Legal Sidebari

The PREP Act and COVID-19, Part 2: The
PREP Act Declaration for COVID-19
Countermeasures
April 13, 2022
To encourage the expeditious development and deployment of medical countermeasures during a public
health emergency, the Public Readiness and Emergency Preparedness Act (PREP Act) authorizes the
Secretary of Health and Human Services (HHS) to limit legal liability for losses relating to the
administration of medical countermeasures such as diagnostics, treatments, and vaccines. In a declaration
effective February 4, 2020 (the HHS Declaration), the Secretary of HHS (the Secretary) invoked the
PREP Act and declared Coronavirus Disease 2019 (COVID-19) to be a public health emergency
warranting liability protections for covered countermeasures. Under the HHS Declaration and its
amendments, covered persons are generally immune from legal liability (i.e., they cannot be sued for
money damages in court) for losses relating to the administration or use of covered countermeasures
against COVID-19. The sole exception to PREP Act immunity is for death or serious physical injury
caused by “willful misconduct.” However, individuals who die or suffer serious injuries directly caused
by the administration of covered countermeasures may be eligible to receive compensation through the
Countermeasures Injury Compensation Program (CICP).
Part 1 of this two-part Sidebar reviews the structure of the PREP Act and provides an overview of the
CICP. This second part examines the HHS Declaration related to the COVID-19 pandemic in detail and
discusses the scope of the PREP Act’s liability immunity as it applies to COVID-19 countermeasures.
HHS’s COVID-19 Declaration and Amendments
On March 10, 2020, the Secretary invoked the PREP Act and determined that COVID-19 constitutes a
public health emergency. The HHS Declaration therefore authorizes PREP Act immunity for the
“manufacture, testing, development, distribution, administration, and use” of covered countermeasures.
(These activities, however, must either relate to present or future federal contracts, or be part of the public
health response to COVID-19 authorized by an “authority having jurisdiction,” such as federal, state,
Tribal, or local governments.) The immunity applies to all covered persons as defined in the PREP Act,
including any person authorized by state and local public health agencies (or an EUA) to “prescribe,
administer, deliver, distribute or dispense” covered countermeasures. Covered countermeasures include
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“any antiviral, any other drug, any biologic, any diagnostic, any other device, or any vaccine, used to
treat, diagnose, cure, prevent, or mitigate COVID-19.” The “administration” of a covered countermeasure
includes “physical provision of the countermeasures” to patients, as well as “activities and decisions
directly relating to . . . delivery, distribution and dispensing of” the countermeasures. The HHS
Declaration provides PREP Act immunity “without geographic limitation” beginning on February 4,
2020, and ending as late as October 1, 2025.
The HHS Declaration has subsequently been amended many times to broaden the scope of PREP Act
immunity, and interpreted by HHS through its advisory opinions. First, on April 10, 2020, the Secretary
amended the Declaration to include respiratory protective devices approved by the National Institute for
Occupational Safety and Health (NIOSH) as covered countermeasures, pursuant to amendments to the
PREP Act made by Section 3103 of the Coronavirus Aid, Relief, and Economic Security Act (CARES
Act). Second, on June 4, 2020, the Secretary amended the Declaration to clarify that drugs, biological
products, and devices that “limit the harm COVID-19 might otherwise cause” are covered
countermeasures, and that the HHS Declaration reaches “all qualified pandemic and epidemic products
defined under the PREP Act.”
A third amendment to the HHS Declaration (the Third Amendment), issued August 19, 2020, expanded
the definitions of covered diseases and covered persons. First, HHS expanded the categories of disease
representing a public health emergency to reach not just COVID-19, but also “other diseases, health
conditions, or threats that may have been caused by COVID-19, SARS-CoV-2, or a virus mutating
therefrom.” In particular, such “other diseases” include diseases resulting from “the decrease in the rate of
childhood immunizations, which will lead to an increase in the rate of infectious diseases.” The Third
Amendment thus declares that pediatric vaccines (if licensed by FDA and recommended by the Centers
for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP)) are
covered countermeasures.
Relying on the PREP Act’s preemption provision, the Third Amendment also adds a new category of
“qualified persons” to authorize state-licensed pharmacists to administer ACIP-recommended vaccines to
children aged 3 to 18, notwithstanding state laws to the contrary, if the pharmacists comply with certain
federal requirements. Although pediatric vaccines are treated as covered countermeasures for preemptive
purposes, the Amendment nonetheless states that National Vaccine Injury Compensation Program (VICP)
will continue to apply to them “for the purposes of liability immunity and injury compensation,” unless
compensation is not available under that program.
During the Trump Administration, the General Counsel of HHS issued six advisory opinions on the PREP
Act. Although these opinions are nonbinding and lack the force of law, they may inform the judicial
interpretation of the PREP Act if courts find their reasoning persuasive.
First, in an omnibus advisory opinion issued April 17, 2020 (as revised May 19, 2020), the General
Counsel summarized the elements for immunity under the PREP Act and set forth his view that immunity
extends to (1) persons who “reasonably could have believed” that they were covered persons (even if they
were not); and (2) products that a person “reasonably could have believed” were covered countermeasures
(even if they were not). Second, on May 19, 2020, the General Counsel set forth his opinion that the
PREP Act preempts any state or local requirement that effectively prohibits a pharmacist from ordering
and administering an FDA-authorized COVID-19 diagnostic test. Third, on October 23, 2020, the General
Counsel issued a third advisory opinion expressing his view that, with respect to the administration of
pediatric vaccines by pharmacists authorized under the Third Amendment, the PREP Act preempts only
more stringent state licensing laws, and that epinephrine, if used to treat an acute reaction to an ACIP-
recommended vaccination, is a covered countermeasure. Fourth, and also on October 23, 2020, the
General Counsel re-emphasized the breadth of PREP Act immunity, explaining that (1) private businesses
may qualify as “program planners” (and thus covered persons) when performing certain functions, and
(2) activities authorized by an “authority having jurisdiction” include uses of covered countermeasures

