FDA’S WORK TO 

COMBAT THE 

COVID-19 PANDEMIC 
2 FDA’s Work to Combat the COVID-19 Pandemic 

 	 	 	 	 	 	 	 	 	 	 	 	

FDA’s Work to Combat the COVID-19 Pandemic 

July 20221 

Introduction 

On March 11, 2020, the World Health Organization declared COVID-19 a 

global pandemic. The pandemic has caused unimaginable harms, with over

1,000,000 American lives lost to the disease. These two years have also seen

unprecedented progress in pandemic preparedness across the U.S. government, 

particularly at the U.S. Food and Drug Administration. The FDA continues to build

on the foundation of scientific rigor, thoughtfulness, and adaptability in rising to 

this challenge. The agency is deeply appreciative of Congress’ support to ensure 

the American public’s access to medical products they need to diagnose, treat, 

and prevent COVID-19. 

The FDA is responsible for monitoring the continued performance, safety, 

availability, and effectiveness of the COVID-19-related products on the market 

now, as well as in the years to come. To accomplish this long-range mission, 

the FDA is hiring and training new talent, building large data infrastructure and 

analytic capacity, modifying processes, and developing new partnerships.

These efforts improve the resiliency of the agency and the health of Americans, 

responding to the COVID-19 pandemic and preparing for future crises such as 

public health emergencies, supply chain disruptions, geopolitical changes, and 

natural disasters. 

This document outlines much of the broad range of work the FDA is undertaking 

to combat the COVID-19 pandemic and prepare for future emergencies. 

Contents 

Vaccines .........................................................................................3 

Pharmaceuticals.............................................................................4 

Devices, including Tests and Personal Protective Equipment .......5 

Resilient Supply Chains..................................................................7 

Advanced Manufacturing and Innovation ......................................9 

Inspections, Investigations, Imports, and Fraud ..........................11 

Crosscutting Research.................................................................13 

1	 Unless otherwise specified, all data presented is current as of April, 2022
FDA’s Work to Combat the COVID-19 Pandemic 3 

	 	 	

	 	 	 	 	 	

 

 

Vaccines 

The FDA has: Vaccines save lives by preventing 

disease, hospitalizations, and • Issued EUAs for three vaccines, two of which 

deaths. Given the COVID-19 public are authorized for the population age 6 months 

health emergency (PHE), development and up.2 

timelines for COVID-19 vaccines were shortened 

CBER conducted 24 

research studies in FY 2020 

and 2021 which have produced 

more than 58 publications,3 

with wide-ranging implications

for evaluating antibody and

vaccine effectiveness, relevant 

for COVID-19 and for future 

vaccine development and

regulation. 

2	 Current as of June 23, 2022

3	 Current as of June 28, 2022

without compromising safety and effectiveness 

standards. The FDA’s Center for Biologics Evaluation 

and Research (CBER), in close partnership with 

industry and governmental partners, facilitated 

the needed scientific studies and manufacturing

process validations to support this timeline. CBER 

issued an Emergency Use Authorization (EUA) for 

the first COVID-19 vaccine within eight months of the 

declaration of a PHE and licensed the first COVID-19 

vaccine within two years, less than 100 days from 

the Biologics License Application submission. Typical 

vaccine development and approval can take 10 years 

or longer. 

Over 570 million doses of vaccines have been 

administered in the U.S., and 82.2% of the 

American public over age five has received at 

least one dose of a vaccine per CDC data. 

After authorization, CBER tracks the safety and

performance of these vaccines in the real world. Even 

very large clinical trials are sometimes too small to 

detect extremely rare side effects and may not be 

designed to learn about the efficacy of a vaccine in 

certain groups, like patients with cancer. Real World 

Evidence (RWE) is the analysis of anonymous health 

information for millions of people collected through 

multiple sources such as 

electronic health records, 

insurance claims, 

reports, and public 

health databases. 

The FDA uses RWE 

and multiple other

tools to detect 

potential safety 

• Approved two vaccines. 

• Reviewed over 1,300 EUA amendments to 

authorized COVID-19 vaccines.2 

• Held nine advisory committee meetings

regarding COVID-19 vaccines. 

• Issued five draft, updated, or final guidances,

related to COVID-19 vaccines. 

• Continually reviewed and updated EUAs 

to include authorizations for boosters, 

immunocompromised people, and other special 

circumstances. 

