The KFF COVID-19 Vaccine Monitor is an ongoing research project tracking the public’s attitudes and experiences with COVID-19 vaccinations. Using a combination of surveys and qualitative research, this project tracks the dynamic nature of public opinion as vaccine development and distribution unfold, including vaccine confidence and acceptance, information needs, trusted messengers and messages, as well as the public’s experiences with vaccination.

Key Findings

• Misinformation about health care topics is nothing new, but social media, the polarization of news sources, and the pace of scientific development on COVID-19 have all contributed to an environment that makes it easier than ever for ambiguous information, misinterpretation, and deliberate disinformation to spread.¹  We find in the latest Vaccine Monitor that belief in pandemic-related misinformation is widespread, with 78% of adults saying they have heard at least one of eight different false statements about COVID-19 and that they believe it to be true or are unsure if it is true or false. One-third (32%) of all adults believe or are uncertain about at least four false statements. Belief in COVID-19 misinformation is correlated with both vaccination status and partisanship, with unvaccinated adults and Republicans much more likely to believe or be unsure about false statements compared to vaccinated adults and Democrats.
• With the public’s trust in news media declining over many years, we find that no news media source garners the trust of a majority of the public when it comes to COVID-19 information. While nearly half trust information about COVID-19 that they see on network and local television news, trust is lower for other news outlets and diverges in expected ways along partisan lines. Unvaccinated adults are far less likely than vaccinated adults to trust most of the news sources included in the survey for information on COVID-19, with the exception of conservative news sources.
• People’s trusted news sources are correlated with their belief in COVID-19 misinformation. The share who hold at least four misconceptions is small (between 11-16%) among those who say they trust COVID-19 information from network news, local TV news, CNN, MSNBC, and NPR. This share rises to nearly four in ten among those who trust COVID-19 information from One America News (37%) and Fox News (36%), and to nearly half (46%) among those who trust information from Newsmax. One thing this study cannot disentangle is whether this is because people are exposed to misinformation from those news sources, or whether the types of people who choose those news sources are the same ones who are pre-disposed to believe certain types of misinformation for other reasons.
• These findings suggest a challenge for reaching people with accurate information about COVID-19. While that challenge is particularly acute when it comes to reaching those who remain unvaccinated, the partisan divisions in misinformation and trusted news sources also have implications for those who are vaccinated, as we have reported a growing partisan divide in intention to get COVID-19 booster shots, even among the fully vaccinated.

Belief In COVID-19 Misinformation

Numerous studies have documented the prevalence of misinformation and disinformation about COVID-19, often fueled by social media² . The latest KFF COVID-19 Vaccine Monitor sheds light on how common it is for people to hear and believe certain “myths” about the disease and the vaccine, and how these beliefs correlate with individuals’ trusted media sources.

Belief or uncertainty about COVID-19 misinformation is widespread, with nearly eight in ten adults saying they have heard at least one of eight different pieces of misinformation and either believe them to be true or are not sure whether they are true or false. Most commonly, six in ten adults have heard that the government is exaggerating the number of COVID-19 deaths by counting deaths due to other factors as coronavirus deaths and either believe this to be true (38%) or aren’t sure if it’s true or false (22%).³  About four in ten have heard that pregnant women should not get the COVID-19 vaccine and think this is true (17%) or aren’t sure (22%). Among women ages 18-44, 18% believe this to be true and 29% are uncertain.

Among other common myths, one-third believe or are unsure whether deaths due to the COVID-19 vaccine are being intentionally hidden by the government (35%), and about three in ten each believe or are unsure whether COVID-19 vaccines have been shown to cause infertility (31%) or whether Ivermectin is a safe and effective treatment for COVID-19 (28%). In addition, between a fifth and a quarter of the public believe or are unsure whether the vaccines can give you COVID-19 (25%), contain a microchip (24%), or can change your DNA (21%).

Overall, about one in five adults (22%) do not believe any of the eight pieces of information tested in the survey, while nearly half (46%) believe or are unsure about between one and three false statements. One-third of adults (32%) say they have heard at least four of these statements and believe them to be true or are uncertain if they’re true or false. There are notable differences in misinformation belief by vaccination status and partisan identity and smaller differences by community type and education level.

Among adults who have not gotten a COVID-19 vaccine, nearly two-thirds (64%) believe or are uncertain about four or more false statements about the virus. Among vaccinated adults, most believe or are unsure about at least one false statement, but just 19% say this about four or more statements. Unvaccinated adults are at least 20 percentage points more likely than vaccinated adults to lack knowledge about each piece of misinformation tested, with the largest gap on the statement that “Deaths due to the COVID-19 vaccine are being intentionally hidden by the government” (61% of unvaccinated adults believe or are unsure if this is true compared to 25% of vaccinated adults).

Nearly half (46%) of Republicans compared to just 14% of Democrats believe or are unsure about four or more misstatements about COVID-19. Strikingly, 84% of Republicans believe or are unsure whether the government is exaggerating the number of COVID-19 deaths by including deaths due to other causes, compared to just one third of Democrats. In addition, there are large gaps between Republicans and Democrats in the shares who believe or are unsure whether pregnant women should not get the vaccine (52% vs. 28%), whether the vaccines have been shown to cause infertility (43% vs. 15%), and whether Ivermectin is a safe and effective treatment for COVID-19 (44% vs. 10%).

