Trump's coronavirus vaccine czar just pulled out of a marquee biotech conference. It would have been his first public appearance since taking the 'Operation Warp Speed' job.
The leader of the US government's effort to accelerate progress on coronavirus vaccines just pulled out of a rare scheduled appearance. Moncef Slaoui, the scientific head of the Trump administration's Operation Warp Speed program, was set to speak Tuesday afternoon at the Biotechnology Innovation Organization's annual conference. Slaoui has not yet had an opportunity to brief Congress, Michael Caputo, HHS assistant secretary of public affairs, told Business Insider, in explaining the cancellation. Since first speaking at the White House on May 15, Slaoui has been silent, and little information is available on Warp Speed. The venture capitalist has been criticized by Democratic lawmakers and patient advocacy groups for his ties to the drug industry. He sat on the board of Moderna, a leading developer of a coronavirus vaccine candidate, before being appointed. Slaoui was heavily promoted by the conference's organizers, including as recently as Sunday in email blasts sent to attendees. For more stories like this, sign up here for our healthcare newsletter Dispensed.
The Trump administration's coronavirus vaccine czar has pulled out of what would have been his first major public appearance since taking the role, Business Insider has learned. Moncef Slaoui was formally announced as the scientific leader of Operation Warp Speed on May 15. At a Rose Garden press conference, Slaoui generally outlined the operation's plans to quickly develop a coronavirus vaccine. The program is aiming to have hundreds of millions of doses available by January 2021. In the weeks since that initial appearance, Slaoui and Operation Warp Speed have gone quiet, raising questions about the initiative. Slaoui was scheduled to appear Tuesday on a panel about coronavirus vaccines at the Biotechnology Innovation Organization's annual conference. Business Insider noticed that Slaoui's name was removed Monday from the coronavirus vaccine panel. Michael Caputo, HHS assistant secretary of public afffairs, told Business Insider that Slaoui withdrew because he hadn't yet briefed Congress. Read more: Here's how 13 top drugmakers are sprinting to develop a coronavirus vaccine or treatment that can halt this pandemic A representative for BIO didn't immediately return a request for comment. The cancellation came at the last minute. As recently as Sunday, conference organizers were promoting Tuesday's appearance by Slaoui, which promised to shed more light on Operation Warp Speed. The New York Times reported on June 3 that the Trump administration is prioritizing five vaccine programs, but HHS hasn't confirmed the reporting. Read more: Here are the 5 coronavirus vaccine programs that the Trump administration is reportedly prioritizing It remains unclear when the public will gain clarity on how the program works, or when Slaoui will answer questions about his work. Slaoui has also faced criticism from patient advocacy groups and some Democratic lawmakers about his financial ties to the drug industry. Prior to being appointed to Operation Warp Speed, Slaoui was a director of Moderna, a biotech at the leading front in the race for a coronavirus vaccine. The former pharma executive and venture capitalist will divest his stock in Moderna, the company told Business Insider on May 18. Read more: The race for coronavirus treatments and vaccines is heating up. Here are the 12 most important events to watch for in June, from fresh vaccine data to new antibody drug trials.Join the conversation about this story » NOW WATCH: Why electric planes haven't taken off yet
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A Biden victory in 2020 would disrupt the race for a coronavirus vaccine. Insiders reveal the future of Operation Warp Speed minus Trump.
