By Marie Rosenthal

Science and technology should guide the reopening of the United States to prevent a resurgence of COVID-19, leading public health officials told the Senate Committee on Health, Education, Labor and Pensions on May 12.

That was not the message many of the committee members wanted to hear.

The problem is the pandemic is playing out differently across the country, with more populous states seeing 50,000 or more cases, while others are seeing fewer than 10,000 cases. Not surprisingly, constituents in the least affected states are clamoring for relief from restrictive social distancing policies. Even within New York, the hardest-hit state with 343,051 cases reported by May 15, the pandemic is uneven, with downstate (New York City and the surrounding areas) seeing the brunt of the cases. Those towns in northern New York are already starting to reopen.

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Still, with more than 1.42 million confirmed cases in the United States as of May 15, now is not the time to be cavalier about reopening any area of the country, the officials warned. Almost 86,000 Americans have died from COVID-19 since January, according to the Johns Hopkins COVID-19 Dashboard, and not following the steps in the White House Guidelines for “Opening Up America Again” could result in a resurgence of cases and deaths, they testified.

“Our nation is confronting the most serious public health crisis in more than a century,” said Robert R. Redfield, MD, the CDC director. “Yet, we’re not defenseless. We have powerful tools to fight this enemy. We have tried-and-true, effective public health interventions such as early case identification, isolation and contact tracing, combined with important mitigation strategies that include social distancing, frequent handwashing, face covering. These public health tools have and will continue to slow the spread of COVID-19.”

Those mitigation tools will need to continue as states reopen, they said.

The dynamics of an area should determine the timetable for any local reopening, explained Anthony Fauci, MD, the director of the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health.

The White House’s plan for reopening provides direction for when states can institute a phased comeback, Dr. Fauci stressed. The first indications that an area can reopen are if they see a steady decline in new COVID-19 and respiratory illnesses or positive test results for a 14-day period. In addition, they should be able to treat all new patients without being overwhelmed and have a robust testing program for at-risk health care workers, including antibody testing. Once areas meet these criteria, there can be a gradual reopening, but if cases resurge, there should be a system in place to test, treat and trace contacts.

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If areas “prematurely open up without having the capability of being able to respond effectively and efficiently, my concern is that we will start to see little spikes that might turn into outbreaks,” Dr. Fauci explained.

This has borne out in other countries. South Korea, China and Germany all reported an uptick in cases after they thought the virus was controlled and lifted stay-at-home measures.

“So, therefore, I have been very clear in my message to try to the best extent possible to go by the guidelines, which have been very well thought out and very well delineated,” Dr. Fauci said.

Not doing so could lead to serious consequences, he added. Just as the country has seen cases and deaths rise despite social distancing and other mitigation measures, states could see a resurgence in COVID-19—even when opening at the pace of the White House guidelines. So they must be able to respond appropriately.

“There is no doubt, even under the best of circumstances: When you pull back on mitigation, you will see some cases appear. 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. So 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 occur,” Dr. Fauci warned.

Testing, Testing, Testing

The ability to test and do contact tracing is paramount if states are going to reopen, testified Admiral Brett P. Giroir, MD, the assistant secretary of the Department of Health and Human Services, and he said he was trying to assure the public about adequate testing and supplies. “We have established the targets with the states of [conducting] over 12 million tests over the next four weeks. We think those targets are going to be good in May and June, but as Dr. Fauci said, we really have to be evidence-based. We expect those targets to go up as we progressively open—as communities go through phase 1 and then into phase 2. 

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“And certainly those numbers will need to go up significantly again in the fall when we potentially have influenza circulating with COVID,” Dr. Giroir explained.

“The targets will need to change based on the evidence that we see,” he said. He expects to test about 3.9% of the overall population in May.
Opening schools in the fall was a sticking point for Sen. Lamar Alexander (R-Tenn.), the chair of the committee, and Sen. Rand Paul (R-Ky.). Mr. Alexander wanted to know what to tell Donde Plowman, the chancellor of the University of Tennessee, in Knoxville, about the safety of allowing young adults back on campus and wanted to know whether treatments or a vaccine would be available by the fall.

“The idea of having treatments available or a vaccine to facilitate the reentry of students into the fall term would be something that would be a bit of a bridge too far,” Dr. Fauci said, so testing will be the tool to ensure that students are not transmitting SARS-CoV-2, the organism that causes COVID-19. 
And the testing strategy “that’s going to be employed really depends heavily on what’s the community spread at that time,” added Dr. Giroir, once again ensuring there will be enough tests. “We expect there to be 25 to 30 million point-of-care tests per month available.” 

Several surveillance strategies are being looked at for schools to ensure that students stay safe, he added. 

“I think there is going to be an important role of testing in these circumstances, and I think it will be individualized based on where these different schools are, how much infection is in there,” Dr. Redfield said. 

Although the University of California and Harvard University said they will offer classes digitally, rather than ask students to attend classes on campus, other schools might not want to do this. So, it will be important to continue to ensure social distancing, even in the classroom, Dr. Redfield added, urging school officials not to forget what has been learned about the virus.

In addition, students should be taught to recognize signs and symptoms and seek medical care, if needed.

