Development and Regulation of Medical Countermeasures for COVID-19 (Vaccines, Diagnostics, and Treatments): Frequently Asked Questions

June 25, 2020 R46427

Development and Regulation of Medical
June 25, 2020
Countermeasures for COVID-19 (Vaccines,
Agata Dabrowska
Diagnostics, and Treatments): Frequently
Analyst in Health Policy

Asked Questions
Frank Gottron
Specialist in Science and
In recent months, the Coronavirus Disease 2019 (COVID-19) pandemic has spread globally, with
Technology Policy
the United States now reporting the highest number of cases of any country in the world.

Currently, there are few treatment options available to lessen the health impact of the disease and
Amanda K. Sarata
no vaccines or other prophylactic treatments to curb the spread of the virus.
Specialist in Health Policy

The biomedical community has been working to develop new therapies or vaccines, and to
repurpose already approved therapeutics, that could prevent COVID-19 infections or lessen
Kavya Sekar
severe outcomes in patients. In addition, efforts have been underway to develop new diagnostic
Analyst in Health Policy
tools (i.e., testing) to help better identify and isolate positive cases, thereby reducing the spread of

the disease. To this end, Congress has appropriated funds for research and development into new
medical countermeasures (MCMs) in several recent supplemental appropriations acts. MCMs are

medical products that may be used to treat, prevent, or diagnose conditions associated with
emerging infectious diseases or chemical, biological, radiological, or nuclear (CBRN) agents. MCMs include biologics (e.g.,
vaccines, monoclonal antibodies), drugs (e.g., antimicrobials, antivirals), and medical devices (e.g., diagnostic tests).
This report answers frequently asked questions about current efforts related to research and development of medical
countermeasures, their regulation, and related policy issues. Although several efforts are underway, medical product research,
development, and approval is a difficult and high-risk endeavor that takes years in typical circumstances. In response to
COVID-19, this process has been expedited, including through several federal programs and mechanisms covered in this
report. However, expedited medical product development can carry certain risks, such as a more limited safety profile for
new products upon approval.
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Development and Regulation of Medical Countermeasures for COVID-19

n recent months, the Coronavirus Disease 2019 (COVID-19) pandemic has spread globally,
with the United States now reporting the highest number of cases of any country in the world.
I Currently, there are few treatment options available to lessen the health impact of the disease
and no vaccines or other prophylactic treatments to curb the spread of the virus. Treatment of
severe COVID-19 cases can require significant health care resources, such as ventilators for
patients with serious respiratory complications. A portion of severe cases are fatal.
The biomedical community has been working to develop new therapies or vaccines, and to
repurpose already approved therapeutics, that could prevent COVID-19 infections or lessen
severe outcomes in patients. In addition, efforts have been underway to develop new diagnostic
tools (i.e., testing) to help better identify and isolate positive cases, thereby reducing the spread of
the disease. To this end, Congress has appropriated funds for research and development into new
medical countermeasures (MCMs) in several recent supplemental appropriations acts.
On May 15, the Trump Administration announced Operation Warp Speed, the major federal effort
to accelerate and coordinate the development, manufacturing, and distribution of MCMs. The
public-private partnership involves several federal agencies (including those covered in this
report), as well as private firms. A key feature of the initiative is greater federal involvement and
coordination in research, development, and manufacturing for selected MCM candidates than is
typical for most U.S. pharmaceutical research and development (R&D).
This report summarizes current efforts related to research and development of medical
countermeasures (including studying novel uses of already approved MCMs), their regulation,
and related policy issues. Although several efforts are underway, medical product research,
development, and approval is a difficult and high-risk endeavor that takes years in typical
circumstances. In response to COVID-19, this process has been expedited, including through
several federal programs and mechanisms covered in this report. However, expedited medical
product development can carry certain risks, such as a more limited safety profile for new
products upon approval. Particularly in the context of a pandemic, regulators are faced with the
challenge of weighing the benefits and risks in introducing any new product into the market on a
rapid timeline. This report focuses on therapeutics, vaccines, and diagnostics for COVID-19 and
generally does not discuss other types of medical devices relevant to the treatment of COVID-19
(e.g., ventilators, personal protective equipment). This report also does not discuss MCM
affordability, coverage, or supply chain issues.
Background
What are MCMs?
MCMs are medical products that may be used to treat, prevent, or diagnose conditions associated
with emerging infectious diseases or chemical, biological, radiological, or nuclear (CBRN)
agents. MCMs include biologics (e.g., vaccines, monoclonal antibodies1), drugs (e.g.,
antimicrobials, antivirals), and medical devices (e.g., diagnostic tests).2

1 Monoclonal antibodies are preparations of a specific type of antibody designed to bind to a single target. See NIH,
“Monoclonal antibodies crucial to fighting emerging infectious diseases, say NIH officials,” March 8, 2018,
https://www.nih.gov/news-events/news-releases/monoclonal-antibodies-crucial-fighting-emerging-infectious-diseases-
say-nih-officials.
2 Food and Drug Administration (FDA), “What Are Medical Countermeasures?,” accessed April 15, 2020,
https://www.fda.gov/emergency-preparedness-and-response/about-mcmi/what-are-medical-countermeasures. Personal
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How are medical products like MCMs typically developed?
Developing any new medical product typically requires several stages of research:
 basic research to understand the fundamental mechanisms of a disease;
 identification of a potential product (i.e., a drug);
 preclinical testing in the laboratory, often using animals, tissue samples, and/or
computer models;
 testing in several stages (typically three phases) of human clinical trials in
progressively larger groups of human subjects to assess products for safety and
effectiveness.
In addition, companies must develop the manufacturing capabilities to produce a new product at
scale. In most cases, medical products must be approved by the U.S. Food and Drug
Administration (FDA) before being marketed in the United States. In typical circumstances, the
development and approval of new drugs takes an average of 10-15 years from discovery to
approval.3 This process may be abbreviated in the case of an already approved therapeutic
whereby safety has been established, but clinical testing is still needed to evaluate its
effectiveness for a new use. This is sometimes referred to as drug repurposing. Additional safety
studies may be needed if the route of administration or dosage of the therapeutic for the new use
differs from that previously approved.
To make products available for the COVID-19 pandemic, the federal government is aiming to
accelerate and coordinate various elements of the process, as shown in the Government
Accountability Office (GAO) graphic below (see Figure 1).

protective equipment is also a type of medical device and MCM; however, a discussion of these products is outside the
scope of this report.
3 CRS Infographic IG10013, The Pharmaceutical Drug Development Process.
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Figure 1. Traditional Pharmaceutical R&D Timeline Versus an Accelerated Timeline

Source: Government Accountability Office (GAO), “The Reward and Risk of Expediting COVID-19 Testing and
Vaccine Development,” May 28, 2020, https://blog.gao.gov/2020/05/28/the-reward-and-risk-of-expediting-covid-
19-testing-and-vaccine-development/.
In typical circumstances, the public sector generally finances much of the basic research and
some preclinical testing and clinical research of new pharmaceutical products—such as through
research supported by the National Institutes of Health (NIH)—mostly in the early stage of R&D,
such as Phase 1 clinical trials.4 The private sector tends to support much of the later-stage R&D of
new medical products, such as late-stage and large-scale Phase 3 clinical trials, and the
development of manufacturing capabilities.5
The federal government has recognized that countermeasures to some public health threats, such
as emerging infectious diseases or bioterrorism agents, may have fewer market incentives than
other pharmaceutical products, such as those treating chronic diseases. Manufacturers generally
lack a profit incentive to develop products or capabilities in anticipation of a potential pandemic
disease. As a result, the federal government has invested in agencies and programs that support
the development of new MCMs. For example, the Biomedical Advanced Research and
Development Authority (BARDA) can specifically support later-stage R&D and the
manufacturing capabilities of new MCMs. Other incentives, such as regulatory exclusivity and
tax incentives, can also support the development of new products.6

4 Gillian K. Gresham, Stephan Ehrhardt, and Jill L. Meinhert, “Characteristics and Trends of Clinical Trials Funded by
the National Institutes of Health Between 2005 and 2015,” Clinical Trials, vol. 15, no. 1 (2018), pp. 65-74.
5 National Academies of Sciences, Engineering, and Medicine, Making Medicines Affordable: A National Imperative,
2018, pp. 31-70.
6 The sponsor of an new drug application (NDA) or biologics license application (BLA) for a new MCM may receive,
upon approval, a period of exclusivity during which FDA may not approve an NDA or BLA from another sponsor for a
certain number of years. For example, provided that statutory criteria are met, a drug that contains a new chemical
entity is eligible for five years of data exclusivity.
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Which federal agencies are usually involved in MCM
development?
Several federal agencies, some of which are listed below, support medical and health R&D, while
the FDA regulates the marketing of medical products in the United States. These agencies can
contribute to and facilitate the development of new medical products, particularly in the event of
an infectious disease threat.
The National Institutes of Health (NIH) within the Department of Health and Human Services
(HHS) is the primary federal agency that supports medical and health research. NIH funds much
of the basic biomedical science research in the United States, and it supports some development
of new medical products.7 One NIH institute, the National Institute of Allergy and Infectious
Diseases (NIAID), aids in the response to new infectious disease threats as a part of its mission—
supporting both basic scientific research and the development of new MCMs.8
The Centers for Disease Control and Prevention (CDC) within HHS generally supports public
health and laboratory research related to new infectious disease threats. In the event of emerging
infectious disease outbreaks, CDC has been the first to develop a diagnostic testing kit for use in
U.S. public health laboratories—a model followed during the H1N1 influenza pandemic, the
2016 Zika outbreak, and now during the COVID-19 pandemic.9 Aside from diagnostic test
development, the agency supports a limited amount of MCM R&D; for example, past clinical
trials for pre-exposure prophylaxis (PrEP) for HIV infections.10 CDC also supports postmarket
surveillance (i.e., data collection) on the safety and effectiveness of certain MCMs on the market,
such as for vaccines.11
The Biomedical Advanced Research and Development Authority (BARDA) under the HHS
Office of the Assistant Secretary for Preparedness and Response (ASPR) supports MCM
development for use against emerging infectious diseases; pandemic influenza; and chemical,
biological, radiological, and nuclear threat agents. Its efforts focus on supporting the transition
from basic research to advanced development, clinical testing, FDA approval, and acquisition of
some MCMs into the Strategic National Stockpile (SNS).12
FDA within HHS regulates the safety, effectiveness, and quality of MCMs through premarket
review and postmarket requirements (e.g., adverse event reporting). FDA provides guidance,
regulatory advice, and technical assistance to entities developing MCMs. The agency also
conducts intramural and funds extramural regulatory science research to support the development

