Defense Health Primer: Military Vaccinations

Defense Health Primer: Military Vaccinations

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Updated August 6, 2021
Defense Health Primer: Military Vaccinations
The Department of Defense (DOD) administers a variety of
Table 1. Mandatory Vaccinations for All
force health protection (FHP) measures to “promote,
Servicemembers
protect, improve, conserve, and restore” the health and
Adenovirus
Meningococcal
well-being of servicemembers. These measures include
health promotion and education programs, periodic health
Hepatitis A & B
Poliovirus
assessments, preventive therapies, medical
countermeasures, and vaccinations. The U.S. military
Influenza
Tetanus-Diphtheria
instituted its first vaccination program in 1777 when
Measles/Mumps/Rubella
Varicella
General George Washington directed the inoculation of the
Continental Army to protect personnel from smallpox.
Source: Joint Service Regulation on Immunizations and
Since then, DOD has implemented a variety of enduring or
Chemoprophylaxis for the Prevention of Infectious Diseases,
situational FHP measures to protect servicemembers from
October 7, 2013, p. 29.
health threats. Certain vaccines are required for all
DOD Immunization Program
servicemembers, while others may only be required for
The Defense Health Agency (DHA) manages the DOD
those deploying to particular locations. Other vaccines may
Immunization Program. Based on the MILDEPs’ and
be available based on public health recommendations or on
combatant commands’ vaccination requirements, as well as
a voluntary basis.
CDC and ACIP recommendations, DHA coordinates the
Since at least the late 1990s, Congress has expressed
administration of vaccines to servicemembers and other
interest in DOD vaccination policies, specifically those on
DOD beneficiaries. Vaccinations are typically available in
compulsory vaccinations. Similar interest among certain
military treatment facilities, certain military-specific
Members of Congress has arisen as DOD administers the
settings (e.g., basic training), or from participating
Coronavirus Disease 2019 (COVID-19) vaccine to
TRICARE providers. DHA is also responsible for relevant
servicemembers on a voluntary basis. This In Focus
medical documentation, patient safety surveillance, and
describes DOD’s military vaccination policies and
coordination with the Defense Logistics Agency and
immunization program, and offers issues for congressional
commercial manufacturers to procure such vaccines. DOD
consideration.
health care providers typically document servicemember
vaccinations and any related adverse health events in the
DOD Policies on Military Vaccinations
electronic health record system (e.g., MHS Genesis), paper
DOD Instruction 6205.02 establishes the DOD
medical records, and the respective MILDEPs’ medical
Immunization Program. The policy generally directs
readiness information system.
combatant commands and the military departments
Opting Out of a Vaccination
(MILDEPs) to identify and define “mandatory
immunization requirements” for servicemembers. The Joint
A servicemember may request to opt out of a mandatory
Regulation on Immunization and Chemoprophylaxis for the
vaccination. Upon request by a servicemember, DOD may
Prevention of Infectious Diseases outlines specific
authorize a temporary or permanent medical or
vaccination requirements for servicemembers, as well as
administrative exemption to a required vaccine. DOD
service-specific procedures for administering such
health care providers may authorize a medical exemption
requirements. In general, DOD vaccination requirements
when a servicemember has an underlying health condition
follow the recommendations of the U.S. Centers for Disease
or known adverse reaction contraindicated with a certain
Control and Prevention (CDC) and the Advisory
vaccine. Unit commanders may authorize an administrative
Committee on Immunization Practices (ACIP). DOD
exemption for a servicemember who is within 180 days
vaccination requirements fall into one of three categories:
from separating or retiring from the military or within 30
days of departing a permanent assignment location.
 vaccinations during initial entry or basic training;
Pursuant to the Religious Freedom Restoration Act (42
 routine adult vaccinations; and
U.S.C. §2000bb-1), administrative exemptions for religious
 special risk-based, or occupation-specific vaccinations.
reasons may also be granted. DOD policy requires that:
Table 1 lists the mandatory vaccinations required for all
 the unit commander seek input from medical, legal, and
servicemembers upon entering initial entry or basic
chaplain representatives;
training. In addition to these vaccinations, combatant
 the unit commander counsel the servicemember on
commands establish further requirements for
potential adverse impact to “deployability, assignment,
servicemembers, other DOD personnel, and certain family
or international travel”; and
members, based on specific health threats in a geographic
 a military physician counsel the servicemember on the
region.
benefits and risks of forgoing a required vaccination.
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Defense Health Primer: Military Vaccinations
Unit commanders may revoke a religious exemption “if the
compulsory vaccinations and may support congressional
individual and/or unit are at imminent risk of exposure to a
oversight of the DOD Immunization Program.
disease for which an immunization is available.”
Program Administration
Commanders may also administratively separate, or initiate
 Are the MILDEPs receiving adequate support from
disciplinary proceedings under the Uniform Code of
DHA to meet their medical readiness requirements?
Military Justice, servicemembers without an authorized
 How do DOD and CDC share pertinent health
exemption, if they are non-compliant with a mandatory
information documented in the Vaccine Adverse Event
vaccination.
Reporting System?
Authority to Waive Informed Consent
 What health communication strategies are used to
DOD Instruction 6205.02 directs the “preferential use of
educate or solicit feedback from servicemembers on
immunizations approved by the U.S. Food and Drug
DOD’s vaccination or other FHP requirements?
Administration” (FDA); however, non-FDA approved
Military Readiness
drugs, biologics (e.g., vaccines), or medical products may
 Does DOD have adequate authorities and processes in
be administered for FHP purposes. DOD may administer an
“
place to protect the health and well-being of
investigational new drug” or “drug unapproved for its
servicemembers and other DOD personnel conducting
applied use” to servicemembers after obtaining prior
the full range of military operations?
consent (also referred to as informed consent). Under 21
 What were the lessons learned from the Anthrax
U.S.C. §355(i)(4) and related regulations, the informed
Vaccine Immunization Program and how were those
consent process typically requires human subjects to agree
lessons used to improve the DOD Immunization
to the receipt of drug, biologic, or medical product upon a
Program?
disclosure that the product in question is not yet FDA
approved and that the receipt of such product is voluntary.
COVID-19 Vaccinations
 What is DOD’s long-term strategy to mitigate risks from
In certain instances, DOD may request a waiver to statutory
COVID-19 and of future pandemics?
and regulatory informed consent requirements in order
 Will DOD’s COVID-19 mitigation strategy require
make an investigational drug, biologic, or medical product
compulsory vaccination of servicemembers? Is DOD
mandatory for servicemembers participating “in a particular
considering requesting a waiver of informed consent for
military operation.” Section 1107 of Title 10, U.S. Code:
the COVID-19 vaccine?
 authorizes the Secretary of Defense to request a waiver;
 assigns approval authority to the President of the United
Relevant Statutes and Policies
States; and