“With regard to going back to school, one thing that was left out of that discussion is mortality,” Mr. Paul said, adding that very few children die from COVID-19, so there is little reason to keep them out of school.

“We never really reached any sort of pandemic levels in Kentucky and other states. We have less deaths in Kentucky than we have in an average flu season. It’s not to say this isn’t deadly, but really, outside of New England, we’ve had a relatively benign course for this virus nationwide. I think the one-size-fits-all that we’re gonna have a national strategy and nobody’s going to go to school is kind of ridiculous,” Mr. Paul said, adding that “I think we ought to have a little bit of humility in our belief that we know what’s best for the economy.”

He went on to say, “As much as I respect you, Dr. Fauci, I don’t think you’re the end-all. I don’t think you’re the one person that gets to make a decision,” adding it would be a huge mistake not to open schools in the fall. 

Dr. Fauci replied: “I have never made myself out to be the end-all and only voice in this. I’m a scientist, a physician and a public health official. I give advice according to the best scientific evidence.” 

Many people are giving advice about every aspect of the pandemic, including about how to get America back on the road to economic recovery. “I don’t give advice about economic things. I don’t give advice about anything other than public health,” he said. 

He agreed the virus was humbling. “You’re right in the numbers that children in general do much, much better than adults and the elderly, and particularly those with underlying conditions, but I am very careful and hopefully humble in knowing that I don’t know everything about this disease. And that’s why I’m very reserved about making broad predictions,” Dr. Fauci said.

He mentioned a new COVID-19-related inflammatory syndrome that is just starting to occur in children. The disease is similar to toxic shock and Kawasaki syndrome. On May 14, Gov. Andrew Cuomo (D-N.Y.) said 16 states and Washington, D.C. have reported cases. New York alone reported 110 cases, and several children have died. In addition, six European countries are also reporting this COVID-19 inflammatory syndrome in children.

“I think we better be careful that we are not cavalier in thinking that children are completely immune to the deleterious effects,” Dr. Fauci said. 

Vaccines

Led by Stephen M. Hahn, MD, the commissioner of the FDA, and the final witness at the hearing—the “Fab Four” as Sen. Robert Byrd (R-Kan.) called them—also discussed COVID-19 vaccination efforts, saying that a safe and effective vaccine will be important to stopping the spread of infection, but it was still some time away.

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“The obstacles from a regulatory point of view, I think are being met by the approach that is being taken by HHS,” Dr. Hahn explained. He said the FDA has established a common preclinical development pathway for all the vaccine candidates, so the agency could “appropriately assess one vaccine against another, and a master protocol that allows for a common control group and assessment for very common end points.

“This will let us be as efficient as possible for the development of vaccines. We will evaluate approximately 10 candidates preclinically and then in the phase 1 and phase 2 studies, and then take four or five into phase 3 studies,” he said.

Several studies are being conducted with NIAID. The NIAID Vaccine Research Center is collaborating with the biotechnology company Moderna to develop a messenger RNA (mRNA) vaccine. Trials for that vaccine are already underway. In addition, scientists at NIAID’s Rocky Mountain Laboratories are collaborating with the University of Oxford researchers to develop a SARS-CoV-2 chimpanzee adenovirus–vectored vaccine candidate, which is in phase 1 and 2 clinical trials. In addition, they are partnering with the University of Washington to investigate another mRNA vaccine candidate, and NIAID is working with other academic and industry partners on several other vaccine concepts. 

Again, Dr. Fauci was cautiously optimistic, but admitted it is too early to know whether any of the candidates will be safe and effective.

“There are a couple of things that I think are inherent in all vaccine development. First of all, there is no guarantee that the vaccine is actually going to be effective,” Dr. Fauci admitted, saying that the vaccine could end up not producing an enduring and protective immune response. “Given the way viruses respond to viruses of this type, I am cautiously optimistic that we will with one of the candidates get an efficacy signal.”

Sen. Bernie Sanders (D-Vt.) exchanged words with Drs. Hahn and Giroir about developing policies to distribute the vaccine.

“If God willing a vaccine is developed and we are able to produce it as quickly as we all hope we can, I would imagine that [the] vaccine [will be] distributed to all people free of charge, and [steps will be taken to ensure] that everybody in America who needs that vaccine can get it regardless of their income. Is that a fair assumption?” Mr. Sanders asked Dr. Hahn.

“I certainly hope so. FDA is very committed to making sure that all populations in the United States, including those who are most vulnerable, are included in clinical trials,” Dr. Hahn began, only to be interrupted by the senator. “That’s not what I am asking. What I’m asking is, if and when the vaccine comes, it won’t do somebody any good if they don’t get it, and if they have to pay money for it in order to profit the drug companies, that will not be helpful. Are you guaranteeing the American people today that that vaccine will be available to all people regardless of their income?”

Dr. Hahn said payment for a vaccine is not the responsibility of the FDA, but he assured the senator he would take his concerns about access and cost back to the task force. “I share your concern that this needs to be available to every American,” Dr. Hahn said.

Overall, the four witnesses outlined where the public health system has gone and where they would like it to go, and issued words of caution about reopening too soon.