“If you do not have an adequate response, we will have the deleterious consequence of more infections and more deaths,” said Fauci, director of the National Institutes of Health’s (NIH) National Institute of Allergy and Infectious Diseases (NIAID). “If we do not respond in an adequate way when the fall comes — given that, without a doubt, there will be infections that will be in the community — then we run the risk of having a resurgence. I would hope by that point in time in the fall that we have more than enough to respond adequately. But if we don’t, there will be problems.”

Speaking at a recent congressional hearing on the pandemic, Fauci said the guidelines for ending social mitigation have checkpoints such as a two-week decline in reported cases.

“My word has been — and I’ve been very consistent in this — that I get concerned if you have a situation where the dynamics of an outbreak in an area are such that you are not seeing that gradual over 14-day decrease that would allow you to go to phase one,” he said.

Areas that “jump over” the mitigation checkpoints, particularly if they are not geared up for a surge, could see spikes in coronavirus cases and outbreaks, he said.

“There is no doubt, even under the best of circumstances, when you pull back on mitigation, you will see some cases appear,” he said. “It’s the ability and the capability of responding to those cases with good identification, isolation, and contact tracing that will determine whether you can continue to go forward as you try to reopen America. It’s not only doing it at the appropriate time with the appropriate constraints but having in place the capability of responding when the inevitable return of infections occurs.”

The Second Wave

Saying it is “entirely conceivable and possible” that a second wave could hit in the fall, Fauci said now is the time to stock up on supplies and equipment that were lacking when the first wave of COVID-19 hit.

“Between now and then — given the capability of doing the testing, the ability to stock up on personal protective equipment, and the workforce that the [Centers for Disease Control and Prevention] will be putting forth to be able to identify, isolate, and contact trace — I hope that if we do have a second wave, we will be able to deal with it very effectively,” he said.

NIAID is proceeding with a four-fold plan to defeat the virus, he said. “One, to improve the fundamental knowledge of the virus and the disease it causes,” Fauci said. “Next, to develop new point-of-care diagnostics. Next, to characterize and test therapeutics. And finally, to develop safe and effective vaccines.”

The NIH has developed a rapid acceleration diagnostics program, earmarking up to half a billion dollars to support the development of COVID-19 tests. “It is a national call for innovative technologies that will be evaluated in a ‘Shark Tank’-like process, to get to either success or failure rapidly,” he said.

In terms of antiviral therapies, remdesivir is showing some success, but Fauci emphasized that there are a number of broad-spectrum antivirals that are in various stages of testing. A remdesivir placebo-controlled, randomized trial was done internationally with a power of more than 1,000 individuals in sites throughout the world. It was in hospitalized patients with lung disease, with the primary endpoint time to recovery.

“The result was statistically significant, but really modest,” Fauci said. “The results showed that the drug had a 31% faster time to recovery. We hope to build on this modest success with combinations of drugs and better drugs.”

Further, researchers are looking at convalescent plasma from those who have recovered from COVID-19 to see if it has implications for prevention or treatment. “In addition, [research is underway with] hyperimmune globulin, which can be used as a gamma globulin shot,” Fauci said. “We’ll be looking at repurposed drugs as well as immune-based therapies, host modifiers, and finally, monoclonal antibodies.”

There are at least eight candidate COVID-19 vaccines in clinical development. The NIH has been collaborating with a number of pharmaceutical companies at various stages of development, he said.

“You might recall in this committee that in January of this year, I said that it would take about one year to 18 months if we were to successfully develop a vaccine,” Fauci said.

The NIH has moved very quickly, starting development of one promising vaccine that very month. “Only 62 days later, we are now in phase I clinical trial with the two doses already fully enrolled,” Fauci said. “There will be animal safety [studies]. Then phase I will directly go into phase II and III in late spring and early summer. If we are successful, we hope to know that in the late fall and early winter.”

Shots on Goal

Researchers are essentially attacking the virus from all directions, using “multiple shots on goal” with the hope that there may be even more than one successful candidate. In addition, vaccine production will be done “at risk,” he said, which means doses will be created before it is even known whether it works.

“I must warn that there’s also the possibility of negative consequences, where certain vaccines can actually enhance the negative effect of the infection,” Fauci said. “The big unknown is efficacy. Will it be present or absent and how durable will it be? I still feel cautiously optimistic that we will have a candidate that will give some degree of efficacy, hopefully a percentage enough that will induce the kind of herd immunity that would give a protection to the population [as a] whole.”

In response to questions from the Senate committee members, Fauci said expecting to have a vaccine or treatments in place to allow children to return to school this coming fall would likely be “a bridge too far.” However, he said this might vary by region and local spread of the virus, in addition to the availability of testing and other intervention factors. “We’re really not talking necessarily about treating a student who gets ill, but how safe the student will feel going back to school,” he said.

While the vast majority of children have shown few signs of infection, some young people have, and there is a troubling syndrome related to COVID-19 seen in some patients.

“We don’t know everything about this virus, and we really better be very careful, particularly when it comes to children,” Fauci said. “Because the more and more we learn, we’re seeing things about what this virus can do that we didn’t see from the studies in China or in Europe. For example, right now [there are] children presenting with COVID-19 who actually have a very strange inflammatory syndrome, very similar to Kawasaki syndrome.”

Fauci was asked if he agreed with some epidemiologists that the death toll in the United States might be about 50% higher than the daily totals reported. Although doubting the uncounted cases were that high, Fauci said “most of us feel that the number of deaths are likely higher.”