March 6, 2021

Volume XI, Number 65

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March 04, 2021

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COVID-19 Weekly Newsletter: CDC Changes Guidance, U.S. Case Trends and New Scientific Developments

The Centers for Disease Control and Prevention (CDC) issued revised guidance that may lead to a decline in individuals seeking COVID-19 tests, as researchers continue to refine pooled testing methods that could streamline testing at a large scale. While the U.S. is seeing a general decline in new COVID-19 cases, hot spots remain, including in the South, the Sun Belt and Hawaii.

CDC Changes COVID-19 Testing Guidance

Earlier this week, the CDC released revised language on their website stating testing is not necessary if one comes in contact with a COVID-19 positive individual as long as they maintained social distancing protocol (six feet) and were not exposed for more than 15 minutes. This is a marked difference from the previous recommendation, which asked for all individuals who came in contact with a COVID-19-positive individual to get tested. Public health experts have expressed their concerns that such guidance will reduce the number of individuals being tested, especially those who are asymptomatic and have shown to spread the disease. Dr. Brett Giroir, the assistant secretary for health at the Department for Health and Human Services (HHS), has reassured that this change in guidance was an “evidence-based decision driven by scientists and physicians” which involved CDC Director Dr. Robert Redfield, White House Task Force COVID-19 Response Coordinator Dr. Deborah Birx, and HHS Secretary Alex Azar. In response to backlash from the scientific and medical community on this change, Dr. Redfield recently walked back the guidance, stating, “All close contacts of confirmed or probable COVID-19 patients may consider getting tested,” even without displaying symptoms. However as of this afternoon, the CDC guidance still remains the same as what was originally published earlier this week.

Declines, Plateaus and Increases in Cases

Southern and Sun Belt states have seen a rise in their number of cases over the last several months. In the past month, Hawaii has seen a similar trend and, as of midnight Thursday, August 27, the second stay-at-home order went in effect for the next two weeks for the island of Oahu. The U.S. has experienced a steady decline in cases; however, with the opening of college campuses, continuous large-crowd gatherings and variable compliance with safety protocols, parts of the country have had to reverse their reopening approach. Some governors are taking proactive action. New York Governor Andrew Cuomo has required New York colleges to halt in-person classes, stating that if the colleges have “100 cases or the number of cases is equal to 5% of their population or more — they must go to remote learning for two weeks.”

Scientific Developments and the Unknowns

Researchers have developed a pooled testing process and algorithm that provides improved accuracy and timing over existing pooled testing methods. The new approach puts each patient sample into multiple sample pools which are then tested, allowing for identification of infected individuals, including asymptomatic ones, without retesting. As with pooled testing generally, the approach works best where rates of infection are low. Meanwhile, a number of saliva-based SARS-CoV-2 tests, including diagnostics and protocols, are being developed that may assist in streamlining the testing process. Although much has been learned regarding SARS CoV-2, many important questions remain: Why is there variability in clinical outcomes? What is the longevity and markers of immunity? Have mutations of the virus developed, and will a vaccine be effective?

More COVID-19 Insights

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.

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© 2020 Faegre Drinker Biddle & Reath LLP. All Rights Reserved.National Law Review, Volume X, Number 241
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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,...

202-230-5439
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...

202-312-7045
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...

202-230-5165
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