(CNN) – Eighteen months may seem like a lot, but in “years” of vaccines it is a blink of an eye. That’s the Trump administration window of time to develop a coronavirus vaccine, and some leaders in the field say it’s too fast and that it could be at the expense of security.
The estimated period hit the headlines last month, when President Donald Trump commented in a televised meeting from the Cabinet Room with pharmaceutical executives that a vaccine could be ready in “three to four months.” There, in front of the cameras, Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases (NIAID), rectified Trump’s estimate, saying it would be more like a year to a year and medium.
Since then, that estimate of 12 to 18 months has become a gospel, its appearance in media stories is ubiquitous. But medical and scientific experts with first-hand experience in vaccine development are skeptical.
“Anthony Fauci says it is from one year to 18 months. I think he’s optimistic, ”said Dr. Peter Hotez, a leading expert in infectious disease and vaccine development at Baylor College of Medicine. “It may be, if all the stars align, but it will probably take longer,” he added.
Dr. Paul Offit, the co-inventor of the successful rotavirus vaccine, put it bluntly.
“When Dr. Fauci said 12 to 18 months, I thought he was ridiculously optimistic,” he told CNN. “And I’m sure he did too.”
Vaccine development is generally measured in years, not months
As the number of deaths from coronavirus in the US exceeds 3,000, the pressure on the scientific community to find a vaccine is immense. In just a few weeks, the virus jammed the cogs of a robust economy and destroyed 3.3 million jobs. Fear is off the charts and with that comes pressure to find a solution.
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On March 16, two weeks after the meeting, the first federally funded trial for the new coronavirus – officially known as SARS-CoV-2 – began at the Kaiser Permanente Washington Health Research Institute in Seattle. By Friday, it expanded to Emory University in Atlanta. Forty-five volunteers in the communities of Seattle and Atlanta are participating in the first phase of the test, which Fauci said was “launched at record speed.” (Although several vaccines are being developed, there is only one other clinical trial underway, in China.)
The problem is, experts say, that the estimated period is ambitious at best.
“I don’t think it’s ever been done on an industrial scale in 18 months,” said Dr. Amesh Adalja, an academic focused on emerging infectious diseases at the Center for Health Safety at Johns Hopkins University. “The development of the vaccine is generally measured in years, not months.”
Vaccine trials usually begin with animal testing before beginning a three-phase process. The first stage is to inject the vaccine into a small group of people to assess safety and monitor their immune response. The second part increases the number of participants, often by hundreds, and often includes more members of groups at risk, for a randomized trial. If the results are promising, the trial goes on to phase three testing to determine efficacy and safety with thousands or tens of thousands of people, according to the US Centers for Disease Control and Prevention.
Dr. Emily Erbelding, an infectious disease expert at NIAID – which is part of the National Institutes of Health – said the typical vaccine takes 8-10 years to develop. Although she is careful not to contradict the period indicated by her boss – despite the fact that she said that “18 months would be almost as fast as I think we can go” -, she recognized that the accelerated pace will imply “not reviewing all the data.”
“Because we are in a race here to beat this epidemic and a vaccine is so important, people may be willing to risk going quickly to phase two,” Erbelding told CNN. “Then the 18 months would depend on speeding things up.”
A researcher works on a vaccine against the new coronavirus in a research laboratory at the University of Copenhagen in Denmark, on March 23, 2020.
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Volunteers in each phase must be monitored for security, Erbelding said. “Generally, you want to follow their immune response for at least a year,” he added.
But that’s not what will happen in the current study in Seattle and Atlanta, where researchers will evaluate animals and humans in parallel, rather than sequentially, according to Stat, a health news website produced by the Boston Globe Media.
CNN contacted Kaiser about possible exchanges related to an accelerated schedule, but investigators at the organization were not available to comment.
Walt Orenstein, a professor of medicine at Emory and former director of the US National Immunization Program, said the solution is a difficult balancing act.
“If you want to go into the more specific details, how many more people will die or suffer from covid-19?” said. “It is not an easy decision, it is a dizzying speed to move things.”
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Orenstein added that while lessons are likely to be available from past efforts to develop vaccines against SARS and MERS, it will be difficult to complete the process in 18 months, although he noted that it is feasible.
“I think the reason it will move so fast is because we have a very serious problem,” he said. “The disease is spreading like a forest fire.”
In rare cases, faulty vaccine trials have been shown to be harmful or even fatal in humans.
Mark Feinberg, president and CEO of the International AIDS Vaccine Initiative, told Stat that while he acknowledges the importance of animal testing, the urgency of the current public emergency makes the exchange worthwhile.
“When you hear predictions that it will take at most a year or a year and a half to have a vaccine available … there is no way to get closer to those deadlines unless we adopt new approaches,” he told the site.
Vaccine being evaluated uses new and never-approved technology
The vaccine under review was created using a new and potentially revolutionary technological platform that, if successful, could cut months off from the development process. However, the technology, which uses genetic material called messenger RNA, has never been approved as a product for distribution; this would be the first time.
Developed by NIAID scientists and researchers at Moderna, a Massachusetts biotechnology company, the experimental product – unlike most licensed vaccines – does not use any part of the live virus. Rather, the researchers built their vaccine on the genetic information on the coronavirus provided by China. Called mRNA-1273, the vaccine uses the messenger RNA material (ribonucleic acid) to direct cells in the body to make proteins to trigger an immune response that prevents or fights disease.
“It is a very elegant solution, and that is why they were able to do vaccine trials so quickly, because all they need is a sequence of the virus,” Adalja explained. “They don’t have to play with the virus to make a candidate vaccine. They can simply make a candidate vaccine with the genetic sequence of the virus. “
Still, Adalja said he believes the process will exceed 18 months, due to the potential for manufacturing or clinical trial problems.
At a White House briefing on March 26, Fauci stuck to his estimate, saying he plans to speed up the process in part with a financial gamble: motivating companies to launch production even before it is proven that the vaccine works.
“Because once you know what it held, you can’t say, ‘Great, it works, now, give me another six months to produce it,'” he reported.
Fauci added that the federal government would help pay the costs.
“We have invested hundreds of millions of dollars in companies to try to make vaccines,” he said. “I wouldn’t hesitate to do that for a moment now.”
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Offit, the director of the Vaccine Education Center at the Children’s Hospital of Philadelphia, fears that prompt follow-up may cause more harm than good.
“Remember: You are probably giving this vaccine to healthy people, who are not the people who are generally dying from this infection,” he said. “Therefore, it is best to ensure that you maintain a high level of security.”
Fauci, who did not respond to a request for comment for this story, acknowledged the importance of security in his March 26 comments.
“The worst thing you can do is vaccinate someone to prevent the infection and make it worse,” he said.
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