COVID-19
Updates on the emerging novel coronavirus pandemic from the Johns Hopkins Center for Health Security.
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The Johns Hopkins Center for Health Security also produces US Travel Industry and Retail Supply Chain Updates that provide a summary of major issues and events impacting the US travel industry and retail supply chain. You can access them here.
EPI UPDATE The WHO COVID-19 Dashboard reports 21.55 million cases (250,285 new) and 767,158 deaths (5,345 new) as of 10:00am EDT on August 17. The global cumulative mortality surpassed 750,000 deaths on August 15, with the second highest daily death total to date—9,989 new deaths. The WHO also reported the second highest daily incidence on August 15—294,386 new cases. The average global daily incidence has been relatively steady over the past 3 weeks at approximately 1.8 million cases per week (~257,000 cases per day).
The WHO published its final daily COVID-19 Situation Report on August 16. Starting today, the WHO will publish weekly epi updates.
Total Daily Incidence (change in average incidence; change in rank, if applicable)
India: 61,798 new cases per day (-217)
USA: 51,201 (-884)
Brazil: 43,539 (-1,127)
Colombia: 11,550 (+680)
Peru: 8,275 (+763)
Argentina: 6,756 (-86)
Mexico: 5,983 (-169)
Russia: 5,045 (-78)
Philippines: 4,477 (+468; ↑ 1)
Spain: 4,064* (+0; new)
*Spain’s average daily incidence is not reported for today; this value corresponds to the previous day’s average. Spain’s average daily incidence has not changed since August 13.
Per Capita Daily Incidence (change in average incidence; change in rank, if applicable)
Peru: 251 new cases per million population (+23; ↑ 2)
Panama: 247 (+14)
Colombia: 227 (+13; ↑ 2)
Brazil: 205 (-5; ↑ 2)
Bahrain: 203 (-35; ↓ 4)
Maldives: 197 (-18; ↓ 2)
Israel: 160 (-1; ↑ 1)
USA: 155 (-2; ↑ 1)
Suriname: 152 (-10; ↓ 2)
Bahamas: 151 (+32; new)
India reported its highest average daily incidence to date on August 15—62,512 new cases per day—before falling slightly. Spain climbed into the top 10 in terms of total daily incidence, and South Africa fell out of the top 10. In terms of per capita daily incidence, Peru is currently the only country reporting more than 250 new daily cases per million population. The Bahamas climbed into the top 10 in terms of per capita daily incidence, and Argentina fell out of the top 10.
The US CDC reported 5.34 million total cases (54,686 new) and 168,696 deaths (1,150 new). In total, 19 states (increase of 4) are reporting more than 100,000 cases. California is reporting more than 600,000 cases; Florida and Texas more than 500,000 cases; New York more than 400,000; and Georgia and Illinois more than 200,000. Puerto Rico is a US territory, but at 194 new daily cases per million population, it would be #7 globally in terms of per capita daily incidence, falling between the Maldives and Israel. For nearly 3 weeks, the US has averaged more than 1,000 deaths per day.
The Johns Hopkins CSSE dashboard reported 5.41 million US cases and 170,178 deaths as of 1:30pm EDT on August 17.
SEASONAL INFLUENZA Public health leaders are looking ahead to the upcoming Northern Hemisphere influenza season and trying to anticipate challenges associated with mounting simultaneous seasonal influenza and pandemic responses. The Northern Hemisphere influenza season typically starts around October and peaks between December and February. In the US, the annual influenza season typically causes 9-45 million cases, including 140-810,000 hospitalizations and 12-61,000 deaths. Last season was relatively mild, but that is not necessarily expected to be the case this year. US CDC Director Dr. Robert Redfield warned Wednesday that the US could face its “worst fall from a public health perspective,” due to seasonal influenza and COVID-19 both straining health systems at once. Dr. Redfield encouraged Americans to wear a mask, avoid crowds, maintain appropriate physical distancing (eg, 6-foot separation), and practice proper hand hygiene, and notably, he emphasized the importance of getting a seasonal influenza vaccination.
Only about 50% of Americans receive their seasonal influenza vaccination in a typical year, but Dr. Redfield hopes to increase that proportion to 65% this year. The CDC usually purchases 500,000 doses of seasonal influenza vaccine to provide for uninsured individuals, but this year, it is acquiring an additional 10 million doses. Despite this investment, some experts are concerned these efforts will not be sufficient. Seasonal influenza vaccination suffers from a number of challenges, including low efficacy on a yearly basis as well as mis- and disinformation spread by anti-vaccine advocates. In order to improve vaccination coverage, health officials have allocated considerable effort and resources to expanding access to the vaccine, including at convenient locations such as schools and workplaces; however, many of these locations may be closed due to social distancing restrictions, which could subsequently limit access for some communities.
