Updates on the emerging novel coronavirus pandemic from the Johns Hopkins Center for Health Security.

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EPI UPDATE The WHO COVID-19 Dashboard reports 29.36 million cases and 930,260 deaths as of 5:45am EDT on September 16.

Globally, at least 11 countries are reporting test positivity greater than 15%, at least 3 times higher than the WHO’s 5% benchmark. Of these countries, 4 are reporting test positivity greater than 30%: Argentina (51.6%), Mexico (47.4%), Oman (38.9%)*, and Bolivia (32.5%). Additionally, a number of these countries are reporting increasing trends, which indicates that testing capacity is not sufficient to accurately capture the existing level of community transmission. Beyond the countries reporting high test positivity, a number of countries currently reporting increasing incidence are also reporting increasing test positivity. Several in Europe are reporting increased test positivity, including the Czech Republic, France, Hungary, Italy, Norway, Spain, and the UK. While a number of these countries have sufficiently low test positivity, including some less than 3%, the increasing trends have persisted over the past several weeks, which is concerning.
*Oman’s most recent data is from July 30.

In the US, test positivity has increased sharply over the past several days as well, up from 4.8% to 6.1% (a 27% increase) from September 10 to September 13—the most recent data available—which is the highest average reported in the US since August 12. Notably, the testing volume in the US decreased sharply over that time as well, falling below 600,000 tests per day for the first time since mid-June. Additionally, COVID-19 incidence has increased in the US over the past several days, so it will be important to continue monitoring test positivity to determine if this could be the early stage of a longer-term trend.

As we have addressed previously, test positivity data is not available for many countries, so it is likely that additional countries are facing similar challenges.

The US CDC reported 6.54 million total cases and 194,092 deaths. The US is averaging 35,752 new cases and 772 deaths per day, both slight increases over the past several days. If the US continues at its current pace, it could reach 200,000 cumulative COVID-19 deaths in the next 8 days. In total, 21 states (no change) are reporting more than 100,000 cases, including California with more than 700,000 cases; Florida and Texas with more than 600,000; New York with more than 400,000; and Arizona, Georgia, and Illinois with more than 200,000.

The Johns Hopkins CSSE dashboard reported 6.61 million US cases and 195,926 deaths as of 10:30am EDT on September 16.

US CDC REPORTING & GUIDANCE Reports have emerged over the past week that publications in the CDC's Morbidity Mortality Weekly Report (MMWR) journal have been subject to review by political appointees. The initial report was made by Politico and then supported by other media outlets. This is a departure from the traditional scientific review process, and has raised concerns by some experts that the involvement of political appointees could jeopardize the impartiality of the information contained in the articles. The MMWR is a key source of information for outside experts, including state and local public health officials and clinicians. Some experts also expressed concern that political involvement, or the appearance of political involvement, in CDC reporting could further undermine confidence in health and regulatory agencies and officials, which could be particularly problematic in terms of establishing confidence in a future vaccine.

HHS Assistant Secretary for Communications, Michael Caputo, said that the effort was designed to increase scrutiny over CDC reporting, but he also accused the CDC reports of including “political content” in their reports, as opposed to strictly technical information and evidence-based guidance. Mr. Caputo has himself recently faced controversy for a video posted on his personal Facebook page in which he levied a series of accusations against CDC scientists, including that they were engaging in acts of “sedition.” It is not clear exactly whether or how the review by government officials outside of the CDC ultimately changed the content of individual reports.

US K-12 SCHOOLS US school districts are employing a wide array of approaches to provide educational opportunities, whether in person or remote, to students. According to Burbio, more than 60% of public schools in the US have decided to begin the academic year with remote learning. While some schools had planned to bring students back in person, at least in some capacity, a renewed increase in COVID-19 cases has forced several districts to return to remote learning plans. School superintendents point to students attending parties before the start of school as one reason for the rise in cases. Coupled with staff shortages, school districts have few choices other than to pursue remote learning. Plans to return students physically to class have not been fully abandoned; many schools are looking at the possibility of delayed return to in-person learning in October or January. Parents counting on the return of their children to school have been disappointed that in-person learning will not occur on schedule, but many agree that the safety of students and staff are paramount under the current circumstances. 

