As the preceding pages have demonstrated, I’m a big believer in the adage that where there’s a will, there’s a way. My personal version of that cliché goes on to add, “and comprehensive data will show us the best way.” I was no more relentless in tracking data once I was out of the White House than I was while there. The Biden data team was still updating and maintaining the HHS Community Profile site and all the state profiles from the governor’s reports that we had quietly put up in December 2020. All Americans continued to be able to track the pandemic’s status in their county and across the United States in real time. I used this data and triangulated the global data in my ongoing communications with some on the task force, on webinar after webinar, and in private conversations to help guide friends, family, and anyone else I spoke with about layered protection and pandemic preparedness. The data had shown us the way in 2020 and it was showing us the way in 2021, and it is still showing us the way in early 2022.
While the virus was silent, the numbers spoke clearly to guide us out of what felt to many of us like a recurring bad dream. Many believed: Once Trump is out of office things will get so much better. Once we get vaccinated, we’ll be able to go back to doing what we did before. The summer of 2021 would be different. This Thanksgiving will be different. This Christmas will be different. This will all be over soon.
I would never suggest that hope isn’t helpful or that we haven’t made strides in tackling this pandemic. That is a realistic assessment, but so is the reality that too many people continue to die, with each surge we do a little worse than our colleagues across the ocean, and some have grown so weary of the pandemic that they appear to be willing to accept an excessive number of preventable casualties from this crisis. Hoping we can learn to live with the pandemic no matter the consequences, or accepting that we have to learn to live with it, and figuring out how to live with it as safely as we can as a country are very different approaches to this ongoing public health crisis.
I don’t hope we have the answers to how to live with it. I know we do. The data has shown us the way forward using commonsense mitigation. Many obstacles continue to exist that prevent that message from being made clear. Some of them have their roots in politics, some in ineffective communication on the benefits of various public health measures, some in our collective failure to account for the variability in human experience and opinion in a socially and geographically diverse country, and some are the result of the desire to find blame and not offer effective solutions.
Some people might say that in my time serving as the White House Coronavirus Task Force coordinator, I didn’t really live the experience that most Americans did from the start of 2020 to the start of 2022. That’s wasn’t true then and it’s not true now. I understand and have felt the frustration and anxiety people have experienced as a result of the government’s response to the pandemic.
The Biden administration hit the ground running in January 2021, focusing their efforts on consistent messaging and ensuring access to vaccine supplies across the United States. The Biden Covid-19 plan was thoughtful and comprehensive—espousing the need to continue to expand testing, and the use of proactive testing, and continued expansion of critical therapeutics as well. After the inauguration, the Biden administration turned their full attention to effectively rolling out vaccines, and so did my family and I. We spent weeks getting an appointment for my mother and father, aged 91 and 96 respectively, in the state where they now lived—Maryland. (I could have gone elsewhere and skirted the rules but opted not to.) Frankly I wanted to see what everyone was up against. Unable to successfully navigate the online process myself, my Millennial children took over. They determined that their phones refreshed faster than my laptop and used them to secure those precious slots.
We weren’t alone in facing and overcoming that challenge. Nor were we the only ones overcoming the difficulties of physically assisting aging parents or grandparents, weakened by a year’s isolation, to vaccination sites that we had to drive to, getting them in and out of the car, to face long lines, dozens and dozens of masked people, with few accommodations being made to account for their diminished mobility. It was a nightmarish scenario for them, but they managed, knowing, as so many other vulnerable Americans did, that the vaccine was a potentially lifesaving measure. I remember sitting with them, during their post-immunization wait time, and wondering about the elderly who didn’t have the extensive support system that my family provided. How would I manage if I had a condition that caused shortness of breath or was in memory care and was told to wear a mask?
I also wondered, as did so many of you: Did every part of this have to be so hard?
The effort and the discomfort were well worth it. But I understood that vaccinations alone weren’t the answer to protect my parents and other family members. I was worried about my parents’ ability to even mount an effective immune response. None of the rest of us, their caregivers, were immunized. I also worried, regardless of a person’s age, whether their immunity, if they developed it, was going to wane over time. At first, resistance to infection would decrease, followed by, in some, a decline in the immune system to ward off significant disease. The original vaccine trials, while large, were short, and most volunteers were only four to six months post two shots. I feared that not everyone was made aware of and fully understood those concepts, because that message wasn’t conveyed clearly. Ultimately my fears were realized.
Reviewing data from around the world both in the vaccinated and unvaccinated in late 2020 into early 2021 painted a clearer picture. The immunity induced after natural infection waned. There was a clear periodicity to the surges and increasing reports about reinfections with each surge from South Africa and other countries. With some viruses, like measles, mumps, and rubella, that initial infection in nature results in years of protection. Many Baby Boomers will remember measles and mumps infections—they were once and done occurrences. The vaccines for measles, mumps, and rubella were created to mimic the long-term protection provided by natural disease. But there are other viruses where natural infection does not result in long-term protection against reinfection. This was clearly the case with this SARS-CoV-2 virus. Natural infection immunity waned and reinfection was not only visible but increasingly common. Vaccines created to mimic this immunity will also wane, lessening the level of protection against infection. So, even the vaccinated could contribute to community spread. It wasn’t just the unvaccinated who were responsible for ongoing transmission of the virus. (Although not as clear, it appeared that there was longer-lived protection against severe disease with prior infection.)
Once again we were slow to act to this global evolving picture. We continued to under-test. We didn’t actively look for those mild and asymptomatic “breakthrough” infections in vaccinees. Once again our data didn’t keep pace with the virus. We kept talking about herd immunity and percent vaccinated. It became clear, after we’d analyzed the global data (since we didn’t collect domestic data on mild and asymptomatic vaccine breakthroughs) that immunity against infection wanes. We were late in recommending boosters because we didn’t have a correlate of protection. We didn’t communicate effectively why they were so needed. Indeed, late into the fall of 2021 many were still talking about the rarity of breakthrough infections—rare only because we weren’t testing and measuring the breakthroughs in this group and not because they were happening infrequently. We were neither telling Americans with prior Covid-19 infection that they were susceptible to becoming reinfected and they may become infected, asymptomatically or mildly and, crucially, nor that they were at risk of infecting others. Fortunately, many colleges continued to require weekly testing of all their college students and they found the breakthrough infections and they were not uncommon, just less symptomatic.
The net effect of this was that the same cycle of silent invasion was recurring.
As was clear in the summer of 2020, and with every surge onward, when there is widespread community viral spread the virus makes its way to the susceptible and vulnerable, both unvaccinated and vaccinated individuals in nursing homes and in the community, resulting in hospitalizations and deaths. Many people, pundits and public health officials alike, focused on the unvaccinated hospitalizations and deaths and didn’t address the mild infection rates in those vaccinated who could infect others. Regardless of vaccination status, people needed to hear that the way to protect the vulnerable remained what they’d been doing for the past year or more—getting tested, using masks, and restricting the size of gatherings. And there was a clear difference in the risk that remained to the vulnerable, especially the unvaccinated, and clear commonsense recommendations should have been made in the summer of 2021 to protect those who were unvaccinated to ensure rapid treatment with antivirals. While our understanding of the virus had changed, while the virus itself had mutated into different variants, those fundamental mitigations were still highly effective. What wasn’t as effective was the protection the vaccines offered against infections six months later.
Many didn’t see this evolution in the pattern, but it was there. In the summer of 2021, when vaccines were still highly effective in those who’d gotten theirs in the spring, the hospitalization data revealed that 99 percent of admitted patients were unvaccinated. Later, that number fell to 85 percent. Yes, far fewer vaccinated individuals got sick, but the highest rate of hospitalizations remained for those over sixty and seventy (over 22 percent of Americans), just as it had during each and every surge. Although due to vaccination, antivirals, monoclonal antibodies, and advances in care many would survive that hospitalization, hospitalization among the elderly significantly impacts future life expectancy. Older Americans are just not as resilient. That trend in hospitalizations was significant, worrisome, and predictable.
Still too many people were surprised that vaccinated people were getting sick. How could that be? they wondered. Without remaining in a higher state of vigilance and employing the basic mitigation measures, it couldn’t have gone any other way. Simple moves like requiring every vaccinated person to read and sign a form that spelled out clearly what these vaccines were studied to do and not do, having those administering the shots reinforcing that basic information prior to or after the jab: “We don’t know how long the protection against infection will last. We believe that you will be protected from severe disease but we are studying the rest. You could get infected. You could potentially spread the virus to others even if you don’t get very sick. We advise you to continue to take the same precautions as before to protect the vulnerable in your household and when you gather.”