The ongoing Southern Hemisphere influenza season has been very mild compared to past years, which some have attributed to social distancing measures implemented for COVID-19. If social distancing can limit seasonal influenza transmission, the Northern Hemisphere could potentially experience a mild influenza season as well, but that would depend heavily on the degree to which communities adhere to social distancing policies.
SALIVA-BASED DIAGNOSTIC TEST The US FDA issued an Emergency Use Authorization for a saliva-based diagnostic test developed by researchers at the Yale School of Public Health. When compared with other FDA-authorized diagnostic tests, the SalivaDirect protocol demonstrated an 83%-100% agreement. A saliva-based test offers a number of potential benefits over existing diagnostic tests. Collecting a saliva sample is more comfortable than nasopharyngeal swabs, and the SalivaDirect tests can use any sterile container, as opposed to requiring expensive tubes as is the case for some other saliva-based tests. Additionally, the testing protocol is reportedly more streamlined than other diagnostic tests, which eliminates the need for certain reagents and decreases testing time, and the tests require no proprietary supplies to process. Yale researchers are also making the protocol “open source,” so any laboratory can order supplies and follow the instructions rather than purchase tests from a single manufacturer. Test materials are also relatively inexpensive, less than US$5 per test.
Researchers are currently working with the National Basketball Association on the Surveillance with Improved Screening and Health (SWISH) study to determine the test’s ability to detect asymptomatic infections, but the ultimate goal is to expand availability more broadly to supplement existing testing capacity. Additional studies to modify the original protocol to increase testing capacity via automation, pooled testing, and rapid detection are also underway. Additional information about the test, including instructions for use and obtaining authorization to use the protocol, can be found here.
US PERSONNEL & PPE SHORTAGES On Friday, the US FDA published a list of medical device and equipment shortages{SEE BELOW} for the first time during COVID-19 pandemic. The list includes a wide variety of items, including personal protective equipment (PPE), such as examination gloves, surgical gowns, and respirators; swabs and viral culture medium used for testing; and mechanical ventilators. Reporting this information is required under the CARES Act.
A report published by Politico describes findings, based on survey and interview responses from frontline healthcare workers and hospital administrators, regarding the challenges that healthcare facilities are facing in terms of securing necessary supplies and personnel. As we have reported previously, without centralized coordination at the national level to distribute limited resources, hospitals and health systems have been forced to compete against each other. Notably, some smaller hospitals do not have the resources to compete with larger and better-funded facilities, both for supplies and personnel, resulting in shortages of both.
LEBANON Lebanon’s Minister of Public Health announced that the country will require a 2-week “lockdown” to curtail a recent rise in COVID-19 incidence. The recent surge of transmission in Beirut has also complicated response efforts following a major explosion at the city’s port last week that resulted in at least 178 deaths and more than 6,000 wounded and left approximately 250,000 individuals homeless. The government has not yet published details regarding how the lockdown measures will be implemented. To date, Lebanon has reported 9,337 total cases, including 105 deaths, and the daily incidence has nearly ten-fold since early July.
RACIAL & ETHNIC DISPARITIES A study, published in the US CDC’s Morbidity and Mortality Weekly Report, evaluated county-level data for areas identified as COVID-19 hotspots between June 5 and June 18, and the findings provide further evidence of racial and ethnic disparities in COVID-19 incidence. In total, 205 counties across 33 states were identified as hotspots during the study period, of which 79 counties (22 states) reported race/ethnicity data for at least 50% of the reported cases. The researchers defined disparity as either a 5% or greater absolute difference between the proportion of COVID-19 cases among a specific race/ethnic group and the proportion of that group among the general population (eg, a race/ethnic group represents 15% of COVID-19 cases but only 10% of the population) or a ratio of 1.5 or greater between the proportions (eg, a race/ethnic group represents 4.5% of cases but only 3% of the population).
Of the 79 included counties, 76 (96.2%) exhibited racial or ethnic disparities for at least one racial or ethnic minority group. These disparities affected minority populations totaling approximately 5.6 million people across the included counties, representing more than 20% of the 27.5 million total population. The most severely affected racial/ethnic groups were Hispanic/Latino and Black/African American populations, totaling 3.5 million and 2 million people, respectively.
