Uncontrolled Spread: Why COVID-19 Crushed Us and How We Can Defeat the Next Pandemic

by Scott Gottlieb

Eighteen months after the pandemic began, on May 7, 2021, the CDC finally updated its explanations on how SARS-CoV-2 is spread, citing inhalation as the main mode of transmission and emphasizing the role of aerosols, and placing less emphasis on fomites.

“The origin of the six-foot distancing recommendation is something of a mystery,” wrote the New York Times in March 2021, a year after the pandemic started. “When the virus first emerged, many experts believed that it was transmitted primarily through large respiratory droplets, which are relatively heavy. Old scientific studies, some dating back more than a century, suggested that these droplets tend not to travel more than three to six feet.”37 One senior HHS official told me that the six-foot recommendation was a compromise reached between the CDC and officials in the Office of Management and Budget (OMB). Initially, in February 2020, the CDC had recommended eight to ten feet of distance. However, the acting head of OMB, Russ Vought, said that such a requirement would be inoperable, hard to follow, and as a practical matter, couldn’t be uniformly implemented. So, the CDC compromised with the White House and settled on six feet. But the CDC’s recommendation for six feet of distance would persist well past the scientific realization that aerosols might be responsible for a lot of the transmission, and that the requirement for six feet of distance would be less relevant for this mode of spread.

That requirement for six feet of distance was particular to the US. The WHO recommended one meter, or 3.3 feet.38 China, France, Denmark, and Hong Kong went with one meter. South Korea opted for 1.4 meters; Germany, Italy, and Australia for 1.5 meters.39 (The European CDC continued to recommend maintaining physical distance of ideally two meters.)40 Even the CDC’s decision in the spring to revise the recommendation from six to three feet seemed arbitrary. While the CDC published some accompanying studies to support the move, it wasn’t any better established that the science had firmed around the new requirement. I was told by one HHS official that the revised three-foot number was based on an experiment that the CDC had shared with the senior leadership of HHS in the fall, six months earlier, showing that two people who were masked and standing three feet apart reduced spread by more than 70 percent. If that experiment formed some of the basis for the change in the recommendation, it begs the question, why did it take the CDC six months to issue the revised guidelines?

In Boston the virus was introduced, perhaps by a single individual, to an international professional conference held by the biotechnology company Biogen with about 175 attendees, more than 99 of whom would end up testing positive.56 The transmission chains ignited by this event would be implicated in up to 300,000 downstream infections, according to one estimate published in the journal Science.

In March 2020 in Mount Vernon, Washington, sixty-one people attended a choir practice and sang in a large room, distanced from one another as a precaution. They were provided hand sanitizer and left the doors open to improve airflow. But fifty-three of them were later confirmed or believed to have contracted COVID as a result of the gathering, and two died.

Studies showed that about 70 percent of patients infected with SARS-CoV-2 wouldn’t spread the virus any further, but about 5 percent of infected individuals without masks could account for as many as 80 percent of all subsequent cases, mostly the result of superspreading events.

The new and more contagious variants that would start to spread in the winter and spring of 2021, such as B.1.1.7, the strain that originated in the U.K., and then B.1.617 which was first found in India, seemed to affect a higher proportion of children than the original strain. It wasn’t that B.1.1.7 was disproportionately targeting children more than adults; it was more contagious and virulent to everyone, children included. Data from about twenty thousand people infected with B.1.1.7, including three thousand children under ten, showed that while everyone was more impacted by the new strain, relative to the adults, the young kids remained about half as likely as adults to transmit the new strain to others.66 A study published in Nature provided some understanding of why young children seemed less likely to develop COVID and transmit the infection. The authors found that children produced lower levels of antibodies in response to coronavirus infection when compared to adults. It was an indication that children might have been clearing the infection more quickly and easily, and therefore weren’t generating the same robust immune reaction to the virus.

