Anthrax shots are back - Vaccinations are mandatory again. Here's what you should know
By Gayle S. Putrich
Staff writer
Get ready, because here they come - mandatory anthrax vaccinations are back.
Since December 2004, the vaccine has been optional for all troops, no matter where they deployed or what their job, in the wake of a court ruling that halted the original mandatory program.
But with the Food and Drug Administration having issued a final rule declaring the vaccine safe and effective against all forms of anthrax, defense officials say the shots will again be required starting early next year for anyone assigned to U.S. Central Command, including Iraq and Afghanistan, or U.S. Forces Korea.
Here's what you need to know, from when the Pentagon expects to start vaccinations to what you should do if you have a bad reaction to the shots.
Q. Why resume the mandatory vaccination program now?
A. Defense officials say it's to "better protect our forces at higher risk," based on classified threat assessments.
"The threat of biological warfare has been a risk to U.S. forces for many years, and the threat of anthrax weapons in the hands of adversarial countries remains strong," officials said.
Q. Who will be required to take the shots under the new mandatory program?
A. The policy announced in October directs mandatory anthrax shots for troops, emergency-essential civilians and Defense Department contractors carrying out mission-essential services in the Central Command area or South Korea for 15 consecutive days or more. Also, some personnel assigned to special mission units, such as forward-deployed forces and biodefense units, will be required to be vaccinated.
Q. How are National Guard and reserve members affected?
A. Reservists due to deploy will follow the same guidelines as active-duty service members who are preparing to deploy or are currently in theater.
Q. When will shots begin and what does the vaccine regimen consist of?
A. Mandatory immunizations will begin once implementation plans from each service have been approved. Defense officials expect that to happen early next year. Until then, anthrax vaccinations remain voluntary.
The vaccine regimen consists of six shots. The second and third come at two-week intervals after the first; the remaining three shots are administered at six, 12 and 18 months after the first shot. Annual booster shots follow.
Q. If someone redeploys out of a high-risk area before the six-shot series is complete, will he continue with the vaccinations?
A. For personnel no longer assigned to a high-threat area or to designated special-mission roles, the vaccinations stop being mandatory, but individuals may continue them voluntarily.
Q. What is the plan for those who began the shots under the previous mandatory program but stopped when the shots became voluntary?
A. Under guidelines issued by the Centers for Disease Control and Prevention, they will not need to restart the series; they can pick up where they left off.
Q. How many people currently in Central Command or Korea have been vaccinated?
A. Defense officials said they do not provide this figure for operational security reasons. In the two years of the voluntary program, defense officials say about half the troops offered the vaccine have taken it.
Q. Have any troops contracted anthrax or died from the disease?
A. The Defense Department has long maintained that Southwest Asia and Korea are "high threat" areas for weaponized anthrax, but to date, no U.S. troops have contracted or died from the disease in an operational environment, officials say.
Q. Have any troops died from taking the anthrax vaccine?
A. Defense officials say they review all serious adverse events after immunization, including deaths where "a strong temporal association with receipt of anthrax or smallpox vaccines" has been identified. "No cases to date have been causally associated with anthrax immunization alone," they said.
Data from the Food and Drug Administration and the CDC indicate at least 21 people have died after taking the anthrax vaccine, although none of those cases reflects a direct cause-and-effect to the vaccine.
In 2003, Army Reserve Spc. Rachel Lacy died after receiving five vaccines, including anthrax vaccine, before deployment. Two independent panels of medical experts said the combination of vaccines probably, but not conclusively, triggered an underlying and undiagnosed immune system disorder that led to her death.
Q. What legal ramifications do troops, civilians and contractors face if they refuse to take the vaccine?
A. Defense officials say service members have a duty to comply with lawful orders, and civilian employees have a duty to comply with terms of employment. "These duties may be enforced by appropriate administrative or disciplinary action," officials said.
Under the previous mandatory program, which ran from late 1998 to late 2004, service members were routinely punished for refusing to take the vaccine. Punishments ranged from letters of reprimand to courts-martial and dismissal from service.
Q. Is the vaccine safe?
A. The Defense Department says the vaccine is safe, with an "adverse event profile" comparable to other vaccines.
The FDA issued a report on adverse reactions to the anthrax vaccine in December 2005, 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 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 acknowledges the voluntary nature of VAERS may lead to underreporting.
The Pentagon assured Congress that hospitalizations and other serious events following anthrax vaccination would be reported to VAERS, one of the few available public sources for vaccine safety information. But an investigation last December by the Hampton Roads (Va.) Daily Press found that 20,765 hospitalizations that met the VAERS definition of a "serious adverse event" following anthrax vaccination were not reported during that time.
