Updates on the COVID-19 pandemic from the Johns Hopkins Center for Health Security.

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EPI UPDATE The WHO COVID-19 Dashboard reports 33.44 million cases and 1.00 million deaths as of 6:00am EDT on September 30.

The US CDC reported 7.13 million total cases and 204,598 deaths. The US is averaging 43,373 new cases and 733 deaths per day. In total, 22 states (no change) are reporting more than 100,000 cases, including California with more than 800,000 cases; Texas with more than 700,000; Florida with more than 600,000; New York with more than 400,000; Georgia with more than 300,000; and Arizona, Illinois, New Jersey, and North Carolina with more than 200,000. Florida’s COVID-19 website is reporting more than 700,000 cases, and we expect this to be reflected in the CDC data in the coming days.

As daily COVID-19 is once again on the rise in the US, the Midwest region* continues to drive the current resurgence. As a whole, Midwestern states are currently reporting more than 12,500 new cases per day, more than a quarter of the national total. This daily incidence is more than 5 times the incidence at the minimum reported in mid-June and more than double the first peak in early May. The Midwest is approaching the peaks reported in the Mid-Atlantic (mid-April), Southwest (mid-June), and West (mid-to-late June). The Midwest and South are currently reporting the highest daily incidence. While the regional incidence is approximately equal, the South is decreasing while the Midwest is increasing. In addition to the Midwest, the Southwest and West regions have reported elevated incidence over the past 2 weeks as well.

Multiple Midwest states are currently reporting daily incidence equal to or exceeding - in some cases by a considerable amount - their respective previous peaks. Wisconsin, North Dakota, and South Dakota are exhibiting the most concerning trends, with all three states reporting record high daily incidence. Wisconsin is currently reporting more than 2,200 new cases per day—and increasing rapidly—which is nearly 150% greater than its peak in late July. Additionally, Wisconsin’s test positivity has increased from 7.6% to 17% since August 23, setting a new record high for the state. North Dakota is currently reporting a record high for both active cases and hospitalizations, and its current daily incidence is nearly 6 times as high as its peak in late May. South Dakota’s first major peak was later than many states (late August); however, the daily incidence just a month later is already exceeding that peak by nearly 25%—and more than 80% greater than the low reported on September 12. Earlier this week, Iowa’s daily incidence was more than 50% greater than its July peak. Missouri’s daily incidence peaked in early August, and after a minor decline, the average is now exceeding the previous peak. Kansas’s and Minnesota’s respective epidemics have peaked several times, the highest and most recent of which occurred in early September for both states, and the daily incidence in both states is once again increasing. Kansas’ epidemic has nearly returned to the height of its previous peak, and Minnesota has already exceeded it (by nearly 20%). Nebraska’s daily incidence initially peaked in early May and declined through early July. Since that time, however, the daily incidence has increased steadily and now exceeds the initial peak. Indiana, Michigan, and Ohio are the only Midwest states currently reporting relatively steady or declining daily incidence, although Michigan’s daily incidence has been increasing slowly since it plateaued in late July.
*Reminder: The states comprising the Midwest region vary slightly, depending on who generated the regional list.

The Johns Hopkins CSSE dashboard reported 7.19 million US cases and 206,252 deaths as of 11:30pm EDT on September 30.

COVID-19 AGE DISTRIBUTION Researchers from the CDC COVID-19 Response Team published analysis of shifts in the age distribution of US COVID-19 cases. The study, published in the CDC’s MMWR, evaluated age data from COVID-19 cases reported in the US between May and August. The analysis included patients who visited the emergency department with COVID-like illness, patients with positive SARS-CoV-2 tests, and confirmed COVID-19 patients as well as test positivity data among the defined age groups. From May to July, COVID-19 incidence increased among all age groups, but the largest increases were observed in individuals under 30 years old, which drove a decrease in the median age of COVID-19 cases—down from 46 years old in May to 38 years old in August. Similar trends were observed at the regional level, although with some variations between regions. The timing of these shifts coincided with many states’ efforts to relax social distancing in order to resume some social and economic activity. Notably, the researchers identified an increase in test positivity among individuals aged 20-39 years in several regions, particularly in the South, that preceded a similar increase among individuals 60 years and older by an average of 8.7 days—with a range of approximately 1-3 incubation periods. This study provides further evidence that transmission among younger portions of the population can drive subsequent increases among older individuals, who are at elevated risk of severe disease and death.

