The nation’s top infectious disease expert said Friday that an aggressive investment into the development and production of a vaccine against the coronavirus might make it possible to distribute millions of doses as the year comes to a close.
In an interview with The Hill, Anthony Fauci, the director of the National Institute for Allergy and Infectious Diseases (NIAID), urged caution and said the rapid development of a safe and effective vaccine was not guaranteed.
But he said the government was taking the unprecedented step of beginning production on promising vaccine candidates even before they are proven, a financial risk that would shave months off a typical development schedule.
“In the standard way you develop a vaccine, you do not make major investments in the next step until you are fairly sure that the prior step works and you are satisfied with it,” he said.
“If you jump ahead and at least prepare and make investments, for example preparing sites for trial and even beginning to produce vaccine before you even know it’s safe and effective, then you’re taking a risk, and the risk is a financial risk, it’s not a safety risk,” Fauci said.
“If you do that, you can cut down by several months the process of getting vaccines available as opposed to waiting until you’re fairly sure everything works and then beginning for example manufacturing the doses,” he said.
Fauci did add a note of caution: Vaccine candidates, even promising ones, fail more often than they succeed.
The number of “shots on goal,” Fauci’s preferred metaphor, is meant to boost the odds of developing a vaccine that works, and lasts.
“Any time you develop a vaccine, you always remember, you always have a question that you may not get an effective vaccine. Even if you do everything right and you do everything on time, there’s no guarantee you’re going to have an effective vaccine. So when we talk about having a vaccine that might be available in December or January, that’s assuming that the vaccine is actually effective,” he said.
More than 100 potential vaccine candidates are being tested in laboratories around the globe. The federal government has identified a handful it sees as the most promising, and it plans to invest in producing those vaccines as phase three trials begin in the coming weeks and months.
Fauci said he was “fairly certain” that if production is started this summer and ramped up, “you could have 100 million doses by the end of the year and maybe a couple of hundred million doses by the beginning of next year.”
“I mean that’s aspirational,” he said. “The companies think that they can do that with the right financial backing.”
President Trump has dubbed the effort “Operation Warp Speed” — and such a fast timetable would certainly set a record for the speed at which a novel vaccine had been developed. Fauci said he did not love the name of the program or an implication that the process would not follow the rigorous scientific and safety steps needed to ensure a drug doesn’t do more harm than good.
“I’m a little concerned by that name because it can imply by warp speed that you’re going so fast that you’re skipping over important steps and are not paying enough attention to safety, which is absolutely not the case,” he said. “But in this program of hastening the development of the vaccine, it’s something that we do feel actually is feasible to get the kinds of doses that you would need.”
Developing the vaccine is only the beginning of what will prove to be a heavy logistical lift.
The U.S. government is busy collecting the associated products that it would need to distribute that vaccine across the country — the vials to transport it, the syringes to hold it, the needles to inject it. To manage the logistical supply chain, the Trump administration has tapped Gen. Gustave Perna, a four-star general who runs the U.S. Army Materiel Command.
Fauci declined to comment on President Trump’s decision to take hydroxychloroquine, a drug that studies show is actually associated with higher death rates among those who take it. A study released Friday in The Lancet, found patients who took the drug were at risk of abnormal heartbeats that could lead to cardiac arrest.
Fauci said he has been routinely tested for the coronavirus. He tested negative as recently as Thursday.
He warned that states will face a rise in the number of coronavirus cases they see as they seek to reopen their economies, and he said states could keep those resurgent outbreaks to a manageable level if they build both the testing capacity and the contact tracing armies necessary to conduct robust surveillance to identify and isolate those who have been infected.
“It is prudent for states who are at various levels of infection to follow the guidelines that have come out about reopening or opening America again. And that is to get past the gateway criteria and then go into the various phases at the rates that are prescribed by the guidelines. Obviously if some states don’t do that, there is always a risk that you may have a resurgence,” Fauci said.
As the national death toll surges past 95,000, Fauci said the future course the virus takes depends on the country’s ability to strangle it at local levels.
“One of the things that is going to be important is that as we open up and try to get back to some degree of normality and pull back on the mitigation, is what is our capability?” he sad.
“And I hope it’s intact. I believe it is in certain areas. What is our capability of being able to respond to the inevitable blips that you will see when you pull back on mitigation, and the workforce that can do it to be able to identify, isolate and contact trace. If we have that in place and it’s good, then there will not be a significantly larger number of infections. If we don’t handle that well, we could have even more infections than the models are projecting,” he said.
He said one model he had quoted had projected between 100,000 and 240,000 deaths.
“Hopefully it doesn’t get significantly more than that, but that will depend on how well we respond to the inevitable rebounds that you will see as you pull back,” he said. “If you respond well, you may keep that number relatively low.”
Fauci, who has led NIAID under six presidents for nearly 40 years, has become more visible during the coronavirus outbreak than in any of the previous outbreaks he has helped manage. His likeness has appeared on t-shirts and bobbleheads, and Brad Pitt played him on “Saturday Night Live” after Fauci’s off-handed casting advice.
But he has also become the target of President Trump’s ire, at times clashing with the White House for offering assessments that are more dire than what the administration would like to claim. The hashtag #FireFauci has appeared on social media.
Despite the newfound stardom, Fauci said he will keep trying to stay out of politics — but that he is not surprised that a government response to a virus would become so politicized.
“I try to dissociate myself from that, and do what I’ve done all along, is to try and give the best public health advice and guidance based on data, based on science and based on evidence,” he said.
“I’ve always done that and I’ve successfully been able to stay out of some of the political whirlwind that happens all the time,” he said. “I’m not surprised this is a political situation. It happens, I mean it isn’t the first time that it’s happened, but I try to dissociate myself with that.”