|Coronavirus Disease (COVID-19)|
Coronavirus Disease (COVID-19) Update
HBMA COVID-19 Federal Response Update
- Republicans and Democrats in Congress are still at an impasse over new COVID-19 relief legislation. In fact, Democrats have increased the amount of funding they want in the new relief bill.
White House and Federal Agencies
- The FDA issued a new final guidance that recommends approaches sponsors of clinical trials for new drugs and biologics can take to increase enrollment of underrepresented populations in their clinical trials.
- The final guidance includes the FDA’s recommendations on designing and executing clinical trials of drugs and biologics that include people with different demographic characteristics (e.g., sex, race, ethnicity, age) and non-demographic characteristics (e.g., patients with organ dysfunction, comorbid conditions, and disabilities.)
- The final guidance provides the agency's current thinking on steps to broaden eligibility criteria in clinical trials through inclusive trial practices, trial designs, and methodological approaches, as well as recommendations for how sponsors can increase enrollment of underrepresented populations in their clinical trials.
- This is particularly critical during the COVID-19 public health emergency as certain segments of the population are being affected by the virus in different ways. These health disparities illustrate why it is important for developers of any medical product, such as treatments or vaccines for COVID-19, to endeavor to include diverse populations to understand their risks or benefits across all groups.
- 60 Minutes profiled Operation Warp Speed’s (OWS) vaccine distribution plans.
- HHS and the U.S. Department of Education is on track to distribute 125 million cloth masks to states and U.S. territories for distribution to schools by November 2020. These masks support students, teachers, and staff in public and private schools, with an emphasis on low-income or other high-needs students and schools providing in-person instruction.
Centers for Disease Control and Prevention (CDC) Updates
- Every state is experiencing an increase in COVID-19 cases.
- The surge is particularly impacting nursing homes.
- CDC released the executive summaries from the vaccine plans submitted by each jurisdiction, a crucial step in the overall U.S. government effort to develop, distribute, and administer COVID-19 vaccines. The summaries provide an overview of each location’s thought process and planning for different COVID-19 vaccine availability scenarios.
- Operation Warp Speed highlights the military experts who are partnering with regional coordinators at CDC headquarters in Atlanta and their efforts to provide decision support for vaccine prioritization and delivery plans across the country.
- Traditional Thanksgiving gatherings with family and friends are fun but can increase the chances of getting or spreading COVID-19 or the flu. Follow these tips to make your Thanksgiving holiday safer.
- This holiday season, consider how your holiday plans can be modified to reduce the spread of COVID-19 to keep your friends, families, and communities healthy and safe.
- A new report from the CDC concludes that wearing masks protects both the mask wearer and the people around the mask wearer.
- CDC released an MMWR on Characteristics of Hospitalized COVID-19 Patients Discharged and Experiencing Same-Hospital Readmission in the U.S. between March and August, 2020. After discharge from an initial COVID-19 hospitalization, 9% of patients were readmitted to the same hospital within 2 months of discharge. Multiple readmissions occurred in 1.6% of patients.
- CDC updated information for workplaces to plan, prepare, and respond to COVID-19.
- This interim guidance is intended to assist with assessment of risk and application of work restrictions for asymptomatic healthcare personnel (HCP) with potential exposure to patients, visitors, or other HCP with confirmed COVID-19.
- CDC updated information on coping with stress at work while dealing with the COVID-19 pandemic.
- CDC updated information on how to stay safe while performing daily activities and going out.
Economy, Vaccine, Testing and Treatment
- The FDA issued an emergency use authorization (EUA) for Eli Lilly’s antibody therapy that has been shown to protect COVID-19 symptoms from becoming extremely severe.
- The Centers for Medicare and Medicaid Services (CMS) announced that it will cover the infusion procedure for the antibody therapy.
- HHS announced plans to allocate initial doses of Eli Lilly and Company’s antibody therapeutic, bamlanivimab, beginning this week. On October 28, the federal government announced a purchase of 300,000 doses of bamlanivimab. HHS will allocate these doses to state and territorial health departments which, in turn, will determine which healthcare facilities receive the infusion drug. The federal government can purchase up to 650,000 additional doses if needed through June 30, 2021, for distribution across the country.
- The FDA required Eli Lilly to hire a quality control consultant to ensure the antibody therapy is being manufactured in compliance with safety requirements.
- HHS Secretary Alex Azar described the government’s efforts to prepare to distribute COVID-19 vaccines which could soon be approved by the FDA. Secretary Azar says there should be enough vaccines for the general population by March or April of 2021.
- NIAID Director Dr. Anthony Fauci expressed confidence in Pfizer’s vaccine candidate and said he has no concerns getting the vaccine himself if it is approved by the FDA. In fact, Dr. Fauci says the end of the virus as a pandemic is near.
- Moderna is preparing to publish initial data on its COVID-19 vaccine candidate.
- FDA authorized the first serology test that detects neutralizing antibodies from recent or prior SARS-CoV-2 infection.
- FDA Commissioner Dr. Stephen Hahn released a statement on enhancing diversity in clinical trials and encouraging inclusivity in medical product development.
- A NIH clinical trial evaluating the safety and effectiveness of hydroxychloroquine for the treatment of adults with COVID-19 has formally concluded that the drug provides no clinical benefit to hospitalized patients.