October 31, 2006

Experts Warn of Potential Adverse Health Effects From AVA Anthrax Vaccine as DoD Plans to Resume Mandatory Vaccinations

Press Release Source: Byron Holcomb, Attorney at Law

Experts Warn of Potential Adverse Health Effects From AVA Anthrax Vaccine as DoD Plans to Resume Mandatory Vaccinations
Lawyers Discuss Legal Strategies to Stop Mandatory Program

WASHINGTON, Oct. 30 /PRNewswire/ -- As the Defense Department (DoD) prepares to resume mandatory AVA (Anthrax Vaccine Absorbed) vaccinations for military overseas, medical experts and military personnel warned of adverse health effects they claim were caused by the vaccine, while victims' attorneys strategized about stopping the vaccinations and discussed securing compensation for victims. The discussions occurred at an October 28 Continuing Legal Education (CLE) seminar organized by Byron Holcomb, a leading attorney for victims of the AVA anthrax vaccine and a retired Navy judge advocate general.

Various military personnel recounted how they believe the AVA anthrax vaccine harmed their health and hurt their careers. U.S. Air Force Judge Advocate Captain Kelli Donley developed Idiopathic Spinal Cerebellar Ataxia after receiving the AVA anthrax vaccine. The disease impaired her brain function and motor skills, a U.S. Air Force Medical Evaluation Board ("Board") found. She retired in April of 2006 after the Board granted her a 100 percent disability because she could not practice law or perform tasks requiring high cognitive function or demanding speech.

"Before receiving the anthrax vaccine, I was perfectly healthy and in good shape. Now, I talk with slurred speech, I have trouble walking, and I stopped seeing those seeking legal assistance because their legal issues paled in comparison to mine," said Donley.

Others who spoke of what they believe are the harmful health effects of receiving the AVA anthrax vaccine included Margaret McFann, an Air Force major diagnosed with lupus, and Frank Fisher, MD, a retired Air Force lieutenant colonel diagnosed with Still's disease, a rare illness marked by high, spiky fevers, rash, and joint pain, which may lead to chronic arthritis.

A medical expert, who strongly believes in the use of safe and efficacious vaccines, warned of serious and significant concerns about the AVA vaccine's safety profile. Mark Geier, MD, PhD, analyzed the safety of millions of doses of the vaccine using the Vaccine Adverse Events Reporting System (VAERS), an epidemiological database maintained by the Centers for Disease Control. His analysis is published in peer-reviewed journals, including Hepato- Gastroenterology and the Journal of Clinical and Experimental Rheumatology. He writes in Hepato-Gastroenterology, "Anthrax vaccine, based upon our analysis of the VAERS, was one of the most reactogenic vaccines we have ever analyzed ... The data showed the use of AVA was frequently followed by a wide variety of reports of adverse reactions that generally occur within 12 days of vaccination."

Lawyers discussed efforts to reverse the government's decision to proceed with mandatory inoculations, as well as legal strategies to gain compensation for victims. Attorney Holcomb said, "Our objective is not to stop vaccination of military personnel, it is to stop the mandatory injection of an experimental vaccine that has failed the safety test time after time."

Holcomb added, "Military boards have already granted permanent military disability to fifteen victims I represented -- professionals in their early 20's and 30's, with bright futures ahead of them -- who became tragically disabled for life by the AVA anthrax vaccine. The military board decisions validate my firm belief that DoD should not resume mandatory inoculations with this vaccine."

Mark Zaid, Esq., whose lawsuit had until recently blocked the Pentagon's mandatory anthrax vaccination program, is committed to stopping its reinstatement. "The anthrax vaccine is unnecessary, unproven and potentially unsafe -- and should not be unlawfully imposed upon our military forces or contractors," he said.

Scientists Uncover New Bird Flu Strain

http://news. yahoo.com/ s/ap/20061031/ ap_on_sc/ new_bird_ flu
By RANDOLPH E. SCHMID, AP Science Writer

WASHINGTON - Scientists have discovered a new strain of bird flu that appears to sidestep current vaccines. It's infecting people as well as poultry in Asia, and some researchers fear its evolution may have been steered by the vaccination programs designed to protect poultry from earlier types of the H5N1 flu.

The discovery by Yi Guan of the University of Hong Kong and colleagues is reported in Tuesday's issue of Proceedings of the National Academy of Sciences. The new variant has become the primary version of the bird flu in several provinces of China and has spread to Hong Kong, Laos, Malaysia and Thailand, the researchers report. It is being called H5N1 Fujian-like, to distinguish it from earlier Hong Kong and Vietnam variants. "We don't know what is driving this," report co-author Dr. Robert G. Webster of St. Jude's Children's Research Hospital in Memphis, Tenn., said in a telephone interview.

New vaccines will have to be developed, Webster said. Many scientists are going to think the vaccination program encouraged the virus to evolve resistance, he added, but high-quality vaccines can reduce the level of illness and prevent emergence of variants.

While the new virus has infected people, there is no evidence that it can pass easily from person to person, Webster said.

However, he added, "this virus is continuing to drift." Dr. Michael L. Perdue, of the World Health Organization's Global Influenza Program in Zurich, Switzerland, said the new variant doesn't indicate any increased risk for people "other than the fact it seems to be pretty widespread." The virus is continuing to change, he added. Perdue, who was not part of Webster's research team, said WHO is working with the Chinese Ministry of Health to develop a vaccine for the new form of the virus.

The H5N1 flu has devastated poultry in China and several other Southeast Asian countries and also has claimed more than 150 human lives. Most of the people affected lived close to flocks of chickens or other poultry. Public health authorities fear that the virus will mutate into a form that can spread easily among people, raising the potential for a worldwide pandemic like the one that killed millions in 1918. That worry has spurred efforts to develop vaccines for the virus as well as to test migrating wildfowl in an effort to detect movement of the disease. Studding the virus' surface are two proteins called hemagglutinin - the H in H5N1 - and neuraminidase, the "N." There are 16 known hemagglutinin versions and nine neuraminidases.

They also trigger the immune system to mount an attack, particularly hemagglutinin, the protein the body aims for when it makes flu-fighting antibodies. The research was funded by the Li Ka Shing Foundation, a Hong Kong group that supports medical, educational and cultural work, and the U.S. National Institute of Allergy and Infectious Disease.

October 30, 2006

Should the Anthrax Vaccine be Mandatory? Take the Poll

Air Force Times

Go to the following website: http://www.airforcetimes.com
Scroll all the way to the bottom and take the poll.



Was the dreaded Spanish Influenza epidemic of 1918 (to which the potential bird flu virus has been ominously compared) the result not of the virus, but of the widespread vaccinations administered, allegedly to ward off this and other diseases?

In an Internet article contained within an alternative health and nutrition newsletter, Eleanora McBean – who claims she is old enough to remember - recalls statements of the day such as, "more soldiers were killed by vaccine shots than by shots from enemy guns," which was indeed a common expression during and after World War I.

In fact, reputable sources have pointed out that the first outbreak of that illness was in a military camp preparing to go overseas, after massive vaccinations, and that the only other sighting of that particular flu strain (according to the Center for Disease Control itself) occurred in 1976, at Fort Dix, New Jersey, and among recently vaccinated troops. Fort Dix was apparently a well known vaccine trial center. - ST

October 29, 2006

Q&A: The Pentagon’s mandatory anthrax vaccine policy

Stars and Stripes

Q: Have any servicemembers contracted anthrax or died from the disease?

A: We do not know of any servicemembers that have contracted anthrax or died from the disease.

Q: Then why vaccinate troops and DOD civilians against anthrax?

A: DOD immunizes servicemembers to protect against a biologic threat agents. Intelligence experts have determined that anthrax poses a clear and present danger to operational forces. The anthrax attacks through the U.S. Postal Service provide evidence that the threat is real, and in those exposed, is potentially deadly. Immunization represents the most effective round-the-clock protection for our troops.

Q: What are the side effects of the anthrax vaccine?

A: Like all vaccines, anthrax vaccine can cause soreness, redness, itching, swelling, and lumps at the injection site. Beyond the injection site, some will notice rashes (an average of 16 percent), headaches (14 percent to 25 percent), joint aches (12 percent to 15 percent), malaise (6 percent to 17 percent), muscle aches (3 percent to 34 percent), nausea (3 percent to 9 percent), chills (2 percent to 6 percent), fever (1 percent to 5 percent). These symptoms usually go away after a few days. The rates of these reactions are similar to those experienced by recipients of other common vaccines.

Q: Is the anthrax vaccine regimen discontinued for troops who develop symptoms of the disease or who have an adverse reaction?

A: The anthrax vaccine does not contain bacillus anthracis bacteria, and does not cause anthrax. Immunity from natural anthrax infection is lifelong. Vaccine-associated adverse reactions are managed through the military health system and medical exemptions are granted by the servicemember’s primary healthcare provider (or specialist consultant) consistent with good medical practice.

Q: How can DOD require emergency-essential civilians and contractors to be vaccinated?

A: DOD has authority to establish appropriate requirements necessary for the successful performance of duties. In the case of emergency-essential employees and comparable contractors, they agree to comply with agency requirements that are generally comparable to those applicable to military personnel.

Q: What legal ramifications do troops and DOD civilians who refuse to take the vaccine face?

A: Any failure to obey a lawful order may result in administrative or disciplinary action. There is no specification provided by law for the particular punishment that might be imposed in any case of failure to obey a lawful order. Authority is vested in the command structure and under the Uniform Code of Military Justice to determine the appropriate action, with protections for the due process rights of the member.

Q: Are the services preparing to prosecute troops and DOD civilians who refuse to be vaccinated?

A: There are no special preparations planned or needed. DOD experience with mandatory anthrax and smallpox vaccination programs, as well as all other mandatory vaccinations, is that there is overwhelming compliance and a very tiny degree of noncompliance.

Q: Why is it important to complete the vaccine regimen for troops who have already rotated out of theater if they might not go back to an area that requires anthrax vaccinations?