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recommended by applicable public-health guidance, such as CDC guidance. The fifth advisory opinion of
January 8, 2021, analyzes whether PREP Act immunity may apply to claims based on the “non-use of a
covered countermeasure,” such as allegations that a nursing home or health care facility negligently failed
to provide personal protective equipment to residents and workers. Finally, on January 12, 2021, the
General Counsel opined that compliance with ACIP’s vaccine allocation recommendations (i.e.,
administering the COVID-19 vaccine to certain prioritized groups first) is not a precondition for PREP
Act immunity.
On December 3, 2020, the Secretary issued a fourth amendment to the HHS Declaration (Fourth
Amendment). Among other things, the Amendment states that the HHS Declaration “must be construed in
accordance with” the HHS advisory opinions, which are expressly “incorporate[d]” into the Declaration.
The Fourth Amendment makes several changes to expand the scope of PREP Act immunity, including
“mak[ing] explicit” that the HHS Declaration (1) covers “all qualified pandemic and epidemic products”
within the meaning of the statute; and (2) may apply to claims based on not administering a covered
countermeasure, such as when the countermeasure is in short supply. The Fourth Amendment further
creates a new category of “qualified persons” to cover health care providers using telehealth to order or
administer covered countermeasures across state lines; adds a third covered means of distribution to
extend liability protections to “additional private distribution channels”; and clarifies the licensing
requirements for pharmacists to administer routine pediatric vaccinations under the Third Amendment,
while expanding this category to expressly include FDA-authorized COVID-19 vaccines as well.
Following the change in presidential administration, the Acting Secretary of HHS issued a series of four
amendments to the HHS Declaration, all intended to “expand the pool” of people who may administer
COVID-19 vaccines and other countermeasures beyond health care providers already licensed in a given
state. The amendments are designed to accomplish this end by broadening the definition of “covered
persons” who may administer COVID-19 vaccines (or other vaccines and countermeasures), and
preempting state laws to the contrary.
Under the Seventh Amendment, issued on March 11, 2021, the covered persons who may administer
COVID-19 vaccines as part of state, federal, and Tribal vaccination efforts include (1) health care
professionals licensed by a state to administer vaccines, including outside their state of licensure;
(2) members of uniformed services (such as the National Guard members) and certain authorized federal
contractors, volunteers, and employees; (3) state-licensed midwives, paramedics, emergency medical
technicians (EMTs), physician assistants, respiratory therapists, dentists, podiatrists, optometrists, and
veterinarians; (4) physicians, registered and practical nurses, pharmacists, pharmacy interns, midwives,
paramedics, EMTs, respiratory therapists, dentists, physician assistants, podiatrists, optometrists, and
veterinarians whose licenses became inactive, expired, or lapsed within the previous five years; and
(5) certain medical, nursing, pharmacy, dental, podiatry, optometry, veterinary, and other students under
the supervision of a practicing health care professional. Most of these groups must meet additional
requirements to be covered under the PREP Act, such as completion of CDC training, an observation
period by a practicing health care professional, a current certificate in cardiopulmonary resuscitation, and
compliance with applicable recordkeeping and reporting requirements.
The Eighth Amendment, issued on August 4, 2021, expands upon the Third and Fourth Amendments’
PREP Act coverage for state-licensed pharmacists who administer COVID-19 vaccines or ACIP-
recommended pediatric vaccines. First, the Amendment clarifies that qualified pharmacy technicians and
supervised pharmacy interns are included as qualified persons authorized to administer these vaccines.
Second, the Amendment expands the vaccines these persons can administer to include seasonal influenza
vaccines for adults. Finally, the Eighth Amendment restates the effective time period for PREP Act
liability protections, which will generally extend through October 1, 2024 (unless the relevant Declaration
is rescinded earlier).

