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“The new speed turned largely on our ability to deploy novel approaches for developing vaccines, where the initial constructs were derived entirely from the virus’s genome. This enabled us to use pieces of synthetic genetic material that could be made quickly available as the vaccine starting point. The application of these tools transformed the way we develop vaccines against a novel viral target. After COVID, these approaches will be routine.”
Scott Gottlieb, Uncontrolled Spread: Why COVID-19 Crushed Us and How We Can Defeat the Next Pandemic
“To get the manufacturers and commercial labs into the market early, senior officials needed to guarantee the purchase and payment for their tests. We needed to anticipate the threat, and the officials at HHS needed to create a market where one didn’t yet exist.”
Scott Gottlieb, Uncontrolled Spread: Why COVID-19 Crushed Us and How We Can Defeat the Next Pandemic
“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.”
Scott Gottlieb, Uncontrolled Spread: Why COVID-19 Crushed Us and How We Can Defeat the Next Pandemic
“This is also the approach used by the two leading COVID vaccines that were made in China and marketed by the Chinese drug makers Sinovac and Sinopharm.”
Scott Gottlieb, Uncontrolled Spread: Why COVID-19 Crushed Us and How We Can Defeat the Next Pandemic
“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.”
Scott Gottlieb, Uncontrolled Spread: Why COVID-19 Crushed Us and How We Can Defeat the Next Pandemic
“As part of our national preparedness, it will be important to stockpile countermeasures to some of the known risks, but it’s equally important to support the development of novel technology platforms that have broad applicability over a range of potential threats. We can’t always see the future. We can’t focus solely on the dangers that we can see today. And we can’t guess which approaches to developing drugs and vaccines will yield the most effective solutions.”
Scott Gottlieb, Uncontrolled Spread: Why COVID-19 Crushed Us and How We Can Defeat the Next Pandemic
“Black New Yorkers were twice as likely as white New Yorkers to die from COVID and more than twice as likely to suffer a nonfatal hospitalization.”
Scott Gottlieb, Uncontrolled Spread: Why COVID-19 Crushed Us and How We Can Defeat the Next Pandemic
“It took more than a month after the authorization of the first vaccine to begin vaccinating the 1.34 million residents of US nursing homes, where the most COVID deaths were occurring.”
Scott Gottlieb, Uncontrolled Spread: Why COVID-19 Crushed Us and How We Can Defeat the Next Pandemic
“RNA viruses mutate relatively quickly, and many, like influenza, are able to undergo a process known as antigenic drift, by which the virus is able to alter the surface antigens that are the targets of our antibodies—thus evading our existing immunity. Some viruses, like measles, cannot change their genomic sequence in ways that substantially alter enough of their surface proteins, so measles remains susceptible to our vaccines or the immunity that we get from prior infection. However, for viruses like influenza, as their surface proteins undergo change, the virus is able to dodge the protective antibodies that we’ve developed from past infection or vaccination”
Scott Gottlieb, Uncontrolled Spread: Why COVID-19 Crushed Us and How We Can Defeat the Next Pandemic
“Early on, Pottinger also raised concerns about potential shortages of medical supplies like masks. But not everyone was similarly convinced of the dangers. As the pandemic later took its grip on the nation, he was one of the rare White House officials who routinely wore a mask to work, despite persistent scorn by colleagues, who labeled him an alarmist. Pottinger had two older relatives living with him at home and was so worried about the lax precautions being observed inside the White House that he had his office moved from the West Wing to the Eisenhower Executive Office Building, an historic and ornate office building located next to the White House that housed many of the staff who supported the president. It was Pottinger’s own act of social distancing. He was worried that he would catch the virus in the White House and bring it home with him.”
Scott Gottlieb, Uncontrolled Spread: Why COVID-19 Crushed Us and How We Can Defeat the Next Pandemic
“When policymakers lost interest in Regeneron’s drug for MERS, the company advanced an idea for a pan-coronavirus antibody that could be used if another coronavirus should emerge and threaten a pandemic.27 Regeneron believed it was possible to develop a cocktail of antibodies that would be effective against any coronavirus. But the project couldn’t attract investment from federal agencies like BARDA that would have had to fund these sorts of countermeasures.”