A: It is important because properly completing the vaccine regimen is good medical practice — following the full FDA-approved dose schedule. By continuing the vaccinations, even when they leave the high threat area, allows them to become fully protected and provides the U.S. Armed Forces with a more medically ready force.

Q: Are troops only fully protected after the sixth dose at 18 months?

A: Each dose is like walking up a set of stairs toward full protection. Most people begin to make antibodies with the first dose of anthrax vaccine. The goal is to climb the whole staircase, which is six doses for anthrax vaccine. The licensed anthrax vaccine recommends a six-dose regimen to be administered over an 18-month schedule. Yearly boosters are administered thereafter to maintain immunity.

Q: Do you have a chart showing how much protection each dose gives troops — for example, does the third dose provide 50 percent protection?

A: We don’t have a chart. The question of levels of protection provided by each dose of the schedule is under active clinical investigation. However, DOD must administer vaccines for force health protection consistent with the product license (FDA-approved schedule). Any changes to the licensed schedule would require FDA-approval of the manufacturer’s supplement to the original biologic license application (a regulatory requirement).

— Source: Defense health officials

Anthrax vaccine opponents gear up to renew fight

By Gayle S. Putrich, Staff writer

As the Pentagon prepares to resume mandatory anthrax shots, vaccines opponents — including lawyers, medical experts and veterans — gathered Saturday in Washington to discuss current cases and potential legal avenues for helping those who say they were harmed by the vaccine.

The day-long seminar was held in the shadow of the Defense Department’s Oct. 16 announcement of its plan to resume mandatory anthrax vaccinations after a nearly two-year, court-ordered hiatus.

But Byron Holcomb, the lawyer who organized the seminar, said the day-long event was not prompted by the Pentagon’s policy change. He said it had been in the works since July with an underlying goal of trying to “see what we can do … to get us yoked together to do the right thing.”

Holcomb, a retired Navy judge advocate general who has been involved with various anthrax-related court cases since 2002, said every victim’s story pains him, and has spurred him to seek ways in which legal, medical and defense officials could cooperate to ensure those harmed by the vaccine get the legal and medical help they need.

“These are young people who are essentially done for in life,” Holcomb said.

The Defense Department’s recent announcement of its decision to restart the mandatory vaccination program made the seminar even more relevant and necessary, Holcomb said.

Part of the reason the Seattle-based lawyer wanted to hold the event in Washington was to make it easier for military lawyers who adjudicate contested findings from military medical and physical evaluations boards and military doctors, especially those from the vaccine health care center at Walter Reed Army Medical Center, to attend.

Holcomb said many were invited — but none came. He said those who had previously indicated they would attend canceled at the last minute, without giving a specific reason.

Although the Pentagon insists the vaccine is safe and effective, with an adverse event rate that is not outside the norm for other vaccines, reported side effects of the anthrax shots range from mild reactions such as rashes and sores to severe, incapacitating, irreversible damage.

For example, retired Air Force Capt. Kelli Donley, a former military lawyer, told seminar attendees she contracted idiopathic spinal cerebellar ataxia, a shrinking of the brain’s cerebellum, which governs motor function, after taking the first three shots of the six-shot anthrax vaccine regimen in 2000.

She said she began to suffer from slurred, slow speech, became clumsy in her movements and experienced numbness in the arm in which she received the shots. After returning to the U.S. from Korea, she underwent tests that showed her cerebellum was shrinking.

“It was a bittersweet relief — I wasn’t imagining this,” she said.

Also attending the seminar were Air Force Reserve Maj. Margaret McFann, a nurse diagnosed with lupus after receiving the vaccine, and former Air Force Reserve Lt. Col. Frank Fisher, a physician who contracted Still’s disease and became disabled after taking the shots. Still’s disease is a rare disorder marked by high, spiky fevers, rashes and joint pain that may lead to chronic arthritis.

Some service members have died after taking the shots, but the Defense Department says the deaths cannot be conclusively linked to the vaccine.

The Food and Drug Administration issued a report on adverse reactions to the anthrax vaccine last December, at about the same time that it made a final ruling on the safety and efficacy of the vaccine.

From July 1990 through March 2005, the government-sponsored Vaccine Adverse Event Reporting System (VAERS) logged 4,279 reports of health problems as a result of anthrax vaccine, 390 of which were classified as “serious.”

But critics of the vaccine have claimed the number of adverse events is actually much higher, and even the FDA acknowledged the voluntary nature of VAERS may lead to underreporting.

Dr. Mark Geier, a Maryland-based physician who previously worked as a researcher at the National Institutes of Health for 10 years and has studied vaccines for more than 30 years, told seminar attendees that his review of available data shows the anthrax vaccine has “a safety profile significantly worse than almost any civilian vaccine.”

Continuing the fight

The U.S District Court for the District of Columbia shut down the military’s mandatory anthrax vaccine program in December 2004 with an injunction.

At that time, Judge Emmet Sullivan ruled that forcing troops to take the vaccine amounted to an illegal order because the FDA had failed to follow its own regulatory procedures in declaring the drug safe and effective against all forms of anthrax, including the inhalation variety that defense officials say poses a threat to U.S. troops.

In the interim, defense officials launched a voluntary vaccination program. About half the troops offered the vaccine have taken it, officials said.

In December 2005, the FDA followed through on the approval process and a federal appeals court dissolved the injunction, clearing the way for the Pentagon to resume mandatory shots.

Mark Zaid, one of the lawyers representing the six anonymous military and civilian plaintiffs in the Doe v. Rumsfeld anthrax lawsuit, said he expects to file a new suit in the coming weeks to challenge the resumption of the mandatory program on the grounds that in addition to being potentially extremely harmful, the vaccine’s effectiveness is questionable at best.

“You can’t show it’s effective in humans from the studies,” said Zaid, who gave a legal history of the vaccine and the fight against the mandatory program at the seminar.

The suit will question the science behind the FDA’s approval of the vaccine, he said, which has been a pillar of the opposition’s strategy all along.

“There will be nothing new in this lawsuit,” Zaid said. “The Defense Department is just exploiting the weakness of the FDA.”

Geier noted that the efficacy of the anthrax vaccine is based on several studies in animals and has never been tested in a double-blind, placebo-controlled human vaccine trial.

The only study of anthrax vaccine use in humans, he said, was published in 1962 of a clinical trial among a little over 1,133 mill workers who handled animal hides.

In addition to being geared specifically toward the skin form of anthrax — not the inhalation variety troops would be expected to encounter on the battlefield — the vaccine in that trial had a different formulation than the current one, Geier said.

As it has from the beginning, the Pentagon maintains that the drug is safe and effective against all forms of anthrax.

“The licensed vaccine is safe, effective and based on sound science,” Dr. William Winkenwerder Jr., the Defense Department’s top health official, said in a statement. “This was determined by eight separate independent reviews, including the National Academy of Sciences’ Institute of Medicine.”

The IOM also states adverse events due to the anthrax vaccine are ‘comparable to those observed with other vaccines administered to adults,’ ” he said.

When the inoculation program resumes in 30 to 60 days, the shots will be mandatory for all service members, defense civilian employees and contractors going for more than 15 days to Korea or anywhere within the U.S. Central Command area of operations, which includes Afghanistan and Iraq.

U.S. personnel in those areas are considered by the Pentagon to be at “high risk” for weaponized anthrax exposure.

“We vaccinate our service members to protect them against deadly diseases — both natural and those potentially spread by terrorists or enemy forces,” Winkenwerder said. “Protection against anthrax is important to the mission, and that’s why we are returning to a mandatory program for those at higher risk.”

October 27, 2006

Expert casts doubt on flu vaccine

The Guardian

Flu vaccines may not be as effective as people think, an expert has warned. There is little clinical evidence that the vaccines have an effect on things like hospital stay, time off work, death in healthy adults or even those with conditions like asthma and cystic fibrosis, he said.

Vaccines given to children under the age of two have the same effect as if they were given a dummy drug, he added.

Tom Jefferson, co-ordinator of the vaccines field of the highly-respected Cochrane Collaboration, called for an "urgent" re-evaluation of vaccination campaigns.

Writing in the British Medical Journal, he said that, because influenza viruses mutate and vary from year to year, it was difficult for scientists to study the precise effects of vaccines.

Most studies are of poor quality, and there is little comparative evidence on the safety of the vaccines, he said.

In addition, policy makers wanted to be seen to be doing something, all of which leads to a "large gap" between policy and the evidence, he said.

The difficulty in distinguishing between flu and flu-like illness added to the confusion, with some illnesses listed as flu when they were not, he said.

Earlier this month, there were fears that vulnerable people in the UK might have to wait for flu jabs after the Government confirmed stocks would arrive late.

The jab is given to high-risk groups first, including the over-65s, people with respiratory conditions such as asthma, and those with chronic conditions such as diabetes.

Federal Court Upholds First Amendment Claim of Air Force Sgt.

Originally published on 8/25/2006

Federal Court Upholds First Amendment Claim of Air Force Sgt. Punished for Speaking Out About Tainted Vaccine; TRI Attorneys Allowed to Move Forward with Action Against Military Officials

WILMINGTON, Del. — Attorneys for The Rutherford Institute have successfully thwarted attempts by the U.S. government to dismiss the First Amendment lawsuit of Air Force Sergeant Jason Adkins. The U.S. District Court in Delaware denied a motion by the Department of Defense to dismiss the entire case of an Air Force officer who was sanctioned after voicing concerns that he could be suffering the ill effects of a tainted anthrax vaccine.

In allowing the First Amendment claim of Sgt. Adkins to move forward, the district court rejected the Defense Department’s arguments that the government was immune from suit and that Sgt. Adkins did not have the right to seek relief for the alleged retaliation.

Recognizing the validity of the constitutional claims, District Court Judge Joseph J. Farnan, Jr. authorized TRI attorneys to begin obtaining information from military officials about the facts behind the alleged punishment of Adkins. Judge Farnan granted the government’s motion to dismiss a second claim, ruling that Adkins did not have enough information to show that the defendants ordered or approved of workplace harassment which Adkins endured after he filed his lawsuit.