The CDC’s guidelines were the single greatest obstacle. I was speaking to the White House over this time period, and some officials there didn’t fully appreciate how much impact the six-foot requirement was having on efforts to reopen schools in the fall. They didn’t connect the lines between their policy goals, the parts of the pandemic plan that impacted those objectives, and the actions of the CDC that frustrated these outcomes. It was a breakdown in policymaking, and the way the pandemic playbook was implemented, that would plague other aspects of our response.

Was fifteen minutes of exposure the right measure to determine when someone who was in contact with an infected individual might have contracted the virus? It seemed like an arbitrary judgment and led to manipulation of the agency’s advice. The CDC eventually changed its guidance from fifteen minutes of sustained exposure to fifteen minutes of cumulative exposure, but how could you measure your cumulative exposure to a person?8 It was almost as if the CDC was treating exposure to the virus like exposure to radiation and trying to measure a cumulative dose. It was reported that some establishments moved people around at the fourteenth minute to avoid passing the fifteen-minute regulatory threshold.

But there were plenty of matters the CDC opined on, that flew well below the radar of its political interlopers, where the CDC had failed to release relevant and timely information. Moreover, the CDC’s approach to these efforts didn’t change much once President Biden took over. Two of the CDC’s most senior career officials left the agency within the first six months of Biden’s term, in part, I’m told, over friction with the new administration.11 Frustration with the agency, it seemed, had bipartisan appeal. It’s perhaps convenient, but self-serving, to blame all of the CDC’s faults during the Trump term on political interference into its work. The CDC wasn’t just slow to develop this evidence, it also didn’t offer it in practical terms that made it actionable.

The challenges played out in how the CDC reported on COVID hospitalizations. It turned out that the CDC wasn’t actually providing data that was being reported to the agency on real hospitalizations, but was instead posting an estimate derived from a predictive model. In other words, the number of hospitalizations that the CDC was reporting each day weren’t people who were actually being admitted to the hospital but were hypothetical patients being modeled off a small sample that the CDC was collecting.

This is why, when the CDC reports flu data each year, its estimates have such a wide range, why they have a big “confidence interval.” For example, in the 2018–19 flu season, the CDC estimated that there were 97,967 people between the ages of fifty and sixty-four who were hospitalized for flu.18 That number sounds fairly precise, right down to the last sixty-seven people. However, it turns out that the confidence interval for that data, the range of potential estimates, was actually between 69,808 and 167,123 hospitalizations. So that means it might have been 70,000 patients. Or 100,000. Or 150,000. Or perhaps 143,294.

Under the new reporting system, 95 percent of US hospitals soon provided 100 percent of their daily hospital admission data. In an unfortunate twist, the CDC declined to work with the new data, worrying that since it wasn’t their data, they couldn’t assure its provenance and couldn’t fully trust its reliability. As one senior HHS official put it to me, the CDC “took their ball and went home.”

Yet when HHS initially took the task of reporting the hospitalization data away from the CDC and set up the new system, many in the media would almost reflexively cite the incident as support for a dominant narrative that the CDC was seeing its role obstructed and reduced by the political leadership at HHS and the White House.25 US senator Patty Murray sent HHS an oversight letter in which she argued that the new system was wasteful and “duplicates existing CDC work.”26 It was alleged that the Trump administration had taken the hospital reporting away from the CDC and given it to TeleTracking with a political not a public health goal in mind—political officials wanted to fudge the data to give a false rosy picture of the pandemic. Or so the narrative went. While the CDC was certainly subject to some deeply unfortunate and ultimately damaging political intrusions into its work, this wasn’t one of those instances. Some of the frustrations with the CDC’s execution had merit, and the CDC’s method for reporting COVID hospitalizations was one of those moments.

