The coronavirus has killed over 108,000 people, and infected millions, in the US alone. As some areas of the country begin to lift infection control precautions, it is critical for the federal response to the COVID-19 pandemic to improve. An important part of this process is Congressional oversight of the Administration’s response to COVID-19, and during Tuesday’s Senate Finance Committee hearing, Members pressed Food and Drug Administration (FDA) officials on decision-making around the potential COVID-19 treatment hydroxychloroquine, the Administration’s commitment to withdraw from the World Health Organization (WHO), and reliance on China and other foreign countries for drug manufacturing.

Policy on hydroxychloroquine as a treatment for COVID-19

Early in the pandemic, anecdotal reports of COVID-19 patients in China and France who seemed to improve when given hydroxychloroquine, combined with laboratory findings of a possible antiviral effect, raised hopes that hydroxychloroquine, and a closely related drug chloroquine, could serve as treatments for the coronavirus. The drugs had been FDA-approved for the safe and effective treatment of malaria, lupus, and rheumatoid arthritis for many years. President Trump began publicly promoting chloroquine as a potential COVID-19 treatment, and later at the end of March, FDA granted an emergency use authorization (EUA) for both chloroquine and hydroxychloroquine to be used for COVID-19 patients.

The first study describing a large, controlled clinical trial of hydroxychloroquine for COVID-19 was released this week. It was found that people, such as healthcare workers, who experienced high risk exposures to the coronavirus, and who were then given hydroxychloroquine and monitored, developed COVID-19 just like those who experienced high-risk exposures and who were given placebo. Furthermore, the study found that hydroxychloroquine did not impact the severity of illness for these individuals. The question of whether hydroxychloroquine can prevent coronavirus infection if people take it before they are exposed to sick patients is under study in other clinical trials.

During Tuesday’s hearing, Senator Ron Wyden (D, OR), the ranking member of the Committee, said he believed FDA gave in to political pressure when it approved the EUA for hydroxychloroquine. Senator Wyden noted that the EUA led to the production of “tens of millions of pills, including some…manufactured inside facilities in Pakistan and India that have either failed FDA’s inspection or never been inspected by the FDA at all.”

The Government Accountability Office is evaluating the FDA process that resulted in the EUA for hydroxychloroquine and chloroquine to learn if the EUA was purely based on the FDA’s science-based best practices.

Plans to terminate relationship with the World Health Organization

Last Friday, President Trump announced his Administration’s intention to withdraw the US from WHO. In the global fight against disease, WHO’s roles in providing assistance, setting health standards, and collecting data are critical. Considering WHO convenes international partners to support the development of COVID-19 drugs, vaccines, and other measures to curb spread, a US withdrawal will weaken our ability to fight the pandemic. Furthermore, US absence from WHO would allow nations like China, which stalled its delivery of essential COVID-19 information to WHO, to have even more influence on the global stage.

When asked about how the US plans to address global health needs, such as the COVID-19 pandemic, or Ebola in Congo, or polio in Yemen, without being a member of WHO, the FDA’s associate commissioner for global policy and strategy Mark Abdoo responded that he had “not been privy to those conversations” and referred the Committee to the National Security Council or the Presidential spokesperson.

Meanwhile, Chinese President Xi Jinping pledged to contribute $2 billion to WHO over the next two years to mitigate the COVID-19 pandemic, as well as share any coronavirus vaccine developed in China with the world. China’s government or Chinese companies have developed five of the ten coronavirus vaccine candidates currently being tested in clinical trials around the globe.

Reliance on foreign drug manufacturing

Most manufacturing of finished drugs and active pharmaceutical ingredients is done outside the US. Throughout the pandemic, there have been shortages of certain drugs. Many members of the Committee, including Senator Pat Toomey (R, PA), asked about the security of the US supply chain for medicines, concerned that countries such as China could withhold drugs or ingredients, or that future global health emergencies could leave the US vulnerable to being without needed drugs.

FDA officials assured the Committee that the US drug supply is safe and supply chains are secure, and that, to their knowledge, no countries had held back medicines. They attributed the limited drug shortages in the US mainly to a sudden surge in demand for drugs as well as domestic distribution issues. They also advised that the US bolster its domestic drug manufacturing capacity now since the US is bound to face future pandemics. Drug companies could move more production back to the US by implementing advanced manufacturing techniques that allow for more rapid production of drugs, while at the same time reducing environmental impacts.

For the full video of the hearing, click here.

As the COVID-19 novel coronavirus emerged abroad and here at home, the Centers for Disease Control and Prevention (CDC) devised a diagnostic testing kit and the criteria for who should be tested. Both of CDC’s processes have come under severe scrutiny.