The free speech retaliation suit, which named Adkins’ supervisors in the Air Force, as well as James Roche, the Secretary of the Air Force, Secretary of Defense Donald Rumsfeld and others, was filed in federal district court in Wilmington, Del., by Institute affiliate attorneys Thomas S. Neuberger and Stephen J. Neuberger of the Neuberger Firm.

“The military is not above the law in our system of government,” stated John W. Whitehead, president of The Rutherford Institute. “Furthermore, this confirms that military personnel do have basic constitutional rights.”

All U.S. troops deployed overseas are required by the military to take a series of six or more anthrax vaccinations. Dover Air Force Base Sgt. Jason Adkins, a C-5 aircraft flight engineer and a decorated airman who served on the first C-5 aircraft flown into Baghdad in the Iraq War and other numerous classified special operations missions, received eight inoculations. However, testing by the Food and Drug Administration discovered squalene in numerous batches of the inoculations administered to Dover Air Force Base personnel. Research indicates that even trace amounts of squalene can stimulate the immune system, causing arthritis, neurological problems, memory loss and incapacitating migraine headaches.

In keeping with flight safety protocol, on Oct. 21, 2004, Sgt. Adkins reported to the Dover Air Force Base flight surgeon with a “crippling” headache and was subsequently grounded from a scheduled flight mission. Since his first day in the Air Force, Sgt. Adkins has been trained in one basic sacred safety principle—that flight officers with unsafe medical conditions are not to fly. Even during a flight, if crew members become ill or overly tired, they are encouraged to declare ‘safety of flight,’ at which point they are relieved of their duties, no questions asked, and always without any fear of discipline or repercussions. However, shortly after reporting to the flight surgeon, Sgt. Adkins was given a career-ending written reprimand and accused of dereliction of duty and faking his medical condition, allegedly in retaliation for having voiced his concerns that he might be suffering effects of the experimental anthrax vaccine.

Other military personnel have since echoed Sgt. Adkins’ concerns about the effects of the tainted vaccine. Institute attorneys filed suit in federal district court in 2004 in defense of the First Amendment rights of Sgt. Adkins.


Nisha N. Mohammed
Ph: (434) 978-3888, ext. 604
Pager: 800-946-4646, Pin #: 1478257
E-mail: nisha@rutherford.org

Mandatory anthrax vaccinations coming soon

U.S. MARINE CORPS FORCES, PACIFIC, CAMP H. M. SMITH, Hawaii(10/26/2006) -- The Department of Defense announced Oct. 16 they will resume the mandatory Anthrax Vaccine Immunization Program, also known as AVIP, for military personnel, mission-essential DoD civilians and contractors, assigned to certain geographic areas of the world.

The military first instituted these vaccinations in 1991 to protect troops against possible anthrax attacks during the Persian Gulf War.

In December 2004, a Federal District Court Judge ruled that forcing troops to take the vaccination was illegal, because the Food and Drug Administration failed to declare the vaccine safe and effective against all forms of anthrax.

After the decision by the judge, the FDA issued its final rule, stating that anthrax vaccine is effective in preventing anthrax disease regardless of the type of exposure. Eight separate independent reviews also determined the licensed vaccine is safe and effective, including the National Academy of Sciences’ Institute of Medicine.

“The DoD is standing behind the extensive testing and education that the vaccine is both safe and effective against all forms of anthrax,” said Navy Capt. Robert G. Schultz, the force surgeon for U.S. Marine Corps Forces, Pacific.

Within 30 to 60 days, the DoD will implement instructions for military services to resume mandatory vaccinations, he said.

The vaccinations are mostly limited to members of military units designated for homeland defense, U.S. forces located in the U.S. Central Command area of responsibility, and Korea.

The immunization program will include personnel assigned to these higher-threat areas for 15 or more consecutive days. If possible, service members will begin vaccinations up to 60 days before their deployment.

Also, DoD personnel previously immunized against anthrax, who are no longer deployed to higher threat areas, will be allowed to receive follow-up vaccine doses and booster shots on a voluntary basis, according to a DoD press release.

“The anthrax vaccine will protect our troops from another threat – a disease that will kill, caused by bacterium that has already been used as a weapon in America, and that terrorists openly discuss,” said Dr. William Winkenwerder Jr., assistant secretary of defense for health affairs, in a DoD press release.

Around 50 percent of military service members received the vaccinations under the current voluntary vaccination policy.

“The percentage is probably higher in the Marine Corps, because the medical staff works really hard to properly educate the Marines and Sailors about anthrax and the protective series of vaccinations,” said Schultz. “The threat is real, so making the vaccinations mandatory helps us improve the Marine Corps’ combat readiness and effectiveness.”

The threat is real on American soil as well. There have been past attacks through the U.S. postal system.

According to the AVIP website, after Sept. 11, 2001, there were 22 victims of this type of anthrax terrorist attack. Of those 22, five died from inhaling the bacteria.

The United Nations Special Commission found evidence of anthrax-filled weapons in Iraq, according the AVIP website. Although the production facility was destroyed, many experts feel Iraq could rebuild its producing capabilities easily.

After the DoD pushes the new policy to all services, the Marine Corps will issue a Marine Administration message to begin enforcing the new policy, said Schultz.

The series of six vaccinations takes 18 months from the initial shot to the last, followed by annual booster shots.

“Anthrax is a deadly infection, and the vaccine has repeatedly shown to be safe, protective and effective,” said Schultz.

For more information on anthrax, visit the AVIP website at www.anthrax.osd.mil/threat/default.asp.
Submitted by: Marine Forces Pacific
Story by: Computed Name: Pfc. Ethan Hoaldridge
Story Identification #: 2006102622426

October 26, 2006

Lawyer: New anthrax rules may face resistance

North County Times, By: JOE BECK - Staff Writer

NORTH COUNTY ---- The Defense Department's decision to revive mandatory anthrax vaccinations for parts of the military has failed to quiet critics of an earlier round of vaccinations in which some service members cited health risks in refusing to be inoculated.

Mark Zaid, a lawyer who represented about a dozen members of the military in court cases involving their refusal to submit to vaccinations, predicted a new wave of resistance to the Pentagon's latest anthrax vaccinations at Camp Pendleton and Miramar Marine Corps Air Station. Several of his clients have come from Miramar and the Marine base at Twentynine Palms.

"I wouldn't doubt if Pendleton and Miramar are going to get some refusals, especially among the younger kids," said Zaid in a telephone interview from Washington, D.C.

The Defense Department announced last week that the mandatory vaccination program would resume in 30 to 60 days, ending a suspension that began nearly two years ago. Voluntary vaccinations were reintroduced in 2005.

The Pentagon's announcement said the vaccines would be required for those deploying to areas such as the Korean Peninsula, the Middle East and Central Asia, where the risk of anthrax being used as a weapon by hostile forces is deemed to be higher than average.

Zaid said the anthrax vaccination program will be challenged again. A federal judge temporarily halted the program in December 2004.

"We're going to file another lawsuit to shut down the mandatory program," said Zaid, who represented a Miramar Marine in the 2004 case.

Officials at Camp Pendleton and Miramar were asked to respond to questions from the North County Times about the vaccination program. Miramar officials did not reply and those at Camp Pendleton e-mailed a series of questions and answers prepared at Marine Corps headquarters in the Pentagon.

Dr. William Winkenwerder Jr., assistant secretary of defense for health affairs, has said that about 50 percent of service members being deployed to high-risk areas have received the vaccination under the voluntary program, a rate that Winkenwerder called unacceptable, according to transcripts of a news conference he held last week.

"This rate of vaccination not only put the service members at risk, but also jeopardized unit effectiveness and degraded our medical readiness," Winkenwerder said during that conference. "Both of those issues are important to me and our military commanders."

The safety and effectiveness of the vaccine have been debated since the late 1990s, when some service members began refusing mandatory vaccinations. Some were court-martialed or received lesser punishments for refusing to follow orders. Meanwhile, Zaid and other lawyers filed lawsuits challenging the legality of mandatory vaccinations.

Lance Cpl. Ocean Rose, formerly based at Miramar, was one of those who paid a price for refusing the vaccine. In a telephone interview, he said he received a bad conduct discharge, an action that has been placed on hold while he continues to appeal the discharge. For now, Rose said he retains his rank as lance corporal in the Marines, although he has returned to his hometown in Georgia, does not participate in military activities and receives no military pay.

Rose, 26, said he objected to the anthrax vaccination after a routine electrocardiogram revealed a serious heart problem. He said his heart appeared healthy at the time he entered the Marine Corps and has shown no signs of problems in tests run several years after he received the vaccine.

"I only had problems during the time I was receiving anthrax vaccine," Rose said.

Defenders of the mandatory vaccine program insist it poses little risk to most people and is necessary to lessen the threat of any attempt by hostile forces to use anthrax on the battlefield.

"The vaccine has been thoroughly reviewed by eight different bodies, including the National Academy of Sciences Institute of Medicine," Winkenwerder said. "The Institute of Medicine states that the adverse events after anthrax immunization are comparable to those observed with other vaccines administered to adults."

Zaid said he plans to challenge the Food and Drug Administration's December 2005 ruling that the vaccine is safe and effective.

Those resisting the vaccine took heart a year earlier, when U.S. District Court Judge Emmet Sullivan ordered the program shut down, citing the FDA's failure to meet certain procedural requirements in approving the vaccine. A three-judge panel of the U.S. District Court of Appeals for the District of Columbia lifted Sullivan's ruling after the FDA satisfied the procedural requirements.

-- Contact staff writer Joe Beck at (760) 740-3516 or jbeck@nctimes.com.

Seminar opposing anthrax program set for Saturday


Army Times
By Gayle S. Putrich, Staff writer

Opponents of the Pentagon's plan to resume mandatory anthrax vaccinations are acting fast to get the word out on the drug by hosting a day-long seminar in Washington on Saturday.