7 CRS Report R41705, The National Institutes of Health (NIH): Background and Congressional Issues.
8 National Institute of Allergy and Infectious Diseases (NIAID), “NIAID Strategic Plan 2017,”
https://www.niaid.nih.gov/sites/default/files/NIAIDStrategicPlan2017.pdf.
9 Centers for Disease Control and Prevention (CDC), “The 2009 H1N1 Pandemic: Summary Highlights, April 2009-
April 2010,” 2010, https://www.cdc.gov/h1n1flu/cdcresponse.htm.
10 CDC, “CDC U.S. Extended PrEP Safety Trial: Quick Facts on Trial Design,” July 2010, https://www.cdc.gov/
nchhstp/newsroom/docs/US-PrEP-Study-7-15-10-508.pdf.
11 CDC, “Vaccine Safety Monitoring,” https://www.cdc.gov/vaccinesafety/ensuringsafety/monitoring/index.html.
12 The Strategic National Stockpile (SNS) refers to the supply of medicine and medical supplies maintained by the U.S.
government to respond to a public health emergency severe enough to deplete local supplies (e.g., hurricane, infectious
disease outbreak, or terrorist attack). The SNS includes antibiotics, intravenous fluids, and other medical supplies such
as PPE and ventilators, as well as certain medicines, such as anthrax and smallpox vaccines and treatments that may not
be otherwise available for public use. For additional information, see CRS In Focus IF11574, National Stockpiles:
Background and Issues for Congress, by G. James Herrera and Frank Gottron.
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of tools, standards, and approaches for assessing and developing MCMs.13 In addition, FDA has
created the Coronavirus Treatment Acceleration Program (CTAP), which seeks to accelerate
clinical testing of potential therapeutics and move new treatments to patients as quickly as
possible.14
The Department of Defense (DOD) operates several medical research and MCM development
efforts, including through the Congressionally Directed Medical Research Program (CDMRP),
the U.S. Army Medical Research and Development Command (USAMRDC), and the Defense
Advanced Research Projects Agency (DARPA). For example, DARPA’s Pandemic Prevention
Platform program is focused on developing a platform that would aid in the rapid development of
new MCMs in response to the identification of any known or unknown infectious threat.15
CDC, NIH, and FDA participate in the Public Health Emergency Medical Countermeasures
Enterprise (PHEMCE), along with DOD, the U.S. Department of Veterans Affairs (VA), the
Department of Homeland Security (DHS), and the U.S. Department of Agriculture (USDA). The
PHEMCE, under the leadership of ASPR, facilitates interagency coordination and strategy for the
development, regulation, and availability of medical countermeasures in preparation for public
health emergencies such as infectious disease outbreaks. As required by Public Health Service
Act (PHSA) Section 2811,16 the PHEMCE assesses and updates a strategy plan annually for
MCM preparedness.17
Research and Development (R&D)
What mechanisms are available for agencies to accelerate MCM
R&D?
Several federal agencies have mechanisms to support rapid MCM R&D in the context of an
infectious disease threat. Typically, agencies’ grant-making, contract, and procurement processes
can take several months when conducted pursuant to laws and regulations. However, several
agencies have other transaction (OT) authority—additional authorities that provide flexibility and
allow for expedited research funding and product procurement—particularly during a public
health emergency. In addition, several agencies have existing research efforts or partnerships that
can be mobilized to address emerging infectious disease threats.
NIH supports both intramural research in NIH-operated facilities and extramural research
conducted by scientists at research institutions (i.e., universities, medical centers, and nonprofits).
During a public health emergency, NIH has authority to award supplemental extramural research
funding to existing research projects and to expedite the review process for new research
proposals.18 NIH also has several OT authorities that allow for expedited and flexible funding of

13 FDA, “MCM Regulatory Science,” https://www.fda.gov/emergency-preparedness-and-response/medical-
countermeasures-initiative-mcmi/mcm-regulatory-science.
14 FDA, “Coronavirus Treatment Acceleration Program (CTAP),” https://www.fda.gov/drugs/coronavirus-covid-19-
drugs/coronavirus-treatment-acceleration-program-ctap.
15 Defense Advanced Research Projects Agency (DARPA), “Pandemic Prevention Platform,” https://www.darpa.mil/
program/pandemic-prevention-platform.
16 42 U.S.C. §300hh-10.
17 The Assistant Secretary for Preparedness and Response (ASPR), “2017-2018 PHEMCE Strategy and Implementation
Plan,” 2017, https://www.phe.gov/Preparedness/mcm/phemce/Pages/strategy.aspx.
18 Public Health Service Act (PHSA) §494.
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new projects. In particular, NIH has OT authority for projects involving “high impact cutting-
edge research that fosters scientific creativity and increases fundamental biological understanding
leading to the prevention, diagnosis, or treatment of diseases and disorders, or research urgently
required to respond to a public health threat.”19
NIH intramural researchers can shift efforts to address a new public health threat, such as the
current work by the NIAID Vaccine Research Center on COVID-19 vaccines.20 NIAID was able
to redirect existing intramural research efforts related to other coronaviruses to the virus causing
COVID-19.21 In addition, NIH can leverage private funding through the Foundation for the NIH22
to support MCM development, such as announced on April 17, 2020, for the Accelerating
COVID-19 Therapeutic Interventions and Vaccines (ACTIV) partnership aimed at accelerating
the development of new vaccines and therapeutic candidates.23
BARDA supports MCM development through funding, technical assistance, and other core
services. Funding support includes contracts with product developers (e.g., pharmaceutical and
biotechnology companies) for advanced development, including preclinical and clinical testing
and manufacturing scale-up. COVID-19-related supplemental appropriations have increased the
number of promising vaccine and therapeutic candidates that BARDA can support. Prior to the
COVID-19 pandemic, BARDA used its OT authority to form partnerships with several
companies to develop MCMs against threats such as pandemic influenza and Ebola.24 In
February, BARDA used the OT authority flexibility to redirect these efforts to speed the
development of COVID-19 countermeasures.25 BARDA’s core services program can provide
technical and regulatory assistance for countermeasure developers. These services include the
Centers for Innovation in Advanced Development and Manufacturing, which is a public-private
partnership that provides infrastructure for domestic production of MCMs; the Fill Finish
Manufacturing Network, which assists MCM developers with final drug product manufacturing
(e.g., vial filling); and the Clinical Studies Network which provides clinical study services from
designing clinical protocols to managing clinical trial sites.26

19 42 U.S.C. §282(n)(1)(C).
20 NIH, “NIH Clinical Trial of Investigational Vaccine for COVID-19 Begins,” press release, March 16, 2020,
https://www.nih.gov/news-events/news-releases/nih-clinical-trial-investigational-vaccine-covid-19-begins.
21 NIH, “New Coronavirus Stable for Hours on Surfaces,” press release, March 17, 2020, https://www.nih.gov/news-
events/news-releases/new-coronavirus-stable-hours-surfaces.
22 The Foundation for the NIH is a not-for-profit organization established by Congress in 1990 to raise private funds in
support of the NIH’s mission and facilitate public-private partnerships. See CRS Report R46109, Agency-Related
Nonprofit Research Foundations and Corporations.
23 NIH, “NIH to Launch Public-Private Partnership to Speed COVID-19 Vaccine and Treatment Options,” press
release, April 17, 2020, https://www.nih.gov/news-events/news-releases/nih-launch-public-private-partnership-speed-
covid-19-vaccine-treatment-options.
24 Department of Health and Human Services (HHS), “HHS, Janssen Research & Development join forces on
innovative influenza products,” press release, September 15, 2017, https://www.phe.gov/Preparedness/news/Pages/
janssen-flu.aspx.
25 The Biomedical Advanced Research and Development Authority (BARDA), “HHS, Regeneron Collaborate to
Develop 2019-nCoV Treatment,” press release, February 4, 2020, https://www.hhs.gov/about/news/2020/02/04/hhs-
regeneron-collaborate-to-develop-2019-ncov-treatment.html; and BARDA, “HHS, Janssen Collaborate To Develop
Coronavirus Therapeutics,” press release, February 18, 2020, https://www.hhs.gov/about/news/2020/02/18/hhs-
janssen-collaborate-to-develop-coronavirus-therapeutics.html.
26 HHS Public Health Emergency, “Core Services,” accessed June 23, 2020, https://www.medicalcountermeasures.gov/
barda/core-services.aspx. See also, “Department of Health and Human Services’ Centers for Innovation in Advanced
Development and Manufacturing,” https://www.medicalcountermeasures.gov/barda/core-services/ciadm/.
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What is Operation Warp Speed and how does it differ from typical
R&D?
Operation Warp Speed is a new national program to “accelerate the development, manufacturing,
and distribution of COVID-19 vaccines, therapeutics, and diagnostics.”27 The program is intended
to coordinate MCM efforts “between components of HHS, including CDC, FDA, NIH, and
BARDA; the Department of Defense; private firms; and other federal agencies.” Its stated goal is
to accelerate selected MCM testing while developing manufacturing infrastructure to allow mass
distribution faster than would be possible otherwise (see Figure 1). Not all government-supported
countermeasures will participate in Operation Warp Speed.
Aside from Operation Warp Speed, how is the federal government
supporting the development of MCMs for COVID-19?
BARDA has used supplemental appropriations to support preclinical and clinical testing of more
than 20 diagnostic, vaccine, and therapeutic candidates.28 In addition, BARDA created the
CoronaWatch portal to serve as a single point of entry that enables potential medical
countermeasure developers to connect with the most appropriate potential federal funding
source.29
NIH is supporting both extramural and intramural research related to COVID-19 and the
development of MCMs. NIH, particularly NIAID, has issued several funding opportunity
announcements for emergency research funding related to COVID-19, including for the
development of new diagnostic tests, therapeutic candidates, and vaccine candidates. NIH
supports basic scientific research on the virus and disease that will help inform the development
of new products.30 NIH can support both basic and laboratory research, as well as clinical
research with humans, such as for clinical testing of new MCMs.
NIH has announced two major research initiatives related to COVID-19. Announced on April 17,
2020, Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) is a public-
private partnership with several companies and federal agencies that aims to accelerate research
and development on new vaccines and therapeutics by prioritizing vaccine and drug candidates,
streamlining clinical trials, coordinating regulatory processes, and leveraging the assets of
partners for new products.31 The Rapid Acceleration of Diagnostics (RADx) initiative announced
on April 29 is a prize competition that aims to incentivize the development of new diagnostics for
COVID-19.32

27 HHS, “Trump Administration Announces Framework and Leadership for ‘Operation Warp Speed,’” press release,
May 15, 2020, https://www.hhs.gov/about/news/2020/05/15/trump-administration-announces-framework-and-
leadership-for-operation-warp-speed.html.
28 HHS Public Health Emergency, https://www.medicalcountermeasures.gov/newsroom/.
29 HHS Public Health Emergency, “Request a USG CoronaWatch Meeting,” https://www.medicalcountermeasures.gov/
Request-BARDA-TechWatch-Meeting/.
30 NIH, “Notice of Special Interest (NOSI) regarding the Availability of Emergency Competitive Revisions for
Research on Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) and Coronavirus Disease 2019
(COVID-19),” March 25, 2020, https://grants.nih.gov/grants/guide/notice-files/NOT-AI-20-034.html.
31 NIH, “NIH to Launch Public-Private Partnership to Speed COVID-19 Vaccine and Treatment Options,” press
release, April 17, 2020, https://www.nih.gov/news-events/news-releases/nih-launch-public-private-partnership-speed-
covid-19-vaccine-treatment-options.
32 NIH, “NIH Mobilizes National Innovation Initiative for COVID-19 Diagnostics,” press release, April 29, 2020,
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DOD has reported research efforts into new vaccines and treatments that complement those of
NIH and BARDA.33
FDA is working with MCM developers to provide regulatory advice and technical assistance with
respect to development programs and testing.34
What is the state of MCM development in the COVID-19 response?
Currently, no FDA-approved MCMs are available to treat COVID-19. Federal agencies,
pharmaceutical and biotech companies, nongovernmental organizations, and global regulators
have been working to develop MCMs for COVID-19. Examples of such efforts are provided
below.
Therapeutics
Researchers have initiated studies examining unapproved drug candidates, as well as unapproved
uses of already approved drugs. NIH has issued COVID-19 treatment guidelines, which identify
several therapeutic options currently under investigation,35 and the federal clinical trials database
maintained by the National Library of Medicine at NIH lists more than 1,000 clinical trials for
COVID-19.
With respect to already approved drugs, on March 28, 2020, FDA issued the first emergency use
authorization (EUA) for a COVID-19 therapeutic, authorizing the emergency use of
hydroxychloroquine and chloroquine, two FDA-approved anti-malarial drugs. The EUA
specifically authorized the use of hydroxychloroquine and chloroquine donated to the SNS by
drug manufacturers and distributed to states to treat patients hospitalized with COVID-19 for
whom a clinical trial is not available or participation is not feasible.36 According to the EUA letter
that has since been revoked, FDA determined that based on the totality of scientific evidence, it
was reasonable to believe that these drugs may be effective in treating COVID-19, and that when
used in accordance with the conditions of the EUA, the known and potential benefits outweigh
the known and potential risks. Some stakeholders—including several former FDA officials—
expressed concern regarding the EUA, stating that the available data on the safety and
effectiveness of these drugs for treatment of COVID-19 was largely anecdotal and that expanding
access may jeopardize research into the drugs.37 On April 24, 2020, FDA issued a drug safety
communication warning against the use of these drugs for treatment of COVID-19 outside of the
hospital setting or a clinical trial due to risk of heart rhythm problems.38 On June 15, 2020, FDA