In addition to these differences by partisanship and vaccination status, believing or having doubts about four or more pieces of COVID-19 misinformation is also more prevalent among rural residents compared to those living in urban and suburban areas, among those without a college degree compared to college graduates, and among those ages 18-49 compared to those ages 50 and over.

Trusted News Media Sources For COVID-19 Information

Previous Vaccine Monitor reports have shown that television news and social media are both prominent sources where people get information about COVID-19, while among non-media sources of information, health care providers are the most trusted. In this latest survey, we sought to understand how much people trust specific news sources when it comes to COVID-19 information.

Overall, there is no news source that garners trust from a majority of the public on the topic of COVID-19. At the top of the list, nearly half say they have “a great deal” or “a fair amount” of trust in COVID-19 information that they see or hear on their local TV news station (47%) and on network news like ABC, NBC, and CBS (45%). About a third put a similar level of trust in information they see on CNN (36%), MSNBC (33%), and NPR (32%) while three in ten say the same about Fox News (29%). A smaller share put at least a fair amount of trust in COVID-19 information from One America News and Newsmax (13% each).

Overall, far fewer people say they trust information about COVID-19 that they see on social media compared to traditional news platforms (13% say they trust information they see on YouTube, 9% on Facebook, 6% each on Twitter and TikTok, and 5% on Instagram). The group that is influenced by information they see on these platforms may be larger than the share that says they trust information they see there, as we previously found in January that 31% of adults got information about COVID-19 vaccines from social media over a two-week period, nearly as large as the share who got information from cable, network, and local TV news.

As has been well documented (in particular by the Pew Research Center), the U.S. media environment has become increasingly polarized in recent years, with Democrats and Republicans placing trust in completely different news sources. This is true when it comes to trust in COVID-19 information as well. Majorities of Democrats say they trust information about COVID-19 from network news (72%), local TV news (66%), CNN (65%), MSNBC (56%), and NPR (51%), while none of these sources is trusted by a majority of independents or Republicans. Republicans’ most trusted sources of COVID-19 information is Fox News (49%) followed by smaller shares who trust local TV news (34%), network news (25%), and Newsmax (22%).

Trusted news sources for COVID-19 information differ by vaccination status in addition to partisanship. Among mainstream news sources, vaccinated adults are at least twice as likely as unvaccinated adults to say they trust COVID-19 information from their local TV news station, network news, CNN, MSNBC, and NPR. Similar shares of vaccinated and unvaccinated adults say they trust COVID-19 information they see on Fox News (29% and 30%, respectively). The one news source that is trusted by a larger share of unvaccinated adults compared to vaccinated adults is Newsmax (17% vs. 11%), though the shares who trust Newsmax are relatively small for both groups.

Relationship Between Trusted News Sources and Belief In COVID-19 Misinformation

People’s trusted news sources are correlated with their belief in COVID-19 misinformation. Among those who say they trust COVID-19 information from CNN, MSNBC, network news, NPR, and local TV news, between three in ten and four in ten do not believe any of the eight pieces of misinformation tested in the survey, while small shares (between 11%-16%) believe or are unsure about at least four falsehoods.

Belief in misinformation is higher among those who say they trust COVID-19 information from conservative news sources, with nearly four in ten of those who trust Fox News (36%) and One America News (37%) and nearly half (46%) of those who trust Newsmax for such information saying they have heard at least four of the falsehoods tested in the survey and either believe them to be true or are unsure if they’re true or false. One thing this study cannot disentangle is whether this is because people are exposed to misinformation from those news sources, or whether the types of people who choose those news sources are the same ones who are pre-disposed to believe certain types of misinformation for other reasons.

This KFF COVID-19 Vaccine Monitor was designed and analyzed by public opinion researchers at the Kaiser Family Foundation (KFF). The survey was conducted October 14-24, 2021, among a nationally representative random digit dial telephone sample of 1,519 adults ages 18 and older (including interviews from 309 Hispanic adults and 305 non-Hispanic Black adults), living in the United States, including Alaska and Hawaii (note: persons without a telephone could not be included in the random selection process). Phone numbers used for this study were randomly generated from cell phone and landline sampling frames, with an overlapping frame design, and disproportionate stratification aimed at reaching Hispanic and non-Hispanic Black respondents as well as those living in areas with high rates of COVID-19 vaccine hesitancy. Stratification was based on incidence of the race/ethnicity subgroups and vaccine hesitancy within each frame. High hesitancy was defined as living in the top 25% of counties as far as the share of the population not intending to get vaccinated based on the U.S. Census Bureau’s Household Pulse Survey.  The sample also included 87 respondents reached by calling back respondents that had previously completed an interview on the KFF Tracking poll at least nine months ago. Another 46 interviews were completed with respondents who had previously completed an interview on the SSRS Omnibus poll (and other RDD polls) and identified as Hispanic (including 23 in Spanish) or non-Hispanic Black (n=62). Computer-assisted telephone interviews conducted by landline (168) and cell phone (1,351, including 1,038 who had no landline telephone) were carried out in English and Spanish by SSRS of Glen Mills, PA. To efficiently obtain a sample of lower-income and non-White respondents, the sample also included an oversample of prepaid (pay-as-you-go) telephone numbers (25% of the cell phone sample consisted of prepaid numbers) Both the random digit dial landline and cell phone samples were provided by Marketing Systems Group (MSG). For the landline sample, respondents were selected by asking for the youngest adult male or female currently at home based on a random rotation. If no one of that gender was available, interviewers asked to speak with the youngest adult of the opposite gender. For the cell phone sample, interviews were conducted with the adult who answered the phone. KFF paid for all costs associated with the survey.

