Ever since, that estimate of 12-18 months has become gospel, its appearance in media stories ubiquitous. But medical experts and scientists with firsthand experience developing vaccines are skeptical.
“When Dr. Fauci said 12 to 18 months, I thought that was ridiculously optimistic,” he told CNN. “And I’m sure he did, too.”
Vaccines development typically measured in years, not months
The problem is, experts say, the oft-stated timetable is ambitious at best.
“Because we are in a race here to beat back this epidemic and a vaccine is very important, people might be willing to take a chance on just going quickly into phase two,” Erbelding told CNN. “So the 18 months would rely upon speeding things up.”
Volunteers in each phase need to be monitored for safety, Erbelding said. “Usually, you want to follow their immune response for at least a year,” she said.
CNN reached out to Kaiser about the potential tradeoffs associated with a quickened timeline, but researchers at the organization were unavailable to comment.
“If you want every ‘t’ crossed and ‘i’ dotted, how many more people will die or suffer from Covid-19?” he said. “It’s not an easy decision, it is a breakneck speed for moving things.”
Orenstein added that while there are likely lessons available from past efforts to develop vaccines against SARS and MERS, it will be tough to complete the process in 18 months, though he said it’s feasible.
“I think the reason it will be moving that fast is we have such a serious problem,” he said. “The disease is spreading like wildfire.”
In rare cases, faulty vaccine trials have proven harmful or even deadly in humans.
Mark Feinberg, president and CEO of the International AIDS Vaccine Initiative, told Stat that while he recognizes the importance of animal trials, the urgency of the current public emergency makes it worth the tradeoff.
Coronavirus vaccine candidate uses new, never-before-approved technology
“It’s a very elegant solution, and that’s why they could go to vaccine trials so quickly, because all they need is a sequence of the virus,” Adalja said. “They don’t have to tinker with the virus to make a vaccine candidate. They can just make a vaccine candidate with genetic sequence of the virus.”
Still, Adalja said he thinks the process will exceed 18 months, due to the possibility of clinical-trial or manufacturing issues.
At a March 26 White House briefing, Fauci stuck to his timeline, saying that he plans to expedite the process in part with a financial gamble: by encouraging companies to launch production even before the vaccine has been proven to work.
“Because once you know it works, you can’t say, ‘Great, it works, now, give me another six months to produce it,'” he said.
Fauci added that the federal government would help foot the bill.
“We’ve put hundreds of millions of dollars into companies to try and make vaccines,” he said. “I wouldn’t hesitate to do that for a moment now.”
Offit, the director of the Vaccine Education Center at Children’s Hospital of Philadelphia, worries that the fast-tracking could cause more harm than good.
“Remember: You’re giving this vaccine, likely, to healthy people — who are not the people typically who are dying from this infection,” he said. “So you better make sure that you are holding it to a high standard of safety.”
Fauci, who did not respond to a request for comment for this story, acknowledged the importance of safety in his March 26 remarks.
“The worst possible thing you do is vaccinate somebody to prevent infection and actually make them worse,” he said.
Devastating vaccine failures
The World Health Organization estimates that vaccines save between 2 and 3 million lives a year. But vaccine history is dotted with devastating failures, in which people who got a dose fared far worse than they would have without it.
“The risk of a failed vaccine to other well established immunisation programs is high,” Moodley wrote in an email to CNN. “It would fuel the agenda of the anti-vax movement and deter parents from immunising their children with other safe vaccines.”
How long did it take for rotavirus, Ebola, measles and SARS?
Historically, the timelines for bringing vaccines to bear on other pathogens show a much longer arc than 18 months.
In 2006, the vaccine co-developed by Offit was introduced for rotavirus — which caused severe diarrhea in infants — significantly blunting the disease. The entire effort spanned 26 years; the trial period took 16 years, he told CNN.
Even back in the 1960s, when regulations were comparatively lax, it took four years for the mumps and measles vaccine to be approved, Offit said.
“The consent form was a three-by-five (inch) index card that says, ‘I allow my child to participate in a BLANK trial,’ and then you would sign it,” Offit said. “That could never happen today. And that’s the fastest it could be done.”
Occasionally a promising vaccine can languish for lack of public interest.
The SARS epidemic broke out in 2003, but it wasn’t until 2016 that a vaccine — developed by Hotez’s team in Texas — was ready for trial.
“It looked really good — it was protective, it was safe,” Hotez, the dean of the National School of Tropical Medicine at the Baylor College of Medicine in Houston, told CNN. “But the problem was we couldn’t raise any money.”
He is looking for funding to reboot it and says the vaccine may partially protect against Covid-19, the disease caused by the current coronavirus, which is in the same viral family as SARS.
“Had investments been made previously, we potentially could have a vaccine ready to go now,” Hotez testified to Congress last month.
“Many people are asking, ‘Well why do we have to test the vaccines? Why don’t we just make the vaccines and give them to people?’ Well the world has learned many lessons in the mass use of vaccines and there’s only one thing more dangerous than a bad virus, and that’s a bad vaccine,” Ryan said. “We have to be very, very, very careful in developing any product that we’re going to inject into potentially most of the world population.”
Sprinting a marathon on the front lines
Although just one NIH-funded trial is underway, dozens of companies and academics around the world have entered the race. Researchers are doing their best to sprint through the marathon.
Dr. David Dowling of Boston Children’s Hospital has been putting in 17-hour days — all while taking care of his two toddlers with his wife, who also works as a scientist.
“Saturdays I try and take time off,” he said. “But then on Sunday I try to do maybe a nine- or 10-hour day.”
The story of how the lab, led by Dr. Ofer Levy, became involved with coronavirus offers a glimpse into the sense of urgency of some in the federal government.
Before the outbreak, the team had been working on a flu vaccine that would protect the elderly by using immune-boosting molecules called adjuvants.
When the lab, which operates in a building at Harvard Medical School, learned of the coronavirus outbreak in January, Dowling said, they sent an email to NIAID essentially asking if they could simply repurpose their flu contract for the coronavirus.
“They emailed back in like 30 seconds,” he said. “It was like, ‘Yes. Please do this as quickly as possible.'”