•	 The Vaccine Adverse Events Reporting 

System (VAERS) relies on healthcare 

providers, vaccine recipients, and parents of 

vaccine recipients to send in reports of their 

experiences. CBER received 812,147 VAERS 

reports in FY 2021 relating to the COVID-19 

vaccines, a 1,488% increase over the FY 2020 

reports. 

•	 The Biologics Effectiveness and Safety

System (BEST) and the Centers for Medicare 

& Medicaid Services data systems are 

tracking 16 potential rare adverse reactions 

in data representing 120 million people. The 

FDA detected four such potential reactions 

(pulmonary embolism, acute myocardial 

infarction, immune thrombocytopenia, and 

disseminated intravascular coagulation) and

issued a protocol and public communication. 

issues early and mitigate them, as well as to answer critical questions

around vaccine effectiveness, duration of protection, impacts of variants and 

mutations, and more. 
4 FDA’s Work to Combat the COVID-19 Pandemic 

 	 	 	 	 	 	

Pharmaceuticals 

Treatments are crucial for saving 

lives from COVID-19 infection. 

Congress established a process 

called Emergency Use Authorization 

(EUA) to make appropriate treatments available to 

patients as quickly as possible during PHEs when

certain criteria are met. The FDA’s Coronavirus 

Treatment Acceleration Program (CTAP) uses multiple

methods to expedite development of treatments 

including targeted guidance, communications, and 

interdisciplinary teams to assist drug sponsors with 

trial design and data submissions. 

The FDA has been closely monitoring data from 

multiple sources to rapidly identify emerging potential 

safety issues associated with drugs and biologics

used to treat or prevent COVID-19. These include 

safety issues that may not have been captured in a 

clinical trial, or those that arise from the misuse or 

off-label use of these products. The FDA can use this 

information to revise EUAs including updating the 

authorized Fact Sheets; communicate with the public,

health care professionals, and other stakeholders; or 

act against fraudulent products. To accomplish this, 

the FDA uses two main systems: 

•	 The FDA Adverse Event Reporting System

(FAERS), enables healthcare professionals, 

consumers, and manufacturers to submit 

adverse event reports, medication error 

reports and product quality complaints. In 

2021, the FDA launched a new COVID-19 EUA 

FAERS Public Dashboard to provide the public 

with easy access to COVID-19 EUA products 

adverse event data. 

Antivirals: > 23 million courses of two types of

antiviral pills have been purchased by the federal 

government for 2022. Millions of doses of an IV 

antiviral medication have been administered. 

Antibodies: 7.1 million courses of antibody

treatments have been distributed by the federal 

government. 

•	 Treatment: 65-90 % reduction in 

hospitalization or death depending on the

product. 

•	 Prevention: 77% reduction in infection in 

those who cannot respond to vaccinations. 

•	 The FDA Sentinel System and other Real World Data (RWD) systems, which assess potential

safety signals in health records, insurance claims, and other RWD. The FDA enhanced these systems 

in response to the COVID-19 pandemic to include new electronic health records data and to increase 

the speed of signal detection. This supports the FDA’s efforts to characterize the natural history of 

COVID-19 and to better understand the use and performance of drugs and biologics used to treat 

or prevent COVID-19. As of June 1, 2022, Sentinel completed 62 COVID-19 related analyses in the 

Sentinel Distributed Databases and associated electronic health record sources. 

4	 As of May 31, 2022, the FDA has authorized 13 treatments, approved 2 treatments, and reviewed more than 460 trials. In addition, 

more than 700 drug development programs are in planning stages. 
FDA’s Work to Combat the COVID-19 Pandemic 5 

 	 	 	 	

Medical diagnostics and other

devices are necessary in combatting 

the pandemic: 

•	 Tests allow people to seek early care, get the 

appropriate medications, quarantine to prevent 

infecting others, and return to travel and work 

more safely. 

•	 Personal Protective Equipment (PPE) like masks,

respirators, and gloves protect against infection. 

•	 Other devices, like ventilators and syringes, are 

needed to treat sick patients. 

Many of these were in short supply at the beginning of 

pandemic, so the FDA leveraged the EUA regulatory 

pathway to make tests and other devices available to

patients as quickly as possible while assuring that they

are appropriately safe and effective. 