Scott Gottlieb, Uncontrolled Spread: Why COVID-19 Crushed Us and How We Can Defeat the Next Pandemic
“The public is willing to follow sensible, evidence-based directions. But experts can only ask people to sacrifice so much before resistance starts to form, given the potential social and economic hardship. If the CDC expects Americans to follow its guidance, it will have to be more transparent and get the public invested in how these decisions are made.”
Scott Gottlieb, Uncontrolled Spread: Why COVID-19 Crushed Us and How We Can Defeat the Next Pandemic
“The point here isn’t that the federal health officials were wrong. The point is that they were working with faulty tools, and from faulty data sets. Because health officials couldn’t test widely for the presence of the virus, they overrelied on information that they had access to, which was based on a model for flu. This is the central failing that needs to be fixed for our future preparedness.”
Scott Gottlieb, Uncontrolled Spread: Why COVID-19 Crushed Us and How We Can Defeat the Next Pandemic
“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.”
Scott Gottlieb, Uncontrolled Spread: Why COVID-19 Crushed Us and How We Can Defeat the Next Pandemic
“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.”
Scott Gottlieb, Uncontrolled Spread: Why COVID-19 Crushed Us and How We Can Defeat the Next Pandemic
“In the next two days, as cases grew (reaching one hundred civilian cases and another nine hundred at a local barracks), Starkloff asked the city’s mayor and other leaders for legal authority to issue public health edicts. His request was granted. Starkloff’s actions were swift and forceful. Starting on October 8, theaters, pool halls, and other public amusement venues were ordered shut. All public gatherings were banned. Churches were also shut. Schools were ordered closed the next day.25 The difference in the response times between Philadelphia and St. Louis amounted to fourteen days when measured from the first reported cases—but those two weeks represented about three to five doubling times for a flu epidemic.”
Scott Gottlieb, Uncontrolled Spread: Why COVID-19 Crushed Us and How We Can Defeat the Next Pandemic
“The mRNA approach could also provide a more reliable way to manufacture the vaccine in large quantities without relying on millions of chicken eggs.”
Scott Gottlieb, Uncontrolled Spread: Why COVID-19 Crushed Us and How We Can Defeat the Next Pandemic
“The federal government had bought the entire available supply, and HHS needed to know where to ship its limited doses, to make sure that the scarce medicine would get to those hospitalized patients who might benefit most from the treatments. However, the CDC didn’t have actual data on who was currently hospitalized for COVID, just estimates built off a model. They couldn’t tell HHS where real patients were, only hypothetical patients that were being extrapolated from an algorithm.”
Scott Gottlieb, Uncontrolled Spread: Why COVID-19 Crushed Us and How We Can Defeat the Next Pandemic
“The law required the CDC to “establish a near real-time electronic nationwide public health situational awareness capability through an interoperable network of systems to share data and information to enhance early detection of rapid response to, and management of, potentially catastrophic infectious disease outbreaks and other public health emergencies that originate domestically or abroad.”30 As Levin observed, “the simplest way to describe the CDC’s response to this binding legal mandate was that it just ignored it. It did nothing.”
Scott Gottlieb, Uncontrolled Spread: Why COVID-19 Crushed Us and How We Can Defeat the Next Pandemic
“From start to finish, it took Lilly eight months to go from concept to a commercially available medicine.30 The company’s previous record for discovering, developing, and commercializing an antibody drug—soup to nuts—was four and a half years. Lilly received FDA authorization for its COVID antibody drug on November 9, and Regeneron soon followed suit on November 21.31”
Scott Gottlieb, Uncontrolled Spread: Why COVID-19 Crushed Us and How We Can Defeat the Next Pandemic
“Most of the notable features on the virus could be found in coronaviruses already identified in nature, including the furin cleavage site. So, in theory, all of its genetic diversity could have evolved through natural selection. The features didn’t necessarily need to arise from a lab, or from any special circumstance.”