Doing that would have gone a long way toward preventing what I experienced at a Walmart store in Berlin, Maryland. I saw an older woman in a wheelchair, moving down the aisle unmasked. I politely asked her why she wasn’t wearing one. “Oh, I’m vaccinated. I won’t get infected.” That same scenario played out countless times in different parts of the country as I traveled. People believed they were invincible. Families believed their grandparents were protected and weddings and gatherings increased in frequency across the United States.
Throughout the fall of 2021 on webinar after webinar speaking to workplace groups, I talked about waning immunity against infection and the potential that the vaccinated were a part of the chain of transmission in the workplace. Each time, those on Zoom were shocked. They believed they were protected completely—both from infection AND severe disease—and didn’t need to mask anymore during viral surges. The CDC, in a significant public health stumble, told the vaccinated that they no longer needed to wear masks, reinforcing that sense of invincibility. Too late, the CDC altered that message, as it had about waning immunity, but by the time they did so the resulting confusion was already at work, just as the virus was.
Along with that, in some circles the concept of herd immunity was still being promoted. Moving forward, it is crucial that we understand that this phase requires us to be aware of the need to protect from severe disease—among the general population and particularly among the most vulnerable. The number of those susceptible to severe disease and hospitalization due to SAR-CoV-2 has significantly declined. The small but not insignificant group without an adequate immune response to the vaccine and those that remain unvaccinated still need to be protected.
As much as I welcomed the rise in the number of vaccinated individuals, I worried because the continuously rising slope of testing we had created throughout the summer and into early winter of 2020 began to immediately decline. We had succeeded in establishing testing per population rate that was on par with the United Kingdom. But that bottomed out at a record 12-month low in the summer of 2021, falling from a peak of nearly 2 million per day in 2020 to 300,000. Of course case counts declined as a result.
Testing was so low before the summer surge of 2021, the test positivity rate rose rapidly across the Sun Belt as the Delta variant exploited the increased frequency of indoor gathering due to the heat. But it was more than that. Quietly, vaccine protection against infection was waning, as were mitigation efforts. The CDC implied in their messaging that vaccines alone would be enough to protect the vaccinated against any infection and then, by saying that the vaccinated do not need to mask, cemented that concept across the country.
On May 13, when the CDC director announced that the fully vaccinated no longer needed to wear masks, she characterized this as the moment “we all longed for.” She went on speaking about how the downward trajectory of cases, the vaccine’s performance, and the better understanding of how the virus spread all contributed to making this “unmasking” guidance possible. She was right about the longing, but wrong about the reasons that underpinned this change in guidance. This was the exact moment that I had feared would come. I dreaded the consequences of its arrival. Time after time we got ahead of ourselves with this virus and then suffered the consequences. We believe we know more than we do. We react too early, and incomplete data combined with hopeful thinking leads to premature or just plain wrong decisions, eroding trust in public health overall.
Once again, we didn’t have eyes on that early silent invasion that could only have been made visible through aggressive testing. With that single CDC announcement on masking, overnight far too many of the vaccinated and unvaccinated stopped wearing masks indoors right before the massive spread of the Delta variant in the South—the variant we could see coming from the UK. Critically, those who had been careful throughout the first fifteen months of the pandemic due to underlying conditions now believed they were invincible if vaccinated. Many of those careful individuals were the first in line for vaccination in January and February, and as a result, by July, many of the vaccinated, including those in the South, had waning protection against infection, while others may never have developed an adequate immune response from the vaccine. This subset of individuals were not only susceptible to infection but to severe infection, hospitalization, and death. Yes, the severe illness in the vaccinated elderly was a small component of the total number of hospitalizations and deaths, but we could have protected them better. We could have learned how to protect those over seventy and those with immunosuppression in that summer surge of 2021, and carried that important knowledge into the fall and winter of 2021. The same series of events that haunted our response from January 2020 had been repeated. Essentially, the CDC was saying what President Trump and other officials were saying then: You are low risk. Drop your guard (instead of not raising it, as had been the case in 2020) and go about your business as before. No need to mitigate at all if vaccinated. You can’t get infected, you can’t infect others, your grandparents and those on cancer treatment are safe. Everyone can exhale after eighteen months of holding our collective breath.
I continued to integrate the data and could see from the curves that vaccinated individuals across the South must be contributing to the community spread. I called and wrote to those still in the federal fight and in the media off the record—something I only did rarely and with full knowledge of White House Comms staff while in the White House. With the CDC telling states that they weren’t going to collect data on asymptomatic and mild SARS-CoV-2 infections post vaccination, states didn’t recommend any testing of vaccinated individuals, which further contributed to community spread. Also, vaccinated individuals, believing that a bad cold had to be something else, waited until they were really sick to come forward, substantially diminishing the effectiveness of our therapeutics. Vaccinated individuals were gathering unmasked indoors, creating superspreader events, thinking all the while Grandma was protected and none of them could possibly be infected. The vaccinated grandma got sick and died.
People presented late because they weren’t tested early.
Maskless vaccinated and unvaccinated silent spreaders were back in full circulation, contributing to community spread.
Surveillance testing wasn’t in full use and wouldn’t find the silent spread.
The virus invaded communities.
Another 135,000 American lives were lost in the summer surge of 2021.
That was the truth.
Through the spring, summer, and fall of 2021, I was again traveling the country. Every place I went I talked with people and they were shocked that so-called “breakthrough” infections were occurring. They were really only seeing the tip of the iceberg, as many of the post-vaccine infections were so mild many thought they had a cold. Others had no symptoms at all. Without testing they never thought they had become infected with SARS-CoV-2, after all, they’d been vaccinated. Their rationale to me was the CDC said the vaccinated do not need to wear masks anymore because we cannot get infected and we cannot pass the virus to others or they wouldn’t have told us not to mask.
But no one should have been surprised that protection against infection waned, because they should have been told from the onset that this was not just possible but likely, especially as the predictable, more transmissible variants came to our shores—Delta and then Omicron. The 95 percent efficacy rate of the Pfizer and Moderna vaccines in clinical trials was against symptomatic infections of the original virus. Also, as in many clinical trials, these were biased results from a study of a highly selected group of volunteers, most with intact and robust immune systems. The truly vulnerable—those in nursing homes, those in their eighties and nineties, those in memory care who couldn’t wear masks, those with significant immunodeficiencies, those undergoing cancer treatments, and those on immunosuppressants, from steroids to the new biologics, were not in the trials. The older individuals in the trials were “healthier” than many of their contemporaries who were not physically capable of making all of those vaccine trial appointments.
Even with this healthier subgroup in the most highly controlled conditions possible, 5 percent of the recipients did develop significant illness, although all were protected from death. In real-world conditions, that number could be expected to rise as high as 15 to 20 percent in the highest risk group, those over seventy, resulting in hospitalizations and potentially but rarer fatalities. The implication that these vaccines could and would induce sterilizing immunity—prevent the vaccinated from even getting a silent or a mild infection—was not fully explored in the real world in that moment. Some made assumptions. Some public health officials without complete data made that assumption. Down the line, without required weekly testing we didn’t measure the asymptomatic breakthroughs that could potentially contribute to community spread.
The harsh reality was that silent spread could occur even among the vaccinated. It is normal and expected that our neutralizing antibodies wane. We can’t have our B cells constantly churning out a high concentration of antibodies for every vaccination we have received throughout our lifetime. It’s why we have a memory immune system—a sophisticated system that can immediately, within hours to days of encountering that pathogen, regenerate high levels of protective antibodies and initiate a full cellular immune response and clear that virus. That is how it works in most of us, but it may not work that way in the vulnerable aged and immune-suppressed vaccinated. They should have been warned that during viral surges in the community they needed to continue wearing masks and taking other precautions.
Requiring a vaccine to prevent even that first small initial invasion of the virus and initial replication is a very high bar, and if natural infection doesn’t produce long-lived sterilizing immunity to reinfection it is very difficult to design a vaccine that does. In the original trials, asymptomatic breakthroughs were not systematically measured. What I had been working so hard to do for so long was to make clear to the Trump administration, and later through back channel exchanges with others, this very message, so it could be effectively communicated to the American people. The vaccines were a cause for celebration because far fewer Americans would get seriously ill and, critically, those with an immune response wouldn’t die. But we still needed to balance the joy of personal protection with the tempered reality of what these vaccines could do and not do. Vaccinated people can infect their loved ones. Perhaps next generation vaccines will be created that produce long-lived immunity to any infection; perhaps an intranasal vaccine to produce high levels of mucosal immunity through generation of local IgA will be the development that will aid those who are needle averse.
