#SootinClaimon.Com : ขอบคุณแหล่งข้อมูล : หนังสือพิมพ์ The Nation.
The ‘deep state’ scientists vilified by Trump helped him deliver an unprecedented achievement
InternationalDec 15. 2020
President Trump delivers remarks in the White House press briefing room on Nov. 20. MUST CREDIT: Washington Post photo by Jabin Botsford.
By The Washington Post · Yasmeen Abutaleb, Laurie McGinley, Carolyn Y. Johnson
The timing of the hastily arranged White House “vaccine summit” last Tuesday bewildered many invitees.
It was days before the authorization of the first coronavirus vaccine developed by Pfizer and German firm BioNTech – and nearly a week before millions of vaccine doses would be loaded onto trucks bound for every state in the nation. Wouldn’t those milestones and the mass vaccination effort that followed be what the White House would want to spotlight?
That was not what the president was interested in. As it became clear that vaccines would be a shining success in an otherwise calamitous pandemic response, he wanted to make sure his administration – and specifically Operation Warp Speed, its initiative to speed vaccines – got credit for an unprecedented scientific achievement.
The Dec. 8 event began with a video that featured scientists and pundits warning that the administration’s goal of delivering a vaccine in less than a year was unrealistic. As music swelled to a crescendo, a narrator boasted about how it had in fact delivered that record achievement.
Trump then took the stage to tout his administration’s success. “You saw that very few people thought that this was possible,” he told a small assembled audience. “Of course, they’ll be saying now, ‘We always told you it was so.'”
“People that aren’t necessarily big fans of Donald Trump are saying, ‘Whether you like him or not, this is one of the greatest miracles in the history of modern-day medicine’ or any other medicine – any other age of medicine,” Trump added.
In fact, the lightning-fast development of two leading coronavirus vaccines happened both because of and despite Trump – perhaps the most anti-science president in modern history, who has previously flirted with anti-vaccine views and savaged those who cited scientific evidence to press for basic public health measures in response to the pandemic.
The lifelong businessman who refused to wear a mask himself was able to understand vaccines as something else entirely: a deliverable that he could make happen with money. And unlike a mask, a vaccine represented a display of American technological prowess, an appealing solution that didn’t require painful steps like closing small businesses. For the president, it exerted an increasingly strong pull as the election approached.
“I do think the urgency for Operation Warp Speed was heightened by the fact that we were in the middle of an election year,” said Daniel Carpenter, a political scientist at Harvard University. “On the whole, it was a good thing – it led a potentially anti-science, anti-vaccine administration to push harder for a vaccine. What we will end up seeing in the long run is this is an unparalleled private and public sector mobilization that happened.”
That mobilization, which is pushing out the first 2.9 million doses of the Pfizer-BioNTech vaccine this week, is a testament to the power of science, and also of a global collaboration involving drug companies and government coordinated by political appointees and civil servants across the government – players and a process that Trump has at times disparaged.
To many attendees of the White House summit – and even more who stayed away – that event underscored the awkward, often uneasy relationship between Trump and pharmaceutical companies, government regulators and scientists, even as they jointly pursued the goal of ending a pandemic that has killed more than 298,000 Americans and infected another 16 million.
None of the companies that developed the most promising vaccines were present. Officials said they worried about participating in an event that might reinforce perceptions of political interference and suspicions of a rushed vaccine just as their shots were on the cusp of emergency clearance.
White House spokesman Brian Morgenstern said Trump hosted the summit to build confidence in the vaccine and to “congratulate those involved in this miraculous achievement.” He added that drug company executives had stayed away to avoid contact with FDA regulators.
The president’s bravado seemed to anticipate the FDA’s announcement three days later that it had cleared the nation’s first vaccine from Pfizer-BioNTech – the administration’s biggest triumph to date in a pandemic response otherwise marred by dysfunction and lack of leadership: A second vaccine from Moderna is expected to be authorized later this week. Others could follow if clinical trials are successful.
