trifold fact sheet

What about long-term side effects?

9

This vaccine has been used for over 30 years.
Like other vaccines, rarely has death or serious illness
been reported after vaccination. Each case is
reviewed by CDC, FDA, and DoD, to make
vaccinations as safe as possible.

If I have a health problem or adverse
event after vaccination, what do I do?

9 First, if a health problem occurs following any
vaccine, seek medical care to take care of your
immediate health problem! If your symptoms persist,
you or your provider may contact the DoD Clinical Call
Center at 866.210.6469. Then follow the information
below to file a report with the Vaccine Adverse Event
Reporting System (VAERS). We are committed to
giving you the best care, no matter what caused the
problem.

When do I file a VAERS report?

9

Adverse events after vaccination are reported to
the Vaccine Adverse Event Reporting System
(VAERS). VAERS forms are available at
www.vaers.org or call 800.822.7967. Healthcare
workers and vaccine recipients are encouraged to
report any severe events that require medical
treatment and/or interfere with work or recreation.
DoD requires VAERS reporting by healthcare workers
for adverse events that cause hospitalization or loss of
work for 24 hours or more.

9

You or any healthcare provider (civilian or military)
treating you may contact the Vaccine Healthcare
Center (VHC) for help with preparing a VAERS report
or vaccine adverse event consultation.

If I started anthrax vaccinations, but had
doses delayed, do I have to restart the
series?

I'm in the Reserves or National Guard.
If I have an adverse event, can I go to a
military hospital or clinic?

WHAT YOU NEED
TO KNOW ABOUT
ANTHRAX VACCINE

9

Adverse events after military-directed vaccinations
are in “line-of-duty” (LOD). Some RC members may
seek medical care from their private physicians, while
others may seek medical care at a local military
Medical Treatment Facility (MTF).

9

Those who seek treatment for an adverse event
related to an official immunization will be treated. Any
necessary line-of-duty (LOD) documents shall be
completed after the person is treated. If you see a
NON-military provider, be sure to notify your
commander for the proper paperwork for an LOD or
Notice of Eligibility determination.

9

Evaluation or treatment will not be denied or
delayed, pending a line-of-duty determination.

9

For civilian health services outside a military
Medical Treatment Facility call: 888.MHS.MMSO
(888.647.6676).

What if I’m pregnant?

9

Good medical practice defers vaccination during
pregnancy, unless clearly needed. If you are unsure if
you are pregnant, you may request a pregnancy test
from your medical provider.

9

4 April 2005
EUA Edition

A study at Fort Stewart found that vaccinated
women get pregnant and give birth at the same rate as
unvaccinated women. Outcomes of pregnancies are
comparable in vaccinated and unvaccinated women.

9

US military forces are at risk of attack with
anthrax spores. A significant potential for a
military emergency exists.
The FDA Commissioner granted an Emergency
Use Authorization (EUA) for anthrax vaccine to
prevent inhalation anthrax.
Your military and civilian leaders strongly
recommend anthrax vaccination.

Preliminary results suggest that anthrax vaccine
may be linked with birth defects if given during
pregnancy. These data are unconfirmed. Pregnant
women should not be vaccinated against anthrax
unless the potential benefits of vaccination outweigh
the potential risk to the fetus.

9
9

The protection of each additional dose builds on
the immune response to earlier doses. This is like
climbing steps on a ladder towards full protection. Six
doses are needed for full protection.

What about Reserve Component (RC)
units that drill every month?

9

Your unit commander, in coordination with the
medical authority responsible for immunizations, will
schedule your vaccinations in a timely manner.

Anthrax Vaccine Immunization Program
 For information about vaccine or policy,
Military Vaccine (MILVAX) Agency:
Websites: www.anthrax.mil www.vaccines.mil
E-Mail: [email protected] Toll-Free: 877.GET.VACC
 For medical advice about your vaccination,
DoD Vaccine Clinical Call Center: Toll-Free: 866.210.6469
 For clinical consultation or exemption assistance,
DoD Vaccine Healthcare Centers: www.vhcinfo.org
E-Mail: [email protected] Phone: 202.782.0411
 CDC National Immunization Hotline: 800.232.2522

For more information:
www.anthrax.mil
www.vaccines.mil
[email protected]
877-GET-VACC, DSN 761-4245

To Civilian Healthcare Providers: If a Reservist or Active Duty Service
Member presents to you for a condition that may be an adverse event
caused by a military vaccination, please provide appropriate care. For
authorization and payment, contact the Military Treatment Facility (MTF)
where the member is enrolled, OR contact the Military Medical Support
Office (MMSO, 888-647-6676) if not enrolled to an MTF.

✂

No, you will not have to restart the series. You will
simply pick up where you left off. This is consistent
with national guidelines from the CDC’s Advisory
Committee on Immunization Practices (ACIP).