Moving forward, we have to learn from these mistakes. CDC guidance and other communications must consistently be based on evidence or, in the cases when that evidence base is being developed, the CDC must explicitly alert the public to the provisional nature of its recommendations and clearly state what is known and not known—what data they are still collecting—and share all the data so every American can look at the data for themselves and make decisions based on all the information. Americans can handle nuance. They can understand that at a point in time this is the CDC’s best judgment and they are working to get definitive evidence.
The CDC and NIH could have created a curriculum for each grade level so schools had an opportunity to seize a teachable moment about the nature of viruses, the immune system, and vaccines. I am sure some teachers did this on their own, but going forward, teaching these scientific concepts in the context of this pandemic is another way to ensure these important concepts get disseminated among younger people early. As is true with so many things, behavioral change begins with knowledge. We can’t continue to rely on people becoming so uncomfortable—due to direct exposure to the devastating effects of trauma, like this one has produced—in order to initiate change in behavior, in how we educate our young people, and in how we as adults respond to new situations that require us to learn. Also, SAMSA and the NIH needed to take the lead on developing comprehensive mental health studies of students across all ages to understand the kinds of mental health support students need to aid them in negotiating a very stressful experience. The same is true of college-age people. So many of us struggled, but understanding the effects on younger people, those with addiction issues, and other vulnerable cohorts of the population is essential to an effective defense against potential collateral damage.
Many of the CDC’s communication missteps were due to lack of data or the utilization of incomplete data. They lacked the real-time data from across the country representing all ages, races, ethnicities, and medical conditions. It is not that the employees at the CDC aren’t dedicated and hard working, but they needed to ensure that all the possible outcomes and impacts were considered and whether the data was robust enough to make such definitive statements. They lacked the behavioral research.
The CDC must engage in directly, or provide grants to behavioral science experts, including marketing specialists, to develop clear strategies to deal with vaccine hesitancy to increase uptake. Implementation of a plan is where the proverbial rubber meets the road. The CDC must engage in implementation science to a far greater degree than it ever has in the past to ensure that its evidence-based guidance is practical and can be implemented on the ground. They also must develop mechanisms to evaluate the outcomes and impacts of all guidance they issue (using real-time data across America, not isolated substudies out of convenience). Those outcomes must be evaluated not only at the broad, national level. They must be done at the state and local level to best reflect the very real local geographic and demographic differences within our country’s regions. A country as vast and as diverse as ours necessitates gathering huge amounts of data that is reflective of that degree of diversity.
TRACKING THE PANDEMIC, DOMESTICALLY, globally, and personally, trying to make sure the rest of my family (except for the three grandchildren under five) was immunized in sequence with the CDC guidelines, took me into late spring. From tracking domestic and global data I learned a lot that kept my family Covid-free, and public health agencies should have been discovering, researching, and appropriately implementing much of what I believed we were both analyzing and projecting. Yes, we worked outside the home, yes, we traveled for work and went into public spaces, yes, we went on vacation, yes the grandchildren went back to preschool; but at this writing my family heeded the call for layered protection—just those extra commonsense steps have kept my family Covid-infection free. We had to because we have very vulnerable family members in each and every one of our collective households.
It was also clear that many states, both red and blue, were having difficulty following the complex tiered vaccine guidelines. It was also evident that those with early high immunization rates were the leaders of states willing to adapt and simplify those guidelines. But the massive early rush for vaccines in the highly motivated was hiding the depth of the underlying hesitancy. Well before the vaccines were rolled out, well before the pandemic began, even, the CDC and the FDA and other agencies should have been working to gather data on how to improve adult immunization uptake. We didn’t know what drove some people to get vaccinated and, critically, what caused others to pass and not get the flu, pneumococcal pneumonia, or other adult vaccines. If we had been armed with the data of who was missing from annual flu vaccination and had developed clear solutions to address those very evident gaps, and removed barriers to vaccine access, and shown progress each and every year in adult immunization rates, we would have had a critical road map to follow to reduce Covid-19 hesitancy and we would have been in a different place in early 2021, with a clear plan, community by community, to roll out the Covid-19 vaccine. Having been out in the states, I believe the underlying and unstudied reasons for not being immunized were as diverse as the composition of our country’s population. This lack of understanding, lack of data, and lack of solutions continues to haunt our pandemic response.
As the months moved on, out of frustration some railed against the vaccine hesitant, pointing fingers at them, demeaning their intelligence. With each negative comment that cascaded across the airwaves and social media, unvaccinated Americans were being pushed further to the margins. I was reminded of years of battling HIV, TB, and Ebola. Creating a hostile environment, alienating people who may have clear concerns, not listening, not hearing, and not addressing their concerns leads to less compliance with public health guidance, not more. Blaming others for behaviors and choices never changed minds or moved us forward in any pandemic, ever. As before, among the measures I recommend to improve this pandemic response and future ones, I call for a rigorous study of vaccine hesitancy across all demographics, including race and ethnicity, and urban/rural geography. This study and the insights gained must be one part of a multi-faceted revision of the pandemic preparedness plan.
While vaccines were rolling out, no one was out in the states listening and learning what was working and not working. Instead of finding out what was happening in rural America, there was further politicization and polarization of the pandemic and vaccination specifically. The majority (two-thirds) of counties in America are red counties by voting choice. But more important than how one votes, many are rural counties that for decades have not had access to routine primary health care. In public health lingo we say these Americans don’t have a “health home” where they receive routine checkups with a primary care physician, nurse practitioner, or physician assistant. I would listen to some of the experts on the nightly news talk about getting information to American’s primary (family) doctors. We were decades from the reality of family doctors and the rural local physicians. Rural residents often had to make choices between driving hours to the emergency room or going to work to support their families.
With Covid-19 disease, as with many prior medical issues in their families, they would wait to see “if it improved on its own,” delaying care and ensuring many rural residents had a poorer response to Covid-19 infections. Rural counties knew they were far beyond the distance of the “golden hour,” that sixty minutes that often makes the difference between life and death with cardiovascular events and traumatic injuries. These were communities that understood they had been left behind in routine health care access. They’d been ignored. Left to their own devices, some consulted with the only “experts” in the field they trusted—traditional and social media, or those in their community they trusted to be more plugged into those outlets than they were themselves. This isolation from routine and preventive health care and from sound information happened not only in our rural counties but also specific isolated urban communities. In my travels in the summer of 2020 I’d witnessed this level of distrust. I’d seen the void in public health education and services in those locales. I’d felt the absence of on-the-ground CDC personnel.
Now residents in these areas were being further marginalized and ostracized. People were pushed further away without dialogue, no one was willing to listen or answer their questions. No one was looking at their unique circumstances. It was spring planting season. Did we make appointments available late Saturday night so that farmers could get inoculated after coming in from the fields? Were they offered the opportunity to get vaccinated on Sunday mornings at their places of worship, so that they could recover from any post-inoculation reaction and be ready for work on Monday morning? Did we fully account for the many diverse needs of our entire population and not just those on the mainstream coasts? Was anyone working with the “flyover” states? No, we could have been and should have been.
Did we go into communities and listen and change our course of action? In many cases the answer was no. And the divide only got wider. I could see on social media that the demeaning comments from public health officials about the “unvaccinated” were being repeated on those platforms, furthering the divide. At times, that vaxxed vs. unvaxxed gap became a rationale—a justification for the overwhelming death rate of the summer surge in 2021. I saw individuals comparing the higher death rates in rural red counties to their presidential voting pattern in the last election. Didn’t they understand health care across this country is not equal and the community hospitals in these rural regions may not have the same access to technology that medical centers in major metropolitan areas have? Look where Level 1 trauma sites are—they aren’t in our rural areas—they are in our main metros.
The vaccination issue ran so much deeper than how people voted. It was more about access. Some struck the tone, that it was “those people, those people who didn’t get vaccinated” that were dying—almost creating a sense that they deserved it. It was the “UNVACCINATED” who were filling our hospitals and dying. But, public health is about the entire public, not just the people who agree with you; it’s critical to find a way to convince those who don’t agree with you. If you choose to be in public health, you must choose to serve the entire public—you cannot dismiss people—you must find a way to reach people where they are. You don’t give up, you don’t walk away, you find a way or make one.