The Anthrax Continuing Legal Education Seminar will be hosted by Byron Holcomb, a retired Navy judge advocate general and one of the attorneys representing anthrax victims. The seminar will be held at the offices of Holcomb's law firm, Garvey, Schubert and Barer, in Georgetown's Flour Mill Building, 1000 Potomac St. NW.

Lawyers who have worked on three key cases in the battle over the mandatory vaccination program will speak, including Mark Zaid, who represented the six anonymous plaintiffs in the federal Doe v. Rumsfeld case.

But the seminar will not be limited to legal questions. Also speaking will be former service members who say they suffered adverse effects from the anthrax shots and medical professionals, including Dr. Mark Geier, of the Vaccine Adverse Event Reporting System, and anthrax expert Dr. Meryl Nass.

For more information or to attend the conference, contact Kathryn Coulter at (202) 419-3257.

October 24, 2006

Anthrax vaccine maker Emergent sets IPO terms


WASHINGTON, Oct 24 (Reuters) - Anthrax vaccine maker Emergent Biosolutions Inc. filed with the U.S. Securities and Exchange Commission on Tuesday to sell up to 5 million shares for between $14 and $16 apiece in an initial public offering.

Underwriters, led by JPMorgan, have the option to buy an additional 750,000
shares to cover over-allotments, according to the filing with the SEC.

The Gaithersburg, Maryland-based company has applied for a Nasdaq listing under the symbol "EBSI" (EBSI.O: Quote, Profile, Research).

PEER: Miss. should tweak laws to prepare for bioterror response


Associated Press

JACKSON, Miss. - Mississippi could be better prepared to respond to pandemics or acts of bioterrorism by making incremental changes in some of its laws, a legislative watchdog group says.

For example, current laws don't require veterinarians or pharmacists to give the state Department of Health information about certain diseases.

Also, state laws don't include pandemics in the definition of natural emergency, "creating some concerns that the governor might not have the legal power to respond to the fullest extent allowable under current emergency management laws," says the report by PEER, the Joint Legislative Committee on Performance Evaluation and Expenditure Review.

The report was dated Oct. 10 but was released to the public on Monday. PEER says the report was prepared in response to legislative concerns about the state's authority to respond to avian flu pandemics or acts of bioterrorism.

The report did not recommend spending any additional state money or hiring any new employees.

Note: See at: www.military-biodefensevaccines.org - "Model State Health Emergency Preparedness Act".

October 20, 2006

Experimental malaria vaccine shows results


ISLAMABAD: A new experimental vaccine developed by scientists in the US attacks the malaria parasite in its early stages and could help prevent the disease that has kills one million people a year.

The new vaccine -- called RTS, S and developed by Walter Reed Army Institute of Research -- reduced the number of clinical malaria episodes by 26 percent for up to 18 months after vaccination among children in Mozambique, where malaria is common, reported the science portal EurekAlert.

There were 58 percent fewer severe episodes among the children over the same time period. The vaccine also reduced the number of clinical malaria episodes in partially immune men in Gambia by 63 percent after they received a booster shot a year later, it said.

The Cochrane Collaboration, an organisation that reviews clinical trials of the vaccine, found that it protected 41 percent of volunteers in the US who were exposed to malarial mosquitoes in the lab.

The RTS,S vaccine showed extremely promising results, the researchers said. The review appears in the latest issue of The Cochrane Library, a publication of The Cochrane Collaboration.

Malaria is a parasite carried by mosquitoes and kills at least a million people a year, especially children in Africa. It increasingly resists anti-malarial drugs, according to a report in the online edition of New Scientist.

Efforts to develop a vaccine have been frustrated because the parasite changes its form several times during an infection.

These changes alter the surface chemicals that vaccines normally exploit to prime the immune system to recognise a pathogen. Scientists are divided over which stage to vaccinate against.

U.S. vaccinates troops against anthrax - UPI

U.S. vaccinates troops against anthrax

WASHINGTON, Oct. 17 (UPI) -- The Pentagon has said it will restart a mandatory anthrax vaccination program for U.S. troops in the Middle East and South Korea.

Dr. William Winkenwerder, assistant secretary of defense for health affairs, said Monday the vaccinations would probably restart in 30 to 60 days and "several hundreds of thousands" of troops will be required to receive them. There are 140,000 troops in Iraq, around 30,000 in Korea, and tens of thousands more in Kuwait, Bahrain, Qatar and other Middle Eastern countries.

The mandatory vaccination program was suspended in October 2004 after a legal challenge of its safety and effectiveness. It has been a voluntary vaccination program since, with about 50 percent of military personnel eligible to receive it actually taking it. "Military members expect if something is truly important ... it would be mandatory," Winkenwerder said. "Obviously we've been sending a signal it's not as important as we believe it is. That's why we are returning to mandatory program for higher risk."

The FDA determined the vaccine to be safe and effective in December 2005.

"The FDA has said after an exhaustive review the vaccine is safe and effective against all forms of exposure of anthrax," Winkenwerder told reporters Monday in a telephone conference. "There is no vaccine, no medical treatment, no drug for which there never has been a single significant side effect or event noted in not one person."

Winkenwerder said the decision was made to limit the vaccinations to overseas deployments because that was where the greatest threat was anticipated.

Winkenwerder said there were sufficient doses to cover all service personnel, as well as mission essential civilian contractors. The program had to be severely scaled back in 2001 after the supply of approved doses ran out.

Anthrax vaccine to be required for troops - Daily Press

After years of controversy and a federal court case, the Defense Department will resume its mandatory vaccination program.


The Defense Department will again require anthrax shots for all service members deployed to overseas hotspots, despite concerns the vaccinations might be unsafe and a federal court ruling that put the policy on hold two years ago.

The inoculations will start 30 to 60 days from now, said Dr. William Winkenwerder Jr., the assistant secretary of Defense for health affairs.

Vaccinations will be mandatory for troops, contractors and department civilians sent to the Korean Peninsula or Central Command, the region that includes Iraq, Afghanistan and the Horn of Africa.

Troops who refuse the shot will be subject to disciplinary action for disobeying a lawful order. Since 2002, 38 service members have been kicked out for refusing.

"The anthrax vaccine will protect our troops from another threat - a disease that will kill, caused by bacteria that already has been used as a weapon in America," Winkenwerder said in a conference call with reporters on Monday.

Five people died in 2001 from anthrax attacks made through the U.S. postal system, Winkenwerder noted.

Anthrax is a rare yet potentially lethal bacterium that can be used, under some conditions, as a biological weapon. Such weapons are outlawed by international treaty and considered weapons of mass destruction.

Winkenwerder said the U.S. Food and Drug Administration and several independent agencies have reviewed the vaccine, and deemed it effective against all exposures: ingestion, inhalation or skin contact.

In 1991, the department began a widespread inoculation program, fearing that then-Iraqi President Saddam Hussein would use chemical and biological weapons on troops deployed for the first Gulf War.

After that war, doctors and researchers began to link the shot to veterans returning home with, among other ailments, joint pain, memory loss and intestinal problems.

A series of federal court rulings in 2004 overturned the mandatory anthrax vaccine program for the military after six unnamed service members and government employees filed suit claiming the vaccine was experimental. The court ruled that the FDA had not offered a meaningful and effective public hearing period before approving the drug.

The department decided to make the vaccine program voluntary. Since October 2005, roughly half of the troops deploying to regions where officials feared the biological weapon could be used accepted the shots.

On Dec. 15, 2005, the FDA announced that after further study, the military's anthrax vaccine met the standards for safety and effectiveness.

Not everyone is convinced, however.

In May 2006, the Government Accountability Office released a report that concluded "the vaccine has not been adequately tested on humans; no studies have been done to determine the optimum number of doses; the long-term safety has not been studied and data on short-term reactions are limited."

The investigative arm of Congress recommended the development of a "better, alternative vaccine."

Winkenwerder disputed that report, saying there have been long-term studies and that "it would not be the first time the GAO made an incorrect statement."

Patrick Kelly, who left the Navy as a junior-grade lieutenant after 19 years in the service, doesn't believe it.

Kelly was diagnosed with multiple myeloma at Naval Medical Center Portsmouth in 2003. Doctors told him he probably had the rare form of cancer for two to three years - or from when Kelly first started receiving the anthrax vaccine.

No scientific research concretely links the cancer to the vaccine, but Kelly is positive the two are connected.

After his anthrax inoculations, Kelly said he suffered from joint pain, loss of eyesight, impotence, fatigue and broken bones in his back.

In the immediate days after he was vaccinated, Kelly remembers his arm being tender. Once, he said, his bicep swelled to double its size.

Kelly is still fighting both the cancer and the military, he said.

He takes three different types of drugs, some experimental, and writes members of Congress to beg them to look at the anthrax issue.

"Everyone wants to dodge this," Kelly said. The Defense Department will "justify it by saying they need it for war. But there's a lot of other ways people can kill you besides anthrax. I wouldn't have any faith in the vaccine."

Staff researcher Tracy Sorensen contributed to this report.

Air Force Time Poll - Get Involved - Mandatory AVIP

Air Force Times
Get involved

In the next few weeks, the U.S. will again become the only nation in the world that forces its military personnel to take anthrax vaccine, which the DoD says is safe and effective. Email us with your comments, concerns and questions about the Pentagon’s mandatory program. Email AF Times at: anthraxvax@atpco.com

October 19, 2006

Drug Provides Monkeys Full Protection from Smallpox

Global Security Newswire

Tests at the Centers for Disease Control and Prevention have shown that an experimental drug provided test monkeys with complete protection against the smallpox virus, Datamonitor NewsWire reported yesterday (see GSN, Sept. 3).

Cynomolgus monkeys that received a high dose of the virus displayed no symptoms afterward, whether they were given the drug, SIGA-246, at the same time as the virus or 24 hours later. No smallpox lesions formed and there were no signs of side effects from the drug itself.

“We are particularly pleased because the amount of virus used in this study is equivalent to the level present in late-state disease in humans, which we believe signals that SIGA-246 can be used to prevent disease in humans,” said Dennis Hruby, chief scientific officer for manufacturer Siga Technologies, in a press release. “This test in nonhuman primates is as close as anyone can get to the real thing because there has not been any natural occurrence of smallpox since 1977” (Datamonitor NewsWire, Oct. 18).