Many of the manufacturers of these products are new 

and unfamiliar with the FDA’s policies and procedures, 

which required the FDA Center for Devices and 

Radiological Health (CDRH) to organize significant 

outreach to prepare them for regulation. CDRH has 

hired new reviewers, conducted town hall meetings, 

created new validation templates and guidances, 

assembled a software SWAT team, partnered with 

sister agencies (such as the National Institutes of

Health (NIH) and Biomedical Advanced Research and 

Development Authority) to support development and

FDA authorization of devices with novel technologies,

and created new review mechanisms. 

Devices, including Tests and Personal Protective Equipment 

5	 As of December, 2021

The FDA has: 

• Reviewed > 8,000 EUA device submissions (>

5,000 for tests), which is 100 times more than in 

any prior public health emergency. 

• Issued EUAs for >800 devices, 450 of which are 

for tests, including 19 OTC tests. 

• Approved/cleared 706 PPE devices, 109

ventilators, and 635 other devices such as infusion 

pumps and syringes through non-EUA pathways. 

CDRH managed >400,000 inquiries and

interactions related to COVID products, and held 

105 town hall webinars for >53,000 participants. 

The FDA and firms have taken postmarket

actions, including EUA revocation and recall for 

many devices5

. 

COVID-19 DEVICE POSTMARKET METRICS 
6 FDA’s Work to Combat the COVID-19 Pandemic 

Tracking real-world performance of tests is important for the FDA to be able to continue to make sure that 

the available tests are working correctly. To accomplish this, test results need to be captured consistently; 

results for most over-the-counter (OTC) rapid tests and tests performed at a hospital or laboratory are not 

always structured in the same ways, and do not always align with the systems that store health information 

from electronic medical records and insurance claims. To solve these issues, the FDA is leading efforts, such 

as the Systematic Harmonization and Interoperability Enhancement for Laboratory Data (SHIELD), to capture 

and integrate test data, laboratory data, and patient health data. The FDA is also 

collaborating with NIH’s Variant Task Force (VTF) program to identify and prioritize tests 

that can detect circulating variants, assess how current tests perform with new variants, 

and model the anticipated effect of new mutations on multiple different kinds of tests.

OTC Tests: Hundreds of millions of COVID-19 tests have already been performed in 

the U.S., and over one billion tests are being contracted by the Biden Administration.

The FDA focused particularly on the authorizations of 18 home-use tests as they are relatively inexpensive, 

allow people to stay in quarantine during testing, and provide faster results. A rollout of home-based 

testing at this scale is unprecedented, and the FDA’s experience regulating novel technologies during this 

pandemic will facilitate a fast and robust response to a future crisis and to emerging variants. 

Over 630,000 

CDRH staff hours 

have been spent on

COVID-19 work in 

2020-2021. 
FDA’s Work to Combat the COVID-19 Pandemic 7 

Resilient Supply Chains 

COVID-19 highlighted vulnerabilities in the medical supply chain. Supply chain disruptions 

for products like ventilators, pharmaceuticals, active ingredients, and PPE were already 

beginning to occur before COVID-19 cases were identified in the U.S. As demand increased, 

stockpiling occurred globally, and manufacturing was disrupted. Although the agency has 

intervened where possible to mitigate medical product shortages, responding to the massive shortages 

complicated by the pandemic has required establishing new or much more comprehensive programs, 

focused on three areas: 

•	 Monitoring and visualization of supply, demand, and the availability of supplies by integrating data 

from a wide variety of sources, such as active ingredient manufacturers, product manufacturers, 

distributors, suppliers, and end-users like hospitals and pharmacies. 

•	 Prediction of products at risk of shortage using statistical methods and artificial intelligence.

•	 Prevention or mitigation of shortages with evidence-based strategies such as enforcement discretion; 

expedited review of manufacturing supplements, generic drug applications, or premarket devices; 

and requesting that manufacturers identify alternative suppliers, redistribute stock, or increase 

manufacturing. 

•	 The programs developed are expected to be beneficial for preventing future shortages including in 

other emergencies like natural disasters (hurricanes and winter storms), labor disputes, and shipping 

disruptions. 

PHARMACEUTICALS 

•	 CDER’s Drug Supply Chain Surveillance System is being For example, starting in April developed to provide enhanced insight into the drug 2020, there were shortages supply chain—from active ingredient suppliers to clinical of Cisatracurium, a necessary settings such as hospitals and pharmacies. This system medication for some patients on will utilize existing as well as new data sources to identify ventilators with dangerously low early signals that may indicate shortages so they can be oxygen levels. The FDA identified prevented and mitigated. this shortage and expedited the

o CDER was able to work with manufacturers to review of a generic version of the prevent 482 potential shortages in 2020-2021. drug to increase supply. CDER Consequently, there was no increase in the number also issued temporary guidances of shortages: 46 in 2019, 43 in 2020 and on compounding to allow for 38 in 2021. a wider array of compounding 

o CDER accomplished this in part by expediting formulations to address certain 

review and approval of > 1,300 manufacturing supply disruptions.

supplements and > 100 generic drugs. 