The combined landline and cell phone sample was weighted to balance the sample demographics to match estimates for the national population using data from the Census Bureau’s 2019 U.S. American Community Survey (ACS), on gender, age, education, race, Hispanic origin, and region, within race-groups, along with data from the 2010 Census on population density. The sample was also weighted to match current patterns of telephone use using data from the July-December 2020 National Health Interview Survey The weight takes into account the fact that respondents with both a landline and cell phone have a higher probability of selection in the combined sample and also adjusts for the household size for the landline sample, and design modifications, namely, the oversampling of potentially undocumented respondents and of prepaid cell phone numbers, as well as the likelihood of non-response for the re-contacted sample. All statistical tests of significance account for the effect of weighting.

The margin of sampling error including the design effect for the full sample is plus or minus 3 percentage points. Numbers of respondents and margins of sampling error for key subgroups are shown in the table below. For results based on other subgroups, the margin of sampling error may be higher. Sample sizes and margins of sampling error for other subgroups are available by request. Sampling error is only one of many potential sources of error and there may be other unmeasured error in this or any other public opinion poll. Kaiser Family Foundation public opinion and survey research is a charter member of the Transparency Initiative of the American Association for Public Opinion Research.

This work was supported in part by grants from the Chan Zuckerberg Initiative DAF (an advised fund of Silicon Valley Community Foundation), the Ford Foundation, and the Molina Family Foundation. We value our funders. KFF maintains full editorial control over all of its policy analysis, polling, and journalism activities.

1. For more information, see Sarah E. Gollust, Rebekah H. Nagler, Erika Franklin Fowler; The Emergence of COVID-19 in the US: A Public Health and Political Communication Crisis. J Health Polit Policy Law 1 December 2020; 45 (6): 967–981. doi: https://doi.org/10.1215/03616878-8641506 ↩︎
2. See “Confronting Health Misinformation: The U.S. Surgeon General’s Advisory on Building a Healthy Information Environment” for a recent summary. https://www.hhs.gov/sites/default/files/surgeon-general-misinformation-advisory.pdf ↩︎
3. While the CDC keeps track of the number of COVID-19 deaths, the actual recording of death certificates is done by medical professions and coroners, not the government. For more detail on how COVID-19 deaths are counted, see https://www.aamc.org/news-insights/how-are-covid-19-deaths-counted-it-s-complicated ↩︎

Overview

The Biden administration has stated its intention to help combat the COVID-19 pandemic around the world and recently convened a global summit to set global targets and announce new commitments. The U.S. has pledged more COVID-19 vaccine doses and funding than any other country. In the latest KFF COVID-19 Vaccine Monitor, we find that the public is generally supportive of this work, though more likely to prefer the U.S. playing a major role versus a leading one, and there are partisan differences. When informed that the U.S. has enough of its own vaccine supply, public support for the U.S. taking a major role in global vaccine distribution rises.

Survey Findings

About half of the public (51%) say that the U.S. government is doing enough to help provide COVID-19 vaccines to other countries, while around three in ten adults (29%) don’t think the U.S. is doing enough and another one in five aren’t sure. Across partisans, a majority of Republicans say the U.S. is doing enough to help provide vaccines to other countries (57%) whereas Democrats are more divided (46% say the U.S. is doing enough vs. 43% who say it is not).

When it comes to how much of a role the U.S. should play, 62% of Americans say the U.S. should take a leading or major role in helping provide vaccines to other countries that need them, including 21% who think the U.S. should take a leading role in distribution (a slight decline from 27% in May).

Partisans are divided on the role the U.S. should take in efforts to distribute the vaccine globally with eight in ten Democrats (81%) saying the U.S. should take a leading or major role in assisting with global distribution compared to less than half of Republicans (43%) who say the same. In addition, about seven in ten vaccinated adults (73%), those with college degrees (70%), Black adults (68%), and Hispanic adults (67%) think the U.S. should take a leading or major role.

The share of adults saying the U.S. should take on a leading or major role in the distribution of COVID-19 vaccines globally increased after hearing that the U.S. has enough supply of the COVID-19 vaccines to help other countries without hurting its own supply (75%). Around seven in ten say the same after hearing that providing vaccines to other countries will help the U.S. achieve levels of immunity necessary to curb the pandemic (71%) or that helping other countries vaccinate their populations will reduce the risk of new COVID variants spreading to the U.S. (71%).

The share of adults saying the U.S. should play a major or leading role in international vaccine distribution rose across partisans when presented with each piece of information tested in the survey. After hearing each piece of information, roughly nine in ten Democrats, more than seven in ten independents, and at least half of Republicans said the U.S. should play a major or leading role.

