\u4f9d\u7136\u662f\u8bb2\u8ff0\u7f8e\u56fd\u5e94\u5bf9\u65b0\u51a0\u75ab\u60c5\u53d1\u660e\u75ab\u82d7\u7684\u6545\u4e8b\u3002\u7f8e\u65b9\u7684\u66f2\u901f\u884c\u52a8\u8ba1\u5212\u52a8\u7528\u4e86\u8fd1300\u4ebf\u7f8e\u5143\uff0c\u5b8c\u6210\u4e86\u75ab\u82d7\u7684\u7814\u53d1\u3001\u751f\u4ea7\u3001\u5206\u914d\u548c\u4f7f\u7528\uff0c\u624d\u6709\u4e86\u4eca\u5929\u75ab\u60c5\u7684\u5f7b\u5e95\u7ec8\u7ed3\u3002\u8fd9\u6bb5\u6709\u8da3\u7684\u5386\u53f2\uff0c\u4e0d\u5e94\u8be5\u88ab\u9057\u5fd8\u3002\u7167\u4f8b\u505a\u4e9b\u6458\u5f55\u3002<\/p>\n\n\n\n
\u201cThere were about 120 viruses known to pose a potential risk to people. Those viruses could be divided into twenty-five different families. There were licensed vaccines for viruses in just thirteen of those families. Most global-health efforts focused on the troubling pathogens that had emerged in the past\u2014but that left a whole swath of the viral landscape unknown, unprobed, unprotected against\u201d<\/p>\n\n\n\n
25\u4e2a\u5bb6\u65cf\u7684120\u4e2a\u75c5\u6bd2\u4e2d\uff0c\u771f\u6b63\u6709\u75ab\u82d7\u7684\u624d13\u4e2a\u5bb6\u65cf\uff0c\u4eba\u7c7b\u4f9d\u7136\u4efb\u91cd\u9053\u8fdc\u3002<\/p>\n\n\n\n
\u201cBack at the NIH, Graham thought he had an inside line on the coronavirus sequence, which he would need for the vaccine work to begin. At Fauci\u2019s suggestion, he reached out to George Gao, the head of China\u2019s CDC, a scientist whom Graham had met at several international meetings. Days went by without a response. In the end, the NIH obtained the sequence when it went global on Virological.org on January 10. \u201cIt\u2019s online so everyone has it now,\u201d McLellan griped in a message to a member of his lab in Texas.\u201d<\/p>\n\n\n\n
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\u201cBig Pharma had, by and large, concluded that there was no upside to going after emerging infectious diseases. As Merck and Sanofi had learned firsthand from their own experiences with Ebola and Zika, most outbreaks are terrifying, headline-grabbing events that quickly become utterly forgettable\u2014at least to those not directly affected. Vaccines cost hundreds of millions of dollars to develop and often take years, decades even, to bring to market. Very few vaccines share the history of Merck\u2019s 1967 mumps vaccine, developed and approved in four years and still needed today.* \u201d<\/p>\n\n\n\n
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\u201cHe discovered that Moderna could manufacture a pilot lot for a safety trial in humans using the small-scale equipment the company used for personalized cancer treatments. This brought the cost down from three to five million dollars to less than a million\u2014a veritable bargain.\u201d<\/p>\n\n\n\n
Moderna\u7684\u4e2a\u6027\u5316\u75ab\u82d7\u8bbe\u5907\u8ba9\u65e9\u671f\u65b0\u51a0\u75ab\u82d7\u4ece3-5\u767e\u4e07\u7f8e\u5143\u7684\u751f\u4ea7\u8d39\u7528\u964d\u4f4e\u5230\u4e00\u767e\u4e07\u4ee5\u4e0b\u3002<\/p>\n\n\n\n
\u201cIf Moderna was the Apple of the vaccine world, an envy-inspiring company that was oozing with cool and bursting with capital, Novavax was Nokia, a has-been that was still selling something but you weren\u2019t entirely sure who was buying it. Novasomes, the company\u2019s trademarked encapsulation technology, were microscopic bubbles of fat developed as a timed-release mechanism for chicken vaccines. But they proved to be more valuable as a moisturizer in a skin-care line, Nova Skin Care. And thanks to their oh-so-creamy mouth-feel, novasomes ended up in low-fat Girl Scout cookies and in Richard Simmons\u2019s Slimmons, 97 percent fat-free cookies. Thirty years later, Novavax had dropped the novasomes but was still trying, unsuccessfully, to get a human vaccine onto the market.\u201d<\/p>\n\n\n\n
