President Donald Trump has suggested multiple times that a coronavirus vaccine could come within months, an accelerated timeline that prominent health experts and veteran vaccine developers say is unlikely absent a miracle.
"We're looking to get it by the end of the year if we can, maybe before," Trump said Friday during in a Rose Garden event centered on his administration's efforts to fast-track a vaccine.
“Vaccine work is looking VERY promising, before end of year,” Trump tweeted on Thursday.
“I think we’re going to have a vaccine by the end of the year,” he told reporters later in the day.
But experts say that the development, testing and production of a vaccine for the public is still at least 12 to 18 months off, and that anything less would be a medical miracle.
“I think it’s possible you could see a vaccine in people’s arms next year — by the middle or end of next year. But this is unprecedented, so it’s hard to predict,” said Dr. Paul Offit, a professor at the Perelman School of Medicine at the University of Pennsylvania and the director of the Vaccine Education Center at Children's Hospital of Philadelphia.
Offit spent 26 years developing a vaccine for rotavirus, a common and dangerous childhood gastrointestinal illness, before it was approved by the Food and Drug Administration in 2006. He said vaccine development typically takes decades, but that efforts to counter COVID-19 are being fast-tracked by scientists, drug companies and nations — rallied by the World Health Organization — to meet the threat posed by the coronavirus, which has killed hundreds of thousands and decimated economies across the globe.
The coronavirus was first reported by China in late 2019 and spread rapidly. Scientists began work on vaccines early in 2020, and the first U.S. clinical trial began in March.
Dr. Walter Orenstein, a professor at Emory University and the associate director of the Emory Vaccine Center, said a vaccine in less than a year would be “miracle.”
While technically possible, he added, it is unlikely.
“There’s a lot of things that could go wrong,” Orenstein said.
Dr. Stanley Plotkin, credited with inventing a rubella vaccine in 1964, said developing a vaccine in a year to a year and half was “feasible,” but dependent on the efficacy of the vaccines currently in development and on the ability to mass produce them.
“In the best of circumstances, we should have a vaccine — or let's say vaccines — between 12 and 18 months," he said. "Whether those circumstances will be the best or not, we don’t know."
Trump's own top infectious disease expert, Dr. Anthony Fauci, told the "Today" show that January 2021 is the earliest a vaccine could be ready, but cautioned that that timeline is "aspirational" and depends on companies producing a vaccine before researchers are sure it will work.
Pressed on the issue at a Senate hearing on Tuesday, Fauci said again that while he was cautiously optimistic, “there’s no guarantee that the vaccine is actually going to be effective."
Rick Bright, who was ousted last month as deputy assistant secretary of health for preparedness and response, testified at a House hearing Thursday that an accelerated timeline might paint too rosy a picture.
“A lot of optimism is swirling around a 12- to 18-month timeframe, if everything goes perfectly. We’ve never seen everything go perfectly,” Bright said. “I still think 12-18 months is an aggressive schedule, and I think it’s going to take longer than that to do so.”
Bright, an internationally recognized vaccine expert, filed a whistleblower complaint alleging that he was fired for opposing the use of an unproven coronavirus treatment promoted publicly by the president. Trump has called Bright a "disgruntled" employee.
Moncef Slaoui, the former head of pharmaceutical giant GlaxoSmithKline's vaccines division who Trump announced Friday would help lead his administration's vaccine effort, called the president's projection of having a vaccine by the end of the year "very credible," but conceded that achieving the goal would be "extremely challenging."
Due to the severe nature of the pandemic, all three experts interviewed said they expect that a promising vaccine will be given emergency-use authorization and deployed before it is licensed by the FDA, because such licensing typically takes years to conduct the large population studies needed to prove its safety.
Offit said National Institutes of Health vaccine trials are expected to begin in July. With multiple vaccines being tested at once, he said the goal is to get some indication of efficacy by the end of the year. There are 110 vaccines under development globally as of May 11, according to the World Health Organization. Eight are in clinical trials.
“Then, I think, you’re going to roll it out if you feel there's some efficacy and you feel it’s safe," Offit said. “When [the virus] is killing 2,000 a day, you’re willing to accept a level of uncertainty you wouldn’t otherwise.”
The president has expressed confidence in the vaccines under development, and his administration has poured federal cash into vaccine projects.
"I think we're doing very well on vaccines. If they wanted to use me as a test, that's OK with me, if it was good," he told reporters last week.
The experts said they want to wait and see.
“One of the things I’ve learned in a long life is not to make predictions, and so, I think all of them have the possibility of working,” Plotkin said.
Asked about reports of promising vaccine studies, Offit said: “Who the hell knows? It’s like science by press release. I don’t see these things published in medical journals. I read about it on Business Insider."
“Wait for the efficacy and safety trials — that’s the pudding. The proof is in the pudding,” he said.
Plotkin, Offit and Orenstein all said the research and money being thrown at finding coronavirus vaccines is unprecedented, but cautioned that success is not guaranteed.
“Vaccines don’t always work,” Orenstein said.
Offit said that crossing the finish line with the rotavirus vaccine he co-invented was an emotional moment.
“It’s more like an enormous sense of relief. It’s not so much joy,” he said. “It’s all very humbling. If you learn anything from all of this, it’s be humble. Because nature is humbling.”