Similarly, the same survey didn’t distinguish between bars and coffee shops when assessing the risk of contracting COVID in those kinds of establishments. Bars and coffee shops were grouped in the same bucket, even though the settings and the behaviors in each establishment (fewer people linger in a Starbucks) and the conditions for spread could be very different. When pressed on why the agency had grouped bars with coffee shops, the CDC said that it judged the two settings to present comparable risk for transmission.

Masks had never been viewed as a standard part of the response to a pandemic. In fact, the much-discussed pandemic plan that the Obama administration had provided to the incoming Trump team didn’t take up the issue of widespread masking as a potential approach to containing a pandemic, or even mention masks a single time.

The data showed that masks were not a panacea, but they could help reduce spread.42 One study later showed that weekly increases in per capita mortality were four times lower in places where masks were the norm or recommended by the government, compared with other regions.43 Another study published around the same time looked at the effects of mandates for mask use issued by governors in April and May. The authors estimated that these state policies reduced the number of new COVID cases by up to two percentage points per day.44 Other studies would go on to report similar findings. Masks were not a solution, but a higher quality mask worn properly could reduce risks.

Wearing a mask was in many respects an act of civic virtue, a way to protect your friends and neighbors if you were one of those individuals who was unknowingly infected and at risk of becoming a superspreader. Many cloth masks weren’t intended to protect you from getting infected, although a high-quality cloth mask would provide a person with some protection. To secure more robust protection, a person would need a higher quality N95 mask. The idea of cloth masks, simply put, was to protect others from you, not you from others, a distinction I made often.

However, in the setting of COVID, it was unfortunately the president who did the most to turn face masks into a political flashpoint, creating an ideological movement that ultimately cornered the administration into a dogmatic position that proved harmful to itself and harmful to the nation.47 It may have been a misreading of the politics: antimasking didn’t become a political movement until many political leaders made it so. In fairness to the White House, the CDC gave political leaders mixed guidance on masks during the early months of the pandemic and was itself initially resistant to their widespread use.

All of our focus was on flu. The next pandemic, it was firmly believed, would be triggered by a novel influenza. It’s likely that the next pandemic will indeed be from a new strain of influenza, and it will be a lot worse than COVID. However, we need to be prepared for the unknowns. That starts with the analytical systems to identify and characterize a new pathogen. It could be a new strain of influenza with features that are irregular. Or another coronavirus that’s even deadlier and more contagious than SARS-CoV-2. Or, instead, something else that we never anticipated.

South Korea’s rapid response to COVID was not a coincidence. The country’s public health system was well prepared. Like the US, South Korea identified its first case of COVID in mid-January. However, the two nations would experience divergent trajectories. South Korea was prepared to deploy widespread testing from the very beginning, and would identify, isolate, and largely eliminate its outbreak. Even before South Korea had its first cluster of cases, it had developed a battery of diagnostic tests and established high-volume testing facilities. It never ran out of testing supplies or protective equipment. They had stockpiled the materials for years. South Korea’s first positive COVID case was identified on January 20. Its daily confirmed cases in the first wave peaked at 851 on March 3, and the country flattened its initial curve without the kinds of strict shutdowns that the US was forced to implement.

South Korea’s testing capacity reached 20,000 tests per day in the opening weeks of its outbreak. That was for a country of just 51 million people. It equates to about 130,000 tests a day in the US. It’s a level of testing that the US wouldn’t reach for about four months into our epidemic. Even though the US and South Korea would each report its first confirmed cases of COVID on the same day, South Korea would record daily testing totals over the next two months that would dwarf those in the US. This wasn’t because the South Koreans had more infection, but because they were actively looking for the virus, diagnosing cases, and then tracking and tracing infected patients to contain the spread. In South Korea, they were finding their cases and isolating those infected with the virus. In the US, over the same time period, SARS-CoV-2 was spreading unchecked.