This KFF COVID-19 Vaccine Monitor was designed and analyzed by public opinion researchers at the Kaiser Family Foundation (KFF). The survey was conducted October 14-24, 2021, among a nationally representative random digit dial telephone sample of 1,519 adults ages 18 and older (including interviews from 309 Hispanic adults and 305 non-Hispanic Black adults), living in the United States, including Alaska and Hawaii (note: persons without a telephone could not be included in the random selection process). Phone numbers used for this study were randomly generated from cell phone and landline sampling frames, with an overlapping frame design, and disproportionate stratification aimed at reaching Hispanic and non-Hispanic Black respondents as well as those living in areas with high rates of COVID-19 vaccine hesitancy. Stratification was based on incidence of the race/ethnicity subgroups and vaccine hesitancy within each frame. High hesitancy was defined as living in the top 25% of counties as far as the share of the population not intending to get vaccinated based on the U.S. Census Bureau’s Household Pulse Survey.  The sample also included 87 respondents reached by calling back respondents that had previously completed an interview on the KFF Tracking poll at least nine months ago. Another 46 interviews were completed with respondents who had previously completed an interview on the SSRS Omnibus poll (and other RDD polls) and identified as Hispanic (including 23 in Spanish) or non-Hispanic Black (n=62). Computer-assisted telephone interviews conducted by landline (168) and cell phone (1,351, including 1,038 who had no landline telephone) were carried out in English and Spanish by SSRS of Glen Mills, PA. To efficiently obtain a sample of lower-income and non-White respondents, the sample also included an oversample of prepaid (pay-as-you-go) telephone numbers (25% of the cell phone sample consisted of prepaid numbers) Both the random digit dial landline and cell phone samples were provided by Marketing Systems Group (MSG). For the landline sample, respondents were selected by asking for the youngest adult male or female currently at home based on a random rotation. If no one of that gender was available, interviewers asked to speak with the youngest adult of the opposite gender. For the cell phone sample, interviews were conducted with the adult who answered the phone. KFF paid for all costs associated with the survey.

The combined landline and cell phone sample was weighted to balance the sample demographics to match estimates for the national population using data from the Census Bureau’s 2019 U.S. American Community Survey (ACS), on gender, age, education, race, Hispanic origin, and region, within race-groups, along with data from the 2010 Census on population density. The sample was also weighted to match current patterns of telephone use using data from the July-December 2020 National Health Interview Survey The weight takes into account the fact that respondents with both a landline and cell phone have a higher probability of selection in the combined sample and also adjusts for the household size for the landline sample, and design modifications, namely, the oversampling of potentially undocumented respondents and of prepaid cell phone numbers, as well as the likelihood of non-response for the re-contacted sample. All statistical tests of significance account for the effect of weighting.

The margin of sampling error including the design effect for the full sample is plus or minus 3 percentage points. Numbers of respondents and margins of sampling error for key subgroups are shown in the table below. For results based on other subgroups, the margin of sampling error may be higher. Sample sizes and margins of sampling error for other subgroups are available by request. Sampling error is only one of many potential sources of error and there may be other unmeasured error in this or any other public opinion poll. Kaiser Family Foundation public opinion and survey research is a charter member of the Transparency Initiative of the American Association for Public Opinion Research.

This work was supported in part by grants from the Chan Zuckerberg Initiative DAF (an advised fund of Silicon Valley Community Foundation), the Ford Foundation, and the Molina Family Foundation. We value our funders. KFF maintains full editorial control over all of its policy analysis, polling, and journalism activities.

While rapid home COVID-19 tests have been identified as an important component of controlling the spread of SARS-CoV-2, the virus that causes COVID-19, there have been ongoing supply challenges in the U.S. Challenges in accessing rapid home tests became more acute as the Delta variant took hold, vaccination rates stagnated, and cases, hospitalizations, and deaths surged. In addition, some workplaces began reopening, millions of school age children returned to in-person school and colleges and universities began the fall semester. Home test supply and access challenges in the U.S. contrast with the experience in several peer countries which have made rapid home tests widely available and at little or no cost. The Biden administration has taken recent steps to address these challenges, including a new announcement that it would work to identify manufacturers of high quality tests to encourage them to bring them to the U.S. market and to streamline the regulatory review pathway for authorization of over-the-counter at-home tests, though it is unclear if or how quickly these measures will fully resolve the issues.

In this brief, we examine the various interrelated factors that have contributed to rapid home test scarcity in the U.S. The five factors we identify include:

• The regulatory framework: The FDA regulatory framework and process are central to the availability of COVID-19 testing, including for home testing. However, some argued the framework for evaluating rapid home tests was initially too stringent, creating challenges for manufacturers seeking authorization and hampering test availability.  While the FDA took steps to modify the process, some suggested that the regulatory environment was still too strict. The new announcement that the FDA aims to further streamline the process is likely to address some of these issues.
• Supply chain and the unpredictability of demand: The COVID-19 pandemic has led to supply chain disruptions worldwide, including for tests and their components, negatively impacting test supply. This, coupled with the unpredictability of the pandemic, have made it difficult for manufacturers to gauge demand and at times limited their willingness to scale up production due to perceived business risk, again impacting test availability. Recent steps taken by the administration are designed to increase supply.
• Federal investment: While this may be beginning to shift, the lack of up-front federal investment in testing, including pre-purchasing of tests, is another factor that appears to have impacted testing availability and affordability, and contrasts with the federal government’s approach to vaccines.
• Federal messaging and guidance: Evolving federal messaging and guidance related to the role of testing over the course of the pandemic and limited messaging about home testing may have led to confusion about its importance and impacted public understanding of home testing specifically.
• Cost and coverage: While COVID-19 tests are generally covered by insurance, as required by emergency COVID-19 legislation passed by Congress, and are also available free of charge at many locations in the U.S., this is not the case for over-the-counter rapid home tests. Instead, consumers must pay out of pocket for these tests which can be costly, limiting access and potentially contributing to existing pandemic disparities. Recently, the federal government accelerated purchasing of rapid tests for use in certain community-based settings and negotiating with retailers to lower store prices, albeit for a time-limited period.