In addition, a review of all data in the VAERS system for every vaccine licensed in the U.S. that was published in a peer-reviewed medical journal in 2004 found that the reported adverse-reaction rate for anthrax vaccine was higher in every category compared to other vaccines.
Q. What are the possible side effects of the anthrax vaccine?
A. The Pentagon says that like all vaccines, anthrax vaccine may cause minor reactions such as soreness, redness, itching, swelling and lumps at the injection site. About 30 percent of men and 60 percent of women report these local reactions, but they usually last only a short while. Lumps can persist a few weeks, but eventually disappear.
Beyond the injection site, between 5 percent and 35 percent of people will notice muscle aches, joint aches, headaches, rash, chills, fever, nausea, loss of appetite, malaise or related symptoms. Officials say these symptoms also usually go away after a few days.
Officials said serious events requiring hospitalization are rare, occurring about once per 200,000 doses. "Severe allergic reactions can occur after any vaccination, at an average rate of less than once per 100,000 doses," they said.
The Defense Department's Vaccine Healthcare Centers can help individuals or health care providers with expert advice on adverse reactions via a secure e-mail consultation system at https://askvhc.wramc.amedd.army.mil or by calling toll-free (866) 210-6469.
Some troops have developed serious illnesses after taking the shots, although their conditions have never been definitively linked to the vaccine. These illnesses have included cysts, blood clots, Lou Gehrig's disease and cancer.
Q. What should service members do if they think they are having an adverse reaction?
A. Officials say adverse events should be evaluated, and if necessary, treated by a health care provider. "It is important for an individual seeking medical attention to inform their health care provider of vaccines they recently received," officials said.
The Vaccine Healthcare Centers can help file a report with the Vaccine Adverse Event Reporting System, document a medical exemption if needed, and manage any ongoing medical problems, to include assistance with access to specialty care.
If at any time a service member feels he is having unusual symptoms, he can contact the Vaccine Heathcare Center and/or file a Vaccine Adverse Event Reporting System report at http://vaers.hhs.gov/.
Q. If troops suffer minor reactions to the vaccine early in the shot series, will they be expected to continue the shots?
A. If an individual experiences a minor reaction to the vaccine early in the series of shots, officials say the service member will continue the series but should avoid strenuous exercise for 24 to 48 hours after the next dose to avoid aggravating a local reaction.
If symptoms worsen, service members are encouraged to seek medical care, document the problems and get an evaluation for either a temporary or permanent medical exemption.
Q. Will an adverse reaction in a service member prior to deployment prevent him from deploying?
A. Officials say that since the majority of adverse reactions are minor and temporary, they will not exempt someone from deployment. But serious adverse events or prolonged, worsening side effects "may result in a medical exemption from continued immunization with the specific vaccine associated with the problem," officials said.
"Medical readiness for deployment involves multiple factors and is related to service and operational specific needs. Vaccines represent only one part of many parameters considered for deployability."
Q. Should a service member have an adverse reaction in the field, particularly in a forward-deployed area, what happens? Will he be sent home?
A. Defense officials say anyone experiencing an adverse event should immediately contact the nearest health care provider. "If the adverse reaction requires emergency medical services, the individual may be taken to the nearest medical facility for evaluation and treatment as required," they said.
Q. Has squalene ever been used in the military's anthrax vaccine? Is it currently being added to the anthrax vaccine?
A. Critics of the military's program have long charged that the Pentagon has used the naturally occurring substance squalene to boost the anthrax vaccine's immune response, and that squalene may be a factor in the mysterious illnesses that have afflicted many veterans of the 1991 Persian Gulf War.
The FDA found trace amounts of squalene in five lots of the vaccine in 2000. But defense officials say neither they "nor anybody else" deliberately added squalene to the vaccine used for U.S. troops.
"Since 1999, four civilian panels have investigated the allegations the squalene was added to the vaccine and repeatedly found them groundless," they said.
The amounts found in the five lots of vaccine were so small that they could have been caused by a human fingerprint left uncleaned on laboratory glassware, defense officials have said.
The anthrax vaccine does contain aluminum hydroxide, which is widely used in many vaccines to enhance antibody production.
Q. Is this the same vaccine used in the Pentagon's original mandatory program?
A. Yes, officials say, "This vaccine has been licensed by the FDA since the 1970s. Based on human and animal data, the National Academy of Science's Institute of Medicine concluded in March 2002 that this anthrax vaccine is "an effective vaccine for the protection of humans against anthrax, including inhalational anthrax, caused by all known or plausible engineered strains of Bacillus anthracis."
"The FDA accepted the panel's recommendation in December 2005, stating that the vaccine is effective in preventing anthrax disease, regardless of the route of exposure."
However, opponents of the program say the vaccine was originally developed to protect mill workers handling infected animal hides and some laboratory workers from the skin form of anthrax. They note there has never been a clinical trial in humans to test the vaccine's effectiveness against inhalation anthrax.