The company focused on protein-subunit vaccines. Unlike Moderna\u2019s mRNA vaccine, which delivered instructions to the body\u2019s cells on how to produce the spike protein, Novavax\u2019s vaccine delivered the spike protein itself. Protein-subunit vaccines were invented during the genetic-engineering revolution in the 1980s, and though they took longer to make than mRNA vaccines, the technique had a solid track record. You could grow virus proteins inside a variety of organisms, from E. coli bacteria to tobacco plants. Back in the 1980s, long before he became Novavax\u2019s head of vaccine development, Gale Smith had invented a technique that used one of the fastest\u2014and strangest\u2014platforms: caterpillar ovary cells. Whenever there was an outbreak of an infectious disease, from swine flu to Ebola, Novavax raced to produce a vaccine candidate in these cells, juicing its stock with a blitz of press releases. But every time, the company let its investors down. It let itself down. This time, Glenn and Smith hoped things would end differently.\u201d<\/p>\n\n\n\n
Apple vs Nokia\u3002Novovax\u7684\u574f\u8fd0\u6c14\u503c\u5f97\u6df1\u5165\u7814\u7a76\u3002\u770b\u8d77\u6765\u53ea\u662f\u8fd0\u6c14\u80cc\u540e\u5b9e\u9645\u5f80\u5f80\u662f\u5b9e\u529b\u4e0d\u8db3\u3002<\/p>\n\n\n\n
\u201cHe soon discovered that when the antibody response went off the rails, the rest of the immune system malfunctioned as well. You might say the immune system was confused about the size of the threat it was facing. A healthy immune response to a virus, as we\u2019ve seen, involves, among other things, sending in killer T cells to destroy infected cells. But for larger interlopers that, unlike viruses, remain outside of cells\u2014like bacteria, pollens, or parasitic worms\u2014the body produces mucus, inflammation, and fighting cells known as eosinophils. This is the type of response we associate with allergies. That response cuts back on the killer T cells and generally makes it more difficult for the body to clear viruses from small airways.\u201d<\/p>\n\n\n\n
\u201cUsing a technique called X-ray crystallography, Graham and McLellan produced three-dimensional images of the antibody-bound protein, and the difference between the prefusion and postfusion structures was obvious. Prefusion, the protein was a squat triangle. Postfusion, it was like the Eiffel Tower, 50 percent taller. When the protein changed shape, it exposed different nooks and crannies, known as epitopes. This explained why so many of the antibodies people produced to the postfusion form were not neutralizing the virus.\u201d<\/p>\n\n\n\n
\u6297\u4f53\u548c\u514d\u75ab\u7cfb\u7edf\u7684\u76f8\u4e92\u4f5c\u7528\u3001\u76f8\u7231\u76f8\u6740\u3002\u6297\u4f53\u7684\u7ed3\u6784\u7279\u5f81\u4e5f\u5f71\u54cd\u5176\u6d88\u706d\u75c5\u6bd2\u7684\u6548\u7387\u3002<\/p>\n\n\n\n
\u201cGoing back to the old platform Smith had developed, Novavax was planning to grow its spike proteins inside cells plucked from caterpillar ovaries. Although the concept had proven itself over and over again, every new protein you made in those cells required time-consuming tweaks to the purification and manufacturing processes, a big difference from the plug-and-play approach of Moderna\u2019s mRNA vaccines.<\/p>\n\n\n\n
Novavax\u2019s general process began by harnessing the power of another virus, one that infected insects rather than people. \u201d<\/p>\n\n\n\n
mRNA\u6280\u672f\u76f8\u6bd4\u86cb\u767d\u82d7\u7684\u4f18\u52bf\uff1a\u5373\u63d2\u5373\u7528 vs \u7e41\u7410\u7684\u7ec6\u80de\u57f9\u517b\u3001\u7eaf\u5316\u4f53\u7cfb\uff0c\u5728\u901f\u5ea6\u4e0a\u62e5\u6709\u538b\u5012\u6027\u7684\u4f18\u52bf\u3002<\/p>\n\n\n\n
Emergency use authorization, or EUA, the agency just needed to be convinced that a product \u201cmay be effective\u201d and that the potential benefits outweighed the safety risks. The agency had issued EUAs for antiviral drugs during the swine flu pandemic, but it had never authorized a vaccine in that manner in its history. Because vaccines are meant for the healthy, everyone knew the risk-benefit calculus was going to be stacked against an EUA for a vaccine.\u201d<\/p>\n\n\n\n