The ramp up in US testing capacity for COVID-19 has been sluggish, in large part due to the initially problematic COVID-19 virus test kit that was devised and manufactured by CDC and shipped to state public health labs. Four COVID-19 virus genome sequences had been deposited in public databases by scientists in China by January 12th. On February 4th, the Food and Drug Administration (FDA) issued an emergency use authorization for the CDC test kit, and kits shipped to state public health labs soon thereafter. At that point, 178 people in the US had been tested. On February 12th, it was reported that some test kits were failing quality checks at state health labs. 360 people in the US had been tested by then. As of February 26th, only 12 out of over 100 US public health labs were able to test for the COVID-19 virus; 445 people in the US had been tested.

The problems with test kit components were due to a manufacturing issue, which according to the FDA, has been resolved. FDA has also authorized public health and hospital labs to use their own tests for the COVID-19 virus as shipments of the newly manufactured CDC test kit make their way to public health labs. An investigation into the exact nature of the CDC manufacturing issue is ongoing, and by the end of the week, the CDC expects to have provided public health labs with sufficient kits for 75,000 people to be tested.

Even so, the California Department of Public Health capacity is limited to 7,400 tests through the weekend. Washington State has very high demand for testing. And state officials in Florida on Thursday said that they do not have enough test kits to evaluate all the patients who could be evaluated according to new CDC guidelines.

The CDC COVID-19 criteria guiding healthcare providers’ and local health departments’ determinations of who should be tested for the virus have gradually changed since January, and have been criticized as being too narrow. Narrow criteria may have resulted in people infected by the COVID-19 virus going undiagnosed.

At the time its test kit was authorized by FDA, CDC recommended considering testing if an individual exhibited COVID-19 symptoms and had traveled from mainland China or had contact with a confirmed COVID-19 patient within 14 days of the beginning of symptoms. In addition to China and the US, there were 22 other countries with confirmed cases of COVID-19, and 36 US states and territories had people under investigation for potentially being infected. On February 12th, the CDC guidance was updated to recommend that severely ill patients without a known source of exposure to COVID-19 virus, but who also were without a known cause for their illness, be considered for evaluation for COVID-19. On February 27th, CDC added travel from Iran, Italy, Japan, and South Korea as well as China. As of February 29th, 472 people in the US had been tested, and there were 9 cases of person-to-person spread that were not travel related.

During Tuesday’s Senate Health, Education, Labor, and Pensions Committee hearing, Dr. Anne Schuchat, principal deputy director of the CDC, explained that CDC devises testing criteria so that tests are not used up on “low-risk situations,” which could reduce testing capacity for addressing situations that are critical. After the hearing, the CDC further amended its policy to recommending that “where there is community transmission in the US, clinicians and public health officials may consider testing patients without severe illness…decisions on which patients receive testing should be based on the local epidemiology of COVID-19, as well as the clinical course of illness.” Community transmission means that there is a person infected with the COVID-19 virus, but how the person became infected is unknown. And then on Wednesday, CDC recommended that clinicians nation-wide use their best judgment based on patients’ symptoms and epidemiological factors. As of Friday morning, there have been 233 confirmed COVID-19 cases in the US, and tragically, 14 deaths.

Out of the 14 people who have died, 13 lived in Washington State. At the hearing, Senator Patty Murray (D, WA), who represents Washington, raised her grave concern (1:19:52 mark in video) about delays in testing and how the COVID-19 virus could have been circulating for weeks, undetected, in her state.

The Committee was given assurances that US testing capacity would ramp up rapidly. By the end of this week, FDA commissioner Dr. Stephen Hahn expects 2,500 newly manufactured test kits, with 500 tests per kit, to be available to hospital labs, and Dr. Schuchat said public health labs will have sufficient kits for 75,000 people to be tested. Upon arriving at labs, the test kits need to clear quality controls, and a given public health lab, for example, can run about 100 tests per day.

We will be tracking this rapidly changing situation; for more COVID-19 information, visit fas.org/covid-19.

Last week, the Senate Homeland Security and Governmental Affairs Committee queried healthcare, disease prevention, and biodefense experts during a hearing about the COVID-19 novel coronavirus outbreak. The take-home message delivered by the witnesses was that the US needs to ramp up its preparedness in a hurry so that if COVID-19 outbreaks emerge on our shores, sick Americans will receive effective care, and spread will be minimized.

COVID-19 severity and transmissibility

The world is grappling with the COVID-19 outbreak, and US public health experts are working with incomplete information to assess the situation, assist globally, and safeguard Americans’ well-being domestically. Amidst the unknowns, the witnesses at Wednesday’s hearing agreed that the case fatality ratio is ultimately likely to be less than the 2.3 percent reported by China’s Center for Disease Control and Prevention. This is because it is very likely that some people who become infected with COVID-19 virus develop no or mild symptoms and do not seek medical care, and so their cases will not be reflected in the reported number of confirmed COVID-19 cases. Indeed, models of the COVID-19 outbreak intended to account for missed cases estimate an infection fatality ratio between 0.3 and 1 percent.