Staff writer
Get ready, because here they come - mandatory anthrax vaccinations are back.
Since December 2004, the vaccine has been optional for all troops, no matter where they deployed or what their job, in the wake of a court ruling that halted the original mandatory program.
But with the Food and Drug Administration having issued a final rule declaring the vaccine safe and effective against all forms of anthrax, defense officials say the shots will again be required starting early next year for anyone assigned to U.S. Central Command, including Iraq and Afghanistan, or U.S. Forces Korea.
Here's what you need to know, from when the Pentagon expects to start vaccinations to what you should do if you have a bad reaction to the shots.
Q. Why resume the mandatory vaccination program now?
A. Defense officials say it's to "better protect our forces at higher risk," based on classified threat assessments.
"The threat of biological warfare has been a risk to U.S. forces for many years, and the threat of anthrax weapons in the hands of adversarial countries remains strong," officials said.
Q. Who will be required to take the shots under the new mandatory program?
A. The policy announced in October directs mandatory anthrax shots for troops, emergency-essential civilians and Defense Department contractors carrying out mission-essential services in the Central Command area or South Korea for 15 consecutive days or more. Also, some personnel assigned to special mission units, such as forward-deployed forces and biodefense units, will be required to be vaccinated.
Q. How are National Guard and reserve members affected?
A. Reservists due to deploy will follow the same guidelines as active-duty service members who are preparing to deploy or are currently in theater.
Q. When will shots begin and what does the vaccine regimen consist of?
A. Mandatory immunizations will begin once implementation plans from each service have been approved. Defense officials expect that to happen early next year. Until then, anthrax vaccinations remain voluntary.
The vaccine regimen consists of six shots. The second and third come at two-week intervals after the first; the remaining three shots are administered at six, 12 and 18 months after the first shot. Annual booster shots follow.
Q. If someone redeploys out of a high-risk area before the six-shot series is complete, will he continue with the vaccinations?
A. For personnel no longer assigned to a high-threat area or to designated special-mission roles, the vaccinations stop being mandatory, but individuals may continue them voluntarily.
Q. What is the plan for those who began the shots under the previous mandatory program but stopped when the shots became voluntary?
A. Under guidelines issued by the Centers for Disease Control and Prevention, they will not need to restart the series; they can pick up where they left off.
Q. How many people currently in Central Command or Korea have been vaccinated?
A. Defense officials said they do not provide this figure for operational security reasons. In the two years of the voluntary program, defense officials say about half the troops offered the vaccine have taken it.
Q. Have any troops contracted anthrax or died from the disease?
A. The Defense Department has long maintained that Southwest Asia and Korea are "high threat" areas for weaponized anthrax, but to date, no U.S. troops have contracted or died from the disease in an operational environment, officials say.
Q. Have any troops died from taking the anthrax vaccine?
A. Defense officials say they review all serious adverse events after immunization, including deaths where "a strong temporal association with receipt of anthrax or smallpox vaccines" has been identified. "No cases to date have been causally associated with anthrax immunization alone," they said.
Data from the Food and Drug Administration and the CDC indicate at least 21 people have died after taking the anthrax vaccine, although none of those cases reflects a direct cause-and-effect to the vaccine.
In 2003, Army Reserve Spc. Rachel Lacy died after receiving five vaccines, including anthrax vaccine, before deployment. Two independent panels of medical experts said the combination of vaccines probably, but not conclusively, triggered an underlying and undiagnosed immune system disorder that led to her death.
Q. What legal ramifications do troops, civilians and contractors face if they refuse to take the vaccine?
A. Defense officials say service members have a duty to comply with lawful orders, and civilian employees have a duty to comply with terms of employment. "These duties may be enforced by appropriate administrative or disciplinary action," officials said.
Under the previous mandatory program, which ran from late 1998 to late 2004, service members were routinely punished for refusing to take the vaccine. Punishments ranged from letters of reprimand to courts-martial and dismissal from service.
Q. Is the vaccine safe?
A. The Defense Department says the vaccine is safe, with an "adverse event profile" comparable to other vaccines.
The FDA issued a report on adverse reactions to the anthrax vaccine in December 2005, 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 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 acknowledges the voluntary nature of VAERS may lead to underreporting.
The Pentagon assured Congress that hospitalizations and other serious events following anthrax vaccination would be reported to VAERS, one of the few available public sources for vaccine safety information. But an investigation last December by the Hampton Roads (Va.) Daily Press found that 20,765 hospitalizations that met the VAERS definition of a "serious adverse event" following anthrax vaccination were not reported during that time.
In addition, a review of all data in the VAERS system for every vaccine licensed in the U.S. that was published in a peer-reviewed medical journal in 2004 found that the reported adverse-reaction rate for anthrax vaccine was higher in every category compared to other vaccines.