 VACCINES AND BIOLOGICS 

•	 CBER’s shortages program was able to work with manufacturers to prevent 34 potential shortages 

in calendar years 2020 and 2021. CBER accomplished this, in part, by expediting review and 

approval of 17 biologics license application supplements and 15 lot release submissions for 

CBER-regulated products. 
8 FDA’s Work to Combat the COVID-19 Pandemic

 ANIMAL DRUGS 

•	 The FDA Center for Veterinary Medicine (CVM) Animal Drug and Manufacturing System is 

launching in 2022 and will generate reports with necessary data for the analysis of potential animal 

drug shortages, which have more than tripled during pandemic.

 DEVICES 

•	 CDRH’s new Resilient Supply Chain Program (RSCP) 

program aims to develop and apply state-of-the-art 

supply chain intelligence to predict and prevent supply 

chain shortages. CDRH has implemented the reporting 

authority that requires manufacturers to report the 

shortage of certain medical devices utilizing a newly

created webform, and actively maintains a medical 

device shortage list. In addition, CDRH has integrated

internal and external data sources for supply chain 

analysis and modeling to inform shortage mitigations. For example, CDRH, in partnership

with the Biomedical Advanced

o The RSCP has performed outreach to >1000 Research and Development manufacturers in 12 countries to perform impact Authority and the U.S. Department assessments and inform mitigation strategies. of Defense, helped to coordinate a 

o CDRH has performed hundreds of shortage series of military airlifts of millions assessments on PPE, COVID-19 testing supplies of testing swabs during a severe and equipment, ventilators, and other related shortage. device shortages, and has provided evidencebased data to support both regulatory and nonregulatory mitigations.

 IMPORT IMPROVEMENTS 

•	 The FDA Office of Regulatory Affairs is investing in import modernization with our partner

government agencies. For example, FDA continues to work with U.S. Customs and Border

Protection to refine existing data interfaces and with the U.S. Postal Service to develop a data

exchange to better track and target international mail. These efforts should enable more effective and

efficient legitimate trade, while intercepting potentially harmful products before they enter the U.S.
FDA’s Work to Combat the COVID-19 Pandemic 9 

	 	 	 	 	 	 

Advanced Manufacturing and Innovation 

The COVID-19 pandemic has revealed that most existing manufacturing systems, which 

depend on a limited number of facilities fed by long and complex global supply chains, 

can be disrupted by delays, shortages of raw materials, contamination events, or other

disturbances. In some cases, this can lead to shortages of much-needed medical products. 

Advanced manufacturing is a set of manufacturing technologies and principles that can allow for products to 

be manufactured in a new or innovative way, such as novel technological approaches that permit production 

through a distributed network of smaller plants capable of responding in an agile and adaptable way to supply 

chain threats. Advanced manufacturing techniques can help protect against emerging threats, public health 

emergencies, natural disasters, and economic supply chain shifts by: 

•	 Matching supply to meet demand by creating agile and high-throughput production systems that 

can scale to respond to new threats and changes in demand. 

•	 Improving supply chain resilience by integrating independent operations end to end so that a single

plant can depend on fewer input sources and is thus less susceptible to shortages. 

•	 Creating cost-effective small-footprint plants that may make the manufacture of medications, 

including those for rare diseases, more financially viable and may lead to cost savings for consumers.

•	 Increasing product quality, manufacturing, consistency, and output through improving process 

design and process controls that can detect non-conforming materials in real time. 

There are multiple production techniques that could be considered “advanced,” and there is explosive growth 

in the development of new techniques. Evaluating and regulating advanced manufacturing is complex: the 

array of different manufacturing techniques is vast, many technologies are designed to be adapted to 

changing circumstances, and the amounts of data collected can be staggering. Yet, the potential of these 

technologies is extraordinary, and the FDA has a critical role in facilitating this innovation with respect to 

medical product manufacturing. 