LASTING IMMUNITY The US CDC published clarifications on some recent guidance regarding quarantine, isolation, and the possibility of SARS-CoV-2 reinfection. On August 3, the CDC updated its isolation guidance to include new information which indicates that individuals infected with SARS-CoV-2 can “continue to test positive for up to 3 months after diagnosis and not be infectious.” On Friday, the CDC clarified that this does not mean that individuals are immune to reinfection for 3 months. Investigation into lasting immunity and risk of reinfection are ongoing, and while there has not been documented evidence of reinfection within 3 months, the possibility or reinfection during this period has not yet been ruled out. The previous guidance stated that “People who have tested positive for COVID-19 do not need to quarantine or get tested again for up to 3 months as long as they do not develop symptoms again.” Some interpreted this statement as implying a 3-month period of immunity, so the CDC clarified that its intent was to state “that retesting someone in the 3 months following initial infection is not necessary” due to the possibility of continued positive tests, even after an individual has recovered and is no longer infectious. The CDC has included updated language about reinfection for multiple guidance pages, including for quarantine and self-isolation.
NEW ZEALAND DELAYS ELECTION New Zealand Prime Minister Jacinda Ardern announced that the country’s general election will be postponed from September 19 to October 17 due to COVID-19, including an ongoing outbreak in the capital city of Auckland. The delay is intended to aid political parties’ ability to plan for campaigning under COVID-19 restrictions. Reportedly, Prime Minister Ardern collaborated with leadership from all major political parties in making the decision, and the decision appears to have broad support among the general public. She indicated that the election date will not be delayed any further due to COVID-19, even if the situation worsens. The outbreak in Auckland is up to 58 total cases, including 9 identified in the past 24 hours.
SOUTH KOREA After bringing its “first wave” of COVID-19 under control, South Korea is battling another outbreak, this time in Seoul. Early in its epidemic, SARS-CoV-2 transmission largely centered around a religious group in Daegu, and the current surge has been linked to a different religious group in the country’s capital. Over the past 3 days, South Korea has reported 642 total cases reported nationwide, and 553 of these are domestically acquired cases in Seoul and the Gyeonggi and Incheon provinces, which surround Seoul. In total, nearly 450 cases in Seoul, Incheon, and Gyeonggi have been linked to clusters at 2 churches in the Seoul metropolitan area, as well as more than a dozen cases in other parts of the country.
As of August 15, all members of the Woori Jaeil Church in Gyeonggi province (approximately 900 individuals) were in quarantine, and all members of the Sarang Jaeil Church in Seoul who were present August 7-13 were directed to quarantine on August 16. The pastor at the Sarang Jaeil Church has reportedly hindered the public health response, including holding a large protest against South Korean President Moon Jae-in that drew a crowd of 10,000 people. In response to the recent increased incidence, South Korea increased the COVID-19 alert level in Seoul to Level 2 (out of 3), which restricts indoor gatherings to no more than 50 people and outdoor gatherings to 100 or fewer and prohibits fans from sporting events, along with other social distancing measures.
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SUPPY SHORTAGE
On March 27, 2020, the CARES Act was signed into law. Section 3121 of the CARES Act amends the Federal Food, Drug, and Cosmetic Act (FD&C Act) by adding section 506J to the statute. Section 506J provides the FDA—for the first time—with authority intended to help prevent or mitigate medical device shortages “during, or in advance of, a public health emergency declared by the Secretary under section 319 of the PHS Act.” The provision includes requirements for manufacturers of certain devices to notify the FDA “of a permanent discontinuance in the manufacture of the device” or “an interruption in the manufacture of the device that is likely to lead to a meaningful disruption in supply of that device in the United States” during a declared public health emergency. One provision of this new statutory authority—section 506J(g) of the FD&C Act— requires the FDA to maintain a publicly-available, up-to-date list of the devices the FDA has determined to be in shortage. In addition, the FDA is providing a list of medical devices for which the FDA has been notified that manufacturing has been permanently discontinued. The list below fulfills this statutory obligation and reflects the categories of devices the FDA has determined to be in shortage at this time, and will be maintained and updated as the COVID-19 public health emergency evolves.*
On this page:
Related pages:
- Medical Device Supply Chain Notifications During the COVID-19 Public Health Emergency