https://www.nih.gov/news-events/news-releases/nih-mobilizes-national-innovation-initiative-covid-19-diagnostics.
33 Department of Defense (DOD), “Defense Department Press Briefing Investigating and Developing Vaccine
Candidates Against COVID-19,” March 5, 2020, https://www.defense.gov/Newsroom/Transcripts/Transcript/Article/
2104736/defense-department-press-briefing-investigating-and-developing-vaccine-candidat/.
34 FDA, “MCM Regulatory Science,” https://www.fda.gov/emergency-preparedness-and-response/medical-
countermeasures-initiative-mcmi/mcm-regulatory-science. FDA, “Coronavirus Treatment Acceleration Program
(CTAP),” https://www.fda.gov/drugs/coronavirus-covid-19-drugs/coronavirus-treatment-acceleration-program-ctap.
35 NIH, “COVID-19 Treatment Guidelines,” accessed June 17, 2020, https://covid19treatmentguidelines.nih.gov/
therapeutic-options-under-investigation/.
36 FDA, Letter of Authorization, March 28, 2020, https://www.fda.gov/media/136534/download.
37 C Piller, “Former FDA leaders decry emergency authorization of malaria drugs for coronavirus,” Science, April 7,
2020, https://www.sciencemag.org/news/2020/04/former-fda-leaders-decry-emergency-authorization-malaria-drugs-
coronavirus.
38 FDA, “FDA cautions against use of hydroxychloroquine or chloroquine for COVID-19 outside of the hospital setting
or a clinical trial due to risk of heart rhythm problems,” April 24, 2020, https://www.fda.gov/drugs/drug-safety-and-
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revoked its EUA, determining that the statutory standard for EUA issuance was no longer met.39
More specifically, FDA determined that based on emerging scientific data, hydroxychloroquine
and chloroquine are unlikely to be effective in treating COVID-19, and that in light of serious
cardiac adverse events and other potential serious side effects, the known and potential benefits of
the drugs no longer outweigh the known and potential risks for this use. NIH updated its
treatment guidelines to recommend against the use of hydroxychloroquine and chloroquine for the
treatment of COVID-19, except in a clinical trial.40
Researchers are investigating the potential of other approved drugs. For example, the Randomised
Evaluation of COVID-19 Therapy (RECOVERY) trial at the University of Oxford in the United
Kingdom is evaluating a range of potential treatments, including the HIV drug lopinavir-ritonavir,
the steroid dexamethasone, and the antibiotic azithromycin.41 Early results reported from the trial
found that low-dose dexamethasone reduced deaths by one-third in ventilated patients with
COVID-19.42 Domestically, FDA has partnered with the Critical Path Institute (C-Path) and
NIH’s National Center for Advancing Translational Sciences (NCATS) on the CURE Drug
Repurposing Collaboratory (CDRC), which includes a COVID-19 pilot project.43 The CDRC
aims to capture real-world clinical outcome data (e.g., data on off-label use captured by electronic
medical records) to advance drug repurposing and inform future clinical trials for diseases of
unmet medical need.
With respect to unapproved drug candidates, some therapeutics are further along in clinical
testing (e.g., Gilead’s antiviral drug remdesivir) than others. Gilead initiated two Phase 3 clinical
studies evaluating the safety and effectiveness of its experimental drug in adults diagnosed with
COVID-19.44 In addition, on February 21, 2020, NIAID launched a randomized, double-blind,
placebo-controlled trial of remdesivir as a potential treatment for hospitalized adult patients
diagnosed with COVID-19.45 NIH reported early results on April 29, 2020, finding that based on
a preliminary analysis of the trial data, hospitalized patients with severe COVID-19 who received
remdesivir recovered faster than similar patients who received placebo.46 Other clinical studies of
remdesivir are being carried out internationally. On the basis of data from the NIAID trial
(NCT04280705) and a Gilead-sponsored Phase 3 trial (NCT04292899), on May 1, 2020, FDA

availability/fda-cautions-against-use-hydroxychloroquine-or-chloroquine-covid-19-outside-hospital-setting-or.
39 FDA, “Coronavirus (COVID-19) Update: FDA Revokes Emergency Use Authorization for Chloroquine and
Hydroxychloroquine,” June 15, 2020, https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-
update-fda-revokes-emergency-use-authorization-chloroquine-and.
40 NIH, “COVID-19 Treatment Guidelines,” as updated June 16, 2020,
https://www.covid19treatmentguidelines.nih.gov/whats-new/.
41 RECOVERY, Randomised Evaluation of COVID-19 Therapy, accessed June 17, 2020,
https://www.recoverytrial.net/.
42 University of Oxford, “Dexamethasone reduces death in hospitalised patients with severe respiratory complications
of COVID-19,” June 16, 2020, http://www.ox.ac.uk/news/2020-06-16-dexamethasone-reduces-death-hospitalised-
patients-severe-respiratory-complications.
43 FDA, “Coronavirus (COVID-19) Update: Daily Roundup,” news release, June 23, 2020, https://www.fda.gov/news-
events/press-announcements/coronavirus-covid-19-update-daily-roundup-june-23-2020. See also, Critical Path
Institute, CURE Drug Repurposing Collaboratory, https://c-path.org/programs/cdrc/.
44 Gilead, Remdesivir Clinical Trials, NCT04292730 and NCT04292899, https://www.gilead.com/purpose/advancing-
global-health/covid-19/remdesivir-clinical-trials.
45 NLM, Clinicaltrials.gov, NCT04280705, accessed April 15, 2020, https://clinicaltrials.gov/ct2/show/NCT04280705.
46 NIH, “NIH clinical trial shows Remdesivir accelerates recovery from advanced COVID-19,” April 29, 2020,
https://www.nih.gov/news-events/news-releases/nih-clinical-trial-shows-remdesivir-accelerates-recovery-advanced-
covid-19.
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granted EUA for remdesivir, determining that it is reasonable to believe that the known and
potential benefits of the drug outweigh the known and potential risks for treatment of patients
hospitalized with severe COVID-19.47
Two investigational blood-derived therapies also are being studied for the treatment of COVID-
19: convalescent plasma and hyperimmune globulin.48 Convalescent plasma refers to blood
plasma collected from an individual who has recovered (i.e., “convalesced”) from a disease, and
thus presumably has developed antibodies against the virus that causes the disease—in this case
SARS-CoV-2—that is then administered to a patient actively sick with COVID-19 for treatment.
A related therapy is hyperimmune globulin, a manufactured biological product containing
concentrated antibodies collected from convalescent plasma. Although convalescent plasma units
vary in antibody specificities and levels based on the plasma donor, hyperimmune globulin
preparations are typically standardized.49 FDA has announced the availability of an expanded
access protocol for convalescent plasma for patients across the United States—limited to those
with severe or life-threatening COVID-19, or those judged by the treating provider to be at high
risk of progression to severe or life-threatening disease.50 More than 2,000 sites and over 8,000
physicians have signed on to participate in the expanded access protocol, with the Mayo Clinic
acting as the Institutional Review Board (IRB).51 Plasma transfusions are generally safe; however,
they are not without risk and can cause allergic reactions and other side effects in some patients.
Data are limited regarding the safety and effectiveness of convalescent plasma in treating
COVID-19, but anecdotal evidence suggests the treatment may be safe and effective for some
patients.52
The antibody-based therapies mentioned above have many different antibodies in them, only
some of which might be effective against COVID-19. At least 50 companies and academic
laboratories are trying to identify and isolate antibodies that specifically bind parts of the
coronavirus and stop the infection process.53 Once isolated, these monoclonal antibodies can be
mass produced. This approach has led to successful treatments for diseases as diverse as cancer
and Ebola. Some groups are also testing whether monoclonal antibodies can confer temporary
immunity from COVID-19 infection so that they could be used prophylactically until the
development of a safe and effective vaccine.

47 FDA, Letter of Authorization to Gilead Sciences, Inc., May 1, 2020, https://www.fda.gov/media/137564/download.
48 FDA, “Coronavirus (COVID-19) Update: FDA Coordinates National Effort to Develop Blood-Related Therapies for
COVID-19,” April 3, 2020, https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-
coordinates-national-effort-develop-blood-related-therapies-covid-19. FDA, “Investigational COVID-19 Convalescent
Plasma,” April 2020, updated May 1, 2020, https://www.fda.gov/media/136798/download.
49 JD Roback and J Guarner, “Convalescent Plasma to Treat COVID-19 Possibilities and Challenges,” JAMA (March
27, 2020).
50 Ibid.
51 FDA, “Coronavirus (COVID-19) Update: FDA Encourages Recovered Patients to Donate Plasma for Development
of Blood-Related Therapies,” April 16, 2020, https://www.fda.gov/news-events/press-announcements/coronavirus-
covid-19-update-fda-encourages-recovered-patients-donate-plasma-development-blood.
52 FDA, “Investigational COVID-19 Convalescent Plasma - Emergency INDs Frequently Asked Questions,” April 3,
2020, https://www.fda.gov/media/136470/download. JD Roback and J Guarner, “Convalescent Plasma to Treat
COVID-19 Possibilities and Challenges,” JAMA (March 27, 2020). A Joseph, “Everything we know about coronavirus
immunity and antibodies—and plenty we still don’t,” STAT News, April 20, 2020, https://www.statnews.com/2020/04/
20/everything-we-know-about-coronavirus-immunity-and-antibodies-and-plenty-we-still-dont/. See also CRS Report
R46375, The U.S. Blood Supply and the COVID-19 Response: In Brief.
53 Jon Cohen, “The Race is on for Antibodies that Stop the New Coronavirus,” Science, May 5, 2020,
https://www.sciencemag.org/news/2020/05/race-antibodies-stop-new-coronavirus.
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Vaccines
Researchers and product developers are testing numerous types of vaccines—both in the
laboratory and in some early-stage testing in humans. As of June 12, 2020, at least 120
experimental vaccines are known to be in development around the world.54 The experimental
vaccines rely on different platforms, or technologies, that aim to induce an immune response to
protect against COVID-19 virus infection. Some rely on technology that has traditionally been
used in vaccines to date, such as inactivated viruses or preparations of proteins involved in the
immune response.55 Others involve novel approaches such as viral vectors, where an existing
virus is weakened so it cannot cause disease and is genetically engineered to produce COVID-19
proteins—an approach used for the recently approved Ebola vaccine.56
Some of the proposed vaccine technologies have never been used before in FDA-licensed
vaccines, such as the nucleic-acid based vaccines. For example, the NIAID-supported Moderna
vaccine uses messenger RNA (mRNA) as a genetic platform to induce cells to produce a protein
involved in the immune response against the virus.57 The new mRNA and DNA-based vaccines
build on epidemic preparedness efforts by DARPA58 and groups such as the Coalition for
Epidemic Preparedness (CEPI)59 that have worked to develop flexible vaccine platforms that
could be used to quickly develop a new vaccine in the event of an epidemic, regardless of the
specific pathogen.60 These vaccines have also built on efforts to develop vaccines for other
coronaviruses such as SAR-CoV-1 and MERS-CoV.61
As of early June 2020, several vaccines are in various stages of clinical trials in several countries,
including the United States, Germany, China, and the United Kingdom.62 Several Phase 1 trials
have been completed, with various vaccines moving onto Phase 2, Phase 3, or combined Phase
2/3 phases. Scientists and product developers are planning innovative clinical trial designs and
coordination or harmonization of multiple trials with the goal of expediting the development
process for COVID-19 vaccines, such as through the efforts by NIH’s ACTIV program.63 As a