US CDC & WHITE HOUSE CORONAVIRUS TASK FORCE Reports continue to emerge from multiple media outlets regarding the role of political appointees on the White House Coronavirus Task Force in US COVID-19 policy. This storyline has persisted for several weeks now, with various reports highlighting efforts by political appointees to dictate or direct COVID-19 reporting and guidance developed by technical experts, including from the CDC. Based on accounts from US government officials, including former White House staff, The New York Times reports that White House officials pressured CDC officials to develop specific reports to support the White House’s position that the epidemic was waning and that the virus minimally affects children. Additionally, political appointees directed White House staff to “circumvent the C.D.C.” and develop their own COVID-19 briefing materials in order to “better support the White House’s position.” The New York Times report focuses on White House efforts to provide support for reopening schools.

According to the report, CDC officials have successfully prevented some guidance and reporting developed by the White House from being published; however, the influence of White House officials and the Coronavirus Task Force affected some aspects of multiple CDC documents. Notably, the “preamble” document to CDC guidance on reopening schools that supported in-person learning for K-12 students “contained information that C.D.C. officials had objected to” after being circulated to White House political appointees, including Chief of Staff Mark Meadows and senior policy advisers Jared Kushner and Stephen Miller.

VACCINE LOGISTICS As several vaccine candidates progress through their respective Phase 3 trials, vaccine manufacturers and the US government must cement plans for widespread distribution. Two of the leading candidate vaccines, from Pfizer/BioNTech and Moderna, have technical limitations that make distribution, storage, and administration more difficult than some traditional vaccines. These candidates use SARS-CoV-2 spike protein mRNA to elicit a protective immune response, and mRNA vaccines are generally hypothesized to be safer than inactivated or attenuated vaccines and are also quicker to manufacture. With that in mind, however, mRNA rapidly degrades in temperatures above freezing, which requires the cold chain to be maintained throughout vaccine distribution and storage in order to maintain efficacy. Some vaccines for other diseases can be stored in refrigerators or even at room temperature for several hours, but the Pfizer/BioNTech and Moderna candidates must be stored at -94°F and -4°F, respectively.

In order to maintain these very cold temperatures, the manufacturers are simultaneously developing distribution systems and units to facilitate shipment and unpackaging for use. Pfizer’s “thermal shippers” are designed to keep vaccines frozen for up to 10 days, and they can be replenished with dry ice after opening. Additionally, both companies are expected to distribute their vaccines in multi-dose vials in order to mitigate the risk of a shortage of glass vials. Vaccine experts expect that multi-use vials could result in wastage as individual doses are extracted. This kind of wastage is already factored into manufacturing estimates, but it could potentially have a significant impact on the overall number of doses, particularly at the scale required for a national mass vaccination campaign—which could require hundreds of millions of doses.

Notably, both of these vaccines require each person to receive 2 doses. Healthcare providers will face additional challenges in keeping track of multi-dose regimes. These vaccine candidates are not interchangeable—i.e., one dose of each vaccine is not the same as 2 doses of the same vaccine. Keeping track of dosing schedules amid patients’ busy schedules will likely create challenges for healthcare providers. While the CDC and state and local health departments coordinate to manage the distribution of existing vaccines, a SARS-CoV-2 vaccine could be a much different scenario. The CDC is implementing the Vaccine Administration Management System to support state and local efforts to implement mass vaccination; however, there are already barriers to linking the system to existing state vaccine databases.

ANTIGEN TESTING Since the onset of the pandemic, many countries around the world have struggled to establish and maintain sufficient testing capacity to support COVID-19 response and prevention measures. Antigen-based tests could potentially provide rapid, on-site/point-of-care testing capacity on a large scale; however, barriers remain to effectively implementing antigen testing strategies. Antigen tests detect the presence of specific viral proteins, as opposed to antibodies or viral RNA, and they are faster and less expensive than traditional PCR-based diagnostic tests.