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The Ninth Amendment, effective as of September 14, 2021, seeks to expand the pool of providers who
may administer COVID-19 therapeutics, such as monoclonal antibodies. The Amendment authorizes
state-licensed pharmacists, pharmacy interns, and qualified pharmacy technicians to administer these
therapeutics, notwithstanding state law requirements and subject to a number of requirements.
Most recently, on December 30, 2021, the Secretary of HHS issued the Tenth Amendment to the COVID-
19 PREP Act Declaration to further expand the providers who may administer seasonal influenza vaccines
to include certain pharmacists and pharmacy interns, including in states other than those in which they are
licensed.
Effective Time Periods Under the PREP Act
The PREP Act allows the Secretary to identify in its declaration, for each covered countermeasure, the
time “periods during which [PREP Act immunity] is in effect,” which “may be designated by dates, or by
milestones or other description of events.” In addition, the Secretary may extend immunity to “a date after
the ending date [specified in the declaration]” to allow for a reasonable period “for the manufacturer to
arrange for disposition of the covered countermeasure” and “take such other actions as may be
appropriate to limit administration or use of the covered countermeasure.”
For COVID-19 countermeasures, the current effective time periods for PREP Act coverage are set forth in
Section XII of the Tenth Amendment to the PREP Act Declaration. The applicable time period for liability
immunity may depend on the type of countermeasure, the means of distribution, the covered person who
administers the countermeasure, and other factors. Under Section XII, liability protections for some
countermeasures extend through the final day the applicable Declaration of Emergency is in effect, or
October 1, 2024, whichever occurs first. Liability protections for other countermeasures last through
October 1, 2024, regardless of whether declarations of emergency are no longer in effect.
Which of these time periods applies to a particular countermeasure depends largely on the means of
distribution set forth in Section VII of the Fourth Amendment to the PREP Act Declaration. The statute
allows the Secretary to make PREP Act immunity “effective only to a particular means of distribution.” In
Section VII, the Secretary limited liability protections for COVID-19 countermeasures to three broad
means of distribution:
(a) Covered Countermeasures that are related to present or future federal contracts, cooperative
agreements, grants, other transactions, interagency agreements, memoranda of understanding, or
other federal agreements;
(b) Covered Countermeasures that are related to activities authorized in accordance with the public
health and medical response of the Authority Having Jurisdiction to prescribe, administer, deliver,
distribute or dispense the Covered Countermeasures following a Declaration of Emergency; or
(c) Covered Countermeasures that are:
i. Licensed, approved, cleared, or authorized by the FDA . . . to treat, diagnose, cure, prevent,
mitigate, or limit the harm from COVID-19 . . . ; or
ii. a respiratory protective device approved by NIOSH . . . that the Secretary determines to be a
priority for use during a public health emergency declared under section 319 of the PHS Act to
prevent, mitigate, or limit the harm from COVID–19 . . . .
For the second distribution channel—Section VII(b)—an “Authority Having Jurisdiction” includes state,
local, and federal public agencies with appropriate jurisdiction, and a “Declaration of Emergency”
includes “any declaration by any authorized local regional, state, or federal official of an emergency
specific to events that indicate an immediate need to administer and use the Covered Countermeasures,
with the exception of a federal declaration in support of an Emergency Use Authorization under Section
564 of the [Federal Food, Drug, and Cosmetic Act] unless such declaration specifies otherwise.” To

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qualify for the third distribution channel—Section VII(c)—the particular use must be made in accordance
with the relevant FDA or NIOSH approval.
For countermeasures falling under Section VII(a)—those relating to federal contracts or other federal
agreements—PREP Act immunity generally extends through October 1, 2024. For example, all COVID-
19 vaccines distributed in the United States have been purchased by the federal government (and to
varying degrees were developed using federal funds). These countermeasures therefore generally relate to
federal contracts and would be immunized under the PREP Act through October 1, 2024, regardless of
whether declarations of emergency for COVID-19 are terminated. The CICP program would therefore
continue to apply to COVID-19 vaccine injuries during this period.
For the Section VII(b) channel of distribution (countermeasures authorized and administered as part of the
public health response of a government authority following a Declaration of Emergency) and the Section
VII(c) channel (countermeasures authorized by FDA or NIOSH), liability protections extend through
(a) the final day the applicable Declaration of Emergency is in effect, or (b) October 1, 2024, whichever
occurs first. Generally speaking, the PREP Act Declaration is legally distinct and independent from other
declarations of emergency, such as the federal public health emergency under Section 319 of the Public
Health Service Act. Under the terms of the PREP Act Declaration, however, the effective time period of
liability immunity may be affected by decisions of state, local, and federal governments to terminate
public health emergency declarations.
Section XII of the Tenth Amendment also creates exceptions to these general effective time periods. For
example, liability protections for uniformed service members and federal government employees extend
through October 1, 2024, regardless of the distribution channel. In addition, the Secretary has exercised
his authority under the PREP Act to provide an additional 12 months of coverage beyond these end dates
to allow manufacturers to arrange for the disposition of the countermeasures and other such actions
appropriate to limit the administration or use of the countermeasures.

Author Information

Kevin J. Hickey

Legislative Attorney




Disclaimer
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