Market Overview

COVID-19 Update: Gottlieb On Vaccine Approval Timeline, GSK Exec Talks Antibody Drug

COVID-19 Update: Gottlieb On Vaccine Approval Timeline, GSK Exec Talks Antibody Drug

Media reports of the U.S. Food and Drug Administration looking to approve a coronavirus vaccine prior to the completion of clinical trials appear to be taken out of context, former FDA Commissioner Dr. Scott Gottlieb said on CNBC's "Squawk Box."

Emergency Use Authorization: FDA Commissioner Dr. Stephen Hahn said in a Financial Times interview that it may be "appropriate" to approve a vaccine prior to the end of a Phase 3 trial.

It is possible that Hahn is referencing an emergency use authorization for high-risk or front-line health care workers, Gottlieb said.

A more realistic timeline would place a vaccine approval after the November presidential election, he said.

The only way in which a trial would offer sufficient data in October would be if the COVID-19 outbreak is defined by very high transmission rates and a vaccine proves to be "very effective" in a trial, Gottlieb said. 

Benzinga is covering every angle of how the coronavirus affects the financial world. For daily updates, sign up for our coronavirus newsletter.

An EUA After Trials Wrap? An emergency authorization for a vaccine is unlikely to occur prior to the completion of a Phase 3 trial, Fox News contributor Dr. Marc Siegel said in a Fox Business interview. 

Instead, an emergency use authorization would be appropriate when the trials are complete as a way to cut through red tape, he said, adding that a vaccine at some point in November is a "very reasonable" timeline. 

GSK Tests Antibody: Drugmaker GlaxoSmithKline plc (NYSE: GSK) began testing its coronavirus antibody therapy on high-risk patients with the desired outcome of preventing hospitalization.

GSK and its partner Vir hope the antibody treatment both blocks the virus from taking over new cells and kills infected cells.

The experiment comes at a time when many other companies are testing similar treatments and vaccines.

GSK's antibody is the result of screening hundreds of infected people to identify the most potent monoclonal antibodies, GSK Chief Scientific Officer Hal Barron said on CNBC's "Squawk on the Street."

The antibody can be injected directly into an infected person instead of waiting for their bodies to naturally produce a defense.

Related Links:

Moderna's Patent Filings, Applications Under Defense Department Review: Report

Novavax CEO Eyes December Regulatory Filing For Coronavirus Vaccine Candidate


Related Articles (GSK)

View Comments and Join the Discussion!

Posted-In: CNBC Coronavirus Covid-19News Health Care FDA Media General Best of Benzinga

Don't Miss Any Updates!
News Directly in Your Inbox
Subscribe to:
Benzinga Premarket Activity
Get pre-market outlook, mid-day update and after-market roundup emails in your inbox.
Market in 5 Minutes
Everything you need to know about the market - quick & easy.
Fintech Focus
A daily collection of all things fintech, interesting developments and market updates.
Thank You

Thank you for subscribing! If you have any questions feel free to call us at 1-877-440-ZING or email us at