COVID-19 Situational Overview for November 1, 2020
Novel Coronavirus (COVID-19) Pandemic
For the week ending October 25, the World Health Organization (WHO) reported over 42 million confirmed cases (including over 2 million new cases over the previous 7 days) and 1.1 million deaths (including 40,000 deaths over the previous 7 days) globally.
As of October 29, the Centers for Disease Control and Prevention (CDC) officially reports 8,924,548 confirmed cases in the US (including 90,155 reported in the last 24 hours), across all 50 states, the District of Columbia, Puerto Rico, Guam, and the US Virgin Islands, and 228,100 deaths (including 1,055 reported in the last 24 hours).
Supply Chain and Cross-sector Impacts
Deloitte and the Healthcare Distribution Alliance (HDA) Research Foundation released a recent report titled “The First 90 Days: US Biopharmaceutical Finished Goods Supply Chain Response to COVID-19.” This report discusses how the pharmaceutical supply chain handled the demands during the first 90 days of the US outbreak.
On October 27, the US Food and Drug Administration (FDA) issued an updated Emergency Use Authorization (EUA) template for developers requesting an EUA for antigen tests detecting SARS-CoV-2. The update includes recommendations on studies for antigen tests to screen asymptomatic cases or for SARS-CoV-2 and seasonal flu.
The National Defense Transportation Association highlighted the role of the Defense Logistics Agency in purchasing and distributing medical supplies and PPE for the Department of Defense (DoD) and other federal agencies. As of September, the organization had executed 21,000 contract actions for over $2 billion of medical supplies and PPE.
A report from the Center for Infectious Disease Research and Policy at the University of Minnesota found that 29 of 40 drugs used for treating COVID-19 and 67 of 156 critical acute drugs are in short supply. The report found that closed factories, shipping delays, and export bans have impacted the supply chain.
DHL Customer Solutions presented at the FreightWaves Cold Chain Summit on what the COVID-19 vaccine distribution process will likely look like from a shipping point of view. The presentation covered initial strains on the supply chain, as well as the expected evolution in distribution processes.
FDA announced it will delay the enforcement of a provision of the Drug Supply Chain Security Act that requires wholesalers to verify saleable returned drugs they intend to further distribute. The delay was due to concern of industry readiness to implement these verification requirements.
FDA issued revised guidance on its enforcement policy for non-invasive remote monitoring devices used during COVID-19. The guidance expands the availability and capability of remote patient monitoring devices, lessening the need for in-clinic visits to obtain patient data.
Dr. Robert Redfield gave a press briefing on Operation Warp Speed on Friday, October 23. The recording and transcript of the briefing are both available.
CDC updated its guidance related to elections, voting, and mitigating the spread of COVID-19. Updates include expanded guidance on changes to operations, procedures, and facilities for polling locations, reminders to maintain accessibility, and recommendations for voters.
The US Department of Health and Human Services (HHS) reported that states who received the BinaxNOW COVID-19 Tests are now reporting where those tests were distributed, including local health departments, schools, nursing homes, hospitals, and correctional facilities.
On October 23, HHS and the Department of Education announced that their joint initiative is on track to distribute 125 million cloth masks to states and US territories for distribution to schools by November 2020. The masks are being prioritized to low-income or high-needs students and schools providing in-person instruction.
On October 21, the CDC updated its definition of “close contact” exposure to being within 6 feet of a COVID-19 infected individual for 15 minutes or more over a 24-hour period. The previous definition was exposure within 6 feet for at least 15 minutes.
The National Center For Health Statistics at the CDC is tracking excess deaths due to COVID-19 by calculating the difference between the number of deaths that were expected to occur in a specific time and the number of deaths that actually occurred.
A new study released by the CDC found that counties in the US with more social vulnerabilities were more likely to become hotspots of COVID-19 during the months of June and July. The study found this was especially likely in rural areas.
A new analysis by Global Health 50/50 found that deaths among men from COVID-19 are happening more frequently than among women. This is despite the fact that over half of confirmed COVID-19 cases are women.
The American Society of Health-System Pharmacists (ASHP) issued principles for COVID-19 vaccine distribution, allocation, and mass immunization. The 10 principles build on best practices and lessons learned from pandemic preparedness, supply chain management, distribution, and clinical practice.
State and Local Government
The Association of State and Territorial Health Officials (ASTHO) announced that 19 healthcare and public health organizations had formed the National Associations’ COVID Vaccine Leadership Council to support implementation of the nation’s COVID-19 vaccination plan. The Council plans to support a cohesive and collaborative national approach to vaccine prioritization, distribution, and administration.
On October 21, the CDC updated its guidance on prioritizing non-healthcare worksite assessments. The information is intended to help state, tribal, local, and territorial health departments make decisions about allocating resources to worksites that report COVID-19-related issues.
Additionally, updated guidance on investigating COVID-19 cases in non-healthcare work settings incorporates the new definition of "close contact".
ASTHO released a report detailing legal challenges that are being made against COVID-19-related orders issued by state and territorial executive officials. The report looks at some of the early results and emerging issues.
The HHS Office of the Assistant Secretary for Preparedness and Response (ASPR) Technical Resources, Assistance Center, and Information Exchange (TRACIE) released a PPE Preservation Planning Toolkit to aid organizations that use PPE in planning and implementing preservation strategies.
In partnership with the American Hospital Association (AHA) and other national healthcare centers, the CDC launched Project Firstline, a national training collaborative to help healthcare workers understand and adhere to recommended infection control practices.
On October 21, HHS authorized qualified pharmacy technicians and state-authorized pharmacy interns to administer childhood vaccines, COVID-19 vaccines when available, and COVID-19 tests. The guidance clarifies that pharmacy interns must be authorized by the state or board of pharmacy in the state where the internship occurs.
The Pharmaceutical Supply and Payment Chain Coalition released their principles for safe, efficacious access to a COVID-19 vaccine. The guidance is intended to represent the private sector's commitment to support distribution, allocation, and mass immunization efforts.
The American Society of Health System Pharmacists (ASHP) released a COVID-19 diagnostic testing chart, breaking down the types of tests available and how they are used.
A recent CDC report analyzed COVID-19 hospitalizations from 13 states and found that 6% of adults hospitalized with COVID-19 between March 1 and May 31 were healthcare personnel. Out of that population, 73% had the underlying condition of obesity, and 28% were admitted to an ICU.
AHA published a summary of the efforts by White Plains Hospital in New York to optimize temperature screening during COVID-19. The hospital developed a system of self-service carts that required significantly less staffing than other measures.
BIO is maintaining a Therapeutic Development Tracker to provide timely data on global efforts to produce COVID-19 vaccines and therapeutics.
On October 22, the FDA approved the antiviral drug Veklury (remdesivir) for the treatment of patients with COVID-19 requiring hospitalization. This is the first FDA-approved treatment for COVID-19 in the US.
BioPharmaDive continues to update their information on the coronavirus vaccine frontrunners. The article offers projections of when the first supply will be available for certain vaccine candidates, assuming clinical development succeeds and progresses on time.
On October 16, the National Institutes of Health (NIH) launched an adaptive Phase 3 clinical trial to evaluate the safety and efficacy of three immune modulator drugs in adults hospitalized in COVID-19. The trial is attempting to determine if modulating an immune response in which the immune system releases excessive amounts of proteins that trigger inflammation can reduce the need for ventilators.
Moderna Inc. announced that its Phase 3 trial for its COVID-19 vaccine candidate is completely enrolled with 30,000 participants.
CDC recently updated its COVID-19 information for Public Health Inspectors. The guidance provides details on how employers can protect their staff who may be at risk of exposure.