Taken together, we identify a number of barriers that have contributed to the scarcity of rapid home COVID-19 tests in the U.S. Recent actions taken by the Biden administration, including steps expected to result in an increase in home test production and to further streamline the authorization process, may alleviate some of these barriers, but others may persist.

Introduction

While diagnostic testing is an important tool for helping to reduce the spread of COVID-19, there have been challenges in scaling up testing in the U.S. throughout the pandemic, and these have been particularly acute in the case of rapid home tests. Rapid home tests, some of which can provide results in as little as 15 minutes, have been identified  as an important public health intervention for controlling COVID-19 transmission because of their ability to be used at home by an individual, provide results quickly, and to identify infection when someone is “likely to be most contagious.” Challenges in accessing rapid home tests became more acute as the Delta variant took hold, vaccination rates stagnated, and cases, hospitalizations, and deaths surged. In addition, some workplaces began reopening, millions of school age children returned to in-person school, and colleges and universities began the fall semester. These challenges contrast with the experiences of several other peer countries which have made rapid home tests widely available and at little or no cost. The UK government, for example, provides up to seven tests per day to those who cannot get tests from work or school and recommends each individual screen themselves twice weekly. Providing up to 7 tests per person allow one individual to collect tests for a whole household.  Germany, until recently, made rapid antigen tests freely available as well (and tests can still be purchased for a few dollars in grocery stores).

President Biden announced early support for rapid tests. The Biden campaign said that if elected it would “Invest in next-generation testing, including at home tests and instant tests, so we can scale up our testing capacity by orders of magnitude.”  The White House National Strategy for COVID-19, released on January 22, 2021, underscored the importance of rapid testing particularly to help “Safely reopen schools, businesses, and travel, while protecting workers” and funding was awarded in February to increase production of at-home tests. But ongoing supply shortages, particularly in the context of Delta, prompted more recent actions. On September 9, the President released a COVID-19 action plan that included, among other elements, the intent to use the Defense Production Act to increase the production of rapid tests; an investment of $2 billion to purchase 280 million rapid point-of-care and OTC at-home COVID-19 tests to be made available in a variety of community settings and long-term care facilities; and an agreement with several top retailers to sell rapid home tests at cost for a three month period. An additional $1 billion investment was announced on October 6 to further mobilize testing production, as well as agreements from some manufacturers to increase production. As a result, the administration expects to double rapid test capacity by the end of the year, from 100 million tests per month to 200 million, rising to 300 million by February 2022.  As part of this effort, in late October, the administration announced additional measures, including a new program which aims to identify manufacturers of high quality tests to encourage them to bring them to the U.S. market, as well as a streamlining of the FDA regulatory pathway. It is not yet clear, however, if these recent actions will fully resolve rapid home test supply and access issues, particularly if there is another surge in cases at some point.

In this brief, we examine the various interrelated factors that have contributed to rapid home test scarcity in the U.S.

Background

The declaration of a public health emergency due to COVID-19, first on January 20, 2020 and renewed every three months since (six times as of October 11, 2021), paved the way for the Food and Drug Administration (FDA) to exercise its expedited emergency use authorization (EUA) process for medical devices, including COVID-19 diagnostics.

To date, the FDA has authorized 16 home tests (several receiving revised EUAs over time) to 11 companies (see Table1). In several cases, one manufacturer has received multiple EUAs for essentially the same product but has different indications in terms of prescription vs. over-the-counter use or with revisions to labeling. Of the 16 tests with EUAs, 12 are OTC while four require a prescription.

The 16 authorized home diagnostics include two types of tests: antigen tests (12 of the 16) and molecular tests (4 of the 16). Antigen tests detect specific viral antigens indicative of SARS-CoV-2, the virus that causes COVID-19. Molecular tests, including polymerase chain reaction (PCR) tests, detect the virus' genetic material (see Table 2). Antigen tests tend to be highly specific (the ability to accurately diagnose negative cases) but are typically less sensitive (the ability to accurately diagnose positive cases) compared with molecular tests. However, antigen tests demonstrate “comparable performance to” molecular tests in “symptomatic persons and/or if culturable virus present, when the person is presumed to be infectious.” They have advantages as well; they have a more simple design and are less expensive than molecular tests, potentially reducing both manufacturing and access barriers, and are available at the point-of-care, including in the home.  Of the 12 authorized antigen tests, 9 appear to have been marketed directly to consumers, while none of the molecular tests have.

The first EUA for a COVID-19 diagnostic test, a laboratory-based PCR, was issued on February 4, 2020. Nine months later, on November 17, 2020, the first EUA for a home COVID-19 test, in this case a molecular test, was issued and the first EUA for a home antigen test was issued December 15, 2020. (See Table 3 for a more detailed timeline of authorization events).

Factors impacting availability of home COVID-19 tests

There are several interrelated factors that impact the availability of rapid home COVID-19 tests. These range from the regulatory environment to the supply chain to federal investment and messaging to affordability. Each is explored below.