However, the panel cautioned that even if the COVID-19 fatality ratio is actually less than what is calculated from confirmed case data, perhaps 0.2 or 0.5 percent, the average number of people who catch the COVID-19 virus from an infected person – the R-naught – may remain around 2 or more, as indicated by preliminary estimates. The combination of a fatality ratio at 0.2 to 0.5 percent along with a R-naught of 2 or more could make for a particularly devastating disease, causing many deaths among the large number of people the COVID-19 virus could infect.

The progression of the COVID-19 outbreak from a US perspective

There have been 15 confirmed COVID-19 cases in the US, but the panel believes that it is likely there are more that are going undetected, and that flare-ups will soon be observed. According to former commissioner of the US Food and Drug Administration Dr. Scott Gottlieb (1:23:24 mark in video):

“Modeling has shown that the time from first introduction in China, which was probably in November, to epidemic spread was about 10 weeks. If you think that cases were introduced into the US, undetected, in late December or early January, which is probably the case (statistically, it’s quite probable), we’re going to start to see those outbreaks emerge sometime in the next two to four weeks.”

Speaking on a press call last week, Dr. Nancy Messonnier, the director of the US Centers for Disease Control and Prevention’s (CDC) National Center for Immunization and Respiratory Diseases, agreed that at least some person-to-person spread in the US is probable. She said the CDC is gearing up for the COVID-19 virus to “take a foothold in the US,” continuing, “at some point, we are likely to see community spread in the US or other countries.” Later in the week, Dr. Messonnier also announced that five US cities will test patients exhibiting flu-like symptoms for COVID-19 virus as CDC works toward national surveillance for the outbreak.

What the US should be planning for

Expressing concern about a potential COVID-19 pandemic to the Committee, Dr. Luciana Borio, the former director of Medical and Biodefense Preparedness at the National Security Council, said that “we need to brace ourselves for difficult weeks or months to come” because “we’re going to see a lot more cases in the US in the near future.”

Unfortunately, funding for US biological threat preparedness has not been consistent, and the country is not in an ideal state of readiness. The witnesses lamented cyclical investment in public health that has boomed during times of crisis and waned when the biological threat landscape has been uneventful. It would be better to have sustained, well-funded public health infrastructure already in place than to scramble reactively when potential crises such as COVID-19, or Ebola, MERS, and SARS before it, emerge. And so, our healthcare system has only limited surge capacity for caring for high numbers of individuals who may become infected by the COVID-19 virus, or a different emergent pathogen. Although we have a strategic national stockpile of medical supplies and medicines, if stocks were to be expended, the resupply chain is marginal. The capability to rapidly develop point-of-care diagnostic tests – those that front-line healthcare workers could use to get results on site, reducing time to diagnosis – has not been prioritized. While the US has historically risen to the occasion when biological threats present themselves, there is no acceptable reason for being unprepared.

But what about what the US can do, proactively, right now? Witnesses stressed that public health stakeholders should review response plans and responsibilities, ensure both federal interagency coordination and federal, state, and local coordination are primed, test communication systems, assure adequate capacity of diagnostic tests, continue work on therapeutics and vaccines, and clarify how emergency funding mechanisms can be accessed.

The Bipartisan Commission on Biodefense’s executive director Dr. Asha George made the stakes for Americans very clear (1:56:43 mark in video):

“We have to plan for the possibility that we have thousands of cases. In schools of public health, they often train us to look at the data that you’ve been provided, and assume that you don’t have the data – even here in the US – that you don’t have a comprehensive set of data, and then multiply. So we’re often taught to multiply by seven or eight times what you’ve been told. For every one case you see, there are seven or eight out there that you don’t. So that means actually we’d be looking at hundreds of thousands of cases. I think that’s the scale at which we should be planning.”

COVID-19 is of concern, and the best defense is to be prepared and stay informed

Last week, the head of the National Institutes of Health Emerging Pathogens Section, Dr. Daniel Chertow, remarked that “preparedness at the individual level, and at the institutional level, both at local healthcare facilities and healthcare systems within local, state, and national levels, is warranted, and it is ongoing.” To learn about how to be prepared for potential COVID-19 outbreaks, visit ready.gov. To find some answers and stay informed about the epidemic, visit our new FAS COVID-19 novel coronavirus resource page, where we’ll be logging up-to-date information and analysis as more is learned.