June 29, 2022

Volume XII, Number 180


June 29, 2022

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June 28, 2022

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June 27, 2022

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COVID-19 Weekly Newsletter: FDA Committee Recommends Vaccine Approval

A milestone in the vaccine approval process and a bipartisan relief package proposal highlighted a busy week in the COVID-19 response.

COVID-19 Relief Package

This week, a group of bipartisan senators put forth the framework for a $908 billion relief package that seems to be a middle-ground between the Democrats’ $2 trillion and Senate Republicans’ $500 billion proposals from summer and fall. While the agreement seems to split key differences, it has yet to secure the necessary backing of leadership, raising continued questions as to if a deal will be possible before Congress recesses for the holidays next Friday. The remaining points of contention are related to liability protections for businesses and additional aid for local and state governments.

FDA Advisory Committee Recommends Pfizer Vaccine

The Food and Drug Administration (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) met on December 10 to review Pfizer’s data and voted, though not unanimously, in favor of recommending FDA to grant the vaccine emergency use authorization (EUA). Though FDA does not have to follow VRBPAC’s recommendation, it is expected that they will, and that an EUA may be issued as early as today (December 11). Health and Human Services Secretary Alex Azar said Americans could begin getting the vaccine as early as Monday, December 14, and signaled the possibility of using the Defense Production Act to expedite the distribution. Assistant Secretary for Health Brett Giroir said that by the end of December, 20 million Americans will have received the vaccine, with 10 million more in January and another 20 million the following month.

FDA Authorizes First Direct-to-Consumer Non-Prescription COVID-19 Test

LabCorp’s Pixel COVID-19 nasal swab home collection kit for individuals over the age of 18 was authorized by FDA. It can currently be purchased directly from LabCorp online. The individual’s health care provider is notified of any positive or inconclusive result, while negative results are sent via email or online portal.

‘Anaphylactoid Reaction’ to Vaccine in the U.K.

Some of those in the U.K. who received the new anti-COVID-19 vaccine, which was granted “temporary approval” there just last week, developed serious allergic reactions, prompting the U.K.’s Medicine & Healthcare products Regulatory Agency (MHRA) to issue a warning that the vaccine should not be given to those with a history of allergic reactions, and that the vaccine “should only be carried out in facilities where resuscitation measures are available."

Delirium Brought on by COVID-19 Is Common

A state of acute mental confusion and disturbances, known as delirium, is one of the more frequent symptoms of COVID-19, even though it is only occasionally discussed in the popular media. In fact, delirium was observed in as many as 28% of COVID-19 patients over 65 years old brought to the Emergency Department. About a sixth of those patients had delirium as the primary symptom for the ED visit, and more than a third had no other “typical” COVID-19 symptoms such as cough or fever, although COVID-19 was confirmed via specific tests.

A similarly high percentage (38.7%) of delirium as initial presentation was reported in an earlier study of COVID-19 cases. In yet another study, 11% of hospitalized COVD-19 patients developed delirium during the hospital stay. In critically ill COVID-19 patients, the percentage of delirium cases rises to over 50%.

Clinical guidelines for the diagnosis and management of delirium associated with COVID-19 are still evolving.

Several research institutions are now gearing up to study the COVID-19 delirium — planning to measure its incidence, potential treatment protocols, and long-term consequences.

One of SARS-CoV-2 Protein’s 3-D Structure Solved, Opening Door to Targeted Drug Design

The SARS-CoV-2 virus particle has only four types of proteins: one structurally associated with the genomic material of the virus (nucleoprotein, N) and three transmembrane proteins incorporated into the viral lipid bilayer: the “signature” spike protein (S) arranged in trimers, a membrane protein (M), and the smallest — only 75 amino acids long — envelope protein (E). Each of the proteins is responsible for some part of the virus-host interactions and, therefore, in one way or another is responsible for the infectivity of SARS-CoV-2.

A 3-D structure of the E protein has recently been elucidated using NMR spectroscopy. That study also confirmed that in SARS-CoV-2, five units of the E protein form a pore, similar to other coronaviruses.

The pore can be blocked, albeit weakly, by two existing drugs: amantadine (first approved in the 1960s for the treatment of Parkinson disease and later also for the prevention of influenza A virus reproduction in the body) and hexamethylene amiloride (used to block E proteins in other coronaviruses, including HIV). Protein E was previously identified as one of the targets for pharmacological interventions against SARS-CoV-2. Having its detailed chemical and 3D structure confirmed should facilitate design of custom-tailored drugs.

Plasma No Better Than Placebo for Hospitalized COVID-19 Patients

In a randomized clinical trial of 333 hospitalized patients with severe COVID-19 pneumonia who received either convalescent plasma or placebo, the results were a wash: mortality in the placebo group was a few decimal points over 11% and in the convalescent plasma group just barely under 11%.

© 2022 Faegre Drinker Biddle & Reath LLP. All Rights Reserved.National Law Review, Volume X, Number 347

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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