Summary List Placement Think a coronavirus vaccine is right around the corner if Joe Biden wins...Summary List Placement Think a coronavirus vaccine is right around the corner if Joe Biden wins the White House? Think again. The Trump administration is pushing for the fastest vaccine turnaround in history, and it's all happening under the cloud of a crucial election. The White House wants to start shipping out the first round of coronavirus shots just 24 hours after it gets the green light. President Donald Trump is hoping it will all get going before Election Day. If the timeline is as fast as Trump officials want it to be, a vaccine campaign would already be underway should Biden become president in January. So far, the Democratic nominee isn't making any promises to preserve the work Trump officials have started under their fast-track vaccine plan, or even whether he'll stick to the name Operation Warp Speed. Biden would inherit public distrust over Trump's vaccine process viewed by Democrats and outside scientists as highly politicized and rushed in a bid to help the Republican win reelection. Recent polling showed voters were increasingly concerned about the safety of a coronavirus vaccine after Trump repeatedly contradicted his own scientists and his political appointees have tried to interfere in the work of the Food and Drug Administration and the Centers for Disease Control and Prevention. Campaign staff, advisers, lawmakers, and other experts Insider interviewed all agreed the road ahead is tricky and disruptions in the vaccine approval or distribution are almost certain. One Democratic operative warned that Biden's team shouldn't rely on Trump's transition officials, who he said could continue to undermine public trust in a vaccine. Should Biden win, the Trump administration would have to start briefing him and his team on the status of the vaccine and other coronavirus operations right after the election, former Utah Gov. Mike Leavitt said. Leavitt was Health and Human Services Secretary under President George W. Bush and tapped to help with Mitt Romney's transition ahead of the 2012 election he ultimately lost to President Barack Obama. Acting on any disagreements or desire to halt specific programs would have to wait until Inauguration Day, January 20, when Biden would be sworn in, Leavitt added. "The basic rule is, there's one president at a time," he said. Scientists at the forefront Biden has vowed that, if elected, he'd put scientists at the forefront of public-health messaging and in charge of deciding whether a vaccine is safe and effective. Biden otherwise hasn't elaborated on what he'd do differently than Trump, but his campaign staff said he and running mate Sen. Kamala Harris receive regular coronavirus briefings from medical and security experts that include planning for a vaccine. Still, a transition would add disruption to a vaccine rollout, already expected to be a colossal undertaking regardless of who's president. "Clearly it's going to be a challenge," said Nicole Lurie, a physician and senior lecturer at Harvard Medical School who is on the outside task force advising the Biden campaign on the pandemic. "A really helpful thing is that there are a lot of people advising the candidates who have had a lot of experience and a lot of experience collectively, and so it's not as though they're starting from scratch." But Democratic leaders are worried that Trump's inconsistent messaging and reports of his interference with health agencies will get in the way of defeating the virus. Biden's advisers have already identified hurdles he'd face to get shots to every American, including overhauling messaging and leadership. Biden's team also will need to make sure the information he'd inherit from the Trump administration is complete and reliable, and his team would need to deal with the logistical challenges of shipping the shot and tracking who has taken it. 'I trust scientists. But I don't trust Donald Trump.' Biden, Harris, and a growing number of congressional Democrats have raised concerns that the Trump administration would pressure regulators to approve a vaccine too quickly as a way to boost his chances of winning the election. And Biden allies insist they can't promise to blindly support a coronavirus vaccine given that Trump has contradicted his own top scientific advisers about when it would be available to most people. The Biden campaign said that the Democrat, in contrast to Trump, "understands, respects, and listens" to scientists. "I trust vaccines, I trust scientists, but I don't trust Donald Trump," Biden said last week after a two-hour video meeting with his coronavirus advisers. Republicans in return accused Democrats of igniting anti-vaccine sentiments, and Trump, during a rally on Tuesday, accused Biden of wanting to "delay the vaccine." Ezekiel Emanuel, vice provost of global initiatives at the University of Pennsylvania who is on Biden's coronavirus team, said that no one should trust any vaccine until experts have reviewed testing data. "What we're seeing here is this president bullying the FDA instead of saying 'the process is there, just let it work,'" said Emanuel, a medical doctor who coauthored a Center for American Progress report on vaccine strategy. He's the older brother of Rahm Emanuel, the former Obama White House chief of