54 Jonathan Corum and Carl Zimmer, “Coronavirus Vaccine Tracker,” New York Times, June 12, 2020,
https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine-tracker.html.
55 Jon Cohen, “With Record-Setting Speed, Vaccinemakers Take Their First Shots at the New Coronavirus,” Science,
March 31, 2020, https://www.sciencemag.org/news/2020/03/record-setting-speed-vaccine-makers-take-their-first-
shots-new-coronavirus; and Fatima Amanat and Florian Krammer, “SARS-CoV-2 Vaccines: Status Report,” Cell, vol.
52 (April 14, 2020), pp. 583-589, https://www.cell.com/immunity/pdf/S1074-7613(20)30120-5.pdf.
56 Ewen Callaway, “The Race for Coronavirus Vaccines: A Graphical Guide,” Nature, April 28, 2020,
https://www.nature.com/articles/d41586-020-01221-y.
57 NIH, “NIH Clinical Trial of Investigational Vaccine for COVID-19 Begins,” March 16, 2020, https://www.nih.gov/
news-events/news-releases/nih-clinical-trial-investigational-vaccine-covid-19-begins.
58 Moderna, “DARPA Awards Moderna Therapeutics a Grant for up to $25 Million to Develop Messenger RNA
Therapeutics™,” press release, October 2, 2013, https://investors.modernatx.com/news-releases/news-release-details/
darpa-awards-moderna-therapeutics-grant-25-million-develop.
59 The Coalition for Epidemic Preparedness (CEPI) is a public-private global partnership that finances vaccine
development for emerging infectious diseases. See https://cepi.net/about/whoweare/.
60 Tung Thanh Le, Zacharias Andreadakis, and Arun Kumar, “The COVID-19 Vaccine Development Landscape,”
Nature Reviews Drug Discovery, April 9, 2020.
61 NIH, “NIH Clinical Trial of Investigational Vaccine for COVID-19 Begins,” press release, March 16, 2020,
https://www.nih.gov/news-events/news-releases/nih-clinical-trial-investigational-vaccine-covid-19-begins.
62 Jonathan Corum and Carl Zimmer, “Coronavirus Vaccine Tracker,” New York Times, June 12, 2020,
https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine-tracker.html.
63 Jocelyn Kaiser, “To Streamline Coronavirus Vaccine and Drug Efforts, NIH and Firms Join Forces,” Science, April
17, 2020, https://www.sciencemag.org/news/2020/04/tame-testing-chaos-nih-and-firms-join-forces-streamline-
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part of Operation Warp Speed, the Trump Administration has selected five companies with
candidate vaccines for investment, and those companies have received more than $2 billion from
the Administration.64 Moving forward, a challenge for large-scale vaccine trials is the shifting
geography of the pandemic. Locations affected by the virus are changing; therefore, planning a
clinical trial in a given location is difficult.65
Vaccine development is usually a long, complex, and risky process—most existing vaccines took
10 to 30 years to go from the beginning of clinical trials to licensure. Most vaccines fail in
preclinical and clinical trials; less than 1 in 15 vaccine candidates that enter Phase 2 clinical trials
gain FDA licensure.66 The claims that a COVID-19 vaccine will be available within one year
would represent the fastest development time of any vaccine to date.67 The Trump Administration
has announced intentions to accelerate the development of AstraZeneca’s vaccine, with the first
doses available in October.68 Some experts express skepticism that this timeline is feasible, given
that many vaccines have faced unexpected challenges during development.69 Other experts posit
that a COVID-19 vaccine should be easier to develop than vaccines for other diseases, such as
HIV and Hepatitis C, which have posed greater challenges in development in part because a
respiratory virus may be easier to develop a vaccine for than for blood-borne viruses.70 Scientists
continue to learn about the biology of COVID-19 and robust data on the efficacy of any vaccine
candidate in protecting against COVID-19 is likely months away.71
Still unknown is whether vaccination or antibodies raised in response to infection with SARS-
CoV-2 will confer immunity at all, and if so, to what extent. Current estimates for potential
duration of immunity come from other coronaviruses, which suggest that immunity may wane
after one or more years.72 Despite anecdotal reports of reinfection with the virus, it is uncertain

coronavirus-vaccine-and-drug; and Lawrence Corey, John R. Mascola, and Anthony S. Fauci, et al., “A Strategic
Approach to COVID-19 Vaccine R&D,” Science, May 29, 2020, pp. 948-50, https://science.sciencemag.org/content/
368/6494/948/tab-figures-data.
64 Noah Weiland and David E. Sanger, “Trump Administration Selects Five Coronavirus Vaccine Candidates as
Finalists,” The New York Times, June 9, 2020, https://www.nytimes.com/2020/06/03/us/politics/coronavirus-vaccine-
trump-moderna.html.
65 Jon Cohen, “‘It’s Really Complicated.’ United States and Others Wrestle with Putting COVID-19 Vaccines to the
Test,” Science, June 12, 2020
66 R. Gordon Douglas and Vijay B. Samant, “The Vaccine Industry,” in Plotkin’s Vaccines, 7th ed. (Elsevier, 2017), pp.
41-50.
67 Tung Thanh Le, Zacharias Andreadakis, and Arun Kumar, “The COVID-19 Vaccine Development Landscape,”
Nature Reviews Drug Discovery, April 9, 2020.
68 HHS, “Trump Administration’s Operation Warp Speed Accelerates AstraZeneca COVID-19 Vaccine to be Available
Beginning in October,” press release, May 21, 2020, https://www.hhs.gov/about/news/2020/05/21/trump-
administration-accelerates-astrazeneca-covid-19-vaccine-to-be-available-beginning-in-october.html.
69 Holden and Thorp, “Underpromise, Overdeliver,” Science, March 27, 2020, https://science.sciencemag.org/content/
367/6485/1405; and Jon Cohen, “Doubts Greet $1.2 Billion Bet by United States on a Coronavirus Vaccine by
October,” Science, May 22, 2020, https://www.sciencemag.org/news/2020/05/doubts-greet-12-billion-bet-united-states-
coronavirus-vaccine-october.
70 Jon Cohen, “With Record-Setting Speed, Vaccinemakers Take Their First Shots at the New Coronavirus,” Science,
March 31, 2020, https://www.sciencemag.org/news/2020/03/record-setting-speed-vaccine-makers-take-their-first-
shots-new-coronavirus.
71 Jon Cohen, “‘It’s Really Complicated.’ United States and Others Wrestle with Putting COVID-19 Vaccines to the
Test,” Science, June 12, 2020, https://www.sciencemag.org/news/2020/06/it-s-really-complicated-united-states-and-
others-wrestle-putting-covid-19-vaccines-test.
72 Daniel M. Altmann, Daniel C. Douek , and Rosemary J. Boyton, “What Policy Makers Need to Know About
COVID-19 Protective Immunity,” The Lancet, April 27, 2020, thelancet.com/journals/lancet/article/PIIS0140-
6736(20)30985-5/fulltext, and Fatima Amanat and Florian Krammer, “SARS-CoV-2 Vaccines: Status Report,” Cell,
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whether patients reporting reinfection may have simply never cleared the virus, despite negative
diagnostic test results. The accuracy of results of diagnostic testing where the virus is at or close
to the limit of detection is not robust. Additionally, positive test results after an initial resolution
of symptoms may indicate the presence of inactive virus leftover from the original infection,
rather than a new unique active infection.
Diagnostics
Generally, coronavirus diagnostics (in vitro diagnostics, or IVDs) may be molecular, serological,
or antigen tests. Tests are characterized by their methods—molecular tests are based on nucleic
acid amplification techniques—as well as by the substance they directly identify—antigens,
antibodies, or viral nucleic acid. To date, development of COVID-19 tests has been largely
focused on molecular tests—specifically on a test using Polymerase Chain Reaction (PCR)—and
serology tests—those tests that identify the presence of antibodies to the SARS-CoV-2 virus. PCR
is a fairly time-intensive and expensive technique, and for this reason, other techniques have been
employed and are being researched, including loop-mediated isothermal amplification (which,
unlike PCR, does not require temperature cycling), CRISPR-based tests, and, most recently, next
generation sequencing (NGS)-based tests. Loop-mediated isothermal amplification, for example,
was used in diagnostics during the outbreak of SARS, and it was found to be faster, less
expensive, and simpler than other molecular methods, while maintaining comparable sensitivity
and specificity.73 The FDA-EUA-authorized Abbott IDNow test uses this technique. Although the
test has encountered some accuracy issues in its roll-out, and FDA now requires negative results
to be considered to be presumptive negatives until they are confirmed using an authorized high
sensitivity molecular test, the test is used at the point of care and helps with access issues in
certain cases.74
CRISPR-based systems are typically used to edit genetic sequences, but they are also an effective
tool for identifying a specific genetic sequence.75 Such systems rely on a combination of (1) an
enzyme that cuts DNA (a nuclease) and (2) a guiding piece of genetic material (guide RNA) to
target a location in a genome for cleavage. Cleaving the genetic material releases a signal that is
detectable by simple methods. Diagnostics using CRISPR can provide for “high sensitivity (can
detect as few as 10 gene copies), specificity, portability, easy read-out (e.g., colorimetric with
paper strips), speed (~45 min), and low cost (few dollars per sample).”76 Researchers recently
published details of a CRISPR-based test, the SARS-CoV-2 DETECTR test, clinical validation of
which the authors report is ongoing in response to FDA guidance for COVID-19 diagnostics.77 In
addition, FDA granted its first EUA for a CRISPR-based test in early May, for a test called
Sherlock CRISPR SARS-CoV-2 Kit.78 This test is for use only in clinical laboratories certified to

vol. 52 (April 14, 2020), pp. 583-589, https://www.cell.com/immunity/pdf/S1074-7613(20)30120-5.pdf.
73 The National Academies Press, “Rapid Expert Consultation on SARS-CoV-2 Laboratory Testing for the COVID-19
Pandemic,” April 8, 2020 https://www.nap.edu/catalog/25775/rapid-expert-consultation-on-sars-cov-2-laboratory-
testing-for-the-covid-19-pandemic-april-8-2020.
74 FDA, “Abbott IDNow COVID-19 EUA Letter of Authorization,” updated June 1, 2020, https://www.fda.gov/media/
136522/download.
75 See CRS Report R44824, Advanced Gene Editing: CRISPR-Cas9, for more information.
76 The National Academies Press, “Rapid Expert Consultation on SARS-CoV-2 Laboratory Testing for the COVID-19
Pandemic,” April 8, 2020 https://www.nap.edu/catalog/25775/rapid-expert-consultation-on-sars-cov-2-laboratory-
testing-for-the-covid-19-pandemic-april-8-2020.
77 JP Broughton et. al., “CRISPR–Cas12-based detection of SARS-CoV-2,” Nature Biotechnology, April 16, 2020,
https://www.nature.com/articles/s41587-020-0513-4.
78 FDA, “Sherlock CRISPR SARS-Cov-2 Kit Letter of Authorization,” May 6, 2020, https://www.fda.gov/media/
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perform high complexity testing per the Clinical Laboratory Improvement Amendments of 1988
(CLIA) regulations (not for use at the point of care),79 returns results in one hour, and requires no
specialized instruments.
Because CRISPR-based tests do not necessarily require specialized laboratory equipment and use
inexpensive components in addition to leveraging a fast and portable read-out, they have the
potential to be used as a point-of-care test.80 Specifically, the DETECTR test “can be performed
with portable heat blocks, readily available reagents, and disposable lateral flow strips.”81 In
addition, this test uses different reagents than those used in PCR tests, and it might eventually be
able to be used without RNA extraction, both of which might ease certain supply chain stressors.
Finally, test manufacturers are developing tests that use next-generation sequencing techniques—
also referred to as massively parallel sequencing—that are both highly accurate and may be used
to monitor changes in the virus’s genetic code over time, because they sequence the partial or
complete viral genome as part of the testing. FDA recently authorized the first COVID-19
diagnostic that uses next-generation sequencing technology.82 In addition, this type of testing
platform is being investigated as a way to support the high-volume testing capacity that many
expect to be needed as employers and schools undertake large-scale screening initiatives.
In addition to research into different molecular techniques for carrying out testing, manufacturers
and clinical laboratories are working to develop testing components and tests that may be used in
decentralized settings, including near-patient settings, such as urgent care centers and emergency
rooms, and in the home. In particular, FDA has authorized a kit for at-home specimen collection
developed by EverlyWell83 and has authorized modifications to existing EUAs to accommodate
the use of at-home collection kits. For example, LabCorp developed a home sample collection kit,
and FDA reissued the EUA for LabCorp’s PCR test to allow for use of samples self-collected by
patients at home.84 In addition, the use of different sample types is also under investigation—
specifically saliva, which would offer benefits including ease of sample collection and a reduction
in supply shortages (e.g., a shortage of swabs used by current tests to collect samples from the
nose and throat). FDA has authorized a Rutgers University PCR-based laboratory-developed test
(LDT) to permit testing of saliva samples self-collected by patients at home.85 FDA has not