In the US, antigen testing is gaining momentum, particularly as some companies and organizations are leaning heavily on antigen testing to resume normal operations. In particular, sports leagues have implemented antigen testing to provide routine surveillance capabilities for athletes, coaches, and other staff (e.g., on a daily basis), and multiple US airlines intend to utilize antigen testing for passengers. These programs may not necessarily be mandatory; however, they can provide increased screening capacity for travelers and crew. United Airlines will begin offering on-site antigen testing for flights from San Francisco to Hawai’i, but passengers will be charged an additional $250 to cover the cost of the test. Passengers will also have the option of conducting the test at home. Lufthansa will implement on-site testing for intercontinental flights in the near future.

President Donald Trump announced a new program that will distribute 150 million antigen tests nationwide, with the aim of supporting screening efforts at schools and for higher-risk populations (e.g., long-term care facilities). The tests can provide results in approximately 15 minutes and can be performed by “medical personnel or trained operators in certain non-clinical environments.” The program could begin shipping 6.5 million tests this week, with additional tests to follow. Notably, the program will utilize antigen tests produced by Abbott Laboratories. The US FDA issued an Emergency Use Authorization for the Abbot tests; however, data published on the FDA website do not include any tests on individuals aged 21 or younger. Without testing pediatric specimens, it is unclear how accurate the test is in kids. Also, there are approximately 50 million children enrolled in public schools alone, so it is unlikely that 150 million tests would provide routine screening capacity nationwide. Elected and health officials in some states have commented that they are struggling to control where the tests will be distributed or to gather data on test results.

In addition to antigen tests, the FDA issued its first Emergency Use Authorization for a point-of-care serological test. While traditional PCR-based diagnostic tests and antigen tests detect active infection, serological tests detect antibodies, which indicate prior infection. The test, produced by Assure Tech (China), uses a lateral flow approach and can provide test results in as little as 15 minutes using fingerstick blood specimens. The tests can be administered at common points of care, such as primary care physician offices and emergency departments, without the need to transport specimens to centralized laboratories with specialized equipment and personnel. The expanded availability of serological tests, particularly rapid tests capable of on-site testing, can further increase critical testing capacity and provide valuable data for both individuals and public health officials.

SCHOOL-AGED CHILDREN Researchers from the CDC COVID-19 Response Team published findings from a study on COVID-19 among school-aged children. The study, published in the CDC’s MMWR, focused principally on children aged 5-17 years in order to better characterize transmission and disease severity among pediatric cases, including associations with demographic characteristics and underlying health conditions. In total, more than 277,000 COVID-19 cases were reported in US children in this age group from March through September. Among the pediatric cases, 3,240 were hospitalized (1.2%), including 404 that were admitted to an intensive care unit (ICU), and 51 died due to COVID-19. Approximately 3% of the pediatric cases had at least 1 underlying health condition, and patients with underlying health conditions account for 16% of hospitalized patients, 27% of ICU patients, and 28% of the deaths.

Notably, children aged 12-17 years had nearly twice the weekly rate of COVID-19 incidence as 5-11-year-olds. Among patients with available demographic information, 42% of COVID-19 cases were Hispanic/Latino, 32% were non-Hispanic White, and 17% were non-Hispanic Black, with slight variations between the 2 age groups. Using data from May-September, this study provides baseline data for pediatric COVID-19 cases. As students return to school, including in-person classes, it will be critical to monitor COVID-19 incidence trends and compare to the period of time prior to the start of the school year.

OPERATION WARP SPEED STAT News published a detailed report on Operation Warp Speed that depicts strong military involvement, especially in leadership roles. STAT News obtained an organizational chart for the program, which shows 61 of 90 leadership positions filled by Department of Defense (DOD) officials, many of whom have never worked in health care or vaccine development. While the DOD officials may not have direct experience in health care or pharmaceuticals research and development, they have extensive experience managing large contracts and logistical operations needed to support national and global distribution efforts. From this perspective, DOD is well positioned to support the goal of developing, producing, and distributing 300 million doses of coronavirus vaccine by January 2021. Some health experts have expressed concern that a lack of familiarity with the US health and public health systems, including associated programs and resources at the state and local levels, could potentially hinder distribution plans and operations. While the majority of leadership positions are military officials, most of the remaining positions are filled by health experts from the Department of Health and Human Services.