I have a solution to resolve these diverse population issues. The CDC has to evolve into a decentralized state presence with strong headquarter coordination and not remain one where 90 to 95 percent of the domestic staff are housed at CDC headquarters in Atlanta. By having more boots on the ground in more areas of the country, the CDC can establish a more continuous, more timely, more real-time data-driven responsive feedback loop between its in-state personnel and those back in Atlanta. They can’t rely on fax machines and viewing data solely on fifteen-inch computer screens. They need fact finders on site to ensure the timely development and modification of guidance based on the reality on the ground. The CDC must fully support the states with these long-term staffing initiatives to address this ongoing pandemic and all other current public health issues.
It bears repeating: you can’t fix the problems you can’t see. Seeing up close and personal what is transpiring in the community is the best way to serve the needs of all of us.
I STATED EARLY ON that all pandemics are political. I hope by now that this distinction is clear: pandemic responses are political but viral infections and the diseases they produce are apolitical. That’s the reality that data supports. Politics can’t guide the response to an apolitical entity. For the most part what I experienced was true in terms of actions, but not in the rhetoric. Words do matter.
As has become abundantly clear, fundamental issues have transcended a change in presidential leadership. Chronic underlying issues in our federal institutions and deep societal issues contributed to the deadly surges that occurred across both administrations. We lost nearly 510,000 Americans in the twelve months from March 1, 2020, to the end of February 2021. What is so dismaying is that despite all our knowledge, our advanced technology, our vaccine rollout and additional therapeutics we lost over another 430,000 Americans in the next twelve months from March 1, 2021, to the end of February 2022. The 2021 summer surge was more deadly than the summer surge of 2020. And although the winter surge of 2021/2022 will be less deadly than the winter surge of 2020/2021, tens of thousands of American lives will still be lost unnecessarily. We will pass 950,000 American lives lost by March 1, 2022.
Explaining that most were unvaccinated is an excuse, not a solution. We need solutions: solutions to hesitancy; solutions to save the lives of those who are currently unvaccinated; we need to make clear to everyone what vaccines can do and not do, we have to let people know we care about them even if unvaccinated; and for the unvaccinated, we need to ensure their access to tests and ensure they are diagnosed early and have immediate access to effective antivirals. We need antiviral cocktails that reduce the risk for the development of resistance prepositioned across the country and in the national stockpile so everyone in urban and rural areas who needs them gets them. Everyone must understand their own risk and their options. There are many solutions.
Other economically secure countries were able to blunt hospitalizations and deaths by routinely making tests available to everyone in the public who wanted them at a minimum or no cost. We didn’t. We needed those tests available without restriction and we didn’t get enough data or tests soon enough. That was true during the Trump administration and the problem has grown worse so far in the Biden White House.
Comprehensive data is unhindered by politics. In my time on the task force, decisions on critical supply distribution were made based on numbers not politics. Projections were critical. We predicted the severity of the winter surge of 2020 in the late spring of 2020, resulting in the Next Generation Stockpile, and the proactive use of the Defense Production Act purchasing all the available Covid antigen tests in the late summer of 2020. These tests were then surged to specific unique needs—BCIUs, tribal nations, nursing homes, and specific states based on where the virus would be the worst.
As much as politics and perceptions filled the social media and mainstream media, at no time did the vice president or any senior leader in the White House tell me or the task force to respond to a state’s needs based on the population’s political affiliations or whether the governor was a Trump supporter or a Biden supporter. I was told over and over—get the governors and mayors what they need to respond to the pandemic. Although at times we didn’t have enough supplies—what we had was aligned to the need. Tests, supplies, and therapeutics were distributed based on need (equity) and vaccines by population. The call lists that went to the vice president were based on where the virus was going and where the response needed to be increased. The visits to the 44 states and over 30 universities that the White House organized were based on need and pushing states to be more proactive and aggressive early. With steers from FEMA and then the Unified Command Group (UCG) under Admiral Abel, the private sector used our data and our requests to deliver tests, supplies, and treatment based on need not based on profits or ability to pay. The innovations I saw at the state and local level were highlighted in the governor’s report independent of whether the innovative state was red or blue. The on-the-ground response and the depth and breadth of the response and the mitigation efforts were independent of party affiliation. No one on the task force, none of the doctors ever discussed the pandemic in terms or red or blue counties or states. The vice president made it clear in task force after task force that these were Americans, not Democrats or Republicans.
While the development of tests, from PCR to point-of-care home tests, vaccines, and many therapeutics were produced in record time by the Trump administration, this had to be combined with the Herculean efforts of the Biden administration, enabling millions of Americans to be rapidly immunized. This clearly demonstrates the best of our administrations building on each other for the benefit of Americans. If you allowed yourself independent of party to step back for even a moment, you could see this was only possible as a bipartisan effort across administrations and represented the best of the American spirit.
Unfortunately, all of that got lost in rhetoric. Our most successful global health programs—like PEPFAR that was controlling HIV in Africa without a vaccine—was only possible due to a depth and breadth of commitment that transcended any one political party. Developed and initiated by President Bush, it was supported through both the Obama and the Trump administrations—through nine Congresses independent of the party of the Speaker of the House. This is the road map of public health impact. This will need to be the road map for the next generation pandemic preparedness. Stop the finger pointing, let’s lay bare what didn’t work, what did work, and let’s learn together and find what works so we can be better prepared next time.
But throughout 2021, everything began with red and blue county and state comparisons. But it wasn’t just vaccination rates that were responsible for the community spread of the summer surge; rather it was the lack of testing, mitigation, and the needed clarity from the CDC that vaccine protection from infection was dramatically waning, turning the immunized into the silent transmitters. The South has more red counties, the North more populous blue counties, so, of course, the summer surge was more in red counties. But as the winter surge evolves into more populous blue urban counties you will see fatalities rise in blue counties—even blue counties with high vaccination rates, because we still have vulnerable Americans who are not adequately protected. I never talked about red or blue counties. I talked about where the virus was and where it was going and what we needed to do. The virus doesn’t know whether that vulnerable American is a Democrat or a Republican.
Throughout the spring, summer, fall, and winter of 2021/2022, I quietly wrote to those I knew who could have an impact. Testing had to be dramatically increased especially among those who were vaccinated, in families with vulnerable members. We needed to know immediately if they were infected to ensure early access to antiviral and monoclonal antibodies. I was watching what Florida was doing to dramatically expand the access to monoclonal antibodies to save more lives and prevent hospitalizations, but it appeared the federal government wasn’t willing to recommend the adoption of this promising proactive practice. It seemed to me the reason for this unwillingness was political. Governor DeSantis is a Republican in a state where recent presidential elections have seen razor-thin margins between winning and losing.
In place of that reasoning, I heard some say that the South was using “too much” of the monoclonal antibodies supply and the federal government needed to adjust supplies. In every surge the region with the most hospitalizations and the most serious infections needed the most access to the most therapeutics—not less. The virus was primarily in the Southern United States and the Southern states were the ones needing the therapeutics. At all times, equitable distribution of resources based on data must guide the response to any public health care crisis.
The focus on a perceived imbalance of distribution distracted from the real issue: With the fall coming we should have been stockpiling tests and all therapeutics, including the new oral antivirals, in advance of the coming winter surge, not waiting for the crisis. We spent the summer of 2020 getting ready for the coming winter surge with PPE, tests, and therapeutics. Did we spend the summer of 2021 getting ready for the pending winter surge? We must develop a better balance of near-term and long-term projections of all aspects of the pandemic response. And how will we spend all of our efforts in the lull that will come after this Omicron surge to prepare for a potential summer surge in 2022 and winter surge in 2022/2023? We need a new plan to address vaccine hesitancy and clear guidance on how families with vulnerable members can protect them in surges while the rest of America moves to ensure we are open, working, and all of our students are in school. We have to provide better access to oral antivirals no matter where we live.
We knew that viral variants would occur at any time and that they would do so again and again. Throughout 2020 numerous variants emerged from natural infection immune pressure, and that would continue through 2021 and will continue. That’s how viruses survive. Not only that, but, so far, most of these variants were first visible in other countries, providing us with a potential head start to combating them. The Alpha variant made its way across the Atlantic and exploded in the Upper Midwest states in April and May 2021, causing thousands of deaths. However, those cases and deaths were in “blue” states so this wasn’t featured prominently on the news. As a result the alert didn’t get out loudly enough and early enough to advise enough Americans of our collective susceptibility to variants that caused serious community spread in Europe. They will get here—use the early warning of what was happening in Europe to prepare in the United States.