The Regulatory Framework

The FDA regulatory framework and process are central to the availability of COVID-19 testing, be that in the home, community, clinic, or laboratory. All tests for COVID-19, including home tests, must go through regulatory review. Recognizing the importance of making safe and effective COVID-19 tests available and to facilitate and streamline the EUA process, the FDA provides manufactures with application templates. Though manufacturers are not required to use these templates, they can expedite the process and they provide agency recommendations for test performance and other elements.

There have been several templates and updates released since the beginning of the pandemic, targeting different types of tests, settings, and strategies. The first template was released in January 2020 for laboratory-based tests, with a template for non-laboratory-based tests, including for home use, coming in July 2020, and one for screening with serial testing (e.g. testing multiple times in a short window to improve chances of detecting infection) in March 2021. Most recently, the first template specifically for home tests was released in early October and then revised at the end of the month in 2021. (See Table 2 for a more detailed timeline.)

The recommendations for test performance continue to evolve over time. Earlier templates for use for rapid home tests set a high bar for efficacy, with FDA generally recommending efficacy quite similar to an “authorized high sensitivity molecular test.” Over time, FDA has changed its recommended benchmarks or created new pathways (e.g. for serial testing for use with asymptomatic individuals) and these changes have coincided with increased home test approval.

Despite these changes in the regulatory framework, however, some have argued that the comparison of antigen test performance to PCR test performance still sets the benchmark too high, making it overly difficult for developers to meet. One rationale behind this critique is that the focus on antigen test efficacy should be on its ability to detect infectious individuals to quickly interrupt onward transmission. Others disagree and suggest that while antigen tests perform well at detecting infectious individuals, they should not be used for assessing infectiousness on their own. CDC has found that Abbott’s antigen, “BinaxNow [test] performs better at identifying rRT-PCR–positive specimens with lower Ct (suggestive of higher viral loads) and positive viral cultures” but it warns “these factors are not precise proxies for infectiousness.”

Indeed, the U.S. recommendations are higher compared to standards in some peer countries, such as  the UK. To the extent that FDA regulatory requirements are a barrier for companies to submit requests for EUAs, fewer tests with authorization could lead to decreased competition in the marketplace, potentially impacting both cost and availability. On the other hand, whether a lower standard would negatively impact test quality, and by association the ability to control the pandemic, is unknown.

While the FDA has not suggested it will lower the recommended threshold for tests, on October 25, 2021, HHS announced that the NIH “would establish an accelerated pathway to support FDA evaluation of tests with potential for large-scale manufacturing” through its new Independent Test Assessment Program (ITAP), an extension of its Rapid Acceleration of Diagnostics (RADx) initiative. HHS states the program, which will be a collaboration of NIH, FDA, and CDC and other HHS experts will “identify manufacturers of high quality tests and encourage them to bring those tests to the U.S. market, increasing options for people and overall supply and potentially lowering costs.” Companies will receive support to “help ensure they are providing the best submissions possible for FDA’s regulatory review” and scalable OTC tests will be prioritized. In addition, FDA made changes to the regulatory pathway for OTC home tests currently authorized only for serial testing by revising recommendations to allow for single-use testing for symptomatic individuals. This reduces the amount of data developers would need to submit and allows them to sell certain tests currently sold as two-packs as singles, potentially leading to more individual tests being available for sale at a lower price.

Finally, just because a test has an EUA does not mean that it will circulate widely in the consumer market, as we have seen with some of the antigen and all of the molecular tests with EUAs for home use, suggesting that regulatory issues alone are not the only factors in test availability.

Supply Chain and the Unpredictability of Demand

The COVID-19 pandemic has led to supply chain disruptions across the world, and this has, in some cases, included the raw materials needed to manufacture COVID-19 diagnostics. Certainly that both the Trump and Biden Administrations have leveraged the Defense Production Act (DPA) to support testing, including Biden’s use of the DPA for home tests, and address other supply shortages, such as for personal protective equipment, is suggestive of challenges in the production and availability of these essential goods.

Additionally, a review of testing manufacturer Securities and Exchange Commission (SEC) filings reveals concerns about supply chain with respect to raw materials and diagnostic components:

“As a result of the COVID-19 pandemic, we have seen delays in receipts for certain raw materials and components for our products. Such delays can result in disruption to our business operations….We cannot currently predict the frequency, duration or scope of these government actions and any supply disruptions, and the availability of various products is dependent on our suppliers, their location and the extent to which they are impacted by the COVID-19 pandemic, among other factors. …Our inventory levels may fluctuate due to supply chain variability in conjunction with larger and more frequent customer orders.” - Quidel Q2 2021 10-Q SEC filing

 “Due to the significant uncertainty that exists relative to the duration and overall impact of the COVID-19 pandemic, our future operating performance, particularly in the short-term, may be subject to volatility. In this regard, we continue to see challenges posed by the pandemic to global transportation channels and other aspects of our supply chain, including the cost and availability of raw materials. As noted above, the pandemic continues to impact demand for certain of our products. The U.S. and other governments may enact or use laws and regulations, such as the Defense Production Act or export restrictions, to ensure availability of needed COVID-19 testing and vaccination delivery devices. Any such action may impact our global supply chain network.” - Becton, Dickinson and Company (BD) Q2 2021 10-Q SEC filing

Further, as manufacturers began securing EUAs for their at-home diagnostics, the pandemic appeared to be shifting, at least domestically. Vaccines were becoming more widely available, soon places of business and entertainment would start opening up, and the Delta variant had not yet taken hold in the United States. However, the landscape quickly reversed as vaccination rates stagnated and the more infectious Delta variant become the dominant strain in the U.S., resulting in increased cases, hospitalizations, and deaths. Investor calls and SEC filings by manufactures regarding testing overall, as well as home testing specifically, discussed this uncertainty, noting how an inability to predict the arc of the pandemic made assessing future testing demand difficult.