staff and Biden's close friend. Concerns about vaccinations are spilling over to the public as voters grow more worried about the safety or effectiveness of a coronavirus shot. In May, 42% of adults surveyed said they'd "definitely" get the vaccine if it were available then, according to the Pew Research Center. By September that number had dropped to 21%. Most people will need to be vaccinated for a shot to be effective. To tamp down concerns, nine drugmakers have promised that their vaccines would meet rigorous standards. Coronavirus vaccine makers Moderna, Pfizer, and Johnson & Johnson are openly sharing details about how their tests are going. The FDA also may impose additional safety requirements on drugmakers that would slow the vaccine's development, The Washington Post reported Tuesday. Fauci would stay, Biden says Biden has already pledged that if he wins he'll keep Anthony Fauci, who's often found himself in Trump's crosshairs, in his role as the nation's top infectious-disease experts. Fauci has been the director of the National Institute of Allergy and Infectious Diseases for 36 years and advised six presidents on HIV/AIDS and other public-health issues. The Democratic nominee hasn't said whether he'd keep other health officials who have been involved in the Trump administration's pandemic response. During a September 17 CNN town-hall-style meeting, Biden said it was "premature" to decide whether he would keep Robert Redfield in charge of the CDC and Stephen Hahn overseeing the FDA. Both were picked for the jobs by Trump and have faced backlash following reports that their agencies were pressured by political appointees on the coronavirus response. "The rank-and-file people, the scientists are solid and they're serious," Biden said. "But you've seen how the president has tried to push things through and put a lot of pressure on them." Biden and Harris understand that part of their job would be to help restore respect for the CDC and the FDA, said Irwin Redlener, a pediatrician who's a former Biden coronavirus task-force member and founding director of the National Center for Disaster Preparedness. "They're going to have to fix that bridge between the scientists and the politicians," he said. "It's doable." But, he added, it will all depend on who gets appointed to fill those positions. The people Biden's campaign has tapped as advisers offer clues into whom he'd pick to lead his COVID-19 and other programs. Vivek Murthy, surgeon general under President Barack Obama, and David Kessler, a former FDA commissioner, are leading Biden's coronavirus briefings. Both could clinch jobs in a new Democratic administration. 'They'll continue to undermine trust' Whenever White House control switches hands, political appointees from one administration have to pass on large amounts of material and data. New officials under Biden will need to be confident in the information handed down from Trump's team, Lurie said. The Trump campaign didn't respond to questions about how it thought a Biden administration would handle Operation Warp Speed. Asked on an August 28 press call about what would happen to the ambitious program under a transition, Paul Mango, HHS deputy chief of staff for policy, said that most people working on it weren't political appointees as he is. "My role is tangential to the core scientist and the logisticians and the public-health professionals who are deeply involved with this," Mango, a former healthcare consultant, said. Leavitt similarly said the career officials working on the vaccine plan and the private-sector partners involved would help mitigate disruptions from one administration to the next. He added that he had no reason to believe Trump officials wouldn't cooperate in a transition. "Anytime that there's a change in power there's a potential disruption, but that's the reason transitions need to be planned and why they need to be done cooperatively," Leavitt said. But Biden allies remain concerned. Leslie Dach, who'd been tapped to lead the HHS transition if Hillary Clinton had won the 2016 presidential election, said "there would be a lot to overcome" during a transition but that he thought the Biden team was prepared to shift leadership smoothly through working with career staff. Dach is the founder and chairman of the healthcare advocacy group Protect Our Care, which works closely with Democrats on their healthcare messaging. "I don't think the Biden transition should plan on any help from the Trump political appointments," he said. "They'll continue to undermine trust." Redlener agreed, saying the handoff problem was "definitely a worry." "I don't know how much that's being articulated or discussed in the Biden campaign, but I would bet anything that is being actively discussed," he said. The Biden campaign declined to comment when asked whether it was concerned about a transition, pointing only to the Democratic nominee's public remarks about his trust in scientists rather than Trump. Both Biden's advisers and Trump administration officials acknowledge that every step of storing and transporting the vaccines will need to be well planned and executed. A couple of the leading shot contenders have to be kept ultracold. Experts also expect people will need two shots, spaced roughly a month apart. All of that will need to be tracked for the nearly 330 million people living in the US. "What I think would characterize the new administration," Lurie, of Harvard Medical School, said, "would be a national plan and national strategy, really consistent messaging, a lot of transparency, both in the process and in information sharing."Join the conversation about this story » NOW WATCH: How waste is dealt with on the world's largest cruise ship