•	 For pharmaceutical manufacturing, the chemical reactions and purification steps to make active 

ingredients typically occur in different rooms, different plants, different companies, or even different 

countries. The blending, weighing, compressing, and coating of a pill may occur somewhere else 
10 FDA’s Work to Combat the COVID-19 Pandemic 

	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	

	 	 	 	 	 	 	 	

 

 

altogether. There are many The FDA is a global leader in advanced manufacturing regulation, advanced manufacturing supporting the development of two International Council for techniques in development Harmonisation of Technical Requirements for Pharmaceuticals to integrate these steps, for Human Use guidelines on continuous manufacturing and incorporate real-time quality manufacturing using cell lines.6

controls, and transform physical 

plant infrastructure. During the 

pandemic, CDER and CBER partnered to launch the Center CDER held > 150 

for the Advancement of Manufacturing Pharmaceuticals and meetings with drug

Biopharmaceuticals. The FDA has conducted COVID-related manufacturers and approved 

research projects exploring active pharmaceutical ingredient 15 applications and supplements,

manufacturing processes, smart data analytics for product which use new technologies (e.g., 

quality, techniques to make monoclonal antibodies, and more. In continuous manufacturing and 3D 

addition, the FDA has increased its support of targeted research, printing) to manufacture products 

used in the treatment of cystic testing, and training in advanced manufacturing technologies. fibrosis, HIV/AIDS, breast cancer, 

•	 For vaccine manufacturing, messenger RNA (mRNA) vaccines leukemia, asthma, and two

have emerged as a powerful platform technology. These critical drugs needed during

vaccines have several advantages: the vaccine antigen can COVID-19. 

be redesigned relatively easily to target new diseases or new 

variants and can be simpler to manufacture. Still, they present 

several new unique manufacturing challenges, such as the need for suitable delivery vehicles (for

example lipid nanoparticles), very cold storage, and reliance on specialized materials (reagents). 

Production of these, and other vaccines, may benefit from several advanced manufacturing 

techniques. For example, distributed manufacturing in decentralized or mobile units could allow

vaccines to be produced near the site of distribution, reducing the cost and risks of transportation. 

CBER is working to launch a demonstration project for mRNA vaccine manufacturing which will 

focus on best practices in integrated and continuous vaccine manufacturing. This work is relevant for 

multiple vaccines, including influenza, COVID-19 variants, and other pathogens.

•	 For medical device manufacturing, new robotics, additive manufacturing 

(also known as 3D printing), and digital design tools can allow changes One CDRH and 

in a manufacturing process in response to a new need. Robotics and industry collaboration

design tools can also be used to reconfigure a device to be able to use reduced technology 

a new part without any loss of effectiveness. CDRH has invested in the implementation time

Medical Device Information Analysis and Sharing Initiative to integrate data from 18 to eight 

from patients, providers, payers, device manufacturers and regulators to months, resulting in 

understand “blind spots” in product safety and manufacturing quality that a reduction in noncan be improved with advanced manufacturing techniques. CDRH also conformances of 45% 

initiated two programs to work directly with manufacturers on “proof-of- and projected savings 

concept” manufacturing technologies, called the Advanced Manufacturing of $30 million. 

Technology Clearinghouse and the Voluntary Improvement Program. 

The Ventilator Digital Twin Project. A digital twin is a model of all the objects, people, designs,

processes, and systems involved in the creation of a complex device. This allows one to virtually “try out” 

a new technique. The Ventilator Digital Twin can model the impact of disruptions like social distancing or 

parts shortages on ventilator production and come up with solutions. 

6	 ICH Q13 Continuous Manufacturing of Drug Substances and Drug Products and Q5A Viral Safety Evaluation of Biotechnology Products

Derived From Cell Lines of Human or Animal Origin
FDA’s Work to Combat the COVID-19 Pandemic 11 

	 	

	 	

 

 

Inspections, Investigations, Imports, and Fraud 

Inspections and examinations of

firms, manufacturing facilities, and

imported products, are a critical

component of the FDA’s strategy to protect

the public from harmful or fraudulent products. 

The need for these field activities, which are led by 

ORA in partnership with the relevant centers, only 

continues to grow. As one example, the number of 

imported medical product lines increased by 42% 

in FY 2015-2021, including a 9% increase during 

pandemic (FY 2020-2021). The pandemic brought 

about additional unique challenges: 

•	 Inspections were initially significantly limited 

due to travel bans and risk to personnel,

though mission critical inspections were 

continued throughout. 