These accomplishments are remarkable, but they are not “miracles,” in the sense that they sprang fully formed from work that began last spring. They relied on basic research done over decades in government, academic and company research labs. Even the financial model used to insulate vaccine makers from financial risk traced back to an agency that Congress created in late 2006 to incentivize companies to develop urgently needed medicines.
And the true test of Operation Warp Speed is about to occur as the administration tries to meet ambitious timelines that it has revised repeatedly. A key plank involves distributing the vaccine to millions of Americans in a matter of months, which began on Sunday. But potential supply problems already threaten the government’s ambitious vaccination schedule.
Pfizer urged the government to purchase 200 million doses of its vaccine in the summer and this fall, an offer the government declined as recently as October over disagreements about delivery dates. The company has since told the government it may not be able to supply substantial additional doses until late June or July, raising questions about the vaccination timeline. Officials insist they will have enough doses.
This account of how government scientists, regulators, politicians and private industry managed to deliver a coronavirus vaccine in under a year, and the political turbulence that accompanied it, is based on interviews with more than 20 current and former senior administration officials and outside advisers and experts, many of whom spoke on the condition of anonymity to reveal private discussions and speak candidly.
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The extraordinary vaccine initiative was propelled by a $14 billion investment from the federal government – which Trump supported and signed off on – that would become Operation Warp Speed, a public-private partnership to hasten vaccines and treatments, in part by footing the bill to manufacture millions of doses before anyone knew if they worked.
Pfizer made a point of not accepting government research funding, a decision its chief executive Albert Bourla said last month on ABC’s “Good Morning America” was “to liberate our scientists from any bureaucracy that could come by accepting money.” But the company did benefit from the government’s zeal for a vaccine in other ways: It agreed to sell nearly $2 billion worth of vaccines to Warp Speed and was bolstered separately by a strong working relationship with federal regulators.
By contrast, Moderna’s vaccine would have taken much longer without the government investment and its partnership with the National Institutes of Health. The federal government has invested $4.1 billion in Moderna’s vaccine, between research and development funding and the purchase of 200 million doses.
Warp Speed was designed to be largely free of political interference and had leaders with deep experience in vaccine development and logistics, said several officials who were involved in the effort. In many ways, it was an example of how much more successful the government’s pandemic response might have been with clear leadership and officials empowered to follow the science, they said.
“In twenty years, you’ll look back and it’s not going to be . . . a story about bleach or a whistleblower, or who wore a mask and who didn’t,” one senior administration official said. “It’s going to be about Warp Speed and the vaccine – a thing that comes along scientifically in less than one year that ends a global pandemic.”
But the race to develop a vaccine also became intensely politicized by the president, with trust in a prospective vaccine plummeting apparently as a result. Trump recognized early that the pandemic would only truly come to an end when a vaccine became widely available – and then became fixated on delivering one before the Nov. 3 presidential election to convince voters he had the virus under control.
That calculation led the president and top aides – especially Chief of Staff Mark Meadows – to apply unrelenting pressure on the FDA to clear a vaccine before the election. Even after Trump lost his bid, that campaign continued, culminating in an extraordinary threat on Friday, when Meadows ordered FDA Commissioner Stephen Hahn to submit his resignation if the agency did not clear Pfizer’s vaccine by day’s end. The agency pushed its timetable from Saturday morning to late Friday – a change that had no effect on the distribution plans that were set to begin Sunday.
Earlier that same day, Trump had tweeted that the FDA was “a big, old, slow turtle” and badgered Hahn. “Get the dam vaccines out NOW, Dr. Hahn @SteveFDA. Stop playing games and start saving lives!!!”
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The public-private partnership created through Operation Warp Speed is not an idea the administration invented. For years, global public health leaders had talked about using government investment to reduce the financial risks that dissuade companies from developing needed products. That was also the model behind the creation of the Biomedical Advanced Research and Development Authority (BARDA) during the George W. Bush administration, with an eye toward working with private industry on bioterrorism countermeasures.
