Inside the FDA Ebola Edition: Frontrunners Merck & Co., Inc. (MRK), GlaxoSmithKline PLC (ADR) (GSK)

Introduction

Back on May 12, 2015, the Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee released a briefing document detailing the process for licensure of Ebola vaccines and the required demonstration of effectiveness. This Market Exclusive Inside the FDA report aims to go inside this briefing document, break it down, and from there extrapolate based on the companies furthest along in developing an effective vaccine, according to the guidelines set out by the FDA itself.

Ebola is one of the world’s deadliest viruses in terms of mortality rate, though thankfully it is not a pandemic. It kills up to 90% of those who contract it, and there is no currently available cure or vaccination. The most recent outbreak began in 2013 in Guinea, West Africa. While it is now considered under control, the outbreak continues to hit certain populations in Africa, and there have been just shy of 30,000 reported cases of infection to date.

This has sparked a government-private industry scramble to develop and manufacture a vaccine that can be used to prevent further outbreaks. Two companies are at the forefront of this scramble, and their vaccine candidates have emerged as frontrunners in the race to commercialization. Here’s a look at the companies in question, and the drugs on which each is working, reflected through the perspective of the FDA panel.

The Ebola Virus

First, let’s take a look at the virus itself and the disease it causes. The image below is an electron micrograph of the Ebola virus virion, which is the form of the virus before it infects a host cell.

Image 1 source

There are actually five currently identified and recognized types of Ebola virus, all categorized within the viral genus Ebolavirus. The five types (referred to as members in the scientific space) are each named after their original region of location:

1. Bundibugyo ebolavirus

2. Reston ebolavirus

3. Sudan ebolavirus

4. Taï Forest ebolavirus (originally Côte d’Ivoire ebolavirus)

5. Zaire ebolavirus

The final one, the Zaire ebolavirus (here on in referred to as ZEBOV) is by far the deadliest, and is responsible for the most breakouts across the 40-year period for which we have known about the virus. It’s the one responsible for the latest outbreak.