137747/download.
79 Point-of-care testing may be defined as follows, “Point-of-care testing means that results are delivered to patients in
the patient care settings, like hospitals, urgent care centers and emergency rooms, instead of samples being sent to a
laboratory.” See https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-issues-first-
emergency-use-authorization-point-care-diagnostic.
80 Science Magazine, “CRISPR Gene Editing May Help Scale Up Coronavirus Testing,” April 23, 2020,
https://www.scientificamerican.com/article/crispr-gene-editing-may-help-scale-up-coronavirus-testing/.
81 360dx.com, “UCSF, Mammoth Bio Develop Rapid Coronavirus Diagnostic Using CRISPR-Cas12 Method,” April
16, 2020, https://www.360dx.com/gene-silencinggene-editing/ucsf-mammoth-bio-develop-rapid-coronavirus-
diagnostic-using-crispr-cas12#.XqiK4GhKg4k.
82 FDA, “Coronavirus (COVID-19) Update: FDA Authorizes First Next Generation Sequence Test for Diagnosing
COVID-19,” https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-first-
next-generation-sequence-test-diagnosing-covid-19.
83 FDA, “Everlywell COVID-19 Test Home Collection Kit Letter of Authorization,” May 15, 2020,
https://www.fda.gov/media/138144/download.
84 FDA, “Coronavirus (COVID-19) Update: FDA Authorizes First Test for Patient At-Home Sample Collection,”
https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-first-test-patient-
home-sample-collection.
85 FDA, “Coronavirus (COVID-19) Update: FDA Authorizes First Diagnostic Test Using At-Home Collection of
Saliva Specimens,” https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-
authorizes-first-diagnostic-test-using-home-collection-saliva.
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granted EUA to any complete at-home tests, but many are under development, and the agency has
stated that it expects to authorize this type of test in the future.86
Regulation and Approval
How are MCMs regulated?
FDA—under the Federal Food, Drug, and Cosmetic Act (FFDCA) and the PHSA—regulates the
safety and effectiveness of MCMs domestically. The statutory and regulatory requirements
governing MCMs vary depending on whether a product meets the definition of a drug, biologic,
or medical device.
Drugs and biologics
Drugs are “articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of
disease”87 and generally include biologics such as monoclonal antibodies and vaccines.88 While
drugs are typically chemically synthesized, small molecule compounds with well-defined
structures, biologics are relatively large and complex molecules derived from living organisms or
made in living systems. An MCM that meets the definition of a drug, including a biologic, must
receive approval or licensure from FDA prior to marketing.89 Except under limited circumstances,
to support approval or licensure, FDA requires a sponsor (typically the drug manufacturer) to
submit data from clinical trials—formally designed, conducted, and analyzed studies in which the
investigational drug or biologic is administered to human subjects to provide evidence of a drug’s
safety and effectiveness, or in the case of a biologic, safety, purity, and potency.90 The
requirements regarding approval and submission of clinical trial data generally apply regardless
of whether the drug is a new molecular entity (i.e., contains a new active ingredient not
previously approved by FDA) or whether the drug has been approved by FDA for one use and is
to be repurposed for a new use.
Before beginning clinical testing, a sponsor must file with FDA an investigational new drug
application (IND), which is a request for permission to administer an investigational drug or
biologic to humans prior to approval or licensure.91 An IND must include information about the
investigational drug or biologic and its chemistry, manufacturing, and controls; the proposed
clinical study design; completed animal test data; and the lead investigator’s qualifications,

86 FDA, “FAQs on Diagnostic Testing for SARS-CoV-2,” https://www.fda.gov/medical-devices/emergency-situations-
medical-devices/faqs-diagnostic-testing-sars-cov-2.
87 FFDCA §201(g)(1) [21 U.S.C. §321(g)(1)].
88 PHSA §351(i)(1) [21 U.S.C. §262(i)(1)] defines a biologic as “a virus, therapeutic serum, toxin, antitoxin, vaccine,
blood, blood component or derivative, allergenic product, protein, or analogous product, or arsphenamine or derivative
of arsphenamine (or any other trivalent organic arsenic compound), applicable to the prevention, treatment, or cure of a
disease or condition of human beings.” For additional information, see CRS Report R44620, Biologics and Biosimilars:
Background and Key Issues.
89 FFDCA §505(a) [21 U.S.C. §355(a)]; PHSA §351(a) [42 U.S.C. §262(a)].
90 PHSA 351(a)(2)(C) [42 U.S.C. §262(a)(2)(C)]. While FDA approves drugs that are safe and effective, the equivalent
terminology for biologics is safe, pure, and potent. In an April 2015 FDA guidance document, Scientific
Considerations in Demonstrating Biosimilarity to a Reference Product, the agency states that the standard for licensure
of a biologic as potent has long been interpreted to include effectiveness (under 21 C.F.R. §600.3(s)). In guidance, FDA
often uses the terms safety and effectiveness and safety, purity, and potency interchangeably.
91 FFDCA §505(i) [21 U.S.C. §355(i)]; PHSA §351(a)(3) [21 U.S.C. §262(a)(3)]. 21 C.F.R. Part 312.
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among other things.92 The investigator also must provide assurance that an Institutional Review
Board (IRB) will provide initial and continuous review and approval of each of the studies in the
clinical investigation to ensure that participants are aware of the drug’s investigative status and
that any risk of harm will be necessary, explained, and minimized.93 FDA has 30 days to review
an IND, after which a manufacturer may begin clinical testing if FDA has not objected and
imposed a clinical hold. Clinical trials are typically conducted in three phases. Phase 1 clinical
trials assess safety—and for biologics, safety and immunogenicity94—in a small number of
volunteers. Phase 2 trials assess dosing and side effects and may enroll hundreds of volunteers.
Phase 3 trials assess effectiveness and continue to monitor safety and typically enroll hundreds to
thousands of volunteers.95
Once a sponsor completes clinical trials, it submits the results of those investigations, along with
other information, to FDA in a new drug application (NDA) or a biologics license application
(BLA).96 While drugs are approved via an NDA under the FFDCA, biologics—including
vaccines—are licensed for marketing via a BLA under the PHSA. The requirements and review
pathways for NDAs and BLAs are generally similar, and biologics are subject to various FFDCA
provisions. In reviewing an NDA or BLA, FDA considers whether the drug is safe and
effective—or whether the biologic is safe, pure, and potent—for its intended use; whether the
proposed labeling is appropriate; and whether the methods and controls used to manufacture the
product are adequate to preserve its identity, strength, quality, and purity.97
Diagnostics
In vitro diagnostic devices (IVDs) are devices used in the laboratory analysis of human samples.
IVDs include commercial test kits, laboratory-developed tests (LDTs), and instruments used in
testing, among other things. LDTs are a class of IVD that is designed, manufactured, and used
within a single laboratory. LDTs are often used to test for conditions or diseases that are either
rapidly changing (e.g., new strains of known infectious diseases) or that are the subject of rapidly
advancing scientific research (e.g., genomic testing for cancer).98 Traditionally, LDTs have been
regulated by FDA differently than commercial test kits. IVDs may be used in a variety of settings,
including a clinical laboratory, a physician’s office, or in the home. IVDs used in the clinical
management of patients fall under the definition of medical “device” in the FFDCA99 and

92 21 C.F.R. §312.23.
93 21 C.F.R. §312.23(a)(1)(iv) and 21 C.F.R. Part 56.
94 Immunogenicity refers to an immune response to a therapeutic that may have the potential to affect product safety
and effectiveness. One FDA guidance document specifically defines immunogenicity (for the purpose of the guidance)
as “the propensity of a therapeutic protein product to generate immune responses to itself and to related proteins or to
induce immunologically related adverse clinical events.” See Immunogenicity Assessment for Therapeutic Protein
Products, August 2014, https://www.fda.gov/media/85017/download.
95 FDA, “Vaccine Product Approval Process,” https://www.fda.gov/vaccines-blood-biologics/development-approval-
process-cber/vaccine-product-approval-process.
96 FFDCA §505(b) [21 U.S.C. §355(b)] and 21 C.F.R. §314.50.
97 For additional information, see CRS Report R41983, How FDA Approves Drugs and Regulates Their Safety and
Effectiveness, by Agata Dabrowska and Susan Thaul.
98 For more information, see CRS In Focus IF11389, FDA Regulation of Laboratory-Developed Tests (LDTs), by
Amanda K. Sarata.
99 The term “device” is statutorily defined as “an instrument, apparatus, implement, machine, contrivance, implant, in
vitro reagent, or other similar or related article, including any component, part, or accessory” (emphasis added) that is
“intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of
disease, in man or other animals, or is intended to affect the structure or any function of the body of man or other
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therefore are subject to regulation by FDA. As with other medical devices, the application of FDA
regulatory requirements to IVDs depends on the IVD’s risk classification according to its
intended use.
Medical devices are grouped into three classes: Class I (low risk, generally no premarket review
required); Class II (usually requires premarket notification and may require special controls, such
as specific labelling); and Class III (usually requires premarket approval prior to marketing).
Generally, Class II devices require 510(k) clearance demonstrating that a device is substantially
equivalent to a device already on the market (i.e., a predicate device). A 510(k) application
typically does not require submission of clinical data. Generally, Class III devices require a
premarket approval application (PMA), with some exceptions. FDA issues an approval order
when a PMA demonstrates reasonable assurance that a device is safe and effective for its intended
use(s). Effectiveness must be based on well-controlled investigations, which generally means
clinical trial data. Unless specifically excluded by regulation, all devices must meet general
controls, which include premarket and postmarket requirements; for example, registration,
labeling, and compliance with current good manufacturing practices (CGMPs) as set forth in
FDA’s quality system regulations (QSRs).100
IVDs are defined in regulation as a specific subset of medical devices that include “reagents,
instruments, and systems intended for use in the diagnosis of disease or other conditions ... in
order to cure, mitigate, treat, or prevent disease ... [s]uch products are intended for use in the
collection, preparation, and examination of specimens taken from the human body.”101 As
indicated by this definition, an IVD may be either a complete test or a component of a test. In
either case, an IVD comes under FDA’s regulatory purview. Regulated test components include
both non-diagnostic ingredients, called general purpose reagents (GPRs), and the active
ingredient(s) in a diagnostic test, referred to as the analyte specific reagent (ASR). LDTs, as
opposed to commercially manufactured and distributed test kits, have traditionally been exempt
from FDA’s premarket review requirements.
In some limited cases, IVDs may fall under the statutory definition of a biological product. In
those cases, the IVD would be subject to the requirements of the PHSA for the licensure of
biological products.102 Such IVDs include, for example, blood donor screening tests for infectious
agents (HIV, hepatitis B and C).
What FDA pathways are available to expedite availability of
MCMs?
Because clinical testing and the FDA review process typically take several years, FDA and
Congress have established mechanisms to (1) expedite the premarket development and review
processes for new products coming onto the market, and (2) expand access to products that are
still under investigation.103 As used in this section, the term drugs generally includes biologics,
unless noted otherwise.