Warp Speed harnessed those ideas on a massive scale for a different kind of public emergency and then partnered with a half-dozen companies and other government agencies to pull it off.
“It’s a 15-year, overnight success story,” said Richard Hatchett, chief executive of the Coalition for Epidemic Preparedness Innovations, a four-year-old nonprofit that works to finance the development of vaccines against emerging infectious diseases.
The idea took hold in February and March after government scientists realized that covid-19, the disease caused by the coronavirus, was a “catastrophe in the making,” as one senior administration official recalled. But they quickly realized that some vaccine manufacturers did not share that sense of urgency.
Unsure of how long the outbreak would last, some executives were reluctant to spend the hundreds of millions of dollars or more to develop a vaccine without knowing whether they would have a market when they finished. Some companies talked about beginning clinical trials in the fall, with the aim of having a vaccine ready by summer 2021.
“The vaccine manufacturers were in a funk,” the senior administration official recalled. “We woke up to that and realized that is not going to fly.”
In early April, Peter Marks, an oncologist who has worked in both academia and the drug industry and who heads the FDA division that regulates vaccines, began laying the groundwork for what would become Operation Warp Speed.
He teamed up with Robert Kadlec, assistant secretary for preparedness and response at the Department of Health and Human Services, to write a proposal for HHS Secretary Alex Azar detailing a process that went from screening potential vaccine candidates to distributing the final product to an estimated 330 million Americans.
The thought was that if the government could eliminate most of the financial risk of vaccine development, more companies would be inclined to take on the herculean challenge. The government would also help speed development by footing the bill to manufacture millions of doses of vaccines without knowing whether they worked, so that normally sequential steps could be completed all at once.
Marks said the most important step in the vaccine effort was “getting started early with a clear direction in mind and having good partners” in various companies that were motivated “to get to the same place.”
Meanwhile, the virus was leaping from one continent to another, leaving a trail of carnage and spurring a torrent of research. Hundreds of academic teams, companies and government researchers were eager to apply different ideas to fight the virus, but there was also a clear need for a national strategy that could prioritize efforts.
“Uncharitably, people might have called it a bit of a scattershot scenario – that was true for therapeutics and vaccines,” said Francis Collins, director of the National Institutes of Health.
Collins called drug company executives, starting with Mikael Dolsten at Pfizer, with whom he had worked closely for years, to talk about creating a scientific public-private partnership to tackle the pandemic. Collins had crafted a similar partnership to speed up the development of new medicines, but that had taken months. This new one crystallized over two weeks in early April – and included a vaccine working group that began to hammer out some of the principles for how to rapidly test vaccines.
The group calculated that trials with 30,000 people would have the statistical power to answer the most important questions about safety and effectiveness, and to get those answers quickly. They debated, and ultimately settled, on a single unified data and safety board for all the trials. That approach had been taken with some HIV trials, and would mean the same group of independent experts would be reviewing the totality of the raw data from all the trials – and might be able to detect any concerning safety trends or important patterns.
Operation Warp Speed would ultimately bet on six efforts – Pfizer-BioNTech, Moderna, AstraZeneca-University of Oxford, Johnson & Johnson, Novavax, and Sanofi and GlaxoSmithKline. Those that accepted research funding – all but Pfizer – could take advantage of a large network of clinical trials developed over decades by the NIH.
Pfizer and Moderna gambled on a promising but unproved technology that relied on messenger RNA, spurring criticism for taking that approach at a time when a vaccine was desperately needed.
In one meeting in late April, Deborah Birx, the White House coronavirus task force coordinator, expressed frustration that the leading vaccine candidates were not relying on tried-and-true technologies, according to four current and former senior administration officials.