Update

• In January 2005, the Food and Drug

Who should not get anthrax vaccine?

Administration (FDA) granted an Emergency
Use Authorization (EUA) for anthrax vaccine
to prevent inhalation anthrax. This permits
vaccinations to resume.

9

Some people should not get anthrax vaccine or
should wait:

• The FDA determined that the known and
potential benefits outweigh the known and
potential risks for this use.

• A study in mill workers showed that anthrax
vaccine was 92.5% effective in preventing
anthrax (including cutaneous [skin] and
inhalation anthrax cases).

• U.S. anthrax vaccine has been FDA-licensed
to prevent anthrax since 1970.

THE THREAT FROM
ANTHRAX SPORES
IS DEADLY AND REAL

• The most deadly form of anthrax is inhalation
anthrax.

• You can be infected with anthrax and not know
it, until it’s too late.

• No other product is approved by FDA to prevent
anthrax before exposure.

¾ You may refuse anthrax vaccination under
the EUA, and you will not be punished. No
disciplinary action or adverse personnel
action will be taken. You will not be
processed for separation, and you will still
be deployable. There will be no penalty or
loss of entitlement for refusing anthrax
vaccination.
¾ The consequences of refusing anthrax
vaccine include that you will be more
vulnerable to lethal anthrax infection. Your
loss could threaten the lives of others in
your unit who depend on you, and could
jeopardize the success of the mission.
¾ On October 27, 2004, a Federal District Court
issued an order declaring unlawful and
prohibiting mandatory anthrax vaccinations
to protect against inhalation anthrax,
pending further FDA review. A copy of the
Court's order and opinion is available at
www.anthrax.mil or from the vaccination
clinic.
¾ The issue of mandatory vaccination will be
reconsidered after the FDA completes its
administrative review, which DoD expects to
occur later in 2005.
Information about anthrax vaccine…

• Without vaccination, you would be more
vulnerable to lethal anthrax infection.

• If you get infected with anthrax, your loss could
endanger other people in your unit who depend
on you.

• If you get infected with anthrax, it could
endanger your mission.

¾ The FDA-licensed dosing schedule is 0-2-4 weeks, 6-12-18
months, plus annual boosters, given subcutaneously.
¾ Injection site reactions, like burning, redness and swelling are
common. Local reactions occur in 30% of men and 60% of women.
Anthrax vaccine can cause a lump under the skin where injected.
These lumps can last a few weeks, but they go away on their own.
¾ Systemic reactions, such as headaches or a fever, are less
common than injection-site reactions. These occur at rates similar to
other vaccines: 5% to 35%.
¾ Report adverse events to the Vaccine Adverse Event Reporting
System (VAERS). Get VAERS forms at www.vaers.org or call
800.822.7967. Healthcare workers and vaccine recipients are
encouraged to report via VAERS any severe events within 30 days of
vaccination, that require medical treatment and/or interfere with work
or recreation. DoD requires healthcare workers report adverse events
that cause hospitalization or loss of work for 24 hours or more.

• People who had a serious allergic reaction or
other serious reaction to a prior dose
• People who have a moderate or severe illness
• Women who are pregnant
• People with a possible history of latex sensitivity
• HIV-infected and immune-suppressed people
• People who had Guillain-Barré Syndrome (GBS)
• People who recovered from anthrax infection

9

You can request an evaluation for a medical
exemption from your provider. If you or your provider
need assistance with medical exemption questions,
the Vaccine Healthcare Center (VHC) is available for
consultation services or referral for a second opinion.

What side effects can I expect?

9

A burning sensation may occur immediately after
getting anthrax vaccine and can last about a minute.

9

Like other vaccines, anthrax vaccine may cause
soreness, redness, itching, and swelling at the
injection site.

9

Up to 30% of men and 60% of women report small
local reactions, but these reactions usually last only a
few days. A lump at the site occurs commonly, up to
50% of the time, lasting for a few weeks.

9

Larger injection-site reactions occur in about 1% to
4% of vaccinees.

9

Beyond the injection site, 5% to 35% may notice
such symptoms as muscle or joint aches, headaches,
rashes, chills, low-grade fever or nausea. These
symptoms usually go away in less than a week.

9

Any vaccine, like any prescription drug, can cause
serious reactions including those requiring
hospitalization or medical care. Severe allergic
reactions occur less than once per 100,000 doses.

How many shots will I get?

9

The FDA-licensed schedule for anthrax vaccine is
6 doses given over 18 months: 0-2-4 weeks, 6-12-18
months, plus annual boosters. Six doses are needed
for full protection. Do not get a dose earlier than your
due date. If your risk of exposure to anthrax changes,
we will reconsider the need for you to continue
vaccination.

U.S. Department of Defense

4 April 05