animals.” FFDCA §201(h); 21 U.S.C. §321.
100 For more information, see CRS In Focus IF11083, Medical Product Regulation: Drugs, Biologics, and Devices, by
Agata Dabrowska and Victoria R. Green.
101 21 C.F.R. §809.3(a); Definitions.
102 PHSA §351 [42 U.S.C. §262]; Regulation of Biological Products.
103 CRS In Focus IF11379, Medical Product Innovation and Regulation: Benefits and Risks.
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Expedited development and review programs for MCMs
FDA uses several formal mechanisms to expedite the development and review processes for
drugs that address unmet medical need in the treatment of a serious or life-threatening condition.
These four programs are fast track product designation, breakthrough therapy designation,
accelerated approval, and priority review.104 An already approved drug being studied for a new
use (e.g., a drug approved for the treatment of HIV being studied for COVID-19) may be eligible
for one of these expedited programs provided the applicable statutory criteria are met, and drugs
may be designated to more than one program. Separately, there is a breakthrough device
designation for medical devices.
Breakthrough therapy and fast track product designation are both intended to streamline the drug
development process, but the qualifying criteria and features of these programs differ. To qualify
for fast track product designation, a drug must be intended to treat a serious condition and
nonclinical or clinical data must demonstrate the drug’s potential to address an unmet medical
need.105 A drug (but not a biologic) also may qualify for fast track if it has been designated as a
qualified infectious disease product (QIDP).106 The sponsor of a fast track-designated drug is
eligible for frequent interactions with the FDA review team, priority review, and rolling review
(i.e., FDA reviews portions of an NDA or BLA before a complete application is submitted).107 To
qualify for breakthrough designation, a drug must be intended to treat a serious condition, and
preliminary clinical evidence must indicate that the drug may demonstrate substantial
improvement on a clinically significant endpoint(s) over available therapies. Features of
breakthrough therapy designation include rolling review; intensive FDA guidance on designing
an efficient drug development program; involvement of “senior managers and experienced review
and regulatory health project management staff in a proactive, collaborative, cross-disciplinary
review” to expedite the development and review of a breakthrough therapy; and eligibility for
other expedited programs. An interested sponsor must submit to FDA a request for fast track
product or breakthrough therapy designation; a request may be submitted either with the IND or
any time after,108 as further specified in FDA guidance.109
The accelerated approval pathway allows a drug to be approved based on its effect on a surrogate
endpoint (e.g., a laboratory measurement) that predicts the effectiveness of a new treatment, or on
a clinical endpoint that can be measured earlier than irreversible morbidity or mortality.
Postmarketing confirmatory studies generally must be completed to demonstrate actual
effectiveness.110 To qualify for accelerated approval, a drug must (1) treat a serious condition, (2)
generally provide a meaningful advantage over available therapies, and (3) demonstrate an effect
on an endpoint that is reasonably likely to predict clinical benefit.
A priority review designation means FDA’s goal is to take action on an application within six
months of its filing, in contrast to 10 months for standard review. An NDA or BLA may qualify

104 FFDCA §506 [21 U.S.C. §356]. FDA, “Guidance for Industry Expedited Programs for Serious Conditions – Drugs
and Biologics,” May 2014, https://www.fda.gov/media/86377/download.
105 FFDCA §506(b) [21 U.S.C. §356(b)].
106 A qualified infectious disease product (QIDP) is an antibacterial or antifungal drug for human use that is intended to
treat serious or life-threatening infections. FFDCA §505E(g) [21 U.S.C. §355E(g)].
107 FFDCA §506(a) [21 U.S.C. §356(a)].
108 FFDCA §506(a)(2) & (b)(2) [21 U.S.C. §356(a)(2) & (b)(2)].
109 FDA, “Guidance for Industry Expedited Programs for Serious Conditions – Drugs and Biologics,” May 2014,
https://www.fda.gov/media/86377/download.
110 FFDCA §506(c) [21 U.S.C. §356(c)].
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for priority review designation if, for example, it is for a drug that treats a serious condition and
that, if approved, would provide a significant improvement in safety or effectiveness. An NDA or
BLA also may qualify for priority review if submitted with a priority review voucher111 or if the
drug (but not biologic) is designated as a QIDP.
The 21st Century Cures Act (P.L. 114-255) and the FDA Reauthorization Act of 2017 (P.L. 115-
52) established a new breakthrough device category allowing FDA to expedite development and
prioritize review of devices that (1) provide more effective diagnosis or treatment of a life-
threatening or irreversibly debilitating condition, and (2) represent breakthrough technologies for
which no approved alternatives exist, offer significant advantages over existing alternatives, or
are in the best interest of patients.112 The Breakthrough Device Program, a voluntary program,
expedites development, assessment, and review of breakthrough devices as they go through
premarket approval, 510(k) clearance, or marketing authorization via the de novo classification
process.
Enabling access to investigational MCMs
In general, a drug, biologic, or medical device may be provided to patients only if FDA has
approved, licensed, or cleared its marketing application or authorized its use in a clinical trial
under an IND or Investigational Device Exemption (IDE). In certain circumstances, however,
patients may access investigational MCMs outside this framework through expanded access (i.e.,
compassionate use) programs and through emergency use authorization (EUA).
Expanded Access
Individuals who are not eligible for participation in a clinical trial (e.g., because they do not meet
the study criteria, or because the trial is not enrolling new patients) may request, through their
physician, access to an investigational product through an expanded access protocol,113 provided
that an IND or IDE is submitted to FDA and
 the physician determines (1) that the patient has no comparable or satisfactory
alternative, and (2) that the probable risk from the investigational product is not
greater than the probable risk from the disease or condition; and
 FDA determines (1) there is sufficient evidence of safety and effectiveness and
(2) that provision of the investigational product will not interfere with “the
initiation, conduct, or completion of clinical investigations to support marketing
approval.”114
A physician also may request an emergency IND (eIND) for an individual patient.115 The
provision of an investigational product in a clinical trial is intended to generate evidence of safety
and effectiveness to support marketing approval. In contrast, expanded access protocols are not

111 Currently, three priority review voucher programs are authorized in the FFDCA: (1) the tropical disease priority
review program, (2) the rare pediatric disease priority review program, and (3) the material threat MCM priority review
voucher program. Under each of these programs, the sponsor of an NDA or BLA that meets the statutory requirements
of the specific program is eligible to receive, upon approval, a transferable voucher, and the sponsor may either use that
voucher for the priority review of another application or sell it to another sponsor to use.
112 FFDCA §515B [21 U.S.C. §360e-3].
113 FFDCA §561(b) [21 U.S.C. §360bbb(b)].
114 FFDCA §561(b)(3) [21 U.S.C. §360bbb(b)(3)].
115 21 C.F.R. §312.310.
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primarily intended to be used to obtain safety and effectiveness data; instead, they are intended to
provide investigational therapies to patients who have exhausted all other options.116 FDA
approves the majority of expanded access requests it receives.117
For FDA to grant permission, a manufacturer must have agreed to provide the investigational
product. Manufacturers are not always willing to provide an investigational product outside of a
clinical trial for various reasons, including supply constraints, liability concerns, and lack of
clarity regarding how FDA may use adverse event or outcome data when considering approval in
the future.
Due to perceived limitations with FDA’s expanded access program, in 2018, the Right to Try
(RTT) Act (P.L. 115-176) was enacted. The RTT Act created a pathway for eligible patients to
access an eligible investigational drug (but not a device) without FDA’s authorization. The
manufacturer must still agree to provide the drug. An eligible patient is a patient who has (1) been
diagnosed with a life-threatening disease or condition; (2) exhausted approved treatment options
and is unable to participate in a clinical trial involving the eligible investigational drug; and (3)
provided written informed consent to the treating physician regarding the eligible investigational
drug.118 An eligible investigational drug is an investigational drug that meets the following
criteria: (1) a Phase 1 clinical trial has been completed; (2) the drug has not been approved or
licensed by FDA for any use; (3) an NDA or BLA has been filed, or the drug is under
investigation in a clinical trial, as specified; and (4) the active development or production of the
drug is ongoing, and FDA has not placed a clinical hold on the trial.119 FDA does not approve or
review RTT Act requests and, with limited exceptions, FDA may not use a clinical outcome
associated with the use of an eligible investigational drug to delay or adversely affect its review
or approval.120 Given interest in generating safety and effectiveness data and resource and supply
constraints, the RTT pathway is unlikely to be used to provide access to COVID-19
investigational therapies.
Emergency Use Authorization (EUA)
FDA may enable access to unapproved MCMs by granting EUA, if the HHS Secretary declares
that circumstances exist to justify the emergency use of an unapproved product or an unapproved
use of an approved medical product.121 This emergency declaration by the HHS Secretary is
authorized under FFDCA Section 564, is distinct from the Public Health Emergency (PHE)
declaration made pursuant to PHSA Section 319, and may be made in the absence of a PHE
declaration made pursuant to PHSA Section 319.122 The HHS Secretary’s declaration must be

116 FDA, Guidance for Industry, Expanded Access to Investigational Drugs for Treatment Use - Questions and
Answers, p. 3, June 2016, https://www.fda.gov/media/85675/download.
117 FDA, “Expanded Access (compassionate use) submission data,” updated March 16, 2020, https://www.fda.gov/
news-events/expanded-access/expanded-access-compassionate-use-submission-data.
118 FFDCA §561B(a)(1) [21 U.S.C. §360bbb-0a(a)(1)].
119 FFDCA §561B(a)(2) [21 U.S.C. §360bbb-0a(a)(2)].
120 FFDCA §561B(c) [21 U.S.C. §360bbb-0a(c)].
121 FFDCA §564 [21 U.S.C. §360bbb-3]. For additional information, see CRS In Focus IF10745, Emergency Use
Authorization and FDA’s Related Authorities.
122 For example, on August 5, 2014, the HHS Secretary declared, pursuant to FFDCA Section 564, that circumstances
exist justifying the authorization of emergency use of in vitro diagnostics for detection of Ebola virus. The HHS
Secretary’s declaration was made in the absence of a PHE declaration under PHSA Section 319. Instead, the HHS
Secretary’s declaration was made on the basis of a determination by the Secretary of the Department of Homeland
Security that the Ebola virus presents a material threat against the U.S. population sufficient to affect national security.
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based on one of four determinations; for example, a determination that there is an actual or
significant potential for a public health emergency that affects or has significant potential to affect
national security or the health and security of U.S. citizens living abroad.123 Following the HHS
Secretary’s declaration, FDA, in consultation with ASPR, NIH, and CDC, may issue an EUA
authorizing the emergency use of a specific drug, device, or biologic, provided that the following
criteria are met:
 the agent that is the subject of the EUA can cause a serious or life-threatening
disease or condition;
 based on the totality of the available scientific evidence, it is reasonable to
believe that the product may be effective in diagnosing, treating, or preventing
such disease or condition, and that the known and potential benefits of the
product outweigh its known and potential risks; and
 there is no adequate, approved, or available alternative to the product.124
FDA must impose certain conditions as part of an EUA to the extent practicable (e.g., distributing
certain information to health care providers and patients) and may impose additional discretionary
conditions where appropriate.125 FDA may waive or limit current good manufacturing practices
(e.g., storage and handling) and prescription dispensing requirements for products authorized
under EUA. FDA also may establish conditions on advertisements and other promotional printed
matter that relates to the emergency use of a product. An EUA remains in effect for the duration
of the emergency declaration made by the HHS Secretary under FFDCA Section 564, unless
revoked at an earlier date.
On February 4, 2020, the HHS Secretary determined that there is a public health emergency that
has a significant potential to affect national security or the health and security of U.S. citizens
living abroad, and that involves COVID-2019.126 On the basis of this determination, the HHS
Secretary subsequently declared that circumstances exist justifying the authorization of
emergency use of unapproved in vitro diagnostics for the detection and/or diagnosis of COVID-
19; personal respiratory protective devices; medical devices, including alternative products used
as medical devices; and therapeutics. Pursuant to these declarations, FDA subsequently issued
numerous EUAs authorizing the emergency use of specific diagnostics, drugs, and other medical
devices during the COVID-19 outbreak.127

123 FFDCA §564(b)(1) [21 U.S.C. §360bbb-3(b)(1)].
124 FFDCA §564(c) [21 U.S.C. §360bbb-3(c)]. These criteria are explained in more detail in the FDA guidance
Emergency Use Authorization of Medical Products and Related Authorities, January 2017, p. 7, https://www.fda.gov/
media/97321/download.
125 FFDCA §564(e) [21 U.S.C. §360bbb-3(e)].
126 85 Federal Register 13907, publication date March 10, 2020, effective date February 4, 2020.
127 FDA “Emergency Use Authorizations,” accessed April 15, 2020, https://www.fda.gov/medical-devices/emergency-
situations-medical-devices/emergency-use-authorizations.
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Availability
How are MCMs in development for COVID-19 available to U.S.
patients?
In the absence of approved MCMs for COVID-19, patients can access investigational,
unapproved MCMs in several ways, including through EUA, by participating in clinical trials,
and through expanded access programs. In addition, FDA-approved drugs may be prescribed off-
label (i.e., for unapproved uses) by physicians for treatment of COVID-19.
Emergency Use Authorization (EUA)
Patients hospitalized with severe COVID-19 may obtain access to products granted EUA. For
therapeutics, as of the date of this report, remdesivir is the only drug subject to an EUA.128
Hydroxychloroquine and chloroquine were subject to an EUA that has since been revoked by
FDA. However, physicians may still prescribe these drugs off-label for individual patients. To
date, FDA has not granted EUA to any COVID-19 vaccines. However, numerous clinical trials
are underway, and some experts and industry members think that if a vaccine shows adequate
results from the first trials, it may be made available to certain populations (such as health care
workers) before clinical trials are completed via an EUA.129
Diagnostics are available for clinical use through authorized marketing pursuant to an EUA
during the COVID-19 emergency. EUAs have been granted for more than 100 molecular
diagnostics (both commercial test kits and LDTs), as well as for several serology tests and one
antigen test.130 The EUA tests include several that may be used at the point of care, including for
example, the Abbott IDNow molecular test. In addition, Quidel’s antigen test is authorized for use
in point-of-care settings. Thus far, no serology test has been authorized for use in point-of-care
settings. The vast majority of EUAs have been granted for tests that must be carried out in a
centralized clinical laboratory environment (i.e., higher complexity tests).
Through guidance, FDA has taken steps to liberalize the EUA process to expand access to tests.131
Specifically, the agency has allowed, in specified cases, tests to be marketed and clinically used
prior to being granted EUA but after validation and notification to FDA. In addition, the FDA
initially allowed serology tests to be made available and marketed without EUA. While these
policies have improved access, they have also resulted in access to diagnostics with less robust
performance characteristics in some cases.

