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%.

More COVID-19 Insights

• Government & Regulatory Affairs
  • Bipartisan Lawmakers Put Forth $908 Billion COVID-19 Relief Package
• Product Liability & Mass Torts
  • HHS Issues New PREP Act Immunity to Marburgvirus Measures

Additional Resources

Information regarding the status of each foreign patent office and the availability of extensions of time in each jurisdiction.

Tracking executive orders, legislation, and other government actions related to COVID-19 by state and major locality across the U.S.

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.