\u75ab\u82d7\u7684EUA\u5c45\u7136\u662f\u5386\u53f2\u4e0a\u7684\u5934\u4e00\u56de\u3002\u8fd9\u4e2a\u4e5f\u662f\u4eba\u7c7b\u548c\u75c5\u6bd2\u6597\u4e89\u7684\u5de8\u5927\u8fdb\u6b65\uff0c\u611f\u67d3\u671f\u4e00\u5e74\u5185\u5c31\u641e\u51fa\u6765\u75ab\u82d7\u4e86\u3002<\/p>\n\n\n\n
\u201cCongress, meanwhile, had upped the administration\u2019s meager request for a funding supplement, passing a bill to give HHS nearly eight billion dollars to fight the coronavirus. Trump signed it a day later, at 9:05 a.m. on Friday, March 6.\u201d<\/p>\n\n\n\n
\u7f8e\u56fd\u7684\u62e8\u6b3e\u6548\u7387\u4e5f\u662f\u591f\u5feb\u7684\uff0c2020\/3\/6\uff0c\u6295\u516580\u4ebf\u7f8e\u5143\u3002<\/p>\n\n\n\n
With the rise of molecular biology in the 1980s, the concept of gene-based vaccines began to take shape. The biggest hurdle was that DNA on its own didn\u2019t generate much of an immune response. When Weissman tested Karik\u00f3\u2019s mRNA in his lab, he found it had the opposite problem that DNA did: It caused too much of a reaction. His cell cultures looked like the aftermath of a bombing raid. He had a hunch about what was happening. To a cell, a strand of foreign mRNA is indistinguishable from an RNA virus. The cell will issue a red alert and stop expressing any and all RNA. A cell that senses it is under attack for long enough will self-destruct. Weissman told Karik\u00f3 that her mRNA produced such an overwhelming immune reaction, it would not only be challenging as a vaccine, it might never work as a therapy either.\u201d<\/p>\n\n\n\n
DNA\u75ab\u82d7\u7684\u95ee\u9898\u5728\u4e8e\u5176\u514d\u75ab\u53cd\u5e94\u8fc7\u5927\u3002mRNA\u8fd9\u65b9\u9762\u7684\u95ee\u9898\u6700\u521d\u8981\u66f4\u5927\u3002<\/p>\n\n\n\n
Moderna became a patent-filing machine, building up a fortress of intellectual property, but it couldn\u2019t outrun the need for the Karik\u00f3 and Weissman technology. Their patent was officially approved in October 2012, and it was broad enough that it was going to be hard to build a business on modified mRNA without infringing on it. The following year, Moderna signed a $420 million deal with AstraZeneca to collaborate on an mRNA-based drug to repair damaged heart tissue, along with possible cancer drugs. A breakthrough seemed imminent. With each passing year, the price of the Karik\u00f3 patent crept upward. The license holder, Gary Dahl, was now unwilling to sublicense the mRNA technology for less than $30 million.\u201d<\/p>\n\n\n\n
\u201cIn 2016, the company was forced to abandon a clinical trial on what was going to be the company\u2019s first therapy, a treatment for a rare disease called Crigler-Najjar syndrome. Patients with the disease are missing a single liver enzyme, and in its most severe form, the disorder can lead to brain damage in infants. As a single-gene disorder that could be treated with only a small amount of enzyme, it seemed like the perfect target. Moderna, however, could never find the correct dose during animal studies. Too much of the drug induced liver toxicity; too little of the drug wasn\u2019t potent enough. In Moderna\u2019s first two clinical trials of flu vaccines, a significant number of people suffered from pain and swelling at the injection site, and the levels of antibodies produced were middling, possibly due to the type of fat Moderna had used to stabilize its mRNA and shuttle it into cells.Moderna agreed to pay seventy-five million dollars for a license to the UPenn patent on top of future royalties.<\/p>\n\n\n\n