128 FDA, Letter of Authorization to Gilead Sciences, Inc., May 1, 2020, https://www.fda.gov/media/137564/download.
129 Jon Cohen, “With Record-Setting Speed, Vaccinemakers Take Their First Shots at the New Coronavirus,” Science,
March 31, 2020, https://www.sciencemag.org/news/2020/03/record-setting-speed-vaccine-makers-take-their-first-
shots-new-coronavirus.
130 A COVID-19 serology test identifies antibodies to the SARS-CoV-2 virus, usually in an individual blood sample.
Antibodies are proteins generated by the immune system in response to an antigen, or foreign substance. An antigen
may be a pathogenic virus or bacteria, for example, or generally any substance that is recognized by the immune
system as both foreign and harmful. An antigen test uses antibodies to a specific antigen (e.g., SARS-CoV-2 virus) to
identify the virus in a patient’s sample. A COVD-19 serology test may determine prior infection, whereas an antigen
test may determine an active infection, because the serology test identifies a product of the immune response whose
generation lags infection, whereas the antigen test directly identifies the actual virus.
131 See, generally, FDA, “Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised),”
May 11, 2020, https://www.fda.gov/media/135659/download.
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Expanded access
Patients may enroll in one of various clinical trials studying the safety and effectiveness of new
drugs and vaccines for COVID-19. If participation in a clinical trial is not feasible—because the
trial is not enrolling new subjects or because the patient does not meet criteria for enrollment—
patients may be able to receive the experimental drug through an expanded access program. In the
case of convalescent plasma, for example, patients may access the Mayo Clinic-led expanded
access protocol, which has more than 2,000 sites and over 8,000 physician investigators
participating.132 The federal clinical trials database maintained by the National Library of
Medicine at NIH lists several expanded access programs for COVID-19 treatments, and it is
likely not an exhaustive list.133 In cases where access to a clinical trial or the expanded access
protocol is not available, a physician may request an eIND for an individual patient for a specific
investigational drug.
Postmarket Surveillance
In light of efforts to expedite access to MCMs for COVID-19, questions have been raised about
postmarket monitoring of adverse events and the continued collection of safety and effectiveness
data. While premarket studies are designed to identify common safety risks associated with a
drug or biologic, they may not identify all long-term or rare adverse events. As such, FDA may
request that sponsors conduct additional studies once a drug or biologic is on the market to further
provide information about its risks, benefits, and optimal use.134 These studies may be particularly
useful when one of the expedited pathways is used because it allows for the marketing and
benefits of a product to be realized sooner, while at the same time allowing for a fuller safety and
effectiveness profile to be developed. FDA also may require a sponsor to conduct a postapproval
study or clinical trial to assess a known serious risk or in response to signals of serious risk
related to use of the drug or biologic.135
FDA has several systems for monitoring medical product safety following approval or licensure.
For example, drug and biologic manufacturers must report all serious and unexpected adverse
events to the FDA Adverse Event Reporting System (FAERS) within 15 days of becoming aware
of them, and they must report other adverse events in mandated periodic reports to the agency.136
The reports are made publicly available through the FAERS public dashboard. For vaccines,
adverse events must be reported to the Vaccine Adverse Event Reporting System (VAERS),
which is co-sponsored by FDA and CDC. For medical devices, manufacturers must report device-
related deaths, serious injuries, and malfunctions within 30 days of becoming aware of them;
medical device reports (MDRs) are stored in the FDA’s Manufacturer and User Facility Device

132 FDA, “Coronavirus (COVID-19) Update: FDA Encourages Recovered Patients to Donate Plasma for Development
of Blood-Related Therapies,” April 16, 2020, https://www.fda.gov/news-events/press-announcements/coronavirus-
covid-19-update-fda-encourages-recovered-patients-donate-plasma-development-blood.
133 NLM, “Clinical Trials,” accessed April 15, 2020, https://clinicaltrials.gov/ct2/results?cond=COVID-19&age_v=&
gndr=&type=Expn&rslt=&Search=Apply.
134 21 C.F.R. §312.85. FFDCA §506(c)(2) [21 U.S.C. §356(c)(2)].
135 PHSA §351(a)(2)(D) [42 U.S.C. §262(a)(2)(D)] and FFDCA §505(o)(3) [21 U.S.C. §355(o)(3)].
136 21 C.F.R. §314.80(c) and 21 C.F.R. §600.80(c). FDA Adverse Event Reporting System (FAERS) Public Dashboard,
https://www.fda.gov/drugs/questions-and-answers-fdas-adverse-event-reporting-system-faers/fda-adverse-event-
reporting-system-faers-public-dashboard. Safety reporting is required during clinical testing and in expanded access
programs (21 C.F.R. §312.32).
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Experience (MAUDE) database. Under typical circumstances, patients and health care providers
are encouraged, but not required, to report adverse events to FDA through MedWatch.137
However, FDA may impose, as part of an EUA, conditions for monitoring and reporting adverse
events associated with the emergency use of a product, including mandatory reporting by health
care providers.138 For example, the EUAs for hydroxychloroquine and chloroquine and for
remdesivir require health care facilities and providers who administer the drugs to track and
report any serious adverse events to FDA through MedWatch.139 Similarly, EUAs for diagnostics
require, as a condition of authorization, the manufacturer or laboratory granted the EUA to track
adverse events (specifically false results) and report them to FDA. Adverse events also may be
reported to the HHS Safety Reporting Portal (SRP), which is intended to streamline the process of
reporting product safety issues to both FDA and NIH.140
FDA conducts active postmarket surveillance through its Sentinel System, which uses data
obtained from electronic health records, patient registries, and other sources to provide
information about the safety of a drug, medical device, vaccine, or biologic. FDA’s Sentinel
System is involved in several COVID-19-related activities, including “monitoring the use of
drugs, describing the course of illness among hospitalized patients, and evaluating the treatment
impact of therapies actively being used under real-world conditions.”141 One component of
Sentinel is the Post-Licensure Rapid Immunization Safety Monitoring (PRISM) program—
established in 2009 as part of vaccine safety surveillance during the H1N1 influenza pandemic—
which uses electronic health records from insurance providers and state immunization registries
to monitor adverse events following vaccination.142 FDA uses safety information and data
generated from FAERS, VAERS, Sentinel, and other sources to inform regulatory action.
Ongoing surveillance and research may be particularly important when drugs or diagnostics are
made available via EUA or expanded access, as the standard of evidence for authorizing early
access to investigational products is different than that required for FDA clearance, approval, or
licensure. EUA issuance, for example, is based on FDA’s determination that the totality of the
available scientific evidence suggests that a product may be effective in diagnosing, treating, or
preventing a disease or condition and that the known and potential benefits of the product
outweigh its known and potential risks. This determination is different from the standard required
for FDA approval of a drug or biologic, which is based on substantial evidence of effectiveness
derived from adequate and well-controlled studies.143 Following issuance of the March 2020 EUA
for hydroxychloroquine and chloroquine, and based on analysis of case reports in FAERS, the
published medical literature, and poison control centers data, in April 2020, FDA published a

137 FDA, “MedWatch: The FDA Safety Information and Adverse Event Reporting Program,” https://www.fda.gov/
safety/medwatch-fda-safety-information-and-adverse-event-reporting-program.
138 FFDCA §564(e).
139 FDA, Letter of Authorization to Gilead Sciences, Inc., May 1, 2020, https://www.fda.gov/media/137564/download.
FDA, Letter of Authorization to BARDA, March 28, 2020, https://www.fda.gov/media/136534/download.
140 HHS, The Safety Reporting Portal, https://www.safetyreporting.hhs.gov/SRP2/en/Home.aspx.
141 Sentinel, FDA Sentinel System’s Coronavirus (COVID-19) Activities, sentinelinitiative.org/drugs/fda-sentinel-
system-coronavirus-covid-19-activities.
142 PRISM is the vaccine component of FDA’s Sentinel Initiative. The Sentinel system was implemented as an “Active
Post-Market Risk Identification and Analysis program” under FFDCA § 505(k)(3), as amended by §905 of the FDA
Amendments Act, P.L. 110-85.
143 FDA, “Understanding the Regulatory Terminology of Potential Preventions and Treatments for COVID-19,”
https://www.fda.gov/consumers/consumer-updates/understanding-regulatory-terminology-potential-preventions-and-
treatments-covid-19.
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Drug Safety Communication cautioning against use of these drugs outside the hospital or clinical
trial setting due to risk of heart rhythm problems.144 Data obtained by FDA further led the agency
to revoke the EUA in June 2020.145 Diagnostic EUAs require manufacturers, laboratories, and
authorized laboratories carrying out testing to “collect information on the performance of their
product,” and, more specifically, false positives, false negatives, and other deviations from a test’s
performance characteristics—all of which must be reported to FDA. In addition, in some cases,
FDA will require a post-authorization clinical evaluation study as a condition of the authorization,
with a requirement to update labelling based on the results of the study.146
Funding
What funding is available for COVID-19 MCM development and
approval?
Recently enacted supplemental appropriations have included funding for several accounts that
can be used to support the development and approval of COVID-19 MCMs, or to support
scientific research that can aid in MCM development (as summarized in Table 1). The table
below shows funding that can be used for MCM R&D or approval activities as provided in the
three coronavirus supplemental appropriations acts:147
 Division A, Coronavirus Preparedness and Response Supplemental
Appropriations Act, 2020 (P.L. 116-123), enacted on March 6, 2020.
 Division B, Coronavirus Aid, Relief, and Economic Security Act (P.L. 116-136),
enacted on March 27, 2020.
 Division B, Paycheck Protection Program and Health Care Enhancement Act
(P.L. 116-139), enacted on April 24, 2020.
Table 1 shows accounts from which funding can be used by FDA, NIH, DOD Defense Health
Research, and components within the HHS Office of the Secretary (including BARDA). In some
cases, funds are appropriated to those accounts; in others, transfers or set-asides to relevant
agencies or accounts are either directed or allowed. (This transfer authority in several instances is
either “not more than” or “not less than” a specified amount.) Funds to be transferred are shown
in the account to which they were appropriated, not in the account to which they are to be
transferred.
The purpose of the funds indicates their allowed uses as specified in the respective appropriations
acts. Additional contextual information is included where appropriate. The period of availability
is either the date after which funds are no longer available for obligation, or “until expended.”

