Legal Sidebari

The PREP Act and COVID-19, Part 2: The
PREP Act Declaration for COVID-19
Countermeasures
Updated July 21, 2023
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. It
also discusses the effective time periods for PREP Act immunity and how they apply after the May 11,
2023, termination of the federal public health emergency (PHE) declared for COVID-19 under Section
319 of the Public Health Service Act (the Section 319 PHE).
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 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
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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 emergency use authorization) to
“prescribe, administer, deliver, distribute or dispense” covered countermeasures. Covered
countermeasures include “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 since 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.”
The Third Amendment to the HHS Declaration was issued on August 19, 2020 and 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 preemption purposes, the Amendment states that the National Vaccine Injury
Compensation Program (VICP) will continue to apply to them “for the purposes of liability immunity and
injury compensation.”)
During the Trump Administration, the HHS General Counsel 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 on April 17, 2020 (and revised on 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. 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

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certain functions, and (2) activities authorized by an “authority having jurisdiction” include uses of
covered countermeasures 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 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 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 beyond health care providers already licensed in a given state. The amendments are
designed to accomplish this 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) 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. The Amendment clarifies that qualified pharmacy technicians and
supervised pharmacy interns are authorized to administer these vaccines, and expands the vaccines these
persons can administer to include seasonal influenza vaccines for adults. Similarly, 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 Ninth 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. Lastly, on December 30,

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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.
On May 9, 2023—two days before the Secretary terminated the Section 319 PHE—HHS issued the
Eleventh Amendment to the Declaration. This amendment, first announced on April 14, 2023, extends
PREP Act immunity for certain COVID-19 countermeasures through December 31, 2024. Prior to the
Eleventh Amendment, liability protections for some COVID-19 countermeasures that are “not related to
any [federal] agreement” would have ended along with the Section 319 PHE (unless some another
federal, state, or local emergency declaration applied). The effect of the Eleventh Amendment on the
effective time periods for PREP Act immunity is explained below.
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 Eleventh Amendment. 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 of the applicable Declaration of Emergency, or December 31, 2024,
whichever occurs first. Liability protections for other countermeasures last through December 31, 2024,
regardless of whether the Section 319 PHE or other Declarations of Emergency have expired. In other
words, liability protections for some COVID-19 countermeasures under the PREP Act terminated in May
2023 along with the Section 319 PHE. For many other COVID-19 countermeasures, PREP Act immunity
is to continue to apply to administrations of that countermeasure through December 31, 2024.
The time period that applies to a particular countermeasure depends largely on the means of distribution.
Section VII of the Eleventh Amendment sets forth five means of distribution eligible for PREP Act
immunity, which in turn determine when PREP Act immunity ends for a particular countermeasure. Those
five categories are:
(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;
(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 . . . .
(d) Covered Countermeasures that are authorized by the FDA under [an Emergency Use
Authorization] to treat, diagnose, cure, prevent, mitigate, or limit the harm from COVID–19 . . . ; or

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(e) Covered Countermeasures that are COVID–19 vaccines licensed by the FDA to prevent,
mitigate, or limit the harm from COVID–19 . . . and any approved or cleared in vitro diagnostic
product or other device used to treat, diagnose, cure, prevent, or mitigate 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 . . .
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
qualify for the third, fourth, and fifth distribution channels—Sections VII(c), VII(d), and VII(e)—the
countermeasure must be made and used in accordance with the relevant FDA or NIOSH authorization or
approval.
For countermeasures falling under Section VII(a)—those relating to federal contracts or other federal
agreements—PREP Act immunity generally extends through December 31, 2024. The same rule applies
to Section VII(d) and VII(e) countermeasures—the two new categories added in the Eleventh
Amendment. These categories explicitly include any authorized or licensed COVID-19 vaccine, FDA-
approved tests for COVID-19 (in vitro diagnostics), and any countermeasure authorized by FDA for use
against COVID-19 under an emergency use authorization (EUA). In other words, under the changes made
by the Eleventh Amendment, liability protections for COVID-19 vaccines, tests, and EUA-authorized oral
antivirals will generally continue through December 31, 2024. The CICP would therefore continue to
apply to COVID-19 vaccine and other covered countermeasure injuries during that period.
For the Section VII(b) and Section VII(c) channels of distribution, liability protections may end earlier
than December 31, 2024. Protection for activities authorized as part of a government authority’s public
health response following a Declaration of Emergency (and for some FDA and NISOH approved
countermeasures that do not qualify under Sections VII(c) or VII(d)) only extends through (a) the final
day the applicable Declaration of Emergency is in effect, or (b) December 31, 2024, whichever occurs
first. If a countermeasure does not fall into Sections VII(a), VII(d) or VII(e), and no other Declaration of
Emergency applies, PREP Act protections for these activities thus ended along with the Section 319 PHE
on May 11, 2023.
In addition, the Secretary has exercised 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.

Author Information

Kevin J. Hickey

Legislative Attorney




Disclaimer
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LSB10730 · VERSION 3 · UPDATED

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