The controversy surrounding use of hydroxychloroquine to treat COVID would illustrate the significant risk of allowing critical scientific questions to linger, where the desire for a swift therapeutic solution and the need for public health rigor collided to produce some unfortunate challenges. Initially, there was some belief among doctors, based on small studies, that hydroxychloroquine might provide a benefit. So the drug was heavily used in the first several months of the pandemic. In April, the majority of hospitalized patients in New York were receiving the therapy. However, subsequent research didn’t support the drug’s hoped-for benefits. Yet more than one hundred studies with the drug would be under way by the summer of 2020, even though by this point its claimed benefits had been fully disproved.

I didn’t believe the president was being well advised on the drug and research evaluating its use in COVID. A group of outside doctors had gained access to the Oval Office and advanced their anecdotal experiences as proof of its purported efficacy. Some of these meetings were attended by FDA commissioner Stephen Hahn, whose involvement lent further credence to the speculative therapy.30 The drug soon became a political ambition for those who believed it could bring an end to COVID, and it continued to be promoted heavily by a handful of TV commentators. During a single two-week period between March 23 and April 6, hydroxychloroquine was mentioned on Fox News nearly three hundred times.

The FDA guidance document would establish a clear and immutable benchmark. However, the guidance would also be issued well in advance of any chance to see the interim data from the ongoing clinical trials. Nobody knew at that time how effective the vaccines were going to be. If you had asked me, I would have guessed 60 or 70 percent based on the earlier data that I had reviewed for the Pfizer vaccine. Before the data from the vaccine’s pivotal study was available, I didn’t expect the vaccine to be 95 percent effective, and I suspect few others did.

At the peak of the winter surge, we were losing as many as seven thousand patients a week in nursing homes to COVID. About thirty thousand long-term care facilities were impacted by COVID with outbreaks. Less than 1 percent of America’s population lives in long-term care facilities, but by the end of 2020, this population accounted for about 40 percent of all COVID deaths—nearly 175,000 in total.55 During the worst week of infections, the week of December 17, there were 72,586 COVID cases diagnosed in nursing homes.

White House aides should never have let the president be put at risk of contracting COVID. In an Oval Office meeting the previous Monday, the president had complained privately to senior aides about an event that had been held inside the White House on Sunday, where guests attending a ceremonial gathering had gotten close to the president. After Trump was diagnosed with COVID, there was a refrain in the media that his infection was the consequence of his own cavalier approach to the virus, a narrative that was overly simplistic. Though the president appeared, on many occasions, to outwardly minimize the threat that COVID posed—downplaying its severity, eschewing the use of masks, giving short shrift to other precautions—inwardly he was cognizant of his own personal risk, and privately he was being reassured that the precautions adopted by the White House would keep him safe.

It was shared by those who knew him that the president was conscious of the risks from contagion. Years earlier, Newsweek had described a series of interviews Trump had given on The Howard Stern Show, where Trump wryly described himself as a “germaphobe” who “washes his hands frequently throughout the day and needed to drink through a straw because he wants to avoid contamination.”4 It seemed clear to me that the president didn’t want to get COVID and that he was led to believe that the White House testing protocols would keep him from being infected.

The process for making these two vaccines began as soon as the SARS-CoV-2 sequence was published. In fact, Moderna never had the actual coronavirus on its premises. It never needed a sample, just the computational sequence of the virus’s RNA. Once Moderna got the sequence, the entire process to construct a candidate vaccine took just two days.21 And in six weeks, Moderna went from having the sequence in their computers to beginning the manufacture of a vaccine to start human testing,

Pfizer began evaluating the vaccine in a pivotal trial on July 27, with the first volunteers receiving shots at the University of Rochester. Moderna’s vaccine also entered its phase three study the same day. About three months later, on Sunday, November 8, I got an email around 2 p.m. “Board Call at 6 tonight” the subject line read, and the email went on to say, “Albert has confidential news to share regarding the vaccine,” referring to Pfizer’s CEO Dr. Albert Bourla. I was apprehensive. Based on the earlier data, we felt reasonably confident that the vaccine would work. However, you never know until the trial is done and you’ve seen the data. And even if the vaccine was proven to be safe and effective, we didn’t have a clear sense of how beneficial it would be, just some hints from the earlier trials. Would the vaccine clear the FDA’s hurdle for approval and prove to be more than 50 percent effective at preventing COVID’s symptoms? Sensing the nervousness on the call, Bourla broke the tension right away. “I have news on the vaccine,” he began, “and it’s good.”