CDC Could Vaccinate Lab Workers Against Anthrax

Global Security Newswire

The U.S. Centers for Disease Control and Prevention is mulling a program to vaccinate personnel at 165 laboratories who might accidentally or deliberately be exposed to anthrax, the Terror Response Technology Report reported yesterday (see GSN, Sept. 28).

The federal health agency would sign a contract with a firm for distribution of Anthrax Vaccine Adsorbed and inoculations at the facilities in the United States and Puerto Rico. The intent is to offer the greatest possible protection to workers and prevent the breakdown of operations at the laboratories (Terror Response Technology Report, Oct. 18).

October 18, 2006

Poisoning U.S. Troops: Anthrax, Lies and Vaccines


Mandatory anthrax vaccines are back

The U.S. Defense Department quietly announced on Monday that mandatory anthrax vaccinations would resume for military personnel and civilians deploying to 28 countries across the globe and even for some based in the U.S. The Assistant Secretary of Defense for Health Affairs said, “Time and again (this vaccine) has been looked at by experts, … and each time the conclusion is the vaccine is safe and it is effective.”

Tell that to the family of Jesse Lusian. The 24-year-old Northern Californian died last month “from complications resulting from an anthrax vaccine he received while serving our country as a Merchant Marine on a cargo ship in Diego Garcia, a Navy support facility in the Middle East (sic) [Diego Garcia is an island in the Indian Ocean – ed.].”

And tell it to Senior Airman Tom Colosimo, who suffered from fatigue, headaches and painful cysts after first being vaccinated in February 1998. Colosimo soon lost 50 pounds, had dangerous fainting spells and was diagnosed with anthrax intoxication, yet faced a “retaliatory” military when he tried to get medical care for his increasingly debilitating condition.

Tragic cases such as those of Lusian and Colosimo will become more commonplace when potentially hundreds of thousands of military personnel and civilians are soon forced to take the anthrax vaccine. There’s no excuse.

It’s worth noting that mandatory vaccination is a bipartisan outrage, first initiated by the Clinton administration in 1997; the Food and Drug Administration (FDA) didn’t even rule the vaccine to be safe and effective until December 2003. In October 2004, a court order ended mandatory vaccinations for active-duty personnel, but under the policy adopted this week, affected servicemembers will be forced to begin the anthrax inoculation series in the next few months. Merry Christmas U.S. troops.

The DoD’s handling of the anthrax vaccine has been atrocious. As The Daily Press reported in December 2005, “The Pentagon never told Congress about more than 20,000 hospitalizations involving troops who’d taken the anthrax vaccine, despite repeated promises that such cases would be publicly disclosed.” Instead, from 1998 through 2000, “a parade of generals and Defense Department officials told Congress and the public that fewer than 100 people were hospitalized or became seriously ill after receiving the shot.”

Even worse, there’s been no long-term study of the health impact of anthrax inoculations, and quite conveniently, the quarterly analysis of medical care data for vaccinated servicemembers was ended in 2002. Hard to fault the anthrax vaccine for your physical breakdown when pertinent medical records aren’t available.

The vaccine scandal is yet another case of well-connected companies cashing in on non-competitive governmental contracts. The firm responsible for producing the military’s anthrax vaccine, for example, has continued to receive hundreds of millions of Pentagon dollars despite being racked with mismanagement and production problems. BioPort Corp didn’t even have FDA approval for its vaccine plant from 1998-2002, but continued pumping out unusable batches at taxpayer expense regardless. Similarly, VaxGen, the company contracted to produce 75 million doses of anthrax vaccine for civilian use in case of a domestic bioterrorism attack, has faced serious accounting problems and FDA accusations of making “false or misleading statements” about its vaccine’s benefits.

Of course, the DoD has also made false and misleading statements by calling the anthrax vaccine “safe,” but that’s another story.

Service members appropriately point to lack of anthrax risk as further justification for refusing the vaccine. Airman Jessica Horjus, for example, ended her military career in 2004 with a less-than-honorable discharge rather than being inoculated. She wrote the appellate authority at her Air Force base in Goldsboro, North Carolina, “There is no evidence that stockpiles of anthrax exist in Iraq or with Al Qaeda in Afghanistan or elsewhere. As a single mother, I cannot afford to unnecessarily risk my long-term health on a highly-reactive vaccine that supposedly protects against a threat that cannot be found.” Horjus noted, “I have a kid to take care of. The Air Force can always fill my slot with someone else, but who’s gonna fill the mommy slot??”

What a shameful irony that hundreds of thousands of U.S. troops told they’re fighting for freedom could soon face court martial for refusing to take a vaccine which has led to disabilities, chronic illnesses and even death in others.

Would you take it?

Action Ideas:

1. To learn more about the anthrax vaccine, read The Daily Press’ amazing 16-part series entitled Special Report: Anthrax Puzzle.
GulfWarVets.com also offers a comprehensive archive of related articles, while The Military and Biodefense Vaccine Project provides news reports and other resources.

2. Active-duty troops and veterans can find support at The Military Vaccine Resource Directory, which covers such topics as “If You Are Refusing A Direct Order To Take A Vaccine” and “If You Are Sick.”

GNN contributor Heather Wokusch is the author of The Progressives’ Handbook: Get the Facts and Make a Difference Now and can be reached at www.heatherwokusch.com.

Transcript from DoD re: Winkenwerder's Telecon and Resumption of AVIP


Subject: DoD News Briefing with Assistant Secretary Winkenwerder

NEWS TRANSCRIPTS from the United States Department of Defense

Presenter: Assistant Secretary of Defense for Health Affairs William Winkenwerder
October 16, 2006
Media Contact: (703) 697-5131/697-5132
Public/Industry(703) 428-0711

DoD News Briefing with Assistant Secretary Winkenwerder
Alsoparticipating; Col. Randall Anderson, director, Military Vaccine Agency

MR. JONES:Hello, everybody.Have we got some folks out there?

Q Yep.

Q Yep.

Q Hello.

Q Hello.

MR. JONES:Oh, glad you're there.This is Terry Jones.I'm here -- (interrupted by computerized message) -- I'm here today with Dr. William Winkenwerder, who is going to be talking to you in a few minutes here.But I just want to alert you to a few things.

First of all, this conversation is on the record, and that we -- (interrupted by computerized message) -- that we are recording for transcript, and we're also recording for C-SPAN.Today -- (Interrupted by computerized message.)

MR. JONES:I guess we're going to have that for the next few minutes or so.But Dr. Winkenwerder is going to be talking to you today about the Department of Defense and our resumption of the mandatory anthrax vaccinations for certain troops.

And with that, I will go ahead and -- (interrupted by computerized message) -- I'm sorry.I wonder if right now we could have a roll call to get an idea -- and as you ask a question after Dr. Winkenwerder has initially given you his statement about what we're going to be doing, I would also like for you to identify yourself so that we can have that on the transcript when it comes out.

So right now, for roll call purposes, would you all go ahead and identify yourselves, please?

Q Julian Barnes, L.A. Times.

Q David Kestenbaum, National Public Radio.

Q Lori Crouch, WAVY-TV, Norfolk, Virginia.

Q Dee Ann Divis, Washington Examiner newspaper.

Q Stephanie Heinatz, Daily Press, Hampton Roads, Virginia.

Q Drew Brown, McClatchy Newspapers.

Q Gail -- (inaudible) -- Military Times -- (inaudible) -- group.

Q Breanne Wagner, Air Force Magazine.

Q (Name inaudible) -- Stars and Stripes.

Q Admiral Joyce Johnson -- (interrupted by computerized message).

Q Lolita Baldor, AP.

Q Kristin Roberts, Reuters.

Q Sandra Basu, U.S. Medicine.

Q Pam Hess, UPI.

Q Chris Lee, Washington Post.

Q Matt Kaufman, Hartford Courant.

Q Lisa Chedekel, Hartford Courant.

Q David Rube (ph), freelancer.

Q Dr. -- (name inaudible) -- Norfolk.

Q Jay Lackman (ph), retired military.

Q Alison Walker-Baird, Frederick News-Post.

Q (Name inaudible) -- freelance.

Q (Inaudible) -- for Air Force.

Q (Inaudible) -- Air Force counterproliferation.

Q Gil Naito (ph), Bureau of Medicine and Surgery.

Q (Inaudible) -- Navy.

MR. JONES:Is that everybody?Has everybody identified themselves that's on this -- on the phone call?

Q This is Sue -- (name inaudible).I'm with the Senate Committee on Veterans Affairs.

Q Kevin Maurer, Fayetteville Observer.

Q Brett England, Daily Press.

MR. JONES:Okay, is there anyone else that's come onto the conversation and hasn't identified themselves yet?Okay, thank you.

DR. WINKENWERDER:Good afternoon.This is Dr. Bill -- (interrupted by computerized message).

Okay, who's just joined?

Q Denise Grady from The New York Times.


This is Dr. Bill Winkenwerder.I'm the assistant secretary of Defense for Health Affairs.Good afternoon.

Q Thank you.

DR. WINKENWERDER:Today we're announcing the resumption of our mandatory anthrax vaccination/immunization program for military personnel, emergency-essential DOD civilians and contractors, all of those individuals based on defined geographic areas and roles.

This updated policy also allows previously immunized persons against anthrax who are no longer deployed to higher-threat areas to receive their follow-up vaccine doses and booster shots on a voluntary basis.

For the most part, mandatory vaccinations are limited to military units designated for homeland bioterrroism defense and to U.S. forces assigned to the Central Command area of responsibility and to Korea.The under secretary of Defense for Personnel and Readiness will soon issue implementing instructions to the military services for resuming the mandatory vaccination program.The mandatory program is expected to resume within 30 to 60 days.