In late May and early June of 2021, at the county level, the status of the pandemic was much like it had been in 2020. We were seeing those now predictable broad improvements, but there were those early troubling signs of increasing test positivity, coupled with fewer tests being conducted and no active sentinel testing in place. Instead of refocusing on the fundamental public health tools we had collectively developed—testing, masking, reducing friend and family gatherings indoors when you see the early warning signs—we chose to ignore the early warning signals and were once again in full community spread across the Sun Belt by July. Public health pundits and federal leaders blamed it on the unvaccinated, the more contagious Delta variant, the lack of mitigation by governors. Yes, all those contributed, but the reasons didn’t matter—what mattered was using data, developing actions, and implementing solutions. What mattered was Americans were sick and dying and we weren’t doing enough. The frequency of my warning emails increased, networks asked me to appear, but I knew if I did the only questions would be about my year in the Trump administration not what was happening and not what needed to be done now.
I’m saddened that it took the explosion of the Delta variant to rouse the country from our collective pandemic slumber and fatigue. As we moved through the summer surge the vaccination rates for eligible Americans remained stalled just shy of 50 percent by the end of July. By January of 2022, it had only risen to 64 percent and 26 percent of them boosted. Did we use those six months to find solutions to the vaccine hesitancy? Did we evaluate granular data to see if any counties were successful in combating hesitancy—did we change the messages, the platforms, the words? Did we bring in more marketing experts to conduct in-depth focus groups across different age, race, ethnicity, and geography? Or did we just map the areas with lower vaccination rates and blame the surges and the resulting fatalities on them?
There needs to be equal emphasis on behavioral science and implementation science research to understand immunization dynamics and how to confront hesitancy and anti-vaxxers. How to communicate risk and how to specifically mitigate that risk based on your family’s profile? Ignoring the hesitant and not giving practical and implementation information to Americans has resulted in our current situation. We need to understand the drivers of personal decisions and choices when it comes to vaccines and other mitigations that we will need in the future. The importance of implementation science to develop a better understanding of who should be the lead agency and how funding should be prioritized can’t be minimized. I am always struck when I hear public health officials say, “We didn’t think the public would do it, so we had to change our approach.” In the case of vaccines we knew full well that many wouldn’t do it, but little was done to help us better understand why and develop approaches to change the public’s mind. Put another way, if we know the product is good but isn’t selling, that’s not the fault of the product developers. It’s a marketing and sales issue. The CDC needs to recognize that and rely on outside help to refine its marketing messages better. That costs money, and those efforts need to be funded.
Masks are another example of this. Some within the CDC said that the KN95 and N95 masks are more “uncomfortable” and Americans won’t wear them. What data supports that premise? I actually find those masks to be more comfortable—but that is anecdotal and they needed data. And this is how public health officials get themselves in trouble. We cannot base public health recommendations on our own personal biases. We can’t say we are following the science when it’s never been studied. We should have studied the acceptability and effectiveness of different masks then and still need to, since we will need them again. We should then present the data transparently to the American people. Following the science requires us to actually fund the science; for too long we haven’t valued implementation science or behavioral science research. We need to fund this area of science now either through the NIH or the CDC and these trials should be rigorous and represent all Americans, not just urban Americans.
The CDC can’t continue to issue guidance like it did in December 2021 when it decreased the length of its recommended days of isolation from ten to five without requiring a test—especially with the availability of antigen tests that track with infectivity. Instead of conducting a thorough study and data analysis, using people from different ages, races, ethnicities, and with different underlying health conditions, it relied on a cohort of convenience—those readily available and not chosen randomly to best represent the general populace. We cannot use biased data, just because it’s the only data available. We need to fund the research proactively so we can truly tell Americans we are following the science because we have the science and the data, not wait and, out of emergency, use small biased data sets.
By July 2021 the vaccine protection against infection had begun to wane across the country in those immunized first. We didn’t let the American people know this was happening. We didn’t use the early data out of Israel and the UK to understand this over the summer. We didn’t ask Americans to test even though they were vaccinated to understand the depth and breadth of breakthroughs that were evident every day among sport teams and college students in August 2021; we didn’t update the data to know if this was occurring. We didn’t tell vaccinated Americans that their protection from infection had waned and they were now a potential risk of infecting their vulnerable family members. They also weren’t aware that despite vaccination some people didn’t develop a robust immune response and weren’t protected from severe disease. We didn’t ask those over eighty to be tested for antibodies to the spike protein—a readily and commercially available test—even if we didn’t know the precise correlation between antibodies in the blood and precise levels of protection. Did we develop the study to define the immune correlates of protection so every American and every American over seventy and every American in a nursing home would know when they were vulnerable to reinfection and potentially significant disease? We have that capability—why didn’t we use it so we would know who needed to be boosted when. Who needed extra layers of protection when the surges came? Did we give specific guidance to parents with children under five about what to do to keep them safe? Did we develop clear risk profiles so that every American knew their risk to serious disease, whether they were vaccinated or unvaccinated; previously infected or not? We have the capacity to know this proactively, not by just tracking hospitalizations and deaths when it’s too late to save them.
We should have done the studies, but even without those studies, we should have known who didn’t have any detectable antibody protection—we would have known who was at significant risk to severe disease. Families would have been informed so they could assess their own family and their risks and make informed decisions.
This would have been a critical information point among the elderly in the community and nursing homes as well as those with significant immunosuppression. They would have known and their families would have known their elders may be at increased risk of severe disease despite vaccination before the holidays. Across this country there are millions of Colin Powells with underlying medical issues who may have a blunted (not fully protective) immune response to the vaccine, or even the vaccine and booster. In my years of work around the globe I have found that more information, even if preliminary, is better than withholding information until all is perfectly understood. When we did surveys across communities in Africa we could see whom we were missing. Who didn’t know their HIV status and who hadn’t accessed lifesaving treatment. We didn’t know why—we didn’t have every detail; that would have taken months to define. Instead we immediately treated this as a crisis. We brought communities and public officials to brainstorm and come up with solutions and immediately implemented those solutions following the data for whether it improved testing uptake and treatment uptake. We didn’t wait for the perfect, we acted. If there’s a change, then explain the rationale behind that change clearly.
In the meantime, I was confused by the fact that while this repeated pattern was detectable, we were allowing this cycle to spin us all in another frustrating revolution that had so many wishing and hoping that it would just stop. We didn’t have all the tools to stop the virus completely, but we have the means to recognize at what point and in what part of the country and at what time we need to be on highest alert. We know when we need to increase our level of mitigation, where and when to mask up, where and when to increase efforts to get the symptomatic and the asymptomatic, the vaccinated and the unvaccinated, tested regularly if they are in contact with vulnerable family members. As humans, it is difficult to be in a constant state of high vigilance. We need to use data down to the county level to let people know when there is a threat in their community—just like our immune system can’t be made to stay at a constant level of vigilance, we can’t stay in that state of constant anxiety and worry. We don’t have to. When our hearts and minds are under attack our mental health suffers, some resort to addictive behaviors, some see suicide as the last resort.
We are now, due to how much time has lapsed and how many of the repeated patterns we’ve been through, better able to see how surges work and how long they last. This is based on what we’ve seen here and elsewhere in the world. In parallel to our experience with vaccines, global supplies were even more limited and additionally very slow to get shots into arms. It was clear from following the curves of the South African data that two things were happening in parallel. They had experienced high rates of general population infections with each surge. Due to the population having fewer comorbidities and the overall youth of their populations, more than a decade younger than the USA, their hospitalization and fatalities, in relationship to community spread and cases, were lower and continued to decline. But there was also evolving real-life data and clarity on durability of natural infection immunity—each surge was five to six months trough to trough and peak to peak and each surge was with a different primary variant in South Africa, where they were carefully and regularly sequencing the virus to detect the presence of variants very quickly.
Along with looking at global numbers, I was examining weather data and other figures to triangulate an analysis of what to expect. By September 2021, I was very worried about the coming fall/winter surge. I heard pundits stating we “were through the Delta surge” and all would be well in November. I knew we were only through the summer and early fall part of the Delta surge—not the winter part. Many who were comparing timelines of when the fall surge occurred last year were reassured when we made it into October without rising cases. They weren’t accounting for the fact that this fall had a different weather pattern than the previous year. By the end of September 2020, the temperatures were consistently around freezing across the Northern Plains. This year was the warmest October on record. I went to the Northern Plains states in October—people were still eating and drinking outside—it was clear we weren’t through the Delta surge across the North—it hadn’t yet started. Late enough that we could have alerted all Americans to get boosted and tested and make it clear there were Americans without an optimal immune response that may be vulnerable to severe disease.