“Our financial performance and results of operations will depend on future developments and other factors that are highly uncertain, continuously evolving and cannot be predicted, including the duration of the COVID-19 outbreak, the severity and continuation of outbreak surges, actions to contain the spread of the virus such as mask wearing, social distancing and vaccination efforts globally, and the impact of these and other factors on testing demand.” – Quidel Q2 2021 10-Q SEC filing

“The real… factor here becomes COVID testing...that’s really the question here. How will testing play itself out in the second half here whether its variants, whether its vaccination rates, etc so that’s just something we are paying attention to…that’s why our guidance rage was pretty wide, to really account for that.” – Abbott Q2 2021 earning call

Indeed, Abbott’s decision to pull back on COVID-19 test production leading into the summer has been widely publicized and SEC filings indicate that this was related, at least in part, to a belief that the course of the pandemic had shifted and there was a reduced need for tests.

“On May 27, 2021, Abbott management approved a restructuring plan related to its Diagnostic Products segment to align its manufacturing network for COVID-19 diagnostic tests with changes in projected testing demand driven by several factors, including significant reductions in cases in the U.S. and other major developed countries, the accelerated rollout of COVID-19 vaccines globally and the U.S. health authority’s updated guidance on testing for fully vaccinated individuals.” - Abbott  Q2 2021 10-Q SEC filing

As a result, by the time the demand for rapid home tests began to increase, due to rising cases, hospitalizations and deaths, re-opening workplaces, and the return to in-person schooling for millions of elementary school students, the supply was not there. The new federal ITAP effort is designed to help increase supply by seeking additional manufacturers to bring tests to the U.S, market and could help to address some of these barriers.

Federal Investment

The lack of up-front federal investment in testing, including advance purchasing of tests, is another factor that appears to have impacted testing availability and affordability. Whereas the federal government channeled billions of dollars into accelerating vaccine development and advance purchasing of millions of doses, which helped to mitigate manufacturer risk and allowed for vaccines to be provided at no cost to all in the United States, no similar strategy was undertaken for testing. Without such up-front investment, the risk and cost of scale up was largely placed on manufacturers, who might be reticent to do so in the face of uncertainty given their fiduciary responsibility to shareholders. As noted, this differs from the experience in the UK and Germany where governments simultaneously supported vaccination and home testing efforts.

The Biden Administration’s use of the DPA in September to spur more domestic production of rapid tests and its procurement of additional rapid tests injected new investments in this area.  Since then, HHS announced contracts with Abbott, Celltrion, OraSure, Quidel, and Acon Laboratories. And, on October 6, 2021, the White House committed another $1 billion towards rapid tests to “further mobilize testing manufacturers…to expand production of tests…based on the United States government’s commitment to procure an additional 180 million rapid tests over the course of the next year.” Much of these new procurements will provide free and increased rapid testing to community sites and long-term care facilities, designed to reach high needs populations in specific settings, but not necessarily increase supply for consumers.

As mentioned above, this additional investment is expected to result in a supply of 200 million rapid antigen tests per month by December, and 300 million by February 2022.  Some experts recommend, however, that rapid antigen testing be conducted once twice or even three times per week to optimally help to identify those who are infectious and interrupt onward transmission. In response to a recent study, an NIH official stated that “Rapid antigen testing at home, two to three times per week, is a powerful and convenient way for individuals to screen for COVID-19 infection,” further noting that “With schools and businesses reopening, an individual’s risk of infection can change from day to day. Serial antigen testing can help people manage this risk and quickly take action to prevent spread of the virus.” Indeed, many colleges and universities have adopted this approach to curb spread. Yet, the new U.S. investment, even if resulting in 300 million rapid tests per month, would be less than one test per month per person in the U.S. For two times per week testing, it would cover less than 40 million individuals. If everyone older than 11 were tested twice per week per the UK’s recommendation, we would need 2.3 billion tests per month. If just half the U.S. population tested weekly, that would translate to a need for more than 150 million tests per week, around 600 million per month. The recent announcement of the new federal ITAP effort invests an additional $70 million and could help to increase supply in the U.S. market, though how quickly is uncertain.

Federal Guidance and Messaging

One other challenge has been federal messaging and changing guidance related to the role of testing as part of the U.S. COVID-19 response over the course of the pandemic. This included mixed messages and changing recommendations during the Trump administration, including down-playing of the importance of testing and shifting guidance from the CDC during vaccine roll-out.