Now, one set of questions I'm sure you may have is:Why the change in the policy now; has there been an elevation in the threat.Let me say very clearly the answer to that is no.There is no elevated threat situation, nor are there new specific circumstances that have given us reason to make this change and update in our policy. We vaccinate our service members to protect them against deadly diseases, both natural and those potentially spread by terrorists or enemy forces.We take very seriously the potential use of weapons of mass destruction by terrorists.Under the voluntary policy, about -- (audio break) -- percent of our service members in high threat areas, who were contacted about vaccination, followed through and received their vaccination.This rate of vaccination not only put the service members at risk, but also jeopardized unit effectiveness and degraded our medical readiness.Both of those issues are important to me and to our military commanders.

Having said that, a 50 percent acceptance rate is about what we expected --

OPERATOR (?):Someone has joined the conference.

DR. WINKENWERDER:Could you identify yourself, please?

Q Yes.My name is Todd Furrs (sp).I work at Melvax (sp).

DR. WINKENWERDER:Hey, Todd.Let me continue.Having said that, a 50 percent acceptance rate is about what we expected based on voluntary vaccination programs in the general public.It's clear that, you know, nobody likes getting shots, if they have to, but I think probably the most important reason for the difference we have had between 100 percent acceptance rate for mandatory anthrax shots and a 50 percent rate for voluntary shots is because military members expect that if something is truly important to the mission and if there truly is a threat, that it would be mandatory.So obviously, we've been sending a signal that it's not as important as in fact we believe it is.

Protection against anthrax is important to the mission, and that's why we're returning to a mandatory program for those at higher risk.

I'll say once again, the vaccine is safe and effective.On December 19th, 2005, a little less than a year ago, the Food and Drug Administration issued a final rule and final order stating that the vaccine is effective in preventing against anthrax regardless of the root of exposure.The vaccine has been thoroughly reviewed by eight different review bodies, including the National Academy of Sciences Institute of Medicine.The Institute of Medicine states that the adverse events after anthrax immunization are comparable to those observed with other vaccines administrated to adults.

Finally, let me say that anthrax remains a deadly infection that's been used as a bioterrorism weapon against our own population.The threat environment and unpredictable nature of terrorism makes it necessary to include biological warfare defense as part of our force protection measures.

And with that, let me take your questions.

Q Dr. Winkenwerder, this is Gail -- (last name inaudible) -- from the Military Times newspapers.I'm wondering -- (inaudible) -- that I've been talking to today -- I'm wondering if you guys are prepared for another legal challenge.

DR. WINKENWERDER:Yes, we're always prepared for any legal challenge.

Q Do you expect to have to -- (inaudible) -- this program again a second time once you start it back up again?

DR. WINKENWERDER:I don't want to predict what may or may not happen.The vaccine, as I just indicated, has been thoroughly reviewed by several independent outside groups.It was reviewed thoroughly by the Food and Drug Administration initially issuing an order, I believe, in 2004, and that order was challenged.And then, the FDA went out again following Judge Sullivan's decision in October of 2004 and obtained wide comment from all sources and reviewed all the data again and came to the very unambiguous and clear conclusion that the vaccine was safe and that it was effective against all forms of exposure.So in our view, that has definitely settled the question.

Some of you -- let me just answer a question that I'm going to anticipate:Why the delay between that period of time and now?And the quick answer is that there were some follow-up legal issues that were, as I recall, additional meetings of the parties to this case that met and reviewed the matter before the judge in the spring of this year, that that took several months.And then, upon the conclusion of those proceedings, we undertook here within the Department of Defense a full review of all of our vaccination programs -- anthrax, smallpox.We also looked at the matter of potential vaccination for pandemic and avian influenza.And after that review was completed, it was put before Deputy Secretary England, and upon our recommendation, we have decided to move forward with just what I have announced today.We will continue our smallpox vaccination program as well, I might add.

Q Dr. Winkenwerder, this is Pam Hess with UPI.Can you update us on where you are with the number of doses that you have?I remember that was one of the earlier problems with being able to vaccinate everyone.And what's the status of a second source for the vaccine?

DR. WINKENWERDER:You're correct that that was a concern early on in late 2001, early 2002.I'm pleased to say at this time that the quantity and supply of vaccine is not at all an issue.We have more than enough vaccine doses on hand, and we have no issues or problems with the manufacturer at this point.And so we have a very stable situation in that regard.

Q Still no second source, though?

DR. WINKENWERDER:There is, as you may know, work that is ongoing through the Department of Health and Human Services for a new and updated vaccine called recombinant protective antigen, sometimes known as rPA -- small "R" then capital "P" and capital "A" -- rPA.And work is ongoing to bring that vaccine to licensure.That's being conducted by the Department of Health and Human Services.We are very much in regular communication about the status of progress of those activities.And should that second source of vaccine become available at some point in the future, then we would certainly look at that as a viable additional vaccine.

Q Dr. Winkenwerder, Jeff Schogol with Stars and Stripes.Do you have an estimate of how many troops and contractors need to be vaccinated for anthrax?

DR. WINKENWERDER:I don't have a precise number for you.There are approximately 140,000 troops deployed in Iraq, additional numbers in the CENTCOM area of responsibility, and then there are the troops that are in the Korean peninsula.And I don't have a quick number for you on that -- the 40,000 range.

OPERATOR:Someone has joined the conference.

DR. WINKENWERDER:Could you identify yourself, please?

Q Excuse me.Luis Martinez, ABC.

DR. WINKENWERDER:Okay.This is speaking Dr. Bill Winkenwerder, assistant secretary of defense for health affairs.

And so we're probably talking, in the aggregate, in the range of at least a couple hundred thousand individuals.But, of course, people deploying and then redeploying, that number over the next 12 months would certainly be considerably greater than that.I'd say several hundreds of thousands.

Q And is there any talk about reducing the doses from six doses to three doses?

DR. WINKENWERDER:Yes.We are working with the Centers for Disease Control, and there are studies that are going on that are looking at the possibility of eliminating at least one of the doses.Obviously, that work needs to be reviewed by the FDA, since the FDA sets the license or standard for the number of doses.We're hopeful that within a few months we would be able to look at the possibility of a different route of administration that is intermuscularly as opposed to subcutaneously, and a five-dose schedule instead of a six-dose schedule.That will depend upon the FDA review.

Q Right.One of the attorneys representing people who plan to challenge the mandatory program in court calls this vaccine "unnecessary, unproven, and potentially unsafe."He wrote an e-mail, quote, "The AVIP is nothing more than a poorly conceived public relations campaign.The perception is that it is currently being implemented to satisfy personal egos and as a result of a lobbying campaign." How would you respond to that?

DR. WINKENWERDER:I would respond by saying that that's a very irresponsible statement.This is a safe and effective vaccine.It's been reviewed, as I had indicated, by independent, outside reviewers who had no relationship to the Department of Defense, and who had no objective, other than review of the safety and effectiveness of a vaccine.

The other point I would make, obviously a point I hope you would all appreciate, and that is there have been very public, very direct comments made by terrorists about the religious duty to obtain chemical, biological and radionuclear capabilities.

We still do not know who perpetrated that anthrax attacks five years ago just this month, in October of 2001.The threat is very real and it has not gone away.

Q Dr. Winkenwerder, this is Chris Lee at The Washington Post.The anthrax attacks you mentioned happened here on U.S. soil.September 11th was on U.S. soil.Why not vaccinate people here?Why not do mandatory vaccinations of people here?And are you, yourself, going to be vaccinated?

DR. WINKENWERDER:I have not been vaccinated because I'm not in any of the targeted groups to be vaccinated.If I was, I would receive it -- the vaccine without hesitation.

Just because the attacks were perpetrated here on U.S. soil does not mean that they were perpetrated by U.S. citizens.And I think the FBI has recently spoken to that issue, that they have under consideration the possibility of threat -- of this -- (inaudible) -- been perpetrated by anyone, domestic or foreign.So --

Q I wasn't implying that it had been done by someone is a U.S. citizen, just simply that the attacks had been here, which would suggest that people here might be vulnerable too, troops here might be vulnerable, and why not have them covered by the order.

DR. WINKENWERDER:Well, some of them will be able to obtain the completion of their schedule on a voluntary basis.It's our judgment that those who are serving in the areas that that's spoken about are at a higher risk because of their location and because of the duties --

OPERATOR :Someone has joined the conference.

DR. WINKENWERDER:-- and because of their duties that they're performing. Can I ask who's just joined us?(No response.)Can I ask who just joined the call?

OPERATOR:Someone has joined the conference.

DR. WINKENWERDER:Yes.Can I ask who's joined the call?

Q Yes.Dack Dalwhipple (ph).


Q From Daupe and Associates (ph), consultant to vaccine companies.

Q Dr. Winkenwerder --


Q -- can you elaborate on what changes, if any, have been made to the Adverse Reaction Tracking System, and if that information, given the controversy surrounding the vaccine, will be made available to the public?

DR. WINKENWERDER:We have a very robust vaccine Adverse Event Reporting System.It's an excellent Adverse Reporting System.It was noted for its excellence and for the professionalism of the people who run that program by the Institute of Medicine in their report four years ago.We'll expect to continue that effort.

Let's see here.Multiple echelons of reporting, and certainly we encourage if there are any adverse reactions that are noted by an individual or by his or her medical provider to report them.We know that there will be some local adverse reactions the vaccine has associated with it, as do other similar vaccines; reactions that can occur like local swelling, pain, redness, inflammation, and of course, people may feel malaise or flu-like symptoms for a short period of time.But in all the studies that we've performed and done looking very, very thoroughly at the vaccine, there is no increase in mortality, there's no increase in morbidity, there's no increase in hospitalizations.And all of that has been determined very definitively --

OPERATOR (?):Someone has joined the conference.

DR. WINKENWERDER:-- by very good studies.

Q Will the tracking information on the new round of shots be made available publicly?

DR. WINKENWERDER:I'm turning to one of our experts on this.The vaccine Adverse Event Reporting data is reported publicly through and with the Centers for Disease Control, as I recall.Yes, that's correct.

Okay.Could I ask who just came on the line?

Q Hi.This is -- (name inaudible) -- Naval Medical Center Portsmouth.