Leading US drugmakers will sign a pact to produce a safe coronavirus vaccine amid concerns about shots being rushed to market before the presidential election
Summary List Placement The race to develop a coronavirus vaccine has already shattered records. In March,...Summary List Placement The race to develop a coronavirus vaccine has already shattered records. In March, the biotechnology company Moderna entered its vaccine candidate in a clinical trial less than 70 days after the virus was sequenced, shaving a year off the development process. Since then, two US drug companies, Moderna and Pfizer, have published early data showing that their vaccines generated immune responses without causing serious side effects. That could put the companies on track to finish their human trials in October, under the most optimistic scenario. But scientists and public-health experts worry about the push to bring a vaccine to market before data clearly shows it's safe and effective. To assuage these concerns, Moderna and Pfizer — along with US pharmaceutical company Johnson & Johnson and French pharmaceutical company Sanofi — are preparing to release a joint statement that promises to put safety before speed. The statement could be released as early as next week, according to the Wall Street Journal, which obtained an early copy. In the draft, the companies pledge to only seek emergency FDA approval for their vaccine candidates after final human trials show "substantial evidence of safety and efficacy." A sentence from the draft reads: "We believe this pledge will help ensure public confidence in the COVID-19 vaccines that may ultimately be approved and adherence to the rigorous scientific and regulatory process by which they are evaluated." Most experts agree there's little hope of a coronavirus vaccine being ready before 2021. But President Donald Trump has suggested otherwise: On Friday, Trump said a coronavirus vaccine would probably be available for distribution next month, according to The Washington Post. Trump has previously said a vaccine may become available "right around" the presidential election on November 3. "I'm rushing it. I am. I'm pushing everybody," Trump told radio host Geraldo Rivera in an August 6 interview. The US Centers for Disease Control and Prevention is prepared for that scenario: The agency has asked public health officials in all 50 states to get ready for vaccine distribution by late October. CDC Director Robert Redfield said the goal was to be ahead of the game. The agency expects there to be one or more vaccines ready by November or December. Still, public-health experts fear that the Trump administration could rush the timeline before researchers know whether a vaccine produces adverse side effects. Some White House officials believe Trump's reelection prospects hinge on whether a vaccine comes to market, the Associated Press reported in July. "This timeline of the initial deployment at the end of October is deeply worrisome for the politicization of public health and the potential safety ramifications," Saskia Popescu, an epidemiologist at the University of Arizona, told The New York Times on Wednesday. "It's hard not to see this as a push for a pre-election vaccine." Under normal circumstances, vaccines take 10 years or more to develop and approve. The Trump administration's effort to accelerate and fund vaccine research, Operation Warp Speed, hopes to deliver 300 million doses of a safe, effective coronavirus vaccine by at least January 2021. The program is manufacturing six vaccine candidates in large quantities while clinical trials are still ongoing. "My concern is even with the name Operation Warp Speed, because it suggests that speed is the determining factor as opposed to science," Dr. Leana Wen, a public-health professor at George Washington University who previously served as Baltimore's Health Commissioner, previously told Business Insider. At an online press conference on Thursday, Dr. Jeanne Marrazzo, director of the University of Alabama at Birmingham's Division of Infectious Diseases, said it would take until at least early 2021 to know whether a vaccine was safe and effective. "People have been incredibly concerned about vaccine safety for decades and we've spent countless hours, countless press conferences, countless meetings, trying to assure them that we have done our absolute best to make sure that every vaccine we give is safe," Marrazzo said. "This is not that. This is exactly the opposite of that so it makes me very concerned."Join the conversation about this story » NOW WATCH: The White House has spent $12 billion on its Operation Warp Speed vaccine plan — but experts are worried about how the money's being used
Operation Warp Speed has moved along at a rapid clip. But some people involved in the...Operation Warp Speed has moved along at a rapid clip. But some people involved in the process fear pressure to deliver an October surprise for President Trump.