multiple sclerosis and slowly faded away until she died May 24, 2002, at 28.

“She went from one of the healthiest people you could know to just dwindling down until she was gone,” said Perry, of Tallahassee, Fla.

After her discharge from the military, Oliver moved near her family in Tallahassee, Fla. Civilian doctors who treated her there and investigated her multiple sclerosis questioned whether she received any vaccinations in the military prior to falling ill, but they could not say what role vaccines may have played in her disease, Oliver’s sister said.

Moses Lacy of Lynwood, Ill., had a similar experience with his daughter, Army Spc. Rachel Lacy, more than a year ago.

Prior to deploying to the Persian Gulf in March 2003, she received these shots in a single day: anthrax, smallpox, hepatitis B, typhoid VI, and measles, mumps and rubella — and died just 33 days later. She was 22 years old.

Two expert panels — one affiliated with the CDC, the other under the Department of Health and Human Services — said one or more of the vaccines may have triggered an undiagnosed autoimmune disorder that killed her. But they could not pinpoint which ones. Her case was the only one of four cases of severe illness or death reviewed by the panel that found a link between vaccination and death.

The coroner said in his official report that smallpox and anthrax vaccines may have contributed to Lacy’s death.

Her father agrees, dismissing the theory that she had an underlying autoimmune disease. He questions giving numerous shots on the same day, saying it can only complicate learning which vaccine caused a problem.

“How do you know? Was it one specific, or the combination of them all?” Lacy said.
Army Col. John Grabenstein, deputy clinical director of the Military Vaccine Agency, acknowledges that “it’s difficult to tease them out.”

“One of the first things you do is look for the usual suspects,” Grabenstein said. “What has vaccine ‘Q’ been shown to cause before?”

But even that doesn’t always yield answers.

New look at immune responses

The human immune system is capable of handling more than one immune stimulus at a time. Young children trade viruses, as do military recruits in barracks and travelers on crowded planes.

One streptococcus vaccine has 23 types of strep. The tetanus shot combines tetanus and diphtheria. One multiple vaccine expert says the human immune system could handle up to 10,000 vaccine ingredients at a time that cause an immune response, or “more [shots] than someone would sit still for,” Grabenstein said.

“What’s the maximum amount that’s safe?” he said. “We don’t know that there is a maximum.”

To find an answer, defense officials plan to study the safety of dispensing multiple vaccines on a single day. “Because we have a very well-monitored population for whom we know who gets sick how often, we have an opportunity to inform the general public,” Grabenstein said.

A newly formed Vaccine Analytic Unit will study whether vaccines are linked to illness and, if so, in what combinations and in which people. Most of the work will focus on anthrax vaccine, but it also will explore the issue of near or concurrent vaccinations.

The VAU, a joint effort of the Pentagon and CDC, will mine the military’s data to find common combinations of simultaneously administered vaccines and whether certain ones may be linked to more or worse side effects than others.

“No one really knows if there is something to be further investigated yet,” said Daniel Payne, a CDC epidemiologist and the unit project officer.

The work will begin early next year, and experts are developing methods to try to differentiate which vaccine might be involved in the case of adverse events.
“If we do find an association, we hope to narrow it down a little bit more,” Payne said.

Waiting in limbo

Duncan believes a vaccine sparked his Guillain-Barré syndrome, but he has no idea which one. Medical experts in Tennessee can’t say for sure that the vaccines injured him, said Harville, his grandmother.

“Nobody really says what caused it,” she said.

But when doctors first examined him after he fell ill, Duncan recalls seeing an Army hospital document that said his condition could be related to vaccination, he said.
As a new recruit, Duncan got four shots on a single day in August 2002. Later that month, he said he got more, but there is no record of at least two shots he had been told he was receiving, for anthrax and flu. Harville said the Army claims he didn’t get those vaccinations, and anthrax vaccine is not included in a Defense Department list of required shots for new recruits. Within a couple of weeks, Duncan began losing control of his limbs. His drill sergeant thought he was faking; Duncan himself thought he was just fatigued. But then two soldiers had to carry him to sick call, and he couldn’t feel his foot when the doctor poked it with a needle. Diagnosed with Guillain-Barré, he was paralyzed for 11 months, spending three of them on a ventilator.

“I’d been getting real draggy. I couldn’t pick up my feet, hold a glass to take a drink,” Duncan said. “Once I started noticing, it took two days and I was completely paralyzed.”

Guillain-Barré syndrome is a rare disorder in which the body’s immune system damages the peripheral nervous system outside the brain and spinal cord. It usually appears after a gastrointestinal or respiratory infection, although it can also follow vaccination or surgery.

It was definitively linked to the 1976 swine flu vaccine. Once since then, in the 1990s, a slight increase in Guillain-Barré was reported after influenza vaccination, but some experts still dispute that. There are also reports of it following anthrax vaccination in service members, but defense officials say the rate in that group was the same as for the general population.

Its onset is also reported following the use of other drugs, said a top Army immunologist.

The cause of Guillain-Barré, which affects one or two people in every 100,000, is unknown, but most victims recover.

“It’s very hard to study because it’s so rare,” said Army Col. (Dr.) Renata Engler, an immunology expert at Walter Reed Army Medical Center in Washington and director of the Vaccine Healthcare Centers Network.

The network, launched at Walter Reed in 2001 and since expanded to three other sites, helps treat patients who have fallen ill with various ailments after vaccination and finds ways to reduce unwanted side effects. Through detailed record keeping and reporting, it also can pinpoint rare adverse reactions to particular vaccines.

Hands-on medicine, where detailed histories are taken and patients are treated, can yield new data, including identifying health problems that may be linked to vaccination.

But that won’t help people such as Duncan, who says his military medical history is incomplete. He can’t supply his full vaccination records because he said the Army has provided only part of his shot records from boot camp. “They claim they can’t find them,” he said.