Q Thank you.

Q Doctor, this is Kristin Roberts with Reuters.Can you tell us what disciplinary action faces service members who refuse the vaccine?

DR. WINKENWERDER:Well, our first approach is not to discipline people, but it is to remind them of the importance of the threat, of all the facts about the vaccine and why it is being used.And the decisions, if any discipline is necessary, are performed in a very careful, thorough way, and the most important point, frankly, is that we have had very, very few service members who have refused the vaccine.I wish that you would report the facts because the facts have been misreported from time to time, as I have read over the last two or three years, that large numbers of people refuse.That's simply not true.

That was true in 1998 and 1999, significant numbers, I think that descriptive term might have been fair at that time.In calendar year 2004, we had 10 people who were separated from all the services out of some 700,000 people vaccinated.So, you know, these are very, very small numbers of people who are being separated for refusing.And in 2005, there were none.Zero.

Q Sir, just to follow up, were there people who were disciplined other than by separation?

DR. WINKENWERDER:Can I ask who's --

Q I'm sorry.Dee Ann Divis.Just to follow up on the previous question.


Q The Washington Examiner.

DR. WINKENWERDER:Okay.We will try to obtain any information to answer your question.I don't have that in front of me right now.
Other questions?

Q Good evening, Dr. Winkenwerder.Vincent Finlanson (sp) from Scotland here, freelance.Could I ask two questions, please?


Q One, could you tell me who the supplier is of the vaccination?

DR. WINKENWERDER:The supplier of the vaccination?

Q Yeah.

DR. WINKENWERDER:Emergent BioSolutions is the name of the manufacturer.

Q I believe that's a private limited company, is it not?

DR. WINKENWERDER:I'm told that it is a privately held company but with plans to issue public shares.

Q Right.Okay.
The second question is, you said that 50 percent -- under a voluntary policy, 50 percent of the troops followed through.Can you tell me what other countries have a mandatory program in place?

DR. WINKENWERDER:I'm not aware that any other countries have a mandatory program in place.

Q That's what I think, as well, yes.That answers my question.Thanks very much.

DR. WINKENWERDER:You're welcome.

Q Thank you.

Q Dr. Winkenwerder, sorry, Jeff with Stripes again.You had mentioned that the Defense Department is looking at intramuscular shots as opposed to the current shots.My understanding is that intramuscular shots hurt a great deal.What are you doing to control the pain?

DR. WINKENWERDER:No, intramuscular shots are not necessarily --

COLROLLAND:It actually reduces --

DR. WINKENWERDER:Yeah, it reduces the --

COL ROLLAND :Swelling.

DR. WINKENWERDER:-- swelling and pain associated with the vaccination.

Q Dr. Winkenwerder, Julian Barnes here from the L.A. Times.


Q I was wondering, are there any long-term adverse effects that the Department of Defense recognizes as associated with the current anthrax vaccine program?

DR. WINKENWERDER:There have been long-term studies that have looked at that question, 2,000 lab workers since the 1940s, 570 workers at Fort Detrick, Maryland, our Defense Medical Surveillance System of vaccinated personnel versus unvaccinated, and long-term health issues with over 700,000 active-duty service members who have been discharged and the rates of problems with those discharged.And to our knowledge, none of those studies has shown any long-term medical consequence, any deleterious effect of the vaccine.

Q Dr. Winkenwerder?

DR. WINKENWERDER:(Inaudible) -- the vaccine versus those who did not receive the vaccine.

Q Dr. Winkenwerder, why did the GAO on May 9th this year state, and I quote, "The long-term safety of the licensed vaccine has not been studied."

DR. WINKENWERDER:I don't know why they would conclude that.I just gave you several long-term studies that suggest otherwise.That wouldn't be the first time that the GAO has made an incorrect statement.

Q Dr. Winkenwerder, Dave Rube (sp), also a freelancer.You said that reviews had concluded that the vaccine was safe, but would you call it perfectly safe?My understanding is that the Vaccine Healthcare Center, a military center, has been examining quite a number of different kinds of illnesses that might be attributed to the vaccine, they just don't have conclusive evidence.But they talk about muscular dystrophy-related illnesses and other things.

DR. WINKENWERDER:So your question is?

Q Well, so are you saying that this is perfectly safe, and that beyond a shadow of a doubt there may not be serious consequences that result, even if, you know, a small percentage of people vaccinated get them?

DR. WINKENWERDER:What I'm saying is that the FDA has said -- the Food and Drug Administration has said, after an exhaustive review, that the vaccine is safe and that it is effective against all forms of exposure of anthrax.And it is, in the conclusions of numerous independent expert groups, safe and effective in the similar way of other vaccines.There is no vaccine, there's no medical treatment, there is no drug for which there has never been a single significant side effect or event noted in not one person.I can't think of a single drug where that has happened.

Q So the information --

DR. WINKENWERDER:Any drug, whether it's penicillin or --

(Telephone rings.)

Q Are you there?

DR. WINKENWERDER:I'm sorry.You can -- you can --

Q Continue.I'm sorry.

DR. WINKENWERDER:You can look at anything that is done in medicine and you cannot say that there's never any adverse effect associated with any particular drug, treatment or vaccine.

Q So to your mind, then, this issue of safety is completely settled and there are no outstanding issues?

DR. WINKENWERDER:Absolutely it is settled.

Q Because the Army released information to me that was reported, I guess it was a year ago, saying that I think it was -- I got to remember, because I haven't seen my story in a while -- 400 people over two years, I think it was 2002 -- or 2003 and 2004 were treated at this Vaccine Healthcare Center Network for a range of complications that may have been tied to the anthrax vaccinations.

DR. WINKENWERDER:I'm going to let Colonel Anderson answer, who is with our Military Vaccine Agency.

COL. ANDERSON:Okay.This is Colonel Anderson.
I'm not familiar with what statistic was briefed to you.But the Vaccine Healthcare Center has the role of anybody who has a concern about any adverse event from a vaccine, no matter if it's smallpox, anthrax, even influenza, they can go in there and be evaluated.I don't have their current numbers of how many people they've examined, but it's very possible that people were concerned.A lot of people get a vaccination against anthrax or any other vaccine and later get sick, and they're concerned about if it's due to that vaccine.Most of the time there is no cause and effect from that vaccine, and a lot of times you'll never know.But they do research each and every one of those.


OPERATOR:Someone has joined the conference.

DR. WINKENWERDER:Could you identify yourself, please?

Q This is Jeff with Stripes, sir.I got disconnected.

DR. WINKENWERDER:Okay, thank you.
All right, any other questions?

Q Dr. Winkenwerder, Julian Bonds here, LA Times.How long does the vaccine last?Will -- between tours in Iraq, will soldiers and Marines need to get second courses of the vaccine?

DR. WINKENWERDER:Well, the current schedule is for an annual booster.And so I think the evidence that the FDA uses is that at least for one year, it's -- in all probability has an effectiveness that goes beyond that period of time.But that is a matter that's currently being studied.And that's part of the -- looking at the dose reduction study and the vaccine series to determine if, in fact, the frequency and the interval of the doses is necessary.

Q Dr. Winkenwerder, this is Chris Lee again.If we could go back to the subject of how many people refused to get the vaccine.You mentioned in 2004 there were 10.That was also the year that Judge Sullivan put the order in, in October, I believe.And you mentioned in 2005 there were none.But it's my impression that it was either a voluntary program at that time, or certain months it wasn't going on.


Q So the last full calendar year that there was mandatory vaccinations, how many people refused?

DR. WINKENWERDER:Well, 2004 would have been that year because it was mandatory through -- at least through the first 10 months of that year, through October.In 2003 the number was 27.

Q Thank you.

DR. WINKENWERDER:And in 2002, it appears that there was one person.So there were, with the introduction of the program in 2003, obviously a lot of people being educated, a lot of people learning about the vaccine.My guess is that it had something to do with a relative increase there.
But if you look over the 2001 to 2005, other than that 2003, you're talking low single digits for each year.

Q And I mentioned Judge Sullivan's order.So the FDA ruling in 2005 in December, that's what gave you the legal go-ahead?Or -- I just want to make sure I understand why you're beyond the reach of that case now.

DR. WINKENWERDER:Yeah.It was -- the FDA issued a final rule and a final order, and that is the basis upon which we can act.Out of deference to the parties that were involved in the lawsuit, it is my understanding that there was subsequent -- a subsequent hearing to resolve whatever issues were still (due a ?) discussion at that point, and I think we felt it best to, you know, ensure that that process was completed to everyone's satisfaction before we undertook our review of all our vaccination programs, as I mentioned earlier in the discussion.

Q Sir, this is Dee Ann Divis with the Examiner.On the numbers that we were just talking about -- in 2004, there were 10, et cetera.Those are active duty only, not Reservists?Or --

DR. WINKENWERDER:They include Reservists.

Q Okay.And that again, (those are the ?) ones that were separated, right?

DR. WINKENWERDER:That's correct.

Q Okay.

Q Dr. Winkenwerder, sorry.Dave Rupe again.You know, you'd mentioned that service people in Iraq would be -- one set would again be receiving the vaccine, but since the war, the Iraq survey group found that Iraq didn't have any anthrax programs going.Is Iraq still a place of concern for anthrax attacks in light of that?Why would it be?

DR. WINKENWERDER:Locations -- well, there are terrorists operating in and around Iraq and in that part of the world.There are people who try to kill American soldiers every day, obviously.That's a higher threat area.

Q Is al Qaeda one of the particular groups of concern?


Q North Korea?

DR. WINKENWERDER:I don't want to comment on North Korea, because I don't have anything to say about that.

Q Dr. Winkenwerder, this is Jay Lacklen (sp), a freelancer.The FDA found the unapproved vaccine additive Squalene in five of the first 50 lot numbers of the anthrax vaccine in 1999.Squalene is not an approved substance because it caused sever autoimmune problems in FDA animal experiments.The bioport vaccine product insert lists ailments that occur infrequently after the anthrax vaccination.Many are autoimmune disorders, including inflammation of the brain, heart and spine; strokes; lupus; multiple sclerosis; and erratic heartbeat.Do you see a connection?