10 U.S.C. §1107 – Notice of use of an investigational new
if a waiver is approved, directs a congressional
drug or a drug unapproved for its applied use
notification process.
10 U.S.C. §1107a – Emergency use products
If a waiver of informed consent is approved, the statute also
21 U.S.C. §355 – New drugs
requires DOD, prior to administering the investigational
product, to notify servicemembers that a non-FDA
DOD Directive 6200.04 – Force Health Protection (FHP)
approved product is being administered, the reasoning for
DOD Instruction 6200.02 – Application of Food and Drug
such use, information on known side effects, and other
Administration Rules to Department of Defense Force Health
information that the “Secretary of Health and Human
Protection Programs
Services may require to be disclosed.” For products subject
DOD Instruction 6205.02 – DoD Immunization Program
to emergency use authority (EUA), as is the case for several
Joint Service Regulation on Immunizations and
COVID-19 vaccines, Section 1107a of Title 10, U.S. Code
Chemoprophylaxis for the Prevention of Infectious Diseases
grants the President the authority to waive certain EUA
conditions “designed to ensure that individuals are
informed of an option to accept or refuse administration” of
CRS Products
the product.
CRS In Focus IF10530, Defense Primer: Military Health System,
by Bryce H. P. Mendez
A waiver of informed consent does not abrogate the Feres
CRS Report R46745, State and Federal Authority to Mandate
doctrine. If a servicemember is harmed from an
COVID-19 Vaccination, by Wen W. Shen
administered drug, biologic, or medical product, Feres
generally prohibits active duty servicemembers from filing
CRS In Focus IF11102, Military Medical Malpractice and the
medical malpractice lawsuits against the United States.
Feres Doctrine, by Bryce H. P. Mendez and Kevin M. Lewis
However, servicemembers may seek alternative recourse
CRS Legal Sidebar LSB10584, Compensation Programs for
through a DOD administrative process, the National
Potential COVID-19 Vaccine Injuries, by Kevin J. Hickey and Erin
Vaccine Injury Compensation Program, the
H. Ward
Countermeasures Injury Compensation Program, or
CRS In Focus IF10745, Emergency Use Authorization and FDA’s
disability compensation administered by the Department of
Related Authorities, by Agata Bodie
Veterans Affairs.
Issues for Congress

The following lines of inquiry may assist Congress in
Bryce H. P. Mendez, Analyst in Defense Health Care
obtaining further clarification on the administration of
Policy
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Defense Health Primer: Military Vaccinations

IF11816

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