I sent out my family alert. We had vulnerable family members in each family cohort. Increase vigilance and increase testing. Even if you don’t have symptoms. We sent the grandchildren back to preschool. We understood the risks and critical rewards of the grandchildren socializing with other children. We made decisions based on data and used available tools to mitigate the risks. We helped the preschool improve its indoor air quality, as we knew two-year-olds couldn’t consistently mask all the time. We worked with the school on practical implementable solutions. We bought at home antigen tests in lots of ten because we could afford them.
Why wasn’t the government distributing these to those who couldn’t? Why weren’t we testing young people in community colleges, which provided a wonderful opportunity to see the earliest community spread in cohorts that were together in one place and easily accessible? That’s where you would find the variants first. Early warnings with high levels of testing change the community spread—we knew this from nursing homes, colleges, and countries like the UK. They kept their hospitalizations and fatalities much lower than ours through aggressive testing with minimal mitigation. We should have tested aggressively early on to identify the first instances of asymptomatic and mild infections in communities. Knowing as soon as possible where and when those infections were taking place would have helped us alert vulnerable Americans and those in contact with them that they needed to mask up and test to make sure they weren’t infected and hadn’t passed the virus to their family members. If we’d tested early, empowered families with the knowledge they needed to protect their family members, and mitigated early, we could have prevented 30–40 percent of the fatalities in each surge in 2020 and 2021. It wasn’t about changing your lifestyle, it was about testing before you visited Grandma. It was about making sure Grandma had access to testing so she could immediately access the effective treatments available, but they needed to be used immediately not after Grandma became so seriously ill that she needed to be hospitalized.
But we still weren’t testing strategically, we still weren’t collecting enough data in real time, and we still weren’t communicating all the information effectively to the American people. I was talking with some in the media off the record. I kept asking them why this wasn’t happening—they felt that no one wanted to discourage people from being immunized so they didn’t want to talk about the potential frequency of breakthrough infections—that would discourage people. Then there were masks. Some were great about telling people to move to KN95 or N95 masks that were now readily available on Amazon all through 2021—but what were we doing for those who couldn’t afford home tests and better masks? This persisted through the most significant spread of the Omicron variant until late into January when the federal government finally acted, expanding tests and mask access.
Finally, the “happy talk” of the early fall met the reality of cooling across the northern United States with the Delta surge, initially in the Northern Plains and Rocky Mountain states, and the predictable arrival of the more infectious Omicron variant in the Northeast that made its way across the country. There were finally some actions on testing and the importance of boosting but we were again in reactive vs. proactive mode. Instead of being fully prepared and sending a clear alert to the dangers that lay ahead, the holiday message was to celebrate with families, celebrate the victory over this virus. These holidays will be different. If you are vaccinated gather together! Don’t worry! As vaccinated families and friends gathered with others of unknown status or those who hadn’t developed an effective immune response, around those dining room tables we would infect others. Many would get sick and some would die, fewer than last winter but still tens of thousands of Americans would lose their lives. From the middle of October to the end of January 160,000 lives have been lost, and by the time the Omicron surge ends and deaths decline, we will have lost nearly 220,000 Americans in the winter surge of 2021/2022. Yes, it was 90,000 less than the winter surge of 2020/2021, when we lost 300,000 Americans, but we have vaccines and additional therapeutics. This 100,000 fewer deaths should not be viewed as a success but as a red flag that we need to do better and be better prepared.
Perhaps since a more “normal” Thanksgiving was promised, the CDC and the Biden administration felt they had to deliver that message. But we knew from 2020 that Thanksgiving proved to be a superspreader holiday. As a family we knew what was coming and we hunkered down again, severely limiting gathering, still traveling, still working in public, but now we had the advantage of testing to ensure we weren’t exposing others. I worried about those without an effective immune response to the vaccine who believed they were fully protected from severe disease. In the months and years to come we will see precisely who was lost and why. It’s what I told every governor in 2020—it will be clear in the next few years, the impact of their actions or inactions. It won’t be cryptic. Messaging matters, information matters, and warning people of actions and risks saves lives.
We need to confront our blind spots and our misperceptions. Yes, even scientists have beliefs and perceptions that color their interpretation of data. Yes, we could see the Delta variant AND the Omicron variant coming. Every variant that made it to the UK and Europe and caused a surge there has made it to the United States. Alpha, Delta, and Omicron all caused surges in Europe and made it to the United States. Not all variants from South America made it to the U.S., but ALL of the European surge variants made it to the United States—predictably.
We cannot ignore predictable patterns. We need to learn from these patterns. We know the regional pattern of the summer surge; we know the massive spread of Thanksgiving and holiday gatherings. We should be using this human behavior knowledge and data to ensure that Americans are empowered with the information they need to adapt to the reality of SARS-CoV-2 now and in the future. Not out of fear but out of clear knowledge. What is clear is had we been testing and sequencing at the same level as the UK, we would have seen that the highly contagious variant was already here. The UK had dramatically lower hospitalizations and deaths with both their Delta and Omicron surge compared to the United States. In January 2021, we were on par with population-adjusted Covid-19 deaths with Europe. Since then we have 20 percent more fatalities than the UK. Why? They ensured the public had the most important tool to prevent spreading during gatherings: testing. The UK made tests available and is testing at nearly five times the rate as the United States—their test positivity despite Omicron didn’t go above 10 percent whereas ours in January 2022 was well over 30 percent. The summer, fall, and winter 2021 recurrent pandemic community spread continues to be largely driven by the asymptomatic unvaccinated, the pre-symptomatic unvaccinated, and also the asymptomatic and mild symptoms vaccinated—to find these infections you need to TEST. Paid leave if you are positive is critical so people don’t have to choose between their own health and family well-being. Many hourly workers don’t want to test because they don’t want to know their status and potentially miss their daily wage. In immigrant communities, rural communities, uninsured, unvaccinated, we need public health tools that meet their specific needs.
What if, instead of delivering that okay to gather, preemptively beginning in late September or early October, the federal government sent all families a pre-holiday “gift.” What if we spent the summer buying and building enough tests for our stockpile and could have stockpiled enough masks to send or to make available free of charge KN95 and N95 masks to every household in the country. Along with that, a simple set of bullet point recommendations/reminders of best practices for social gatherings could have been included on a one-sheet or a card. Better yet, instead of mailing them out to every address, we could have used our vast data collection and aggregation tools to deliver them to the residences (private and communal like nursing homes and memory care facilities) of people over the age of sixty-five who might not have had the ability or desire to go out and who were more likely to be receptive to this “gift.” We could have also utilized schools to distribute those packages to parents of K–12 students. For the age cohort that covers college age to thirty-five and possibly to sixty-five the packages could have been made available at places that age group frequented—grocery stores, at drive-through restaurants, coffee shops, churches, community centers. Since the private sector was so eager to contribute, places like Starbucks, for example, could have had them available at their locations.
I could go on, but the point is clear. The government had to overcome any possible barrier through clear and effective communication, age and platform specific—making the risk clear to specific Americans and the need to mask up as effectively as possible and to test prior to hosting or attending gatherings that included vulnerable family members. Many people were doing this anyway, but for those who didn’t, not having to go out and secure these supplies, seeing masks and testing normalized to a greater degree than before could have stimulated them to do what was best to protect themselves and their loved ones. We need to address social pressures occurring at the community level that decrease vaccine uptake. My colleague heard from people in South Dakota who didn’t tell their friends they were vaccinated because of peer pressure—adult men not telling their friends they are vaccinated for fear of how it would be perceived . . . we can and must change these societal pressures.
Again, I witnessed local leadership. Five blocks from my house I saw long lines snaking up the street. Many people respectfully waiting in line—the young, the old, at least four feet apart, outside waiting for hours. I wondered what was happening and investigated. The mayor of the District of Columbia was making at-home tests available to its residents at local libraries so everyone could test before gathering with others. That proactive effort by the mayor decreased Covid-19 spread during the holidays and protected the vulnerable. She did this before the holidays—proactively. But what it also showed me was people were willing to do the right thing to protect others if we reduce barriers and make mitigation like testing available. Imagine if you could walk to your local library everywhere across the country and pick up free masks and tests. If clearly explained, everyone would understand their personal risk and what situations were most likely to lead to potential exposure, and I know they would have been willing to protect their grandparents with testing and masking. I have seen this across the country.