But Anthony S. Fauci, director of the National Institute of Allergy and Infectious Diseases, along with some other experts, was enthusiastic about including those vaccines in the government’s portfolio, since they were backed by years of research and might be developed much more quickly than conventional vaccines
Pfizer and Moderna’s strategy paid off in November, with both companies reporting trial results that showed their vaccines were more than 90 percent effective at preventing disease. By contrast, the vaccine being developed by Sanofi and GlaxoSmithKline, using a proven technology, hit a setback last week when results showed the shot didn’t trigger strong responses in older people. The companies now project their vaccine won’t be available until the end of 2021.
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In April, after Marks and Kadlec gave Azar their proposal, the secretary presented it to the White House coronavirus task force. Some were skeptical about whether it would work and wary of the enormous price tag.
Trump, however, was enthusiastic. Unlike other aspects of the response, he agreed to spend billions on the effort – even as he was publicly predicting the virus would soon be gone.
The project was announced through a reporter at Bloomberg News, when officials were still casting about for a name.
Initially, they called it MP2, shorthand for Manhattan Project 2.0. The name seemed fitting, one senior official recalled, because “it was the historic implication that this was to do something never done before . . . with the same commitment at the national level as the Manhattan Project.”
But they soon realized that referring back to a nuclear bomb wouldn’t work for a vaccine. Marks, a Star Trek fan, and a small group of government officials had been privately calling the project Operation Warp Speed, based on the term “warp speed” popularized by the Star Trek series. In one internal email, Marks used the Star Trek logo with a needle in the middle of it.
Scrambling just before the interview, the officials seized on the name and it stuck.
Azar scouted for a drug industry veteran to run Warp Speed, calling Jim Greenwood to ask for recommendations. At the time, Greenwood, a former congressman, was president of the Biotechnology Innovation Organization, a trade group that represents biotech companies.
Jared Kushner, the president’s son-in-law and one of his most trusted advisers, joined Azar and other health officials to interview four or five candidates. They landed on Moncef Slaoui, who had spent much of his career as a GlaxoSmithKline vaccine researcher and executive.
Slaoui had led an effort to create a dedicated biopreparedness facility in 2016, a research organization that would systematically tick through every virus that had the potential to cause a pandemic and create vaccines for each one.
The proposal flopped, but Slaoui remained convinced that a model that joined government and industry to counter such risks was essential.
“I could have also sat on the sidelines and said why it would never work,” Slaoui said of his decision to join Warp Speed. ” . . . in the month of May when the operation was announced, I do not remember hearing a single expert say, ‘Yes, this is possible.’ I heard everybody explaining to us why it will never work.”
On May 1, Azar met at the Pentagon with then-Defense Secretary Mark T. Esper and a handful of aides to discuss how their agencies could work together, aware that HHS alone could not handle a logistics operation as complex as a nationwide vaccination effort.
They agreed on Gen. Gustave Perna as the logistics chief, a man whose expertise would become critical in managing and coordinating one of the largest ever vaccine distribution efforts in American history.
At one point, when 60 electricians were needed at one facility, Operation Warp Speed used the Defense Production Act to get them.
Slaoui and Perna were mostly walled off from the White House, as well as from Capitol Hill and the media, so they could avoid distractions. Still, Birx and Kushner sat on the board of Operation Warp Speed and attended meetings – a decision officials made intentionally to give the White House a seat at the table but not an outsize role.
“It was recognized that having larger participation from other offices in the White House could be disruptive,” one senior administration official said.
“Perna and Slaoui really wanted to be independent of the politics. They wanted to be able to chase the science and make bets,” a second official said. “In normal times, people will say you wasted a lot of money taking six or seven shots on goals with different types of vaccines. . . . but if we only get one of them, we got one at least.”
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After helping to launch Warp Speed, Marks quickly retreated to the FDA. He and Slaoui had clashed, according to individuals familiar with the situation who spoke on the condition of anonymity because they were not authorized to discuss the issue. Marks also realized that he was most valuable to the vaccine effort as a regulator, not as a developer, he has said. And the FDA drew a bright line between its activities and those of Warp Speed to avoid conflicts of interest.