It was indeed. Pfizer filed with the FDA on Friday, November 20, seeking authorization for emergency use of the vaccine.35 It was the first company to seek permission to offer a COVID vaccine to US patients. It was just 248 days since the company had first set out with BioNTech to develop the vaccine. No vaccine had ever been developed that fast. The process involved 150 different clinical trial sites, 43,661 patient volunteers, the work of thousands of Pfizer colleagues, and the hopes of a weary nation: it was one of the largest, fastest, and most important scientific endeavors of its kind in modern history.

Pfizer initially committed $1 billion to the project, a sum that would soon double as the company ramped up manufacturing sites across the US and Europe and started to produce the vaccine. Much of that money would pay for facilities specially designed to manufacture the mRNA vaccines. The specially formulated mRNA used in the vaccine was produced by batteries of highly specialized mixing machines that Pfizer had custom-made for the purpose at a cost of $200 million each. I remember the board meeting when we voted to buy more of them. We initially purchased five of the batteries of machines in all, at a cost of $1 billion—before we even knew if the vaccine was going to work. We would end up purchasing many more. While other companies took grants from the federal government to offset the cost of development and to pay for the investments they would need to expand their manufacturing facilities, Pfizer made a decision to forgo federal money to support the venture. Pfizer agreed in advance to sell an initial allotment of 100 million doses of vaccine to the federal government at an agreed-upon price, but only if the vaccine was successful and won FDA authorization. The US government would pay Pfizer only if the vaccine worked, and only for the doses they were buying.37 Bourla wanted it that way. He was concerned that the strings attached with federal grant money could slow the process. He wanted his scientists unencumbered. He knew that speed to market would save lives.

As it turned out, when new strains emerged over the winter of 2020–21 in Brazil and South Africa and raised concerns that the existing mRNA vaccines might offer less robust protection against these new variants, Pfizer and Moderna were able to develop new constructs that targeted these mutant strains and get them into development in under a few months.38 The speed and adaptability of the mRNA approach demonstrated its superior utility. The companies were able to generate boosters for new variants as soon as scientists isolated the new viral sequences, and have the modified vaccines ready if they were needed.

Across multiple administrations, the willingness to view pandemic preparedness through the lens of national security has waxed and waned, being downgraded only to be elevated after new threats emerged, and then marginalized again when the immediate risks seemed to recede. This cycle took place most visibly in relation to the National Security Council (NSC). At the beginning of the Bush administration in 2001, there had been a person charged with overseeing biothreats on the NSC, but the position was eliminated only to be reinstated after 9/11, with an emphasis on bioterrorism. In 2009, the incoming Obama administration disbanded the biothreats staff on the NSC, as the Bush administration initially had done, but then reinstituted the function after the H1N1 swine flu pandemic and the Ebola epidemic.22 And yet once again, in 2018, this NSC function was disbanded by the Trump administration, not long before COVID struck.

Given the intense isolation that nations are now likely to experience when they disclose that they’re host to a menacing outbreak of a novel disease, and the economic repercussions they’ll incur, we can expect countries to adjust their behaviors. They’ll be even more reluctant to reveal the existence of a new pathogen or to share strains and sequence information. There’s currently no requirement, under any international law or convention, that can compel nations to share samples of pathogens in a public health crisis.37 To this day, China has never shared the initial strains of SARS-CoV-2, which are key if we wish to firmly establish the virus’s origin. These source strains would also have helped support the early development of drugs and diagnostics.