Above the school district level, state-level interventions to support in-person learning are also highly varied across the US. In Rhode Island, the state government has initiated a school testing program that offers free diagnostic testing to students, teachers, and staff. This program is separate from the normal state testing program. Rhode Island Health Director Dr. Nicole Alexander-Scott reported that the school testing program would be able to run 5,000 tests per day. Meanwhile, Florida Governor Ron DeSantis declared that school testing data is considered confidential by the government and has not encouraged schools to independently report their data. However, many school districts have decided to continue publishing their case data in the interest of transparency for students, staff, and the community. While open and transparent data sharing practices are important for controlling COVID-19 in communities, the lack of standardization for reporting across school districts could complicate response efforts. 

US COLLEGES & UNIVERSITIES On a per capita basis, college towns are accounting for many of the country’s most severe outbreaks. According to data published by USA Today on September 11, 19 of the top 25 local outbreaks in the US were in college towns. Harrisonburg, Virginia—home to James Madison University—topped the list with more than 1,500 cases per 100,000 population over the previous 2 weeks. The school suspended in-person classes and sent students home in order to reduce the number of people on campus after detecting more than 500 cases within the first week of classes.

Universities continue to issue suspensions and other punishments for students who violate university COVID-19 policies or public health guidelines. Virginia Tech has now issued more than 40 interim suspensions to students and removed some students from campus housing. Oxford, Mississippi, home to the University of Mississippi (Ole Miss), has issued more than 60 citations since August to people for violations of local social distancing restrictions. Transmission around college campuses is not limited to students and staff. In Oxford, 26 residents in a long-term care facility for veterans “died in connection with” COVID-19 in the past month. Although it is likely not possible to link students directly to individual cases and deaths in the local community in most instances, transmission between the university population and local public is inevitable.

US PEDIATRIC TESTING Since the onset of the pandemic, SARS-CoV-2 testing has been a challenge in the US. Following the summer resurgence, the US appeared to be recovering in terms of testing capacity, with the national-level test positivity settling in at approximately 5%—in line with the WHO’s benchmark. Notably, however, national testing volume has decreased drastically over the past several days—dropping from 800,000 tests per day to fewer than 600,000 in just 4 days—and test positivity has sharply increased. But the national trends do not tell the entire story. One problem in particular, lies in testing availability for pediatric patients. This barrier is especially problematic as the school year starts and children across the country resume in-person classes. Many public testing sites are not able to provide tests for children (or have an age cutoff that excludes younger children), and many pediatricians do not offer testing or have limited testing supplies, making it difficult for parents and guardians to identify testing locations that will accept their children. As it becomes increasingly clear that children can be infected and transmit the virus it is critical that health systems and public health agencies incorporate pediatric patients into their testing strategies.

US ELECTION & VOTING The US presidential election is less than 50 days away, and it is clear that this election will be like no other in history. Election experts anticipate an increase in the use of mail-in voting in many parts of the country, as many people are concerned about the risk of SARS-CoV-2 transmission at polling locations. States vary widely in how they are addressing the need or desire to vote by mail during the pandemic, as opposed to in person, as well as their readiness to implement vote-by-mail programs. According to Ballotpedia, at least 35 states have adapted voting regulations regarding absentee or mail-in voting in response to COVID-19. Efforts to increase access to mail-in voting in some states have been challenged in court, with outcomes of these lawsuits varying from state to state. In addition to voters in the US, US citizens currently living in other countries may also face challenges to the normal absentee voting process. In Hong Kong, for example, government officials warned that standard mail to the US could take several months to arrive, so individuals might need to use couriers or other services in order to request, receive, and return ballots on time. Additionally, the US Postal Service (USPS) has suspended international mail service to more than 40 countries and territories due to COVID-19.

In addition to voting, presidential and other campaigns are navigating restrictions imposed to contain COVID-19. As we covered previously, the Democratic and Republican National Conventions incorporated a variety of changes, including remote speeches and delegate voting. The Presidential debate schedule and format have been finalized, although the location of several debates has already changed due to COVID-19 concerns. As the election season continues, both presidential candidates, President Donald Trump and former Vice President Joe Biden, are ramping up their campaign schedules. 

Notably, the two candidates are taking different approaches to campaign events, including rallies. Earlier this week, President Trump held his first indoor rally since June. The event, held in Nevada (which prohibits indoor gatherings of more than 50 people), drew thousands of people. Many attendees did not wear masks or practice appropriate physical distancing, prompting the local government to issue a fine of $3,000 to the company hosting the event for violating state COVID-19 restrictions. Conversely, Joe Biden and running mate Senator Kamala Harris continue to host remote events or smaller in-person events rather than large rallies. These events reportedly maintain strict adherence to mask use and social distancing recommendations or requirements.