•	 Accelerated growth in the vaccine industry 

necessitated new inspection programs. 

•	 Online marketplace revenue grew from $360 

billion in 2019 to $768 billion in 2021, including

~$56 billion in health products, increasing the 

potential for fraudulent online activities. 

To facilitate inspection activities, the FDA is initiating a new inspection planning system that will be more 

efficient, transparent, and adaptable to changing needs. This will help prioritize high-impact inspections such 

as those for facilities manufacturing COVID-19 vaccines or ingredients used in multiple critical products, 

as well as the inspections needed for clinical trials of COVID-19 drugs. The FDA is also developing new 

approaches to inspect firms utilizing novel advanced manufacturing techniques. 

To identify fraudulent products, ORA has begun a

proof of concept using handheld, field-deployable, 

fraud detection tools including Raman Spectrometers 

(Progeny) and counterfeit detection devices (CD5). 

Additionally, ORA is standing up 2-person satellite 

laboratories at selected international mail facilities. 

These hand-held devices and satellite laboratories 

can be used to analyze the chemical composition of a 

detect potential contamination

product to verify authenticity and 

The FDA 

launched a data 

system to track and

flag online sales of

potentially fraudulent

COVID-19 related 

products. 

directly on site. The ORA’s 

Forensic Chemistry Center 

experts can then review 

this field-generated data in

real time. If successful, one 

The FDA has: 

•	 Identified > 1,706 fraudulent and/or

unapproved medical products related to 

COVID-19. 

•	 Issued > 219 warning letters to companies

and individuals selling unproven products and 

>70% of recipients took voluntary action in 

response. 

•	 Identified 340 contaminated hand sanitizers 

(see Box 4). 

•	 Continued mission-critical inspections

throughout. 

•	 Reinvigorated a system to conduct >

1,400 domestic and > 500 foreign remote 

assessments. 

•	 Conducted domestic inspections at standard 

operational levels since October 2021. 

•	 Resumed foreign facility surveillance 

inspections in March 2022. 

Combatting False Marketing: 

The Genesis II Church of Florida falsely marketed 

a chlorine dioxide formulation, a bleach-like 

disinfectant, as a treatment for a range of 

conditions including COVID-19. The FDA sent

a joint warning letter with the Federal Trade 

Commission, which the manufacturer defied. 

The FDA then successfully pursued in court

a temporary restraining order, a preliminary 

injunction, and, ultimately, a permanent injunction, 

which enjoins the manufacturer from labeling, 

holding, or distributing the product. 

or more of these pilots could allow field staff to decide about admitting an imported 

product much faster than if they need to send samples to a fixed laboratory and wait 
12 FDA’s Work to Combat the COVID-19 Pandemic 

 	 	 	 	 	 	 	

hours or days for a result. This could reduce the time it takes for the FDA to intercept fraudulent products, 

expedite legitimate trade, and potentially promote mitigation of supply chain issues. 

To prevent harm to consumers and animals from violative or fraudulent products, the FDA takes 

multiple different actions. Illustrative examples include issuing consumer warnings about unapproved and 

unauthorized products distributed with fraudulent claims to treat or prevent COVID-19 in humans and 

animals; alerting healthcare providers on how to identify fraudulent PPE; and pursuing regulatory actions to 

stop the production, importation, distribution, and use of potentially harmful products like contaminated hand 

sanitizers. 

Combatting Fatal Contamination: The FDA noted 2,660 cases of poisonings

reported to the National Poison Data System7

, including 18 confirmed deaths,

from ingestion of contaminated hand sanitizers. The FDA saw a sharp increase 

in hand sanitizer products from Mexico that were labeled to contain ethanol (also 

known as ethyl alcohol) but, among other concerns, tested positive for methanol 

contamination; 84% of the samples of alcohol-based hand sanitizers imported

from Mexico analyzed by the agency from April 2020 through December 2020 

were not in compliance with the FDA’s regulations, and more than half of the 

samples were found to contain toxic ingredients, including methanol and/or 

1-propanol, at dangerous levels. The FDA worked with companies and retailers 

to recall dozens of violative products. In January 2021, due to safety concerns 

about alcohol-based hand sanitizers manufactured in Mexico, the agency placed 

all such products on an import alert, which was the first time the FDA had issued 

a countrywide import alert for any category of drug product. In addition, as 

part of the agency’s efforts to protect consumers from potentially dangerous or 

violative hand sanitizers, the agency published on its website a list of over 250 

hand sanitizers that consumers should not use, released a guidance, developed

safety toolkits in multiple languages, and issued warning letters. 