Or, we could take advantage of the corporate/private sector’s desire to be involved and to contribute. Fast food restaurants, retail businesses, and others could become distribution centers for free masks and tests. The government had the ability to provide stimulus funds to millions of Americans. What if we had been given the choice to opt out, and instead had those funds go to the purchase of mitigation supplies to be delivered to those in need? Clearly, many Americans continue to be generous throughout this pandemic, and a program that would allow for funds, or the supplies themselves, to be diverted to charitable organizations, community organizations, already doing outreach in the community, could help overcome some of the wariness of the federal government many people I met in different states around the country felt. If the government showed that those people were seen and heard, they’d be more willing to listen, I believe, when the CDC, for example, had something to tell them. They’d better understand that the government understood them, and, at the very least, acknowledged they existed.
The Biden administration has just enacted a similar program to send free tests to every household. However, it requires people interested in receiving them to go to a website to enroll. While I hope the program works, I also hope that this current administration and those supervising this program remain flexible, and move from reactive to proactive. It’s February, and in many areas the cases are waning and many haven’t received their tests yet. Also, many of us have had bad experiences while trying to register to get vaccinated via online systems. Some of the people who most need these free supplies may not have the infrastructure or the time to navigate a system that gets too easily overwhelmed. There are multiple barriers to entry the government has to account for when providing services that they believe most everyone will want simply because they are free. As we all know, all programs like this need to take into account that they have to be flexible in devising distribution channels that will meet the diverse needs of ethnically, economically, age, and attitude variable groups.
One of the most important takeaways here is to not wait until the surge or the holidays are upon us. We have learned that there are lulls in the outbreaks. During these interludes, we needed to expand testing access. We should have used that time to prepare for the next surge by getting as many Americans as possible to buy into making critical behavioral changes needed to protect their vulnerable family members. Many communities have done similar things on their own, and with more CDC personnel on the ground in those communities they can work with mayors, governors, and public health officials to make these efforts happen, evaluate their effectiveness, and make changes as necessary.
To put it another way, the CDC must become more customer-friendly as they deliver services to the American people. The trickle-down effect of their limited research and generic guidance is a starting point—but working with states and local communities to water the grass roots efforts that currently exist and providing people with what they need, not what the CDC believes they need. They can do both, but only if they engage in dialogue. As we’ve all likely experienced at one time or another, top-down authoritative management has its place in some crises, but not at all times and in all places. The CDC is a part of public health, but it also needs to be part of evidence-based community health as well. As before, words matter, and though “Centers for Community Disease Control and Prevention” might be more of a mouthful, it can serve as a reminder to us and to the CDC what its true mission is.
I have seen the CDCers do this elsewhere and in other contexts. For the last twenty years they have been in the trenches working alongside Ministries of Health officials and communities to serve those most in need of both prevention and treatment services to combat the HIV pandemic. They use weekly and monthly comprehensive data to engage in data-driven decision making week by week to improve access and quality of services down to the local clinic and community. They define gaps and find solutions. Through the data we could all see the tyranny of averages—not just looking at country-level data and applauding our progress but using demographics and geographic location to see who we were missing, young men and women and, critically, the most vulnerable key population groups. Hidden marginalized people lost in the averages. Together the CDC worked in deep partnership alongside those they served. Working with key populations—people who inject drugs, men who have sex with men, transgender women, and young women and men—allowed the CDC and PEPFAR to address the cultural and policy barriers to access. This is the CDC I have seen across the globe and this is the CDC we need domestically. A CDC that works with everyone to increase vaccine uptake through listening rather than solely mandating their uses. A CDC that works to create commonsense guidance that Americans utilize. A CDC that recognizes not everyone will choose to get vaccinated and some will need specific guidance linking the level of viral community spread to recommendations of enhanced testing and immediate access to antiviral and effective cocktails or monoclonal antibodies to save their lives without hospitalization. A CDC that recognizes guidance needs to evolve with the science and the community cultures and be adaptable. CDC guidance must be unambiguous to bring communities together and not drive them apart.
An evolved CDC would have an enhanced mission to ensure effective services at the community level. Intertwined with that shift in perspective is a greater need to hold itself accountable, and for us as those receiving those services to hold it accountable, for what it promises and what it delivers. In my work at PEPFAR, the conference I was attending while deciding to come to the White House served as a model of accountability. Annually, each country’s program was subject to review and analysis of progress, holding each of us accountable, from the funders to the program implementers, to the communities in need of the services.
We need a CDC that is practical and focused on changing the public health of this country—focusing on decreasing health inequities and addressing the social determinants of health and disease. Our fatality rates are higher than most European countries because we are unhealthy in comparison. By using big data and continuous data analysis to define in real time improved outcomes and the impact of interventions, we can not only continuously make improvements in the health of Americans and develop the implementation science platform that will serve us in pandemics and pandemic preparedness but can also improve the nation’s health by addressing both chronic diseases (comorbidities) and infectious diseases. By diving into and addressing the social determinants of health, ensuring progress in health equity year after year. We learned from HIV/AIDS you need to be embedded in communities, to understand the core structural barriers to access, to address concerns and be in continuous dialogue to understand not only access issues but issues around vaccine hesitancy. We have clarity on what isn’t working and now we need to develop the evidence and in-depth behavioral science studies to understand what does work. Transforming the CDC into a proactive partner in implementation makes sense and is adoptable and adaptable community by community. This requires a new model—a model of being in the states, being flexible, and learning and gathering evidence through population-based studies and not isolated cohorts of convenience. We need to address our overall health with specific funding and focus on areas of greatest need, including tribal nations. There are solutions—we saw them and we need to fund them.
Much of what we need to do to be better prepared for the next pandemic begins with the routine definitive laboratory diagnosis of viral diseases. We do that for bacterial diseases, including mapping antibiotic resistance. We need to definitively diagnosis by a lab test each and every viral disease at all levels of health-service providers—urgent care, doctor offices, emergency rooms, and hospitals. Importantly, we already have the technology to do it. To show how important this is, health insurance companies and Medicare and Medicaid must demand that a confirmed laboratory diagnosis (test) has to be performed and coded in the database any time a patient comes in with a possible viral infection or for treatment of a viral disease. If CMS makes this one rule change, we will always know what viral respiratory diseases are circulating in the community. We need a national database with reporting in real time that collects both the laboratory and medical codes for community-acquired infections. Not creating a parallel system but using the electronic systems that already exist, collated together. I believe hospitals and clinics would be happy to provide this electronic data stripped of personal identifiers, with ages blurred by creation of age bands but including sex, race, and ethnicity. This will provide our baseline so we can “see” in the data any disruption in the pattern. This will allow us to see when something different is out there but it will also allow us to develop vaccines and treatments for current viral diseases as more rapid clinical trials can be done once you know who is infected. We have been flying blind or using sentinel sites and collecting syndromes rather than definitive laboratory diagnoses. This national database should be publicly available in an easy to interpret form down to the county or zip code so parents can know what’s in the community, and assess the risk to their children, and know what is in the community when their own child gets sick. Too many viral diseases present similarly, and without a lab diagnosis you are making assumptions.
The CDC should have access to all the data to bring the full strength of their data analysts and experts to the table, but so should the private sector and state and local officials, along with the public. It starts with the data, and data gets better when it’s used. The CDC should work with each state to decide if any other critical public health data should eventually be added. Imagine if we were using real-time data to understand our opioid epidemic, suicide attempts, and childhood obesity, and held ourselves, the state and local governments, and the CDC accountable to improve step by step the health of our nation. It’s possible with data and using the data to chart outcomes and impact in real time, expanding the solutions that work and stopping those that don’t. It’s not about more money; it’s about using the money we have more effectively. We did this in PEPFAR. In a flat budget for twelve years, we tripled the number on lifesaving treatment and we rolled out or increased the most effective prevention programming each quarter, evaluating outcomes and impact and holding ourselves jointly accountable. You can’t manage what you don’t measure, and we should not accept monies going to programs or states if not linked to mutually defined outcomes and impacts. States need cooperative agreements with the federal government and not grants. The CDC needs a permanent presence in states—a team, not just one individual, so they have a deep understanding of the issues that need to be addressed at the local level, the performance of the programs they are funding at the state and local level based on objective outcomes and impact, the effectiveness of their federal guidance, and direct funding of and support of populations-based implementation science.
