November 30, 2020

Volume X, Number 335

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COVID-19 Weekly Newsletter: U.S. Eyes Third Wave as Scientific Understanding, FDA Actions Advance

As talks of a third wave of infections bubble up and political negotiations over another COVID-19 relief package continue to stall, the pressure is on for the health and life science fields to better understand and tamp down the current public health emergency. The Centers for Disease Control and Prevention (CDC) revised its stance on close contact after a case study investigation overturned previous understanding of cumulative exposure. At the same time, the Food and Drug Administration (FDA) has approved the first treatment for COVID-19, and the agency’s Vaccine and Related Biological Products Advisory Committee (VRBPAC) recently convened to present processes to approve an eventual vaccine.

United States May Be Entering Third Wave

According to the Johns Hopkins University data, the U.S. reported more than 71,000 new daily cases of COVID-19, the highest number of daily cases since July, the height of the pandemic in the U.S. These new cases are coupled to 12 states setting new records for weekly infections. Experts are worried the resurgence in cases indicates a third wave of infections, which will be further complicated by seasonal influenza, which has similar symptoms as COVID-19. As people experience “pandemic fatigue,” everyone is reminded to remain vigilant and follow public health guidance.

Pfizer Seeks EUA by End of November

Pfizer CEO Albert Bourla stated the biopharmaceutical company plans to seek emergency use authorization (EUA) in the third week of November. In order to obtain an EUA, Pfizer will have to provide two months of safety data on half of the trail participants following the final dose of the administered vaccine and prove the vaccine’s effectiveness in the majority of vaccinated patients. Pfizer said it could manufacture more than 1.3 million doses by the end of 2021.

FDA Approves Remdesivir for COVID-19 Treatment

This week, the FDA approved the first treatment for COVID-19, remdesivir — an antiviral drug for use in adults and children 12 years of age and older requiring hospitalization. For younger patients, remdesivir can be used under an EUA while clinical trials continue to assess the safety and efficacy of the drug in this patient population.

FDA Vaccine Advisory Committee Meets on COVID-19

On October 22, the FDA held a public meeting of the VRBPAC. This was the 161st meeting of the advisory committee but likely the most widely watched given the importance of the topic. Throughout the day, officials presented on the processes to approve an eventual COVID-19 vaccine and how they will ensure safety and efficacy. However, some stakeholders raised concerns around the federal government’s recommended timeline to support an EUA, trial representation of communities of color, and the threshold level of efficacy set by the agency. Four vaccine candidates are already in Phase III trials in the U.S.

Could There Be Another COVID-19 Relief Package Before the Election?

After months of failed negotiations, House Speaker Pelosi and Treasury Secretary Mnuchin continued to have conversations this week about moving forward with a new, bipartisan COVID-19 relief package in Washington. On October 22, Speaker Pelosi stated they were close to a deal; however, Senate Republicans, who have largely been absent from recent negotiations, may not support this newest potential compromise.

‘Close Contact’ Redefined, Acknowledging Cumulative Exposure to SARS-CoV-2

The CDC updated its definition of “close contact” with an infected person, acknowledging that accumulated exposure could be as harmful as one-time exposure. The previous definition was based on being within six feet of an infected individual or individuals for 15 minutes or longer. The new definition says that those 15 (or more) minutes spread over 24 hours could be just as dangerous. The change was prompted by the CDC’s own investigation of a recent case study. The revised definition may have implications for medical and policy guidelines regarding diagnosing in suspected casestesting priorities and tracing.

© 2020 Faegre Drinker Biddle & Reath LLP. All Rights Reserved.National Law Review, Volume X, Number 297
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About this Author

Sarah Lloyd Stevenson Life Sciences Policy Advisor
Director

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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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...

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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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