Scott Gottlieb, Uncontrolled Spread: Why COVID-19 Crushed Us and How We Can Defeat the Next Pandemic
“Cases continued to surge. And yet many civic leaders would argue that the Spanish flu was driven by misguided fears and wasn’t that dangerous. In 1918, one of the most prominent of these individuals was Krusen, who would declare that the end of the pandemic was near and that the cases had reached a “crest.” Dr. John W. Croskey, president of the West Philadelphia Medical Association, similarly said that “the public should be educated to the fact that the disease is not as deadly as many believe it to be.” However, Croskey had grossly underestimated the severity of the flu, putting the case fatality rate—the percentage of people who developed symptoms of flu and would die from the disease—at about 0.5 percent, which was far less than its real fatality rate.”
Scott Gottlieb, Uncontrolled Spread: Why COVID-19 Crushed Us and How We Can Defeat the Next Pandemic
“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.”
Scott Gottlieb, Uncontrolled Spread: Why COVID-19 Crushed Us and How We Can Defeat the Next Pandemic
“Without a way to reliably test patients who had symptoms suggestive of SARS-CoV-2 infection, US doctors had no way to diagnose the sick or take measures to contain the spread.”
Scott Gottlieb, Uncontrolled Spread: Why COVID-19 Crushed Us and How We Can Defeat the Next Pandemic
“However, neither Lilly nor Regeneron would be able to produce enough supply in 2020 to meet the expected demand in the epidemic that was surging in the winter of 2020–21.”
Scott Gottlieb, Uncontrolled Spread: Why COVID-19 Crushed Us and How We Can Defeat the Next Pandemic
“The winter was even worse for the country, when the epidemic widened. Yet at the same time, on many days, the nations of China, Japan, South Korea, Taiwan, Singapore, Hong Kong, Thailand, Malaysia, Vietnam, New Zealand, and Australia were collectively registering fewer daily COVID cases than the city of Los Angeles.27 Some of these nations, especially China, had employed draconian tactics that would have been firmly rejected in the US.”
Scott Gottlieb, Uncontrolled Spread: Why COVID-19 Crushed Us and How We Can Defeat the Next Pandemic
“Birx said that the government couldn’t ship scarce doses of the valuable medicine to treat estimated patients that were hypothetically hospitalized according to a mathematical formula. So she gave hospitals an ultimatum. If they wanted to get access to remdesivir, they would need to start reporting real data on the total number of COVID patients that they admitted each day. Hospitals quickly started to comply, reporting actual data on their total daily hospitalizations to a new portal that Birx had helped set up inside HHS. Rather than try to cajole the CDC into fixing its reporting system, Ambassador Birx and Secretary Azar decided to re-create that structure outside the agency. They had concluded that getting the CDC to change its own scheme, and abandon its historical approach to modeling these data, would have been too hard.”
Scott Gottlieb, Uncontrolled Spread: Why COVID-19 Crushed Us and How We Can Defeat the Next Pandemic
“A highly respected pair of researchers put the odds that such an effort (in this case involving a hypothetical strain of a novel influenza) could create a dangerous pathogen that would accidentally escape from a lab and trigger a pandemic at 1 in 10,000 to 1 in 100,000 per lab year.64 This was a meaningful risk. The US government imposed a moratorium on gain-of-function studies in 2014. No such restrictions were imposed in China. The US moratorium was later lifted by the NIH in 2017 and gain of function experiments continued including one widely cited study that was done by US researchers in collaboration with the WIV.65”
Scott Gottlieb, Uncontrolled Spread: Why COVID-19 Crushed Us and How We Can Defeat the Next Pandemic
“It was always likely that, in the event that a new virus emerged, the first therapeutics that could be made available would be antibody drugs fashioned to attack proteins on the virus’s surface. Yet we didn’t have a plan on the shelf for how we would maximize their use.”
Scott Gottlieb, Uncontrolled Spread: Why COVID-19 Crushed Us and How We Can Defeat the Next Pandemic
“But a good vaccine maximizes its ability to kindle all of our immune system’s machinery, not only stimulating the production of antibodies but also spurring the activity of T cells and B cells that have memory, and are able to churn out new antibodies and other mediators of our immune response after they come into contact with a virus months or years later.”
Scott Gottlieb, Uncontrolled Spread: Why COVID-19 Crushed Us and How We Can Defeat the Next Pandemic

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