CORONAVIRUS RESEARCH The FDA is collaborating with researchers in the UK, Saudi Arabia, and Singapore to conduct a study of SARS-CoV, SARS-CoV-2, and MERS-CoV clinical specimens in order to better characterize coronavirus evolution, virulence, and immunity. The research could provide critical insight for vaccine and therapeutic development and identify biomarkers for disease severity and progression as well as enhanced immunity or protection. Additionally, the study aims to research the potential for these coronaviruses to develop antiviral resistance. As part of the study, the researchers will develop and evaluate in vitro models for coronavirus infections, including “organs-on-chips,” and validate them against animal and human in vivo responses to support advanced MCM screening efforts. The study is scheduled to run through 2023 and projected to cost US$5.4 million.

VACCINE CLINICAL TRIALS Following news that Phase 3 clinical trials for the AstraZeneca/Oxford University vaccine will resume in the UK after pausing to evaluate a serious adverse event in one of the participants, US regulatory authorities are evaluating the available data to determine whether or not to proceed with the clinical trials. Reportedly, there is considerable concern among senior officials at the NIH, and the agency is awaiting tissue samples for evaluation. One senior agency researcher indicated that an assessment could take a month or longer to determine whether it is appropriate to continue the clinical trials in the US. Regulatory officials and experts at the NIH may compare tissue samples to those from US trial participants or request additional data from the UK researchers and safety monitoring board.

In the UK, researchers at Imperial College London and Oxford University are reportedly initiating a study to determine if candidate SARS-CoV-2 vaccines could potentially be inhaled rather than injected. Previous studies for other vaccines have found that nasal formulations require lower doses compared to intramuscular injection, which could increase the number of doses available, particularly early on as production capacity is scaling up. Additionally, many people prefer nasal sprays to injections. The study will include 30 participants and test vaccines developed by both universities.

DIVERSITY & ETHICS IN CLINICAL TRIALS One of the major challenges facing clinical trials in the midst of the COVID-19 pandemic is ensuring appropriate inclusion and diversity among participants. Certain populations, including racial and ethnic minorities and incarcerated individuals, have faced a disproportionate burden during the pandemic, but there are concerns among researchers and health experts that clinical trial subjects are not sufficiently representative of the affected population. As we covered earlier this week, Pfizer, Inc., recently announced its intent to expand the study population for the Phase 3 trials of its candidate vaccine, in part to improve the diversity among the participants. Despite awareness campaigns, some trials—for vaccines and other investigational drugs—continue to struggle to enroll racial and ethnic minorities, which can hinder efforts to effectively evaluate candidate vaccines’ efficacy through clinical trials.

While incarcerated individuals represent a high-risk population, both for infection and severe disease and death, it is difficult to include these individuals in clinical trials. From an ethical perspective, there is concern that these individuals, due to the control and restrictions associated with their incarceration, may not be able to fully consent to be included in clinical trials.

BARICITINIB Pharmaceutical company Eli Lilly announced preliminary findings from a study that indicates that baricitinib, a drug typically used to treat rheumatoid arthritis, could provide treatment benefit for hospitalized COVID-19 patients when administered in conjunction with remdesivir. The study was conducted under the Adaptive COVID-19 Treatment Trial (ACTT-2), which is administered by the US National Institute of Allergy and Infectious Disease (NIAID). According to a press release issued by Eli Lilly, the study was randomized, double-blinded, and placebo-controlled and included more than 1,000 hospitalized COVID-19 patients. Participants received either baricitinib in conjunction with remdesivir or remdesivir treatment alone.

The patients who received baricitinib exhibited a statistically significant decrease of 1 day in their time to hospital discharge. Additional analysis is ongoing, including for safety and mortality. Based on the data, Eli Lilly intends to discuss the possibility of an Emergency Use Authorization. Eli Lilly is also conducting a Phase 3 clinical trial for the drug—”baricitinib versus background therapy”—in the US and multiple countries in Europe, Asia, and Latin America. While this preliminary data is promising, additional study is needed to better characterize the treatment benefits of baricitinib as well as its safety profile. Like numerous previous examples during the COVID-19 pandemic, early results from clinical trials are being published first in press release form rather than in peer-reviewed publications, and we have not yet been able to locate the underlying data and analysis that supports the press release.