When a cargo plane saves lives: DTRA ensures that Ebola vaccine material arrives on time via USAF airlifter.

Courtesy Photo | When a cargo plane saves lives: DTRA ensures that Ebola vaccine material arrives on time via USAF airlifter.  

FORT BELVOIR, VIRGINIA, UNITED STATES

03.19.2020

Courtesy Story

Defense Threat Reduction Agency's Chemical and Biological Technologies Department

Sometimes, a U.S. Air Force C-17 Globemaster III airlifter can be just what the doctor ordered to help prevent the spread of Ebola virus disease. In August 2019, the Defense Threat Reduction Agency (DTRA) responded to a request from the Biomedical Advanced Research and Development Authority (BARDA) to assist in transporting a bulk quantity of the Ebola vaccine material from Germany to Pennsylvania.

Merck, a pharmaceutical company, manufactures the Ebola vaccine material in Germany, where it has a facility certified to prepare a concentrated supply of the main, virus-derived ingredient in the vaccine. However, the German facility did not have capacity to prepare and package vials of the vaccine (called the fill-and-finish process) for administration in the volumes necessary to respond to the Ebola virus disease outbreak in Africa, so the preparation, packaging, and shipment needed to occur at the fill-and-finish facility in West Point, Pennsylvania. In the summer of 2019, Merck’s plan to commercially transport the bulk vaccine material to the U.S. threatened to disrupt facility schedules and, possibly, the continuous supply of usable doses of the vaccine in Africa.

Facilities must adhere to their schedules related to manufacturing and distribution to ensure timely and continuous availability of not only the Ebola vaccine but also other vaccines and therapeutics produced at those facilities. Given the ongoing outbreak of Ebola virus disease in the Democratic Republic of the Congo (DRC), Merck needed the bulk vaccine material to arrive at the Pennsylvania facility by August 22, 2019. Then, scientists would dilute and prepare the material for dispensing to individuals, and the vials of vaccine would be shipped to the DRC by mid-January in 2020.

Merck sought help from BARDA, the U.S. government agency responsible for the advanced development of the Ebola vaccine, Ervebo. BARDA approached its transition partner DTRA, looking for an innovative solution to transport the bulk vaccine material, which was kept frozen on dry ice to preserve the efficacy of the main ingredient, to Pennsylvania before the deadline.

However, vaccine transport wasn’t DTRA’s first encounter with the Ebola vaccine.

DTRA has been involved in the development of this Ebola vaccine since 2014. DTRA funded the manufacture of three lots of the vaccine. Also, DTRA funded pivotal animal safety and efficacy studies, which are prerequisites for submitting an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA). Having an accepted IND is one of the necessary steps before a drug or vaccine candidate can be administered to humans for any reason, even for compassionate use.

With its IND application accepted, DTRA then funded the first-in-human Phase I clinical trial to evaluate the safety of the vaccine at the Walter Reed Army Institute of Research. While these preliminary research activities were occurring, an outbreak of the Ebola virus disease was taking place in West Africa. Once the first-in-human Phase I clinical trial completed enough testing to satisfy the FDA, DTRA arranged for the remaining doses of the vaccine to be trans¬ported to West Africa so that the doses could be administered for compassionate use to stem the outbreak. DTRA's efforts resulted in the administration of over 17,000 doses of the vaccine in 2015–2016. Follow-up and statistical analysis of the vaccinated individuals showed that the vaccine was at least 75% effective in preventing Ebola virus disease when the vaccine was administered within six days of a person’s exposure to the virus.

By 2018, when the epidemic in the DRC began, DTRA had funded additional vaccine research, and the World Health Organization had made the vaccine available to health care workers and as many identified contacts as possible. Between August 1, 2018, and March 25, 2019, a total of 91,492 individuals were vaccinated, regardless of their exposure to the virus. Based on this new data set of vaccinated individuals, the vaccine’s effectiveness was determined to be at least 97.5%.

Because of DTRA’s partnership with BARDA, the C-17 transported bulk vaccine material — on time — from Germany to Pennsylvania. DTRA helped avert a disruption in facility schedules and assured that 100,000 doses of the Ebola vaccine could be available for people in the DRC.

POC: MAJ Jeff Froude, Ph.D; [e-mail]

• Date Taken: 03.19.2020
• Date Posted: 03.19.2020 15:42
• Story ID: 365530
• Location: FORT BELVOIR, VIRGINIA, US