The pandemic response must evolve with the evidence—which requires systemic collection of data—big data across the country and utilization of these data sets for decision making. The decisions made in March 2020 were based on the evidence that the virus was extremely deadly for those over seventy, with case fatality rates of near 30 percent, and we didn’t have a proven therapeutic to blunt the deadly virus and needed to buy time to protect the highly populated cities. The virus was isolated to fewer than ten cities of more than one million residents. With the availability of remdesivir and vastly improved clinical practice in the care of patients, the fatality rate in those over seventy dropped to under 10 percent. Still too high and requiring additional layers of protection, but throughout the summer surge of 2020 we learned how to maintain retail, restaurants, and schools fully open with masking and testing, and decrease in home gatherings during community surges. With the development of monoclonal antibodies, the fatality rates in those over seventy dropped first to under 5 percent and then continued to fall through the surges of 2021 with vastly expanded treatment options. Now with vaccines, oral antivirals, and all of the other treatment advances, there is a clear pathway to living with Covid-19 with dramatically decreased fatalities. But this will require more durable vaccines with improved immunogenicity in the elderly, routinely available home tests for those that are still vulnerable, and rapid access to antivirals. We have learned who is susceptible to severe disease and we can define those without a protective immune response despite vaccination. These individuals need to proactively test during a community surge in their location—these community surges are predictable: fall and winter for the Northern United States, and for the Southern United States potentially summer and late November to February. With proactive access to Covid-19 tests, with potentially weekly testing during community surges and immediate linkage to aggressive antiviral and immune therapy, lives can be saved without disruption to everyday activities. During these clear periods of high community spread—readily identified by a color alert system at the county level—multigenerational households, households with immunosuppressed family members, households with children not eligible for vaccination, and unvaccinated Americans with risk factors will have to take additional precautions centered on regular testing while the majority of Americans can continue normally. It is estimated that nearly forty million Americans are in this category of high vulnerability and will need clear guidance on testing and access to immediate treatment. It is more difficult for workplaces and schools, as they need to protect the most vulnerable workers and students during this time, with limited community-spreading events. Other issues to consider or rethink are in-person meetings, air quality, and direct support for high-risk students and workers. It sounds complicated, but we have twenty-first-century technology that can be deployed to improve safety in public spaces, including active viral inactivation in the air in a safe manner.
All universities receiving federal research dollars must be required to immediately engage in a pandemic response, bringing all of its personnel and equipment to the fight. This alone would allow us to do 250,000 to 500,000 additional nucleic tests per day. But it’s more than equipment; it is the ability to do behavioral and implementation science research.
There needs to be a national pandemic team that is constantly reviewing the available data and includes the private sector, universities, and the federal government, including the military and National Guard—not tabletop exercises but use of real-time viral disease data to chart responses to current viral seasons and outbreaks. Ensuring everyone is used to reviewing the data, understanding patterns, and reacting to deviations from baseline in a proactive rather than reactive manner.
Why there was no central clearinghouse organized for states to share best practices, worst practices to be avoided, and all areas of the distribution and inoculations is inexcusable. We can’t repeat that mistake again. Fortunately, through various health agencies, through public health officials, and with some governors communicating with one another, some of that valuable information was exchanged. It should not have been a catch-as-catch-can effort; instead, if there had been a more proactive approach to every phase of the response, including vaccination and how to best facilitate it, more doses would have been administered sooner.
There needs to be equal emphasis on behavioral science and behavioral science research to understand immunization dynamics and how to confront hesitancy and anti-vaxxers. Ignoring them and this issue has resulted in our current situation. We need to understand the drivers of personal decisions and choices when it comes to vaccines and other mitigations that we will need in the future. The importance of implementation science is encapsulated in the questions Who is the lead agency and will funding be prioritized? I am always struck when I hear public health officials say, “We didn’t think the public would do it.” Like recommending more effective masks. To say the KN95 and N95 masks are more “uncomfortable” and Americans won’t wear them. What data supports that premise? And this is how public health officials get themselves in trouble. We cannot base public health recommendations on perception. We can’t say we are following the science when it’s never been studied. We should have studied the acceptability and effectiveness of different masks, as we will need them again, and we should present the data transparently to the American people. Following the science requires us to actually fund the science; for too long we haven’t valued implementation science or behavioral science research. We need to fund this area of science now, either through the NIH or through the CDC, and these trials should be rigorous and represent all Americans. Not a cohort of convenience. The data on the change from ten days to five days of isolation could have been done weeks ago in Americans of different ages, races, ethnicities, and underlying health conditions. We cannot use biased data just because it’s the only data available—we need to fund the research so we can truly tell Americans we are following the science because we have the science and data.
This pandemic laid bare the gaps we have in the United States, and it’s not about funding more of what resulted in these gaps. First and foremost, we are a country of health disparities and devastating social determinants of health, where zip code determines the quality and access to health care. Second, we don’t have the national databases we need to respond to this or the next pandemic, which would need to include 100 percent of the community-acquired infectious diseases, whether presenting at urgent care, a clinic, or a hospital emergency room, and 100 percent of these community-acquired infectious diseases must be definitively diagnosed by a laboratory assay or a point of care test. Every approved vaccine must have research to define the correlate of protection that is measurable or a surrogate of the correlate—such as this antibody titer to spike protein that correlates with neutralizing antibody titers. We need to ensure a vibrant biotech industry in this country and move critical essential medicine and PPE production back to the United States and back to the Northern Hemisphere. We cannot ignore the lessons learned and must ensure they are part of pandemic preparedness in the future. Core to this is seamless integration of the public and private sector into the response. Our health care delivery and our entire supply chain for everything the hospitals use and need are through the private sector. Let’s for a minute use testing as an illustration. During 2020, the federal government, through research as well as financial incentives to the private sector in the form of massive purchases of tests given to the states to use, supported the research and development of next generation testing through the congressionally-funded RADx. These incentives stopped in 2021 and tests no longer purchased by the federal government, especially antigen tests, overflowed in warehouses because the federal government had no plan to stockpile tests. There was no plan for viral surges of Covid-19 in 2021 and supplies were not purchased to combat these surges. We have an economy based on supply and demand and the federal government needs to stockpile supplies for when the demand occurs. This requires prioritization and discussion. Tests could be part of the national stockpile and be provided to states during surges or in between surges to support routine cohort screening.
In early February of 2022, media outlets reported on a bipartisan group of senators expressing support for an independent commission to investigate the origins of the pandemic and the federal response to it across both administrations. Modeled after the National Commission on Terrorist Attacks Upon the United States (aka the 9/11 Commission), this pandemic investigation would be comprised of a twelve-member panel with subpoena power. Two members of the Senate Health Committee, Patty Murray (D-WA) and Richard M. Burr (R-NC) were working on a draft of legislation to make this a reality. I applaud their efforts and urge readers to contact their senators to pledge their support of this commission. Much like this book, its job would be two-fold—to investigate how the response was handled and to offer recommendations for moving forward.
Among those recommendations, I hope they will include a provision to establish an office of National Pandemic Preparedness—an independent office whose oversight would supersede HHS and its preparedness plan. It would bring together not just the federal agencies and state and local governments, but the private sector and our research institutions that receive federal dollars. It should also include representatives from members of the community. Not only would this group oversee preparedness for future novel viral outbreaks, but by using national data tracking systems, it would also take on other current health pandemics—obesity, diabetes, cardiovascular diseases, and opioid and other addictions.
If 9/11 permanently altered the intelligence community, Covid-19 must similarly force a reckoning at HHS and other related agencies. The federal institutions must evolve to address the failures that have occurred so that they are better prepared to embrace the kinds of approaches that will protect us in the future. And often these kinds of commissions are the only way to instigate that kind of broad, dramatic change when it comes to institutions as entrenched as these.
It is my greatest hope that 2022 will see our response to this pandemic, individually and collectively, adapt to the evolving nature of the outbreaks. We have to hold on to what has been successful, adapt, and understand that the cyclical nature of the surges demands different things from us. Just as our immune systems can break down over time, so does our ability to remain vigilant. A constant state of hyper-vigilance isn’t healthy, possible, or needed. Using the right tools at the right time, we can learn how to live with this virus, while we continue to evolve and develop even better tools. Science and medicine have an amazing track record of success in eradicating some diseases, and treating and managing those that were once considered death sentences, and I’m confident that a similar story arc is one we can expect with Covid-19. As much as I am a worrier, I am also a believer. I don’t just believe that we have to do better; I know that we will.