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10/12/2020

As the head of the White House’s coronavirus task force, he’s been close to the project. Operation Warp Speed Is Testing Out Over 100 Potential Treatments While Working With the FDA, NIH, & HHS Getty President Donald Trump and … A confused Biden mixed up the numbers. The public hears what Trump says about a vaccine — and it seems to be creating more distrust, based on polls that show many Americans are skeptical of getting vaccinated. The claim: Official with Operation Warp Speed said 'All of America must receive the vaccine within 24 hours of distribution' After coronavirus … It’s a problem that should have been preventable. The problem is Trump. “PhRMA [Pharmaceutical Research and Manufacturers of America] supports any efforts by FDA to provide clarifying guidance and we have engaged with the agency to support bringing greater transparency to the review process for COVID-19 vaccines,” the industry’s top lobbying group said. “I don’t know how much [Operation Warp Speed] even matters if the president’s comments drive the media narrative nearly every day.”. As per the government's HHS website, Operation Warp Speed's goal is to produce and deliver 300 million doses of safe and effective vaccines with the initial doses to be made available by January 2021. OWS seems to have been handled well and I’m happy to give Donald Trump credit for it since it happened on his watch. During World War II, the government offered funding for companies that figured out a way to mass-produce penicillin. Called “Operation Warp Speed,” the program will pull together private pharmaceutical companies, government agencies and the military to try to cut the development time for … “In concept, this idea that you can marshal a variety of resources across the federal government to deal with a national emergency, like Warp Speed, is actually a really good idea,” said the vaccine expert. You can watch the press conference below. The FDA released the guidance anyway, with support from the drug industry. Risk-averse pharmaceutical companies wouldn’t ordinarily spend hundreds of millions of dollars in that way otherwise. But it’s gained the most attention as a hub for vaccine development and distribution. “They put money on the table, and they let them go. When Trump declared a national emergency on March 13, Alex Azar, the Director of HHS was given specific powers to activate the 2005 PREP Act and initiate the Emergency Use Authorization (EUA). You don’t run stage 1, 2, and 3 trials or make vaccine in advance without the money.”, Others were more tepid in their praise, acknowledging the benefits of public funding to incentivize pharma companies but pointing out that most of this work likely would have been done under any administration. Operation Warp Speed is a partnership among several federal government agencies to accelerate the development, manufacturing, and distribution of COVID-19 vaccines, therapeutics, and diagnostics, including the specific goal of delivering 300 million doses of … Those are merely the latest examples of the White House appearing to intrude on what is supposed to be a sacrosanct process driven by science. Covid-19 has tested the proposition of these public-private partnerships like never before. And about $1 billion in CDC funding, which otherwise would have been sent to state and local health agencies, was also steered to the project, according to Bloomberg. The Operation Warp Speed (OWS) program was initiated by the Trump administration to accelerate the development, manufacturing, and distribution of the coronavirus vaccines and treatments. The Covid-19 [coronavirus] vaccine developed by Pfizer and BioNTech is being produced as part of the Trump administration’s Operation Warp Speed, the revolutionary public-private partnership launched earlier this year to speed the development, production, and distribution of vaccines to protect against the virus. During the Nov. 18 episode of her show, Reid said, “I should correct what we reported last night, Moderna did receive funding from the administration’s Operation Warp Speed to develop the vaccine, Pfizer did not.” MSNBC did not respond to Check Your Fact’s inquiry about whether Reid would acknowledge that Pfizer participates in Operation Warp Speed as a supplier by the time of publication. Pfizer said on Wednesday that it plans to apply for emergency use authorization with the FDA “within days,” according to CBS News. As Sachs put it. Kathrin Jansen, Pfizer senior vice president and head of vaccine research and development, had told The New York Times that the company was “never part of the Warp Speed” and that it has “never taken money from the U.S. government, or from anyone.” However, a Pfizer spokesperson more recently told CNN and The New York Times that Jansen was referring to the research and development of Pfizer’s vaccine. But it could have gone better if the president had gotten out of his own way. And yet, Trump continues to undermine trust in the approval process. In July, it reached a $1.95 billion agreement with the U.S. government through Operation Warp Speed to deliver 100 million doses of its vaccine, if approved by Food and Drug Administration, according to a Pfizer press release and The New York Times. Researchers working on Operation Warp Speed say they have identified 14 vaccine candidates being tested around the world and hope to be able to push ahead with eight of those potential vaccines by July. A Covid-19 vaccine could be approved in record time, thanks to an unprecedented mobilization by the federal government and private sector — but it almost certainly isn’t coming before Election Day, as President Donald Trump has suggested throughout the year that it could. “What you’re witnessing today is the extraordinary talent and ingenuity of American scientists, of American pharmaceutical industries, and of the American people,” Pence said in July at an event promoting Warp Speed’s progress. Dr. Moncef Slaoui, head of Operation Warp Speed, predicts 20 million doses will be shipped out on Dec. … During a Nov. 17 segment, MSNBC’s Joy Reid claimed the pharmaceutical companies Moderna and Pfizer “were not involved in Operation Warp Speed.”