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.
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."