- Medical Device Types to Help Determine Section 506J Notification Obligations
- Contact the FDA About a Medical Device Supply Chain Issue
Device Shortage List
Categories of devices in the device shortage list are:
- Personal Protective Equipment
- Testing Supplies and Equipment
- Ventilation-Related Products
Search:
Show 102550100All entries
Date Posted
Category
Product Code
Reason for Interruption
Estimated Shortage Duration
Additional Information
08/14/2020
Personal Protective Equipment
FME (Examination gown)
Demand increase for the device
Duration of COVID-19 PHE
Availability: Limited supply
08/14/2020
Personal Protective Equipment
FXX (Surgical apparel)
Demand increase for the device;
Delay in shipping of the device;
Shortage or discontinuance of a component or part
Duration of COVID-19 PHE
Availability: Limited supply
08/14/2020
Personal Protective Equipment
FYA (Surgical gown)
Demand increase for the device
Duration of COVID-19 PHE
Availability: Limited supply
08/14/2020
Personal Protective Equipment
LYY (Latex, non-powdered patient examination glove)
Demand increase for the device
Duration of COVID-19 PHE
Availability: Limited supply
08/14/2020
Personal Protective Equipment
LYZ (Vinyl patient examination glove)
Demand increase for the device
Duration of COVID-19 PHE
Availability: Limited supply
08/14/2020
Personal Protective Equipment
LZA (Polymer, non-powdered patient examination glove)
Demand increase for the device
Duration of COVID-19 PHE
Availability: Limited supply
08/14/2020
Personal Protective Equipment
LZC (Specialty, non-powdered patient examination glove)
Demand increase for the device
Duration of COVID-19 PHE
Availability: Limited supply
08/14/2020
Personal Protective Equipment
MSH (Surgical respirator)
Demand increase for the device
Duration of COVID-19 PHE
Availability: Limited supply
08/14/2020
Personal Protective Equipment
OEA (Non-surgical isolation gown)
Demand increase for the device
Duration of COVID-19 PHE
Availability: Limited supply
08/14/2020
Testing Supplies and Equipment
JJH (Clinical sample concentrator)
Demand increase for the device
Duration of COVID-19 PHE
Availability: Limited supply
08/14/2020
Testing Supplies and Equipment
JSM (Transport culture medium)
Demand increase for the device
Duration of COVID-19 PHE
Availability: Limited supply
08/14/2020
Testing Supplies and Equipment
KXG (Sterile swabs)
Demand increase for the device
Duration of COVID-19 PHE
Availability: Limited supply
08/14/2020
Testing Supplies and Equipment
LIO (Microbiological specimen collection and transport device)
Demand increase for the device
Duration of COVID-19 PHE
Availability: Limited supply
08/14/2020
Testing Supplies and Equipment
NSU (Instrumentation for clinical multiplex test systems)
Demand increase for the device
Duration of COVID-19 PHE
Availability: Limited supply
08/14/2020
Testing Supplies and Equipment
OOI (Real time nucleic acid amplification system)
Demand increase for the device
Duration of COVID-19 PHE
Availability: Limited supply
08/14/2020
Testing Supplies and Equipment
PPM (General purpose reagents for in vitro diagnostic tests)
Demand increase for the device
Duration of COVID-19 PHE
Availability: Limited supply
08/14/2020
Testing Supplies and Equipment
QBD (Microbial nucleic acid storage and stabilization device)
Demand increase for the device
Duration of COVID-19 PHE
Availability: Limited supply
08/14/2020
Ventilation-Related Products
BZD (Non-continuous ventilator)
Demand increase for the device
Duration of COVID-19 PHE
Availability: Limited supply
08/14/2020
Ventilation-Related Products
CBK (Continuous ventilator, facility use)
Demand increase for the device
Duration of COVID-19 PHE
Availability: Limited supply
08/14/2020
Ventilation-Related Products
NOU (Continuous ventilator, home use)
Demand increase for the device
Duration of COVID-19 PHE
Availability: Limited supply
Showing 1 to 20 of 20 entries
* FDA has determined, pursuant to section 506J(g)(3)(C) of the FD&C Act (titled “Public Health Exception”), that disclosure of the manufacturer’s name of the devices determined to be in shortage during the COVID-19 PHE will adversely affect the public health by increasing the potential for hoarding or other disruptions in device availability to patients.
Discontinuance List
As part of the list required pursuant to section 506J(g) of the FD&C Act, the FDA is providing a separate, publicly-available, up-to-date list of the devices for which the FDA has been informed by the manufacturer have been discontinued. The FDA will update this list when it receives additional information regarding device discontinuances.
Categories of devices in the discontinuance list are:
- Infusion Pumps and Related Accessories
Search:
Show 102550100All entries
Date Posted
Category
Product Code
Manufacturer Name
Device Trade Name
Reason for Discontinuance
08/14/2020
Infusion Pumps and Related Accessories
FRN (Infusion Pump)
MEA (Infusion Pump, Patient Controlled Analgesic))
Becton Dickinson and Company (CME America, LLC)
BodyGuard Infusion Pump System
BodyGuard Syringe Pump System, BodyGuard microsets
Shortage or discontinuance of a component or part;
Discontinuance of the manufacture of the device;
Facility closure