Q. What are the possible side effects of the anthrax vaccine?
A. The Pentagon says that like all vaccines, anthrax vaccine may cause minor reactions such as soreness, redness, itching, swelling and lumps at the injection site. About 30 percent of men and 60 percent of women report these local reactions, but they usually last only a short while. Lumps can persist a few weeks, but eventually disappear.
Beyond the injection site, between 5 percent and 35 percent of people will notice muscle aches, joint aches, headaches, rash, chills, fever, nausea, loss of appetite, malaise or related symptoms. Officials say these symptoms also usually go away after a few days.
Officials said serious events requiring hospitalization are rare, occurring about once per 200,000 doses. "Severe allergic reactions can occur after any vaccination, at an average rate of less than once per 100,000 doses," they said.
The Defense Department's Vaccine Healthcare Centers can help individuals or health care providers with expert advice on adverse reactions via a secure e-mail consultation system at https://askvhc.wramc.amedd.army.mil or by calling toll-free (866) 210-6469.
Some troops have developed serious illnesses after taking the shots, although their conditions have never been definitively linked to the vaccine. These illnesses have included cysts, blood clots, Lou Gehrig's disease and cancer.
Q. What should service members do if they think they are having an adverse reaction?
A. Officials say adverse events should be evaluated, and if necessary, treated by a health care provider. "It is important for an individual seeking medical attention to inform their health care provider of vaccines they recently received," officials said.
The Vaccine Healthcare Centers can help file a report with the Vaccine Adverse Event Reporting System, document a medical exemption if needed, and manage any ongoing medical problems, to include assistance with access to specialty care.
If at any time a service member feels he is having unusual symptoms, he can contact the Vaccine Heathcare Center and/or file a Vaccine Adverse Event Reporting System report at http://vaers.hhs.gov/.
Q. If troops suffer minor reactions to the vaccine early in the shot series, will they be expected to continue the shots?
A. If an individual experiences a minor reaction to the vaccine early in the series of shots, officials say the service member will continue the series but should avoid strenuous exercise for 24 to 48 hours after the next dose to avoid aggravating a local reaction.
If symptoms worsen, service members are encouraged to seek medical care, document the problems and get an evaluation for either a temporary or permanent medical exemption.
Q. Will an adverse reaction in a service member prior to deployment prevent him from deploying?
A. Officials say that since the majority of adverse reactions are minor and temporary, they will not exempt someone from deployment. But serious adverse events or prolonged, worsening side effects "may result in a medical exemption from continued immunization with the specific vaccine associated with the problem," officials said.
"Medical readiness for deployment involves multiple factors and is related to service and operational specific needs. Vaccines represent only one part of many parameters considered for deployability."
Q. Should a service member have an adverse reaction in the field, particularly in a forward-deployed area, what happens? Will he be sent home?
A. Defense officials say anyone experiencing an adverse event should immediately contact the nearest health care provider. "If the adverse reaction requires emergency medical services, the individual may be taken to the nearest medical facility for evaluation and treatment as required," they said.
Q. Has squalene ever been used in the military's anthrax vaccine? Is it currently being added to the anthrax vaccine?
A. Critics of the military's program have long charged that the Pentagon has used the naturally occurring substance squalene to boost the anthrax vaccine's immune response, and that squalene may be a factor in the mysterious illnesses that have afflicted many veterans of the 1991 Persian Gulf War.
The FDA found trace amounts of squalene in five lots of the vaccine in 2000. But defense officials say neither they "nor anybody else" deliberately added squalene to the vaccine used for U.S. troops.
"Since 1999, four civilian panels have investigated the allegations the squalene was added to the vaccine and repeatedly found them groundless," they said.
The amounts found in the five lots of vaccine were so small that they could have been caused by a human fingerprint left uncleaned on laboratory glassware, defense officials have said.
The anthrax vaccine does contain aluminum hydroxide, which is widely used in many vaccines to enhance antibody production.
Q. Is this the same vaccine used in the Pentagon's original mandatory program?
A. Yes, officials say, "This vaccine has been licensed by the FDA since the 1970s. Based on human and animal data, the National Academy of Science's Institute of Medicine concluded in March 2002 that this anthrax vaccine is "an effective vaccine for the protection of humans against anthrax, including inhalational anthrax, caused by all known or plausible engineered strains of Bacillus anthracis."
"The FDA accepted the panel's recommendation in December 2005, stating that the vaccine is effective in preventing anthrax disease, regardless of the route of exposure."
However, opponents of the program say the vaccine was originally developed to protect mill workers handling infected animal hides and some laboratory workers from the skin form of anthrax. They note there has never been a clinical trial in humans to test the vaccine's effectiveness against inhalation anthrax.