Q Dr. Winkenwerder, this is Denise Grady from The New York Times.Would women have to be given a pregnancy test before they get this vaccination?And if so, do you have to do it every time?

DR. WINKENWERDER:Let me -- we do ask about pregnancy or the possibility of pregnancy before this vaccination and in fact I believe before any vaccination.And my -- we'll have to get you an answer on that.I don't recall that there is a mandatory pregnancy test, but people are certainly questioned about it very directly each and every time.

Q Okay.Thank you.

Q Dr. Winkenwerder, Jeff with Stripes again.To clarify -- is this for service members who are serving 15 days or more on the Korean peninsula or CENTCOM AOR?

DR. WINKENWERDER:That's correct.

Q And will this vaccine be administered to troops both about to deploy out of theater and troops on the ground in theater?

DR. WINKENWERDER:Well, if they're within a very short period of time to redeploy, I suspect that the consideration would be given to not vaccinating those people on a mandatory basis if they're within a very short window of redeploying, because it would not make a great deal of sense to do that.For those deploying yet, they would see the vaccination within 60 days prior to deployment.

MR. JONES:Okay.Any other last questions?

Q Yeah.Vince Tomooson (sp), freelance again.Just going back on a point previously.I'm puzzled as to why the contract for the production of the vaccines is currently entrusted to a private limited company.

DR. WINKENWERDER:Why is it entrusted to them?

Q Yeah.

DR. WINKENWERDER:Most of the vaccines made in the United States -- in fact, I think all of them -- are manufactured by private companies.

Q Yeah, but that then -- doesn't -- that causes the (protein ?) problem, does it not, where, you know, they don't have to report fully on what -- on the results and what they're doing.I mean, I don't understand why it's not a public company.

DR. WINKENWERDER:Well, yeah, it's an FDA licensed vaccine.The FDA regulates all vaccines and drugs and products of that nature, and sets forth certain reporting requirements for safety and effectiveness of those products.

In our case, in the anthrax vaccine, we go beyond that.The adverse reporting systems and surveillance systems that I've talked about today are not required by FDA.These are things that we do because we believe that they're the right thing to do, and we felt it important to demonstrate beyond any doubt that the vaccine is safe and effective, just as we've described it.

Q Yeah, but this is a private limited company.Would it not be better with a public company?You say the area -- the plans to issue --

DR. WINKENWERDER:I don't -- (audio break) -- the status of a company, whether it's privately held or publicly held, is a factor in the FDA's decision -- (audio break) -- talk to them.But I don't think that that factors into their thinking about -- the accountability to the FDA does not (differ ?) -- (audio break).

Q Okay.

Q Kristin -- I'm sorry, this is Kristin Roberts with Reuters again.Is there any discussion or thought about expanding the population of service members who would be vaccinated if supplies would allow?So beyond the CENTCOM area, beyond Korea.

DR. WINKENWERDER:No, not at this time.We don't see a need to expand the program beyond the groups of individuals that I've spoken about.

Q This is Gail Petrich (ph) from the Military Times newspapers again.You mentioned the procedures as far as vaccinating members of the military, but what's the plan for civilian contractors and civilian DOD employees?

DR. WINKENWERDER:Well, if the civilian contractors are deploying to these areas and they're mission-essential -- and we have definitions for who meets that criteria -- then they are included in the vaccination program.

Q As physical --

DR. WINKENWERDER:As far as civilians go who are not mission-essential or who are not in those areas, then they are not subject to the terms of the program.

Q And if those civilians -- employees and/or contractors -- don't want to take the shot, are they not going to those areas, then?Would they not be permitted?

DR. WINKENWERDER:The -- if a civilian refused to take -- who is a mission-essential contractor refused to take the vaccination?

Q Mm-hmm.Or a DOD employee.

DR. WINKENWERDER:Or a DOD employee?I don't know that we've encountered that, to my knowledge. Any other questions?

Q Just to follow up on that, you must have, if it's a mandatory program -- this is Dee Ann Divis with the Examiner -- what is the plan for those who decline?And is it different for the DOD employees and the civilian contractors?

DR. WINKENWERDER:The plan is always to provide education to ensure that people understand that this program is for their safety and it's for their protection.And as I said, when those efforts are undertaken in that way, we find that there are an extremely small number of people who at that point decline to take the shot.At that juncture, for a military person, then the supervisor or the commander would get involved, and it would be resolved like any other similar matter.To refuse to follow a lawful order -- that's what it is.

For a contractor or a civilian, as I said, I'm not aware that we've had any refusals among that group of people.So I don't want to speculate as to what the contractor's supervisor may or may not choose to do or be directed to do.

Q Dr. Winkenwerder, Jeff with (Stars and) Stripes.Can you elaborate on what legal ramifications service members face if they do fail to get the shot?For example, do they face confinement, loss of rank, loss of pay?

Q Just to follow up on that, you must have, if it's a mandatory program -- this is Dee Ann Divis with the Examiner -- what is the plan for those who decline?And is it different for the DOD employees and the civilian contractors?

DR. WINKENWERDER:The plan is always to provide education to ensure that people understand that this program is for their safety and it's for their protection.And as I said, when those efforts are undertaken in that way, we find that there are an extremely small number of people who at that point decline to take the shot.At that juncture, for a military person, then the supervisor or the commander would get involved, and it would be resolved like any other similar matter.To refuse to follow a lawful order -- that's what it is.

For a contractor or a civilian, as I said, I'm not aware that we've had any refusals among that group of people.So I don't want to speculate as to what the contractor's supervisor may or may not choose to do or be directed to do.

DR. WINKENWERDER:Well, I'm not a lawyer, and I'm not here to talk about that particular issue today.If there's a specific question, if you would submit it to us, and we'll try to get you other information on it.

Q Dr. Winkenwerder, if terrorists are a threat concern for this sort of attack, then why not have all DOD personnel, not just the ones in these specific areas?Why not vaccinate all DOD personnel?

DR. WINKENWERDER:Because in our judgment, the persons that we are now vaccinating are the persons who are at highest risk.(Technical difficulty.)I'm sorry.Have we just been interrupted again?

Q No, that's okay.I mean, is it a cost issue or a supply issue?

DR. WINKENWERDER:It is neither a cost nor a supply issue.It's an issue of the relative risk for those individuals and the optimal way to provide around-the-clock protection for them.You also have antibiotics.We can use antibiotics to treat people, and antibiotics are effective in people who have been (exposed ?).And should we have a situation here in the United States, we would be prepared to use antibiotics, and we would also be prepared to use vaccine if we felt that that was the appropriate step to take at that time.

We did have an anthrax scare, if you will, a potential exposure on a detector system here about a year and a half ago, and we treated at that time, not knowing the final result, several hundred employees in the Pentagon with antibiotics as a preventative and protective measure.

Okay.I think --

Q Dr. Winkenwerder, sir, no more questions directly on anthrax.This is Matt Kaufman with the Hartford Courant.I wonder if I might ask your thoughts on the legislation passed in Congress recently enhancing mental health screen in the services, sir, members of the armed forces.

DR. WINKENWERDER:I'm just not taking any questions on that issue today.

Q Something you'd be amenable to talking about --

DR. WINKENWERDER:Sure.If you'd like to talk to us separately on that, we'd be glad to work with.Contact Cynthia Smith from our Public Affairs Office.

Q Okay.I appreciate that.Will do.


MR. JONES: All right.If anyone does need to do any follow up, they can do that with Cynthia Smith or myself, Terry Jones.I'm the guy that sent out the original e-mail, so my information is on there, and most of you already have Cynthia's.

So we thank you for your participation today, and we will have the transcript posted hopefully by tomorrow morning on Defenselink.So you can look for it there.Thanks again.

Q Thank you, Mr. Secretary.

Q Thank you.


[Web Version: http://www.defenselink.mil/Transcripts/Transcript.aspx?TranscriptID=3756]

Anthrax Vaccine For Soldiers Serving In Iraq, Afghanistan And South Korea To Resume


The US Defense Department said compulsory anthrax vaccination of military personnel serving in Iraq, Afghanistan and South Korea will resume within the next 30 to 60 days. Anthrax immunization is said to raise the risk of infertility, multiple sclerosis and lupus. Although people have died following a vaccination, the Pentagon says the link between anthrax immunization and death is not evident.

Anthrax immunization has been a controversial subject - it has even been halted by a federal court.

As well as military personnel, defense contractors in those three countries will also be immunized.

According to William Winkenwerder Jr., Assistant Secretary of Defense for Health Affairs, the vaccine is effective and safe. He said the only side effects are swelling, redness, flu-like symptoms, some pain and malaise. "In all the studies we have performed, looking very, very thoroughly at the vaccine, there is no increase in mortality, there is no increase in morbidity, there is no increase in hospitalizations," he said.

Mark Zaid, a lawyer who has challenged the immunization program, said there is no scientific proof that the vaccine is effective in human beings.

Meryl Nass, M.D., Director of the Military and Biodefense Vaccine Project (MBVP), said "America's military service members deserve to be fully informed about the deaths, chronic illness and disabilities that many soldiers have experienced following anthrax vaccination. The FDA-approved anthrax vaccine package insert acknowledges only six deaths and two dozen autoimmune diseases associated with the vaccine, but the FDA has not directed the manufacturer to update the insert in nearly five years. More than 1200 anthrax vaccine-injured soldiers have been treated at the congressionally mandated Vaccine Healthcare Centers, which DOD has attempted to close. They are suffering with crippling, life-altering illnesses that are being swept under the rug. We know the anthrax vaccine is reactive and we suspect it is especially risky for those with hereditary and other risk factors that DOD refuses to investigate or acknowledge."

Soldiers who refuse to be vaccinated may face a court martial.

US Dept of Defense (http://www.defenselink.mil/Releases/Release.aspx?ReleaseID=10083)
Military and Biodefense Vaccine Project (MBVP)(http://www.military-biodefensevaccines.org/)