Modena\u7684\u521b\u4e1a\u4e5f\u4e0d\u5bb9\u6613\uff0c\u8fd8\u597d\u62ff\u5230\u4e86\u5927\u5382\u7684\u8d44\u91d1\uff0c\u4f46\u4e13\u5229\u4e0a\u95ee\u9898\u4e5f\u5f88\u660e\u663e\uff0c\u6388\u6743\u8d39\u8fd8\u4e00\u4e0b\u5b50\u9ad8\u5230\u79bb\u8c31\u4e86\u3002\u51e0\u4e2a\u4e34\u5e8a\u4e5f\u8fdb\u5c55\u4e0d\u987a\uff0c\u809d\u4e0a\u7684\u4e34\u5e8a\u59cb\u7ec8\u5728\u52a8\u7269\u5b9e\u9a8c\u4e0a\u627e\u4e0d\u5230\u4f55\u65f6\u7684\u5242\u91cf\uff1b\u8f6c\u75ab\u82d7\u4e5f\u4e0d\u5bb9\u6613\uff0c\u6d41\u611f\u75ab\u82d7\u9047\u5230\u4e86\u6548\u679c\u4e00\u822c\u4f46\u526f\u4f5c\u7528\u66f4\u5927\u7684\u95ee\u9898\uff0c\u6210\u4e0d\u4e86\u3002\u6700\u540e\u7684\u4e13\u5229\u6388\u6743\u82b1\u4e867500\u4e07\u7f8e\u5143\u3002<\/p>\n\n\n\n
Project Warp Speed\uff1aMaximally expediting a safe effective vaccine\uff0c A safe, effective, broadly-administered vaccine is the single most important solution to COVID-19 pandemic<\/p>\n\n\n\n
MISSION: Maximally expedite the development of a safe and effective vaccine with sufficient scale to inoculate all Americans who need it <\/p>\n\n\n\n
DEADLINE: Enable broad access to the public by October 2020<\/p>\n\n\n\n
PLAN: Modeled after the Manhattan Project approach, a multi-disciplinary, multi-sector team that brings the numerous in-flight efforts under a single authority to drive relentless coordination, barrier elimination, and accountability for mission success\u201d<\/p>\n\n\n\n
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\u201cWorking closely with BARDA, Marks was narrowing down the list of ninety-two vaccine candidates the MP 2.0 team was considering. The Defense Department, for instance, had been funding the biotech firm Inovio, which was developing a DNA-based vaccine that required a special device, known as a gene gun, in order to be injected. Marks didn\u2019t think it was practical, but he wasn\u2019t quite ready to write it off. \u201cBeam me up, Scotty,\u201d he said, adding it to the portfolio.\u201d<\/p>\n\n\n\n
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\u201cMarks began again, describing how he and his team had come up with a scheme to prioritize fourteen vaccines using a five-point scale under five different criteria, including the status of development and the likelihood of success with a particular manufacturing platform. At the top of the list, with fourteen points, he ranked the vaccine Merck was developing using the same platform as its Ebola vaccine, which had received FDA approval six months earlier. This coronavirus vaccine was a chimera; it would use a weakened strain of the vesicular stomatitis virus outfitted with a functional coronavirus spike that did the dirty work of infecting cells. Unlike the Oxford vaccine, which generated a onetime burst of spike proteins inside cells, the viruses in Merck\u2019s live-attenuated vaccine made copies of themselves, producing multiple generations of spike-covered viruses. Next up was Sanofi\u2019s protein-subunit vaccine, which earned thirteen points. Tied for third place were the mRNA vaccines from Moderna and Pfizer, with ten points each. Johnson and Johnson and Novavax were in fourth place, while the Oxford vaccine, with just five points, was tied for last place with an obscure company in California. \u201cAbout half of those vaccines had already received some support from the federal government, but Marks had a few long-shot candidates on the list, including an oral vaccine made by a company called VaxArt.\u201d<\/p>\n\n\n\n
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\u201cIn April 2004, two researchers studying the first SARS virus at the Beijing Institute of Virology were infected in separate incidents and they spread the virus to seven others. Hundreds were quarantined and one person died.\u201d<\/p>\n\n\n\n
