September 25, 2020

Volume X, Number 269

September 25, 2020

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September 23, 2020

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COVID-19 Weekly Newsletter: Questions Swirl Around Federal Response, Back-to-School Plans as COVID-19 Studies Continue

President Trump’s recent executive order and memoranda addressing payroll tax, student loans and unemployment benefits have triggered conversations regarding executive overreach and the most practicable course of action for states navigating the concurrent public health and economic crisis. At the same time, school districts continue to manage a tough balancing act of their own, with new cases prompting them to reevaluate back-to-school plans. Highlights from the scientific community include new clinical trials, studies on asymptomatic individuals, and an evaluation on the effectiveness of popular mask types.

COVID-19 Executive Order & Memoranda

Earlier this week, President Trump released an executive order and three memoranda addressing payroll tax, student loans and unemployment benefits. The memoranda call for the federal government to use unspent Federal Emergency Management Agency (FEMA) funds to pay for $300 of the $400 unemployment benefits payment, with states covering the remaining $100 difference. Many governors have already raised concern that budget cuts would have to be made to account for this. As part of the Coronavirus Aid, Relief and Economic Security (CARES) Act, student loans deferral was set to expire on September 30, but the memorandum has now extended it to January 1, 2021. The payroll tax has been one of the administration’s priorities to defer federal tax withholdings for a four-month period from September 1 to December 31 for certain eligible people based off their annual earnings. Since this is a deferral, this does not imply tax forgiveness; individuals will still be expected to pay those taxes after the deferral period is over unless a change in law is later made. The legality and ability of an executive order or memoranda to direct funds or tax deferrals without congressional approval has come into question. 

Back to School or Remote Learning?

School districts are struggling to strike a balance between providing a safe learning environment for their students and being cognizant that remote learning has its limitations. Some schools have already seen new cases after conducting their in-person orientations, making some rethink how they should adjust their protocols and sanitation practices. Of note, children’s hospitals across numerous states, including Arkansas, Oklahoma and Colorado, are partnering with some school districts to develop apps to check students’ symptoms. 

Asymptomatic Individuals: Clinical Characteristics and Screening

 The scientific community continues to gather information on the clinical characteristics of asymptomatic versus symptomatic individuals infected with SARS-CoV-2. A  recent study including over 300 infected people – all isolated in a community treatment center with some asymptomatic and others symptomatic – indicates that asymptomatic and symptomatic individuals carry similar viral loads. Study authors noted, however, that these results do not suggest any link to likelihood of transmission from asymptomatic patients, as the study was not designed to assess viral shedding and any causal relationships. This investigation adds further information to other studies, some done earlier in the year. On the diagnostics front, the Food and Drug Administration (FDA) has updated its Emergency Use Authorization (EUA) submissions templates to provide information on its expectations for how tests may be validated to screen asymptomatic individuals and to facilitate data pooling. 

Clinical Trials of Antibodies to Prevent Infection

 Two Phase 3 clinical trials studying the safety and effectiveness of monoclonal antibodies (mAbs) to prevent SARS-CoV-2 infection are now each seeking to enroll approximately 2,000 volunteers. One trial will study the dual mAb combination developed by Regeneron in volunteers who have been in close contact with an infected person. The other trial will study the Eli Lilly mAb in volunteers who are living in or working at nursing or assisted living communities. Some current discussions on mAb therapies are noting the need for and difficulty of rapid and enhanced trial enrollment, as well as scaled-up manufacture.

Funding Proposed for Studying MIS-C

 The National Institutes of Health (NIH) is proposing to fund up to $20 million in research over four years to develop ways to identify children at high risk for developing multisystem inflammatory syndrome in children (MIS-C). Funded studies will seek to improve understanding of COVID-19 symptoms in children and factors that may be linked to MIS-C development. Funded research will investigate genetic information, biomarkers and immune responses, among other things, and include use of artificial intelligence to organize data. 

Russia Approves First COVID-19 Vaccine

 A vaccine developed by Gamaleya Research Institute of Epidemiology and Microbiology in Moscow was approved this week in Russia despite only being tested in 76 people. The vaccine, Sputnik V, was met with worldwide skepticism by the medical and scientific community since there has been no data shared or findings published to provide any evidence that it is safe and effective in preventing COVID-19.

Choose Your Mask Wisely

recent study at Duke University has looked at the effectiveness of various types of commonly available masks in their ability to reduce the transmission of droplets while talking. In this comparison, the researchers found that cotton cloth masks demonstrate similar effectiveness as standard surgical masks while knitted masks, fleece masks, bandanas and neck gaiters did not offer much protection. It was also noted in the study that while a valved N95 mask may offer protection to the wearer, droplets can be transmitted to nearby individuals due to the outward flow of air through the valve.

© 2020 Faegre Drinker Biddle & Reath LLP. All Rights Reserved.National Law Review, Volume X, Number 227

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About this Author

James M. Vergis, Ph.D. Director of Science & Technology Faegre Drinker Biddle & Reath Washington, D.C.
Director, Science & Technology

James Vergis is a multidisciplinary Ph.D. scientist who provides scientific and management support to pharmaceutical, biotechnology and medical device industry consortia. He is particularly adept at helping clients streamline the development of new technology and data-sharing processes. A researcher whose work has touched on various fields of study, Jamie is passionate about helping clients cultivate new scientific knowledge and drive public policy changes that enhance the drug-development process.

Scientific Background

Jamie is an experienced biochemistry, biophysics,...

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Nisha K. Quasba Public Health Policy Advisor Faegre Drinker Biddle & Reath Washington, D.C.
Advisor

Nisha Quasba serves as a strategic advisor in complex matters regarding public health policy. Staying nimble in an evolving legislative and policy environment is her greatest strength. Through effective advocacy, stakeholder, and coalition engagement, Nisha is able to address client needs and pinch-points. Translating complex policy and scientific jargon into understandable language is her strong suit.

Public Health Experience

Prior to her time with Faegre Drinker, Nisha served as a public policy specialist with the Association of Public Health Laboratories, liaising between government agencies, the association’s membership and policy makers. She monitored federal and state legislation and regulation regarding newborn screening, emerging outbreaks, emergency preparedness and global health. To ensure the successes and challenges of the laboratory community were elevated at the federal level, she worked collaboratively with key external partners to host and organize Hill visits, annual policy symposiums and briefings.

Nisha is a consulting professional within Faegre Drinker Consulting, and does not act as a lawyer for clients. 

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Lee Mia Nagao Ph.D. Senior Director Science, Regulation, & Policy Faegre Drinker Biddle & Reath Washington, D.C.
Senior Director Science, Regulation & Policy

Lee Mia Nagao partners with pharmaceutical innovators to identify and overcome regulatory and product-development obstacles as they shepherd their products from the lab to the marketplace. Driven by her own background as a scientist, Lee is passionate about helping clients maximize efficiency in the product development lifecycle so that high-quality, life-saving products reach patients quickly and clients have more time to focus on new innovations.

Advising Pharmaceutical and Biopharmaceutical Companies

Lee advises domestic and international clients on current and emerging...

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