7	Between Jan 1, 2020 and March 20, 2022
FDA’s Work to Combat the COVID-19 Pandemic 13 

	 	 

Crosscutting Activities 

Crosscutting Research 

Regulatory science is the science of developing evidence-based

tools, standards, and approaches to assess safety, efficacy, quality, The FDA has and performance of all FDA-regulated products. Much research conducted at the created translations FDA is relevant to multiple different products and may involve more than one FDA of FDA health center or office. The studies below have resulted in more than 60 publications: communications in 

•	 Laboratory standards and techniques such as the development of numerous languages, 

reagents, reference panels, and artificial intelligence (AI) to identify targets including EUA fact 

for new drug development. sheets in multiple

languages. •	 Immunology research including neutralizing antibody studies, cytokine

studies, and a model of the interactions between the virus, immune system,

and body tissues. 

•	 Advanced manufacturing research including an analysis of the current advanced manufacturing 

landscape, 3D printing pilots, and IT and physical infrastructure plans. 

•	 The RWD Research Lab including pilot projects to establish rapid-cycle analytic approaches and 

foster collaboration on topics such as understanding vaccine effectiveness. 

•	 Transmission research including studies on SARS-CoV-2 transmission in food or on surfaces, and 

algorithms to link maternal and infant data to understand perinatal transmission.

Health Equity 

Many diseases, including COVID-19, disproportionately impact racial and ethnic minority communities. 

The FDA Office of Minority Health and Health Equity (OMHHE) launched The Enhance EQUITY Initiative to 

advance diversity in clinical trials, increase equitable data efforts, and increase understanding of diverse 

stakeholder perspectives. OMHHE launched The COVID-19 and Health Equity Innovation Award which 

has funded five studies on topics such as understanding COVID-19 outcomes by different demographic 

variables, including ethnicity, race, age, and geography among others; racial and ethnic minority participation 

in COVID-19 clinical trials; and understanding diverse patient perspectives, preferences, and unmet needs. 

OMHHE also supported four additional COVID-19 research projects. 

Identifying Variants in Wastewater 

Testing for SARS-CoV-2 in wastewater can indicate a surge one to two weeks before a rise in cases. 

Wastewater also gives a snapshot of a whole population served by a wastewater system, not just those who 

get tested. Most of the wastewater surveillance for SARS-CoV-2 tests only small fragments of the virus, 

which can indicate the quantity of the virus present but unfortunately does not give any indication about 

the proportion of variants within a sample. The FDA Center for Food Safety and Applied Nutrition’s (CFSAN) 

existing GenomeTrakr program uses whole genome sequencing to evaluate the genomes of pathogens in 

the food supply. CFSAN deployed a similar technology to sequence SARS-CoV-2 in > 50 sites in the U.S. 

geographic regions with high percentages of agricultural and food facility workers, whose health is critical 

for stability of the U.S. food supply chain. These data can be used to monitor circulating variants and their 

impact on vaccines, therapeutics, and diagnostics. Furthermore, the analysis software CFSAN developed has 

been adopted by other partners, including the U.S. Centers for Disease Control and Prevention (CDC). 
14 FDA’s Work to Combat the COVID-19 Pandemic 

Understanding COVID-19 Spread from Animals 

Approximately 75% of recently emerging infectious 

diseases affecting humans are of animal origin, 

including HIV, Ebola, and influenza. Mink, deer, 

and other animals are known to be reservoirs for 

SARS-CoV-2. Humans have transmitted SARSCoV-2 back to animals, including some domestic 

dogs and cats. Researchers are currently exploring 

how environmental factors, including ground 

and wastewater, play a role in viral transmission. 

Recognizing that the health of people, animals, and

the environment is intertwined, CVM is partnering 

with other government agencies, such as the U.S. 

Department of Agriculture and CDC, to solidify a One 

Health approach to the FDA’s human and animal 

public health work, and the FDA is standing up a One

Health Center of Excellence. An example of CVM’s 

One Health approach is the work being done with 

other veterinary diagnostic laboratories to identify

COVID-19 variants in animal populations and compare 

them to those in humans. This type of approach is vital 

to understanding not just COVID-19, but many other

emerging threats, such as antimicrobial resistance. 
FDA’s Work to Combat the COVID-19 Pandemic 15