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COVID-19 Weekly Newsletter: Case Count, Death Toll Both Rising as Public Health Officials Work to Instill Confidence in a Vaccine

As COVID-19 cases rise across the U.S. and the death toll tops a staggering 200,000, four public health officials expressed confidence in an eventual vaccine even as the public's confidence in the vaccine appears to be waning significantly. The Food and Drug Administration is expected to make its guidelines for a vaccine’s Emergency Use Authorization more stringent while national lawmakers attempt to work out new stimulus measures and T-cell immunity gets increased focus in the fight against the virus.

U.S. Reaches 200,000 COVID-19 Deaths 

On Tuesday, September 22, it was announced that the United States passed the 200,000 mark in COVID-19 deaths. According to an online dashboard, the U.S. coronavirus fatality count is at 203,240, and rising, out of the current 7,005,746 cases reported. This number is outpacing past projections from earlier in the summer, which predicted that the U.S. death toll could reach 169,890 by October 1. 

Cases Across the U.S. Continue to Rise 

As the temperature drops and Americans find themselves heading back into school and the workplace, the infection rate continues to rise. At least 22 states are now reporting a rise in new cases, a stark increase from last Monday, when only nine states reported an upward trend. Public health officials are predicting that cases will continue to rise into the winter, as cold weather and attempts to return to “normal” have Americans back inside and into close quarters. 

Confidence in a COVID-19 Vaccine

At a Senate Health, Education, Labor and Pensions (HELP) Committee hearing on September 23, Dr. Anthony Fauci, director of the National Institute of Allergy and Infection Disease, Dr. Stephen Hahn, commissioner of food and drugs for the Food and Drug Administration (FDA), Dr. Robert Redfield, director of the Centers for Disease Control and Prevention, and Adm. Brett Giroir, assistant secretary for health at the Department of Health and Human Services, all expressed confidence in the safety of the eventual COVID-19 vaccine, all going as far to say they would be willing to take it themselves. This comes at a time when public confidence in the vaccine is dropping: In a survey conducted this month, results showed only 51% of Americans would either probably or definitely take a vaccine. This is a vast decline from May, where 72% stated they would do so. As mentioned in last week’s newsletter, state governments are showing their lack of trust in the federal government as well. Recently, Gov. Andrew Cuomo announced that New York would further review any COVID-19 vaccines approved by the federal government, citing a lack of trust in the Trump administration’s opinion, and other states seem likely to follow suit.

FDA Expected to Issue Tougher Guidelines for Emergency Use Authorization of a COVID-19 Vaccine

Amid public and scientific concerns that politics over science will influence the approval of any COVID-19 vaccine, the Food and Drug Administration (FDA) plans to issue more stringent guidelines for how a vaccine can be approved under an Emergency Use Authorization (EUA). The guidelines are meant to increase transparency in the approval process and to provide confidence in the safety and efficacy of any vaccine. Under these new guidelines, companies would be required to follow late-stage clinical trial patients for median of at least two months after they receive their second dose of the vaccine candidate. Based upon the current status of vaccines currently in clinical trials, this additional observation period would not provide a company the opportunity to receive an EUA before mid-November at the earliest. These guidelines have been reviewed by the Department of Health and Human Services (HHS) but still need the approval of the White House before being implemented. President Trump has stated the White House may or may not approve the stricter requirements.

Democrats Push Forward With New Bill Amid Congressional Stalemate

Despite the gridlock and contentious negotiations that have been occurring on both sides of the aisle, House Speaker Nancy Pelosi has moved forward with the development of the Democrats’ next attempt at a coronavirus stimulus bill. This roughly $2.4 trillion stimulus bill is still far higher than what Republicans would likely accept, but Speaker Pelosi is likely to move forward with a vote in the House despite that. While both Republicans and Democrats have noted that they are ready and willing to negotiate on bipartisan legislation, it does not seem likely that this bill will make it past the Senate. Treasury Secretary Steven Mnuchin and Speaker Pelosi have announced that they have agreed to resume talks on a future coronavirus stimulus measure, and it is likely this bill will be used as a tactic to help push forward these negotiations.

T-Cells May Be More Important Than Antibodies for Lasting Immunity to SARS-CoV-2

Until recently, most attention when discussing immunity to SARS-CoV-2 has focused on antibodies. However, with an increasing amount of research revealing that anti-SARS-CoV-2 antibodies disappear from patients’ blood relatively quickly (over a couple of months or so), a greater research focus has started shifting to T-cells, another of the body’s defense mechanisms against infection that may impart long-lasting immunity to SARS-CoV-2.

So far, the findings are encouraging. Some researchers are even interpreting available evidence on T-cell reactivity to SARS-CoV-2 as an indication that humans had been exposed to this virus long before the current pandemic. Some are speculating whether such pre-existing immunity — potentially induced by prior exposure to coronaviruses — might explain, at least in part, asymptomatic and mild COVID-19 cases. On the other hand, hypersensitivity due to a pre-existing pool of differentiated T-cells has also been speculated to be responsible, at least in part, for the progression of the disease to severe stages in some patients.

Although these considerations may raise new hopes as well as new concerns, they should be taken with a healthy dose of skepticism until rigorous clinical studies designed specifically to answer questions about the impact of T-cells on the course of the COVID-19 disease are conducted and results are analyzed. This will take time, dedicated resources and collaboration. Unfortunately, testing for T-cells is more difficult than for antibodies, which may necessitate the development of new tests and methodologies to facilitate this quest. 

In the meantime, some of the vaccines under development already rely on T-cells for eliciting a desired immune response. Data from the ongoing trials should yield more information about the functioning of the immune system in the context of COVID-19, enabling new insights and eventually leading to effective solutions.

© 2020 Faegre Drinker Biddle & Reath LLP. All Rights Reserved.National Law Review, Volume X, Number 269
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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, molecular biology and chemistry researcher. During his scientific career, Jamie has conducted research and acquired particular skills in protein expression and purification, enzymology, macromolecular x-ray crystallography, analytical characterization of small molecules and proteins, laboratory robotics and automation, membrane protein techniques, assay development, and scientific computing.

Prior to joining the firm, Jamie was a senior scientist at the Henry M. Jackson Foundation for the Advancement of Military Medicine, where he worked as a Department of Defense contractor at the Uniformed Services University of the Health Sciences in Bethesda, Maryland. While at Uniformed Services University, James conducted basic science and biodefense research to develop new strategies to combat and protect against Bacillus anthracis and related anthrax-causing organisms.

Jamie has published several first-author articles on his scientific research.

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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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Caroline E. Waldo Health Policy Advisor Faegre Drinker Biddle & Reath Washington, D.C.
Advisor

Caroline Waldo monitors Capitol Hill and Washington, D.C., at large, for health policy news and developments that impact stakeholders in the health and life sciences industry. A former intern for Congressman Jim Himes (D-CT), Caroline helps clients anticipate and respond to policy changes that affect their goals.

Personal Interests

In her free time, Caroline can be found skiing, exploring the independent bookstores of D.C. and cheering for the Alabama Crimson Tide.

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

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