. “What you’re also witnessing though is what’s possible when we’re able to come together and provide the resources to support those efforts.”. Operation Warp Speed will not only entail the development of a vaccine but also work to ensure that a successful vaccine can be produced rapidly and distributed efficiently, Trump said. (RELATED: Fact-Checking Rachel Maddow’s Math On Potential COVID-19 Herd Immunity Deaths). Support from our readers helps us keep it free for everyone. In the end, the US will likely be better off because the Trump administration threw money at this problem. After 9/11, Congress and the George W. Bush administration established Project Bioshield, a $6 billion program to encourage drug makers to develop vaccines that would be used in the event of a bioterrorist attack. This story is part of a group of stories called. Launched in May, Operation Warp Speed (OWS) is a government initiated private/public $10 billion US program to help provide support to companies in … According to the Department of Health and Human Services (HHS), which sponsors the program, Operation Warp Speed aims to "deliver 300 million … Evidence-based explanations of the coronavirus crisis, from how it started to how it might end to how to protect yourself and others. The Department of Health and Human Services (HHS) also announced in August up to about $1.5 billion to “support the large-scale manufacturing and delivery” of Moderna’s vaccine, according to an HHS fact sheet on Operation Warp Speed. Even Joe Biden has compared that process to a large-scale military operation. “I think it undermines the FDA every day, undermines the NIH ... FDA should be the clear arbiter of the regulatory process and how things become prioritized,” the pharma executive said. If you have already made a financial contribution to Vox, thank you. But for months, Warp Speed and the companies it’s working with, including Moderna, didn’t rely upon that group’s expertise in developing its plans for clinical trials, according to one source familiar with its workings. Trump’s agitations have put him at odds with the drug industry, which issued a statement supporting the FDA’s decision that read like a brushback of Trump even if it did not mention him directly. Not only have Trump’s public comments and this lack of coordination hindered the project, but the administration’s singular focus on Warp Speed has arguably led to other parts of the US pandemic response being undermined. Warp Speed’s problems are more in its execution than its conception. (RELATED: Fact-Checking Rachel Maddow’s Math On Potential COVID-19 Herd Immunity Deaths), (RELATED: There Have Been A Lot Of Allegations Of Election Fraud, We Looked Into Them). "Operation Warp Speed" seeks to quickly ramp up production, organize distribution and determine who gets the first doses of a potential vaccine. “It could set a model for these types of public-private partnerships that move science and regulation along to achieve great things.”. The recent reports that Moderna had failed to enroll enough minorities for its phase 3 vaccine trial, forcing that research to be slowed down, is a telling example. If the US public doesn’t trust a Covid-19 vaccine, Operation Warp Speed will fail. Operation Warp Speed is the Trump administration’s efforts to fast-track the development, production, and distribution of drugs to combat the virus. As one drug executive, who requested anonymity to speak candidly, put it: “It feels like marketing.”, “While I think the effort has shown good results, I don’t know how much of it is ‘Warp Speed specific,’” Derek Lowe, who writes about drug development for Science, said in an email. The same was true for testing, with Warp Speed largely sidelined while NIH took the lead, STAT found. After the FDA did finally release those guidelines, Trump accused his own agency of being part of a political conspiracy against him. There could be better coordination from the start among the federal agencies and outside experts who are advising clinical trials. We believe it pays off for all of us, as a society and a democracy, when our neighbors and fellow citizens can access clear, concise information on the pandemic. Moderna is also expected to submit its vaccine testing data to the FDA soon, the Wall Street Journal reported. Reid, the MSNBC host of the show “The ReidOut,” made the claim after Pfizer and Moderna respectively announced this month that they had developed COVID-19 vaccines. If people won’t get the Covid-19 vaccine because they don’t trust it, all of the project’s accomplishments will be moot. President Trump unveils "Operation Warp Speed," a program to develop a coronavirus vaccine, during a press conference in the Rose Garden. A Pew Research Center survey found that the percentage of Americans who said they would definitely or probably get a Covid-19 vaccine fell from 72 percent in May to just 51 percent in September. As Bloomberg reported in late September, the Trump administration has redirected about $6 billion in federal funding meant for the National Strategic Stockpile to Operation Warp Speed, even though protective equipment shortages persist. A STAT review concluded the program had had a modest impact on production, with just one $450 million contract signed for Regeneron to produce doses of the antibody treatment Trump received during his own Covid-19 hospitalization. Rather than let the vaccine science run its course, irrespective of electoral deadlines, Trump has meddled. many Americans are skeptical of getting vaccinated, Moderna had failed to enroll enough minorities, The second debate between Trump and Biden is canceled, The fight over plexiglass dividers at the VP debate is a microcosm of Pence’s coronavirus failures. Even people I spoke with who had specific criticisms of Operation Warp Speed thought the model could be effective if it were better implemented. There is a frustration within the industry that Trump has sown doubts during this delicate time for public health. Earlier this year, around the same time Warp Speed was getting off the ground, the NIH convened a large network of vaccine experts to work on Covid-19. Just another political hit job! Operation Warp Speed created a software system called Tiberius that allows states and local jurisdictions to order and track vaccine doses. There's power in