Trump's new vaccine timeline met with deep skepticism

Trump's new vaccine timeline met with deep skepticism
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Public health experts are pushing back on President TrumpDonald John TrumpSessions accepts 'Fox News Sunday' invitation to debate, Tuberville declines Priest among those police cleared from St. John's Church patio for Trump visit Trump criticizes CNN on split-screen audio of Rose Garden address, protesters clashing with police MORE's claim that a COVID-19 vaccine will be available by the end of the year.

The Trump administration is racing to get a vaccine to the market quickly with "Operation Warp Speed" and has started to whittle down candidates.

The project’s goal is to have 300 million vaccine doses available by January, an accelerated version of the administration’s previous projections of needing 12-18 months to get a vaccine ready for the public.

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Drug industry experts say the new timeline is unrealistic. Many of the vaccine candidates are still in the early stages of development, and proving safety in humans is a time consuming task.

Even if a vaccine were produced before 2021, experts agree that hundreds of millions of doses, at a minimum, would be required to prevent the disease from spreading across the entire country.

"You're absolutely compressing the manufacturing time, but the kind of scale that you would need to make a meaningful dent, even if you had multiple companies manufacturing the drug ... it's a highly aggressive view of this place that we're at today," said Jeff Myers, a senior vice president at Catalyst Healthcare Consulting.

The world is pinning its hopes on a vaccine to prevent COVID-19, the disease caused by the novel coronavirus. People want to be able to attend sporting events, travel without worry and celebrate major life events in person with family and friends.

But until a vaccine is successfully deployed, it will be difficult to completely lift the social distancing restrictions that have devastated the U.S. economy.

During a Fox News town hall Sunday evening at the Lincoln Memorial, Trump said he was confident a vaccine could be fast-tracked.

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"We think we’re going to have a vaccine by the end of this year. And we’re pushing very hard. We’re building supply lines, now, we don’t even have the final vaccine," Trump said.

That timeline has been echoed, on a more nuanced note, by some of the administration's top scientists.

Deborah Birx, the White House coronavirus response coordinator, told Fox News on Sunday that "on paper it's possible" to have a vaccine available in January, which would be the very edge of the 12 month estimate.

The key question, Birx said, is "whether we can execute and execute around the globe.”

Anthony FauciAnthony FauciOvernight Health Care: Protests risk spread of coronavirus | Health groups: Police brutality is a public health issue, too | Fauci says meetings with Trump have decreased Trump official leading COVID-19 testing to return to regular duties The Hill's Coronavirus Report: Former Rep. Delaney says Trump is spewing venom when he should be leading; Protests roil the nation as fears of new virus outbreaks grow MORE, the country's leading infectious disease expert and a member of the White House coronavirus task force, also said it was possible for the U.S. to have a viable vaccine by January.

"We want to go quickly, but we want to make sure it's safe and it's effective," Fauci told NBC’s Savannah Guthrie last week. "I think that is doable if things fall in the right place."

Operation Warp Speed aims to condense the typical timeline of clinical trials by testing multiple vaccine candidates at once.

Instead of waiting for complete evidence of safety before testing efficacy, they will test for both at once. Clinical trials typically go through three phases, with the final phase consisting of a randomly controlled study that often measures thousands of patients over the course of several years.

Vaccine experts admit the technology has sped up in recent years, but the process can only be condensed so much before putting people at risk.

"The issue is going to be: How quickly can you amass data in thousands of patients in a short period of time to know there's an efficacy signal, and know there's no safety flare that rises up?" said Peter Hotez, dean of the National School of Tropical Medicine at Baylor College of Medicine in Houston.

Hotez said he is concerned about what could happen if companies rush the safety and efficacy trials, and test too small a group of people too quickly.

"If we get it wrong it's going to have consequences that go beyond COVID," Hotez said. "The one place I would draw a line in the sand is rushing a phase three to ... prevent you from getting adequate information about whether it works and whether it's safe." 

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Amesh Adalja, a senior scholar focused on emerging infectious disease at the Center for Health Security at Johns Hopkins University, said he doesn't think wrapping up by the end of December is realistic, and that everything would have to be perfect for the White House to meet its 12 month goal of January.

"The leading candidates are all using novel technologies that there may be unforeseen difficulties with in clinical trials," Adalja said.

On top of that, he said, scientists will need to have confidence in understanding dosing information, side effects and immunity across the entire U.S. population.

"It's much more rapid, but I wouldn’t put a timeline on it," Adalja said. "There's never been a human coronavirus vaccine ... I don't know how you can speed the answers to those questions."