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August 14, 2020

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

A 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.

More COVID-19 Insights

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Additional Resources

Global COVID-19-Related Patent Office Status and Deadline Extension Updates
Information regarding the status of each foreign patent office and the availability of extensions of time in each jurisdiction.

Government Actions: COVID-19
Tracking executive orders, legislation, and other government actions related to COVID-19 by state and major locality across the U.S.

Tracking Fraud Related to the COVID-19 Pandemic
Tracking federal and state law enforcement and regulatory actions taken against bad actors who have exploited the COVID-19 emergency to defraud consumers and payers.

Faegre Drinker’s Coronavirus Resource Center is available to help you understand and assess the legal, regulatory and commercial implications of COVID-19.

The material contained in this communication is informational, general in nature and does not constitute legal advice. The material contained in this communication should not be relied upon or used without consulting a lawyer to consider your specific circumstances. This communication was published on the date specified and may not include any changes in the topics, laws, rules or regulations covered. Receipt of this communication does not establish an attorney-client relationship. In some jurisdictions, this communication may be considered attorney advertising.

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