Before vaccine roll-out, in late 2020 CDC’s testing guidance was that “people who have had close contact (within 6 feet for a total of 15 minutes or more) with someone with confirmed COVID-19” should get tested. Then, as of  March 17^th 2021, when vaccines were starting to become more widely available to all adults in the United States, case rates were down, and Delta had not yet taken hold, CDC stated that “fully vaccinated people with no COVID-19 symptoms do not need to be tested following an exposure to someone with COVID-19.” Just a few months later, however, in early August 2021, the CDC again changed its guidance to recommend testing for fully vaccinated people following exposure: “fully vaccinated people should be tested 3-5 days following a known exposure to someone with suspected or confirmed COVID-19.” While this shift in messaging was responding to a rapidly changing pandemic and new evidence on an emerging and evolving disease, industry communications indicate that it had an impact on manufacturing:

“While we expect to close more accounts with employers and have several promising partnerships in the pipeline, they involve a good deal of blocking and tackling and are very hard to predict or value especially when guidance from CDC and the landscape of COVID testing seem to evolve daily. Recently the warning from public health officials that vaccinated people can become infected and spread the highly contagious delta variant of COVID-19 appears to be a near term driver for more masking and testing especially as schools and office look to reopen in the fall.” – Quidel Q2 2021 investor call

And as noted above:

“…changes in projected testing demand [are] driven by several factors, including significant reductions in cases in the U.S. and other major developed countries, the accelerated rollout of COVID-19 vaccines globally and the U.S. health authority’s updated guidance on testing for fully vaccinated individuals.” - Abbott  Q2 2021 10-Q SEC filing

Beyond impact on industry, shifting messaging could have affected public understanding of testing and confidence in agency recommendations. More broadly, the CDC has provided limited guidance on the role of home or routine testing, as a public health tool in addressing the pandemic and how it may differ from testing in other settings. Guidance on preventing COVID-19 has focused on vaccination and the CDC page on COVID-19 testing is aimed at those who are at risk for infection, symptomatic or are traveling with no information on testing routinely or as a public health practice. In the How to Protect Yourself and Others factsheet (last updated in August 2021), there is no mention of how testing may be a tool in the pandemic response. Similarly, the home testing page focuses on testing among those who may be at risk for having COVID-19, and suggests that home testing may be something to pursue if you cannot get tested by a provider: “If you need to be tested for COVID-19 and can’t get tested by a healthcare provider, you can consider using either a self-collection kit or a self-test that can be performed at home or anywhere else.” CDC guidance on testing in schools and workplaces is more comprehensive in its discussion of tests as a public health or screening tools but is limited to those settings. The limited information on home tests and little explanation of their role as a public health tool for home use may impact public understanding of home testing and willingness to use rapid test kits. However, a recent FDA press release for a newly authorized home antigen test states that the agency “considers at-home COVID-19 diagnostic tests to be a high priority and we have continued to prioritize their review given their public health importance.”

Cost and Insurance Coverage Considerations

Cost may also be a barrier to accessing OTC rapid home tests. Domestically available OTC tests typically range from $14 for two tests, or $7 per test, to $38.99 per test.¹   If a consumer wanted to test regularly, even the least expensive test ($14 for two tests) used twice a week would amount to $728 per year, assuming they could get tests in this quantity. The more typical (non-discounted) price would cost an individual more than $1,000 per year, and the most expensive test used twice a week would amount to over $4,000 per year. Elsewhere, outside the U.S., home tests are about a dollar and in some cases, like in the UK, Israel, and Singapore, free to all or many people.

While federal COVID-19 legislation ensures that a range of tests are available free of charge through insurance, federal guidance indicates that home tests are only required to be covered if “ordered by an attending health care provider who has determined that the test is medically appropriate for the individual based on current accepted standards of medical practice and the test otherwise meets the statutory criteria.” Further, if OTC home tests were covered by commercial insurance, it could be logistically cumbersome for an individual testing regularly to seek reimbursement each time.

The new ITAP aims to bring more tests to market which could increase competition and decrease costs. In addition, the revisions to the FDA pathway to allow for the sale of certain single use, rather than serial, tests could decrease the purchase price for some consumers. However, the real impact of these changes is yet to be realized.

Finally, even if supply problems are solved, cost could remain a barrier for some. Unless there is widespread scale up with multiple access points and free or truly inexpensive tests, disparities in terms of diagnosis and community transmission that already exist could be exacerbated. Some of these issues may be alleviated by recent federal investments to provide free rapid testing to certain community sites but that has yet to be proven.

Looking Ahead

Taken together, there are multiple interrelated factors that have contributed to the lack of availability of rapid home tests in the U.S., including the regulatory framework, supply chain and demand issues, federal investment, federal messaging, and affordability. Recent actions by the Biden administration are likely to help alleviate some of these challenges though it is not yet clear if they can fully resolve the issues. Even if scale-up hits the projected increase in supply to 300 million rapid tests per month by early next year, this would translate into less than one test per individual per month, not enough to test most people weekly as some recommend. Additionally, even with scale up and more widespread retail availability, cost will likely persist as a barrier for many people, and could run the risk of exacerbating existing inequities in the pandemic. It will also be important to monitor whether the growing vaccination or testing requirements from employers and other places of business/entertainment will generate more demand for tests and stress the already limited supply. As has been the case since the early days of the pandemic, the future of COVID-19 in the United States, from case load to vaccination to testing is hard to predict. More widespread use of testing, and home testing in particular, could help to address the pandemic in the face of ongoing uncertainty.

1. Prices come from searches for OTC COVID tests conducted twice a day over a week period (between September 21 and 27, 2021) on Amazon, Walgreens, CVS, Kroger, Target, and Walmart websites. ↩︎