144 FDA, “FDA cautions against use of hydroxychloroquine or chloroquine for COVID-19 outside of the hospital
setting or a clinical trial due to risk of heart rhythm problems,” April 24, 2020, https://www.fda.gov/drugs/drug-safety-
and-availability/fda-cautions-against-use-hydroxychloroquine-or-chloroquine-covid-19-outside-hospital-setting-or.
145 FDA, “Coronavirus (COVID-19) Update: FDA Revokes Emergency Use Authorization for Chloroquine and
Hydroxychloroquine,” June 15, 2020, https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-
update-fda-revokes-emergency-use-authorization-chloroquine-and.
146 See for example FDA, “Cue COVID-19 Test: Letter of Authorization,” https://www.fda.gov/media/138823/
download.
147 The second supplemental appropriations measure, The Families First Coronavirus Response Act (P.L. 116-127) did
not include available funding for MCM R&D.
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In some cases, funds are provided to accounts that are mostly for activities related to MCMs, such
as funding for FDA, DOD Defense Health Program, or NIH accounts. In other cases, funds
appropriated to the listed account may be allocated to MCM R&D-related activities at the
discretion of the funded agency. For example, funds have been appropriated to the Public Health
and Social Services Emergency Fund (PHSSEF) for a broad array of HHS emergency
preparedness and response activities related to COVID-19, particularly those conducted by
ASPR, where BARDA is based. The HHS Secretary generally has broad discretion to allocate the
PHSSEF account amounts listed below to BARDA, except where set-asides or transfers are
specified.
Table 1. Funding for MCM R&D in Coronavirus Supplemental Appropriations
Accounts with specific funding available for MCM R&D
Account
Amount
Purpose
Availability
Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 (P.L. 116-123)a
FDA—Salaries and
$61 mil ion
“to prevent, prepare for, and
Until expended
Expenses
respond to coronavirus,
domestically or internationally,
including the development of
necessary medical
countermeasures and vaccines,
advanced manufacturing for
medical products, the monitoring
of medical product supply chains,
and related administrative
activities.”
NIH—NIAID
$836 mil ion (less
“to prevent, prepare for, and
September 30,
specified transfer of not
respond to coronavirus,
2024
less than $10 mil ion)b
domestically or internationally.”
HHS Office of the
$3.1 bil ion and $300
“to prevent, prepare for, and
September 30,
Secretary (OS)—Public
mil ion in contingent
respond to coronavirus,
2024
Health and Social Services
appropriations (less
domestically or internationally,
Emergency Fund (PHSSEF; specified transfers of not
including the development of
parent account for
more than $102 mil ion)c
necessary countermeasures and
BARDA)
vaccines, prioritizing platform-
based technologies with U.S.-based
manufacturing capabilities, and the
purchase of vaccines, therapeutics,
diagnostics, necessary medical
supplies, medical surge capacity,
and related administrative
activities.” The HHS Secretary
may direct funding from this
account to BARDA.
CDC—CDC-Wide
Transfer of not less than
“to prevent, prepare for, and
September 30,
Activities and Program
$300 mil ion
respond to coronavirus,
2022
Support—Transfer to
domestically or internationally.”
Infectious Disease Rapid
Funding from IDRRRF is
Response Reserve
transferrable to NIH and PHSSEF
Fund (IRRRDF)
accounts by the CDC Director
pursuant to 42 U.S.C. §247d-4a.
Coronavirus Aid, Relief, and Economic Security Act (CARES Act) (P.L. 116-136)d
DOD—Defense Health
$415 mil ion
“Research, development, test and
September 30,
Program
evaluation to prevent, prepare for,
2021
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Account
Amount
Purpose
Availability
and respond to coronavirus,
domestically or internationally.”
FDA—Salaries and
$80 mil ion
“to prevent, prepare for, and
Until expended
Expenses
respond to coronavirus,
domestically or internationally,
including funds for the
development of necessary medical
countermeasures and vaccines,
advanced manufacturing for
medical products, the monitoring
of medical product supply chains,
and related administrative
activities.”
NIH—National Heart,
$103 mil ion
“to prevent, prepare for, and
September 30,
Lung, and Blood Institute
respond to coronavirus,
2024
(NHLBI)
domestically or internationally.”
NIH—NIAID
$706 mil ion
“to prevent, prepare for, and
September 30,
respond to coronavirus,
2024
domestically or internationally.”
Not less than $156 mil ion of the
total is for “the study of,
construction of, demolition of,
renovation of, and acquisition of
equipment for, vaccine and
infectious diseases research
facilities of or used by NIH,
including the acquisition of real
property.”
NIH—National Institute
$60 mil ion
“to prevent, prepare for, and
September 30,
of Biomedical Imaging and
respond to coronavirus,
2024
Bioengineering (NIBIB)
domestically or internationally.”
NIH—National Library of
$10 mil ion
“to prevent, prepare for, and
September 30,
Medicine (NLM)
respond to coronavirus,
2024
domestically or internationally.”
National Center for
$36 mil ion
“to prevent, prepare for, and
September 30,
Advancing Translational
respond to coronavirus,
2024
Sciences (NCATS)
domestically or internationally.”
NIH—Office of the
$30 mil ion
“to prevent, prepare for, and
September 30,
Director
respond to coronavirus,
2024
domestically or internationally.”
OS—PHSSEF (parent
$27 bil ion including the
“to prevent, prepare for, and
September 30,
account for BARDA)e
BARDA set-aside below
respond to coronavirus,
2024
(less other specified set-
domestically or internationally,
asides or transfers of
including the development of
roughly $16.5 bil ion)g
necessary countermeasures and
vaccines, prioritizing platform-
based technologies with U.S.-based
manufacturing capabilities, the
purchase of vaccines, therapeutics,
diagnostics, necessary medical
supplies, as well as medical surge
capacity, addressing blood supply
chain, workforce modernization,
telehealth access and
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Account
Amount
Purpose
Availability
infrastructure, initial advanced
manufacturing, novel dispensing,
enhancements to the U.S.
Commissioned Corps, and other
preparedness and response
activities.” The HHS Secretary
may direct funding from this
account to BARDA.
Set-aside to BARDA
Set-aside of not less than
“for necessary expenses of
As above
(non-add)
$3.5 billion
manufacturing, production, and
purchase, at the discretion of the
Secretary, of vaccines, therapeutics,
diagnostics, and small molecule active
pharmaceutical ingredients, including
the development, translation, and
demonstration at scale of innovations
in manufacturing platforms.”
CDC—CDC-Wide
Transfer of $300 mil ion
“to prevent, prepare for, and
September 30,
Activities and Program
respond to coronavirus,
2024
Support- Transfer to
domestically or internationally.”
IRRRDF
Funding from IDRRRF is
transferrable to NIH and PHSSEF
accounts by the CDC Director
pursuant to 42 U.S.C. §247d-4a.
Paycheck Protection Program and Health Care Enhancement Act (P.L. 116-139)h
OS—PHSSEFi
$25 bil ion including
“to prevent, prepare for, and
Until expended
transfers below (less
respond to coronavirus,
other specified set-asides
domestically or internationally, for
or transfers of not less
necessary expenses to research,
than $13.8 bil ion)j
develop, validate, manufacture,
purchase, administer, and expand
capacity for COVID–19 tests to
effectively monitor and suppress
COVID–19, including tests for
both active infection and prior
exposure, including molecular,
antigen, and serological tests, the
manufacturing, procurement and
distribution of tests, testing
equipment and testing supplies,
including personal protective
equipment needed for
administering tests, the
development and validation of
rapid, molecular point-of-care
tests, and other tests, support for
workforce, epidemiology, to scale
up academic, commercial, public
health, and hospital laboratories,
to conduct surveillance and
contact tracing, support
development of COVID–19 testing
plans, and other related activities
related to COVID–19 testing.”
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Development and Regulation of Medical Countermeasures for COVID-19

Account
Amount
Purpose
Availability
Transfer to NIH
Transfer of not less than
“to develop, validate, improve, and
As above
National Cancer
$306 million
implement serological testing and
Institute (non-add)
associated technologies.”
Transfer to NIH NIBIB
Transfer of not less than
“to accelerate research, development, As above
(non-add)
$500 million
and implementation of point of care
and other rapid testing related to
coronavirus.”
Transfer to NIH Office
Transfer of not less than $1
“to develop, validate, improve, and
As above
of the Director (non-
billion
implement testing and associated
add)
technologies; to accelerate research,
development, and implementation of
point of care and other rapid testing;
and for partnerships with
governmental and non-governmental
entities to research, develop, and
implement the activities outlined in
this proviso.”
Set-aside to BARDA
Transfer of not less than $1
“for necessary expenses of advanced
As above
(non-add)
billion
research, development,
manufacturing, production, and
purchase of diagnostic, serologic, or
other COVID–19 tests or related
supplies, and other activities related
to COVID–19 testing at the discretion
of the Secretary.”
Transfer to FDA (non-
Transfer of $22 million
“to support activities associated with
As above
add)
diagnostic, serological, antigen, and
other tests, and related administrative
activities.”
Notes: Funding in other accounts not included in this table could potentially be used for activities related to
MCM R&D, such as funding for Global Health, National Science Foundation and others. However, such funding is
excluded from this presentation because MCM R&D is not a primary purpose of these accounts. Amounts
shown rounded to first decimal place. The second supplemental appropriations measure, The Families First
Coronavirus Response Act (P.L. 116-127) did not include available funding for MCM R&D.
Acronyms: FDA= Food and Drug Administration; NIH= National Institutes of Health; NIAID= National
Institute of Allergy and Infectious Diseases; HHS= Department of Health and Human Services; BARDA=
Biomedical Advanced Research and Development Authority; DOD= Department of Defense.
a. HHS may transfer nearly all the funds appropriated to it in Title III, Division A, of P.L. 116-123 among
accounts at CDC, NIH, or PHSSEF, provided the transfers are made to prevent, prepare for, and respond
to the COVID-19 pandemic, domestically or internationally (see §304). HHS is to notify the House and the
Senate appropriations committees 10 days in advance of such a transfer.
b. Transfer to the National Institute of Environmental Health Sciences (NIEHS) for “worker-based training to
prevent and reduce exposure of hospital employees, emergency first responders, and other workers who
are at risk of exposure to coronavirus through their work duties.”
c. Transfers specified are $100 mil ion to the Health Resources and Services Administration (HRSA) and up to
$2 mil ion to the HHS Office of Inspector General (OIG).
d. HHS may transfer nearly all the funds appropriated to it in Title VIII, Division B, of P.L. 116-136 among
accounts at CDC, PHSSEF, NIH, Administration for Children and Families (ACF), and the Administration
for Community Living (ACL), provided the transfers are made to prevent, prepare for, and respond to the
COVID-19 pandemic, domestically or internationally (see §18111). HHS is to notify the House and the
Senate appropriations committees 10 days in advance of such a transfer.
e. Not more than $4 mil ion per Title VIII, Division B, Section 8113, is to be transferred to the HHS Office of
the Inspector General (OIG) from the $127.29 bil ion total appropriated to PHSSEF for oversight of all
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Development and Regulation of Medical Countermeasures for COVID-19

f.
activities supported with funds appropriated to HHS to prevent, prepare for, and respond to the COVID-
19 pandemic.
g. Transfers specified are not more than $16 bil ion for the Strategic National Stockpile; not less than $250
mil ion for grants or cooperative agreements with existing grantees or sub-grantees of the Hospital
Preparedness Program; not more than $289 mil ion to other federal agencies for care of persons under
federal quarantine; and $1.5 mil ion for a National Academies of Science, Engineering, and Medicine
(NASEM) study on the security of the U.S. medical supply chain.
h. HHS may transfer certain funds appropriated to it in Title I, Division B, of P.L. 116-139 among accounts at
CDC, NIH, PHSSEF, and FDA, provided the transfers are made to prevent, prepare for, and respond to the
COVID-19 pandemic (see §102). HHS is to notify the House and the Senate appropriations committees 10
days in advance of such a transfer.
i.
Not more than $6 mil ion per Title I, Division B, Section 103, of P.L. 116-139 is to be transferred to the
HHS Office of the Inspector General (OIG) from the $127.29 bil ion total appropriated to PHSSEF for
oversight of all activities supported with funds appropriated to HHS to prevent, prepare for, and respond to
the COVID-19 pandemic.
j.
Other specified transfers include not less than $11 bil ion for grants and cooperative agreements with
states, localities, territories, tribes, and other jurisdictions/entities; not less than $1 bil ion to CDC-wide
activities and program support; $600 mil ion to HRSA for community health centers; $225 mil ion for rural
health clinics; and $1 bil ion for the cost of testing for the uninsured.

Author Information

Agata Dabrowska
Amanda K. Sarata
Analyst in Health Policy
Specialist in Health Policy

Frank Gottron
Kavya Sekar
Specialist in Science and Technology Policy
Analyst in Health Policy

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