June 28, 2022

Volume XII, Number 179


June 28, 2022

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June 27, 2022

Subscribe to Latest Legal News and Analysis

COVID-19 Weekly Newsletter: New Cases Climb in the U.S.

The daily number of new positive COVID-19 cases in the U.S. has exceeded 100,000 twice in the past week, prompting some states to issue more restrictive safety measures and guidance. Amid these heightened concerns, the most thorough (to date) study of remdesivir concluded that the drug shortened hospitalization time for COVID-19 patients, and researchers developed a new saliva-based rapid test for the virus that may rival PCR-based tests for diagnostic accuracy.

100,000+ COVID-19 U.S. Cases Daily

The daily number of new positive cases in the United States has exceeded 100,000 twice this week, an increase from last. Given the United States’ lackluster response to the pandemic, health authorities expected daily infections to top 100,000 — but not this soon. The increase is nationwide, with 20 states reporting record highs in just the first five days of November; however, Midwestern states are being hit the hardest. The hospitalization numbers are nearing those that were seen in July, during the second COVID-19 wave. Some states are enacting additional measures — for example, Massachusetts Governor Charlie Baker and Maine Governor Janet Mills both issued executive orders this week mandating masks to be worn in public, regardless of being socially distant, a stricter restriction from previous measures that only required wearing a mask if within six feet of another individual.

Increased Testing for Congress

The U.S. Air Force will provide up to 2,000 COVID-19 tests weekly for all of Congress for the next six weeks, which provide results in 12 hours. This comes shortly after the D.C. Mayor Muriel Bowser required all D.C. visitors to have a negative test result 72 hours prior to coming to the city. This is an expansion of resources from existing screening practices at the Hill.

Remdesivir Shown to Shorten Hospitalization Times for COVID-19 Patients

A final report from the most-thorough-to-date study of remdesivir has been published. This study adhered to the “gold standard” methodology for clinical research — it was double-blind, randomized, placebo-controlled, and sufficiently large to enable statistically robust conclusions. The “end point,” or primary outcome, on which the data analysis focused, was the time to recovery. For the purposes of this study, “recovery” was defined NOT as a cure of COVID-19 but rather as “either discharge from the hospital or hospitalization for infection-control purposes only.”

Over a thousand hospitalized COVID-19 patients participated in the study, with their ages ranging from 18 to over 65 years old. These trial participants also reflected the global nature of the patient population, with clinical sites in the United States, Denmark, the United Kingdom, Greece, Germany, Korea, Mexico, Spain, Japan and Singapore. For patients who were in the group receiving remdesivir, the median recovery time was 10 days. Those who received placebo had a median recovery time of 15 days. Mortality rates were also estimated, and were 11.4% with remdesivir compared to 15.2% with placebo by day 29. The authors conclude that remdesivir shortens times to recovery in hospitalized adult patients, compared to placebo.

Using Physics to Detect COVID-19 Infections

Researchers at Massachusetts Institute of Technology (MIT) have developed a new saliva-based rapid test for COVID-19 infections. The technology doesn’t rely on the life sciences techniques current testing is based on but instead leverages physics to measure the strength of microscopic interactions between magnetic beads coated with viral proteins and molecules in the saliva sample. The sensitivity of the test is reported to be similar to that of currently available PCR-based tests, but more work is needed to verify the accuracy of this diagnostic testing technique.

© 2022 Faegre Drinker Biddle & Reath LLP. All Rights Reserved.National Law Review, Volume X, Number 311

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,...

Sarah Lloyd Stevenson Life Sciences Policy Advisor

A former policy advisor to federal government agencies and elected officials, Sarah-Lloyd Stevenson helps health and life sciences stakeholders advance policy goals before Congress and federal agencies. Having worked to draft, enact and gain support for health laws and policies at the highest levels of federal government, Sarah-Lloyd delivers policy advocacy strategies informed by firsthand experience getting results in Washington, D.C.

White House Policy Advisor

Prior to joining Faegre Drinker Consulting, Sarah-Lloyd served as policy advisor to the White House’s Domestic...

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

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...

Svetlana Lyapustina Ph.D. a pharmaceutical scientist with Drinker Biddle
Senior Director, Science, Regulation, & Policy

Svetlana Lyapustina, Ph.D. counsels individual companies and consortia comprised of industry, government and academia representatives on a wide range of topics related to medical product development (pharmaceuticals, medical devices, biologics, and combination products), quality control, manufacturing, regulatory compliance, patient adherence, and regulatory submissions.

Svetlana has represented clients in interactions with the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), Health Canada, the Medicines...

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