As Marks and his veteran vaccine experts began working with the pharmaceutical companies on the regulatory requirements, they remained in constant contact in hopes of avoiding unnecessary speed bumps.
“What helped at the outset was having clear guidance on what the expectations were,” Marks said.
In June, the FDA issued guidelines that said any coronavirus vaccine would have to be at least 50 percent more effective than a placebo, or a saltwater shot, in preventing covid-19. The agency proposed updating that guidance in the fall, spelling out additional safety requirements to bolster public confidence in an emergency authorization.
The idea enraged Trump and Meadows, who realized the criteria made it all but impossible for a vaccine to be authorized before the election. FDA ignored their objections and issued the guidelines, whose substance had already been conveyed to the manufacturers.
The FDA had already endured a bruising year, under the leadership of a new and untested commissioner, Stephen Hahn, who came under constant pressure from Trump and the White House to authorize or examine treatments that had no proven effectiveness against covid-19.
In a series of of high-profile missteps, the agency cleared the antimalarial drug hydroxychloroquine – then revoked that authorization – and initially took a hands-off approach to coronavirus antibody tests. On the eve of the Republican National Convention, Hahn overstated the benefits of convalescent plasma during a hastily arranged briefing with Trump, then apologized the next day.
Trump continued to accuse the FDA of moving too slowly, even as the agency staff worked almost around-the-clock. Marks’s pandemic schedule, for example, involves getting up at 3 a.m., taking his dog Eddie for a walk, and beginning work at 4:30 on a torrent of emails and meetings before knocking off at 9 p.m. Dozens of others working on coronavirus vaccines have been maintaining similar schedules.
As Trump pushed to get a vaccine before the election, public trust in the vaccine plummeted from more than 70 percent in May to just over 50 percent in September.
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By November, Americans had become inured to one grim milestone after another, as the nation set countless records for daily infections, deaths and hospitalizations and endured a bitterly divisive presidential campaign.
Six days after a polarizing election called for Joe Biden, Pfizer reported astonishing news: Its coronavirus vaccine, the one that relied on a new genetic technology, was more than 90 percent effective. Those results also augured well for Moderna’s vaccine, which used the same technology and reported equally striking results only seven days later.
Exhausted company and government scientists and regulators were elated. For the first time all year, they could envision an end to the pandemic. The idea that the country could have one effective vaccine by year’s end had seemed like a long shot. Now, it looked like it could have two.
“I would say it’s a historical moment,” Kathrin Jansen, Pfizer’s head of vaccine research and development, said in an interview. “Hearing that at the interim analysis we are over 90 percent effective – it was almost stunning to hear.”
Trump, however, was furious. The additional safety steps the FDA had taken to shore up public trust in the vaccine strengthened his conviction that the agency had conspired against him. Now he said the “medical deep state” had deliberately sought to sabotage his electoral prospects, and he demanded that Azar “get to the bottom” of what happened.
His anger would grow to a fever pitch when Britain cleared Pfizer’s vaccine on Dec. 2. Meadows summoned Hahn to the Oval Office and asked why the United States had not been first. The pressure campaign culminated in the Friday threat to Hahn to clear the vaccine by day’s end or submit his resignation.
The irony is that the quest for a vaccine needed no meddling.
Back in May, when the vaccine trials were still in the planning stages and success was far from certain, Fauci had said he was tuning out politics.
“I worry about a lot of things,” he said in an interview. “But I’m going to do the best possible science, to develop what I consider convincing evidence that it works and is safe, or does not work and is not safe.”
Which is precisely what he and hundreds of other scientists did.
Georgia Gov. Brian Kemp speaks during a rally in support of President Trump on Oct. 16, 2020 in Macon, Ga. MUST CREDIT: Photo by Nicole Craine for The Washington Post 
Artiwara “Toon” Kongmalai 
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