understanding. And yet, there has been little sign of Trump receiving a political boost from that progress. Nikkie Haley, Trump's former ambassador to the UN, thanked the president and Operation Warp Speed in a tweet. Millions rely on Vox’s journalism to understand the coronavirus crisis. One of its goals was to help ramp up production of Covid-19 therapeutics and diagnostics, to tide the US over until a vaccine is widely available. The upfront investment for drug companies to produce vaccine doses without knowing whether they will ever be used is the kind of thing the federal government is best positioned to do. “Pfizer has self-funded all of its COVID-19 vaccine development and manufacturing costs. Operation Warp Speed's goal is to produce and deliver 300 million doses of safe and effective vaccines with the initial doses available by January 2021, as part of a broader strategy to accelerate the development, manufacturing, and distribution of COVID-19 vaccines, therapeutics, and diagnostics (collectively known as countermeasures). Trump’s Operation Warp Speed could be a success. Under its agreement with the U.S. government, Pfizer will only receive payment for successful delivery of vaccine doses, following regulatory authorization or approval.”. Instead, drug makers and public health experts think early 2021 is a more likely timeframe for the rollout of a vaccination campaign. The Operation Warp Speed is touted by the federal government to help ramp up production of Covid-19 therapeutics and diagnostics. It’s an idea that’s been acted upon before, but never in a public health emergency like this. The money matters. The quick progress on a Covid-19 vaccine has been partly the result of good fortune (coronaviruses, the family SARS-Cov-2 is part of, are a pathogen very familiar to modern science so vaccine work on some of its relatives had already been underway) and partly by the investment made by the federal government. These were people with years of experience running clinical trials. “And of course it could all be undone by political interference, or even the appearance of such, which we’re in the process of getting right now, thanks to Trump.”. “These are the kinds of policy tools that should be used in this situation.”. But the vice president will likely leave unmentioned one of the biggest obstacles to the project’s eventual success: his boss. That likely reflects the consensus among experts and insiders close to the project that it will succeed in spite of, not because of, the president himself. With Operation Warp Speed, President Trump is trying to push the development of a vaccine sooner than the 12-18 month timeframe. Operation Warp Speed's overall goal is to deliver 300 million doses of a vaccine by January. @SteveFDA. Pfizer, unlike Moderna, did not take money from the federal government for the development and testing of its vaccine, according to CNN. The first news report of Operation Warp Speed was on April 29, 2020, and the program was officially announced on May 15, 2020. Her statement, however, is inaccurate and lacks important context. When all is said and done, the development of these vaccines will be an enormous scientific and commercial accomplishment,” Doug Holtz-Eakin, president of the American Action Forum, told me. Trump had clung to the speedy development of a vaccine as the best hope for ending the coronavirus pandemic and for boosting his reelection chances — and his administration’s Operation Warp Speed can claim some credit for the rapid scientific advancements that we have seen over the last eight months. Operation Warp Speed is a partnership between the Centers for Disease Control, the Department of Health and Human Services, the National Institutes of … Help keep Vox free for all by making a contribution today. “I think some people are learning a great lesson in the power of the private sector. If not, please consider making a contribution today from as little as $3. The New York Times reported this week that the White House had initially blocked the FDA from releasing more stringent criteria for approving the emergency use of a Covid-19 vaccine. In this view, the existence of Warp Speed itself is a problem because it puts a political cast on what should be an apolitical, science-driven process. There is some variation in how much the drugmakers are participating — for example, Pfizer is not getting any money for its clinical trials but signed a contract for manufacturing — but most of the companies with vaccines in phase 3 trials are participating: AstraZeneca, Johnson & Johnson, Moderna, Novavax, Pfizer. This week, the president’s aides reportedly wanted to stop the FDA from releasing its criteria for evaluating a Covid-19 vaccine that would all but assure there is no approved option before November 3. Most people said they were more concerned about the approval process moving too fast (as opposed to too slow) and most thought it was likely a vaccine would be used before it was fully understood whether it was safe or effective. Moderna and Pfizer are both involved to some extent in Operation Warp Speed, according to spokespeople from the respective companies. Operation Warp Speed’s central goal is to develop, produce, and distribute 300 million doses of a coronavirus vaccine by January. We could also have a president who doesn’t undermine faith in the effort. Reid’s claim may have stemmed from Pfizer seeming to previously attempt to distance itself from Operation Warp Speed. Verdict: False. “Pfizer is proud to be one of various vaccine manufacturers participating in Operation Warp Speed as a supplier of a potential COVID-19 vaccine,” the company statement provided to Check Your Fact says. April 29: Operation Warp Speed is revealed in the press. The goal -- … Moderna received funding through Operation Warp Speed to help develop and test the vaccine the company jointly developed with scientists from the National Institute of Allergy and Infectious Diseases, while Pfizer participates as a supplier of a potential COVID-19 vaccine. Vice President Mike Pence could decide to tout Warp Speed’s accomplishments at his debate with Democratic vice presidential nominee Kamala Harris. There will be some truth to his version of the story. 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