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The other four companies that had, at least in principle, joined Operation Warp Speed would have to undertake the same process to get sign-offs on their trial protocols. AstraZeneca was aiming for a July start to its trial; Johnson and Johnson was gearing up for early fall; cash-poor Novavax and venerable Sanofi were a distant fourth and fifth place. Notably absent from Operation Warp Speed\u2019s harmonized trials: Pfizer. The unstoppable multinational was likely going to be the second company to enter phase 3 clinical trials in the United States, but, as chief scientific officer Mikael Dolsten had already made clear to Francis Collins, Pfizer would be taking no money for development. The company would be assuming all the risk and, it hoped, reaping all the reward. It would soon offer Operation Warp Speed a chance to lock in its two-dose mRNA vaccine at an exorbitant one hundred dollars per dose\u2014that meant ten billion dollars to vaccinate fifty million people, less than a sixth of the U.S. population. That was more than double the sum Moderna had floated. Moncef Slaoui and General Perna declined.<\/p>\n\n\n\n
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\u201cIn reality, convalescent plasma wasn\u2019t going to save the lives of thirty-five people out of a hundred. It was going to reduce the relative risk of death in this subgroup by 35 percent, from, say, ten out of every hundred patients to around seven out of a hundred. No self-respecting cancer doctor would ever talk in terms of absolute-risk reductions! Marks thought. That would be a miracle.<\/p>\n\n\n\n
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Mascola rang Graham, but he wasn\u2019t answering. After a few minutes, Graham called him back. He listened intently but expressed little emotion. \u201cI can\u2019t believe it worked so well,\u201d he said, his scientist hat firmly on his head. It was only later, after he set down the phone, that he recognized the heft of it, and once again he grew emotional. Two vaccines, both mRNA, both with his stabilized spike design, had worked extraordinarily well. The shock of it all turned to exuberance, and he realized that, beyond a shadow of a doubt, this vaccine truly had the potential to end the pandemic.<\/p>\n\n\n\n
It couldn\u2019t come soon enough.\u201d<\/p>\n\n\n\n
mRNA\u7684\u6548\u679c\u597d\u7684\u4ee4\u79d1\u5b66\u5bb6\u90fd\u60ca\u8bb6\u3002<\/p>\n\n\n\n
\u201cAstraZeneca-Oxford vaccine was unlikely to gain approval in the United States anytime soon. The company had, as Moncef Slaoui anticipated, overhyped the results from the Oxford-run clinical trials in Brazil and the United Kingdom. It touted a result showing that it was 90 percent effective, but this was based on an analysis of a subset of subjects who had accidentally received a half dose as their first dose. When participants received two full doses, as they had in the Operation Warp Speed trial in the United States, the efficacy dropped to 62 percent. It was a passing grade, but not by much. Johnson and Johnson would top that with just one dose.\u201d<\/p>\n\n\n\n
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\u201cBased on the agreements the company had already inked with governments around the world for its COVID-19 vaccine, Bancel said it was on track to bring in at least $11.7 billion in revenue by the end of 2021. With its growing war chest, the company was investing in a major way in eight other vaccines, including one against that diabolical virus that Barney Graham had studied so long ago, RSV. Also in its pipeline were additional vaccines being developed with the NIH for HIV and emerging disease-causing viruses, such as Nipah, which, like the novel coronavirus, was endemic to bats. But that was not all, Bancel said. The company was also working to propel more mRNA therapeutics onto the market, including those against cancers, rare diseases, autoimmune diseases, and heart disease. He told viewers that he could not wait to see what the next ten years was going to look like. \u201cI believe this is just the beginning,\u201d he said.\u201d<\/p>\n\n\n\n
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