CONVALESCENT PLASMA The NIH Treatment Guidelines Panel published an overview of the use of convalescent plasma as a treatment for COVID-19. The article, published in the Annals of Internal Medicine, reviews the current scientific data on convalescent plasma use and associated recommendations. The article comes just a few days after the FDA announced updated evidence on the emergency use of convalescent plasma, including data from animal studies as well as results from the expanded access treatment protocol. The FDA noted that the use of convalescent plasma meets the “may be effective” standard for an Emergency Use Authorization, and strongly encouraged the continuation of randomized clinical trials to demonstrate efficacy. Additionally, the NIH announced a plan to expand placebo-controlled clinical trials, which will enroll hospitalized COVID-19 patients across the country, including new trial sites. These trials are funded, in part, by Operation Warp Speed, which is providing US$48 million. 

RACIAL & ETHNIC DISPARITIES In the US, it has been well established that racial and ethnic minorities have been disproportionately affected by COVID-19, particularly in hospitalizations and ICU admissions. One study published in JAMA: Network Open evaluated COVID-19 risk, including admission to the hospital and ICU, at a frontline hospital in Milwaukee, Wisconsin. Based on data from more than 2,500 patients in March (including 116 COVID-19 patients), the researchers found that Black individuals were significantly more likely to test positive for COVID-19 and be admitted to the hospital than people of other races/ethnicities. The odds of Black patients testing positive for SARS-CoV-2 were more than 5 times higher than other races, even after adjusting for socioeconomic status, comorbidities, zip code, and other factors. The odds of hospitalization or ICU admission for individuals enrolled in Medicaid—used as a proxy for evaluating the role of poverty—were more than 3.5 times those who were not, regardless of race.

Some states have implemented measures that specifically aim to address the racial and ethnic disparities related to COVID-19. For example, Black residents in Michigan represented 29.4% of the cases and 40.7% of the deaths at the beginning of the pandemic despite only representing 15% of the state’s population. Now, Black residents represent just 8.2% of cases and 9.9% of deaths. Michigan credits its Coronavirus Task Force on Racial Disparities for the decrease in racial disparities for COVID-19. The Task Force implemented several targeted initiatives, including widespread public mask distribution and community testing in communities of color. Michigan’s success can serve as an example for other states and localities that implementing targeted measures can mitigate the elevated risk faced by racial and ethnic minorities.

SEASONAL INFLUENZA VACCINATION As influenza season approaches for the Northern Hemisphere, primary care providers and public health officials are concerned that parents may be hesitant to seek seasonal influenza vaccination for their children. A recent national poll conducted by the University of Michigan C.S. Mott Children’s Hospital found that fewer parents intend to get their children vaccinated against seasonal influenza compared to last year, particularly among parents of teenagers. The survey found that one-third of parents do not intend to get their children vaccinated against seasonal influenza. The most commonly cited concern was potential side effects of the vaccine (42%).

Notably, 92% of parents who reported that their child’s regular healthcare provider strongly recommended seasonal influenza vaccination intend to get their child vaccinated, compared to only 62% of those whose provider simply recommended vaccination and 40% for those that could not recall their child’s healthcare provider making a recommendation. Among the parents who do not intend to get their children vaccinated, 14% are keeping their children away from healthcare facilities due to COVID-19 exposure concerns. Public health experts are encouraging parents to vaccinate their children against seasonal influenza, particularly since COVID-19 and influenza often present with similar symptoms. Increased vaccination will contribute to lower seasonal influenza incidence and, therefore, the fewer diagnostic tests that need to be conducted in order to distinguish between the two diseases. Healthcare providers will likely need to redouble their efforts to communicate the benefits of the seasonal influenza vaccination to parents as we progress further into flu season.