April 19, 2021

Volume XI, Number 109

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April 19, 2021

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COVID-19 Weekly Newsletter: Pharma Companies Sign Vaccine Pledge, Relief Package Stalls

AstraZeneca’s Phase 3 vaccine clinical trials came to a halt this week as the pharmaceutical company works to identify the underlying cause of a case of transverse myelitis emerging in a volunteer. The pause coincided with pharmaceutical companies signing a joint pledge that science, not politics, would drive the vaccine development process. 

Vaccine Trial Halted

AstraZeneca’s Phase 3 COVID-19 vaccine clinical trials began at the end of August and were halted within a week when a volunteer developed transverse myelitis, a spinal inflammatory disorder after being injected with the candidate vaccine. Though unclear when the hold will be lifted, as the pharma company must explain the cause of the symptoms, it should be emphasized that such pauses are routine in clinical trials, especially in Phase 3 large-scale trials in order to allow time for a review of the safety data by an independent committee. In July another participant in AstraZeneca’s trials experienced neurological symptoms that were later found to be unrelated to the vaccine, but similarly, the trials were halted at that time for further investigation to be conducted. For this recent adverse event, details of the severity have not been shared so it is too early to determine how it will impact the vaccine candidate if a linkage is found. AstraZeneca’s Phase 3 trials targets to have 30,000 participants at 80 sites across the U.S.

Pharmaceutical Companies Sign Vaccine Pledge

In response to concerns of the general public and scientific community of political pressure to release a vaccine before sufficient testing is completed, nine U.S. and European pharmaceutical companies have issued a joint “historic pledge” stating that science, not politics, will drive their decision to seek regulatory approval or emergency use authorization of their vaccines. This will require the vaccine to demonstrate safety and efficacy through a rigorous phase 3 clinical trial.

New Cases in Europe Worsen

Based off numbers from the European Centre for Disease Prevention and Control, over two dozen Western European countries collectively have surpassed the number of daily new cases in the U.S. In the beginning of the pandemic, Italy and Spain were the two hardest hit European countries which triggered a series of strict lockdowns throughout the continent. With the new spike in infections linked to vacationers and social gatherings, some countries are once again initiating restrictions. Fortunately, the new spike appears to be producing lower mortality rates; however, with the unpredictability of the disease and numbers rising up to the levels of March, many worry this new trajectory is not promising, especially with other seasonal diseases typically emerging in the winter months that are just around the corner.

Senate Fails to Move ‘Skinny’ COVID Relief Package

On Monday, Senate Majority Leader Mitch McConnell (R-KY) introduced the GOP’s latest COVID-19 relief proposal. A cloture vote on the measure failed on Thursday, essentially killing the bill. All Democrats voted against the measure as well as Sen. Rand Paul (R-KY). There is increasing belief in Washington that a relief package will not happen. One option could be to include additional relief in a continuing resolution at the end of the fiscal year which ends on September 30. President Trump has also discussed the option of providing additional economic and public health funding through an executive order.

As lawmakers prepare to enter the November election season without a concrete relief measure enacted in several months, they are under an enormous amount of political pressure to extend economic relief program and provide additional funding for public health measurers as the effects of the public health emergency are ever-lasting and even worsening in some respects. State Medicaid program enrollment is starting to accelerate and lead to shrinking state budgets and shortfalls as more people continue to file for unemployment.

Online Searches for COVID-Related Information Carry Privacy Risks

Researchers from Pennsylvania studied over 500 unique webpages that were most likely to be visited by those seeking information related to COVID-19 using non-personalized Google searches. The results showed that 99% of the webpages carried at least one third-party data request from a domain other than that of the given webpage. Such data requests initiate data transfer from the user’s computer to the third party. In addition, 89% of these webpages placed a third-party cookie on the user’s computer, enabling tracking of the user’s behavior across multiple websites. These numbers are higher than those found previously for a million popular webpages, which had 91% third-party data requests and 70% third-party cookies. The study highlights the risks to privacy of personal data for those seeking medical information online.

Supercomputer Analysis Leads to COVID-19 Theory 

The world’s second fastest computer housed in Oak Ridge National Lab analyzed genetic samples collected from COVID-19 patients, finding a distinct pattern of gene activity in COVID-19 patients when compared to heathy populations. This allowed the researchers to hypothesize a mechanism of action for the disease through a blood pressure regulating molecule produced in the body called bradykinin. In COVID-19 samples, genes that produce bradykinin were overexpressed and genes that inhibit or breakdown bradykinin were repressed. Besides hypothesizing the role of bradykinin, other symptoms observed in the clinic were predicted and explained such as increased production of hyaluronic acid, which is linked to fluid buildup in the lungs.  Lastly, several potential therapies were hypothesized from the data, all of which are currently FDA approved, including predicting a potential role of Vitamin D, which has already been implied to help COVID-19 patients.  These potential therapies warrant further study and evaluation to determine if they are effective to treat COVID-19.

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© 2021 Faegre Drinker Biddle & Reath LLP. All Rights Reserved.National Law Review, Volume X, Number 255
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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
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...

(202) 230-5179
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...

1 202 312 7415
Vincent Giglierano Legislative Advisor Faegre Drinker

Vincent Giglierano draws on a broad knowledge of legislation and dual experiences in the public and private sector to provide clients with the background they need to address federal budgetary, legislative and regulatory challenges. A policy wonk at heart, Vincent prides himself on helping clients make sense of legislative and policy impacts and implement flexible strategies that evolve with the industry.

Experience on Capitol Hill

Prior to joining Faegre Drinker, Vincent served as a legislative assistant for Rep. Glenn Grothman (R-WI), analyzing policy trends to offer...

202 312 7037
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