Method demonstrates manufacturing standards to achieve FDA approval
KANSAS CITY, Mo., Sept. 15, 2021 /PRNewswire/ -- Francisella tularensis (Ft) is a highly infectious pathogen generally found in many animal species like rodents and rabbits, as well as humans.
"Tularemia is a bona fide bioterrorism weapon and a threat to our military and national security."
When inhaled into the lungs, even a tiny amount of Ft organisms can cause an infection that can be fatal. Often fatal, aerosolized Ft is classified by the U.S. Centers for Disease Control as a Category A biothreat agent.
Though researchers have worked for decades to develop a safe and effective vaccine, no tularemia licensed vaccine is currently available in the U.S., due in part to uncertainties in its development and manufacturing.
Exploring solutions under a contract with the Defense Threat Reduction Agency, MRIGlobal Principal Scientist Carl Gelhaus, Ph.D., was among the authors of research recently published in Pathogens, an international peer reviewed scientific journal.
The research describes laboratory methods developed by MRIGlobal and its partners to produce an effective vaccine under Good Manufacturing Practices (GMP), necessary to obtain Food and Drug Administration (FDA) approval for a vaccine to combat the infectious organisms.
"Tularemia is a bona fide bioterrorism weapon and a threat to our military and national security," says Dr. Gelhaus. "There exists a pressing need to develop novel countermeasures against it that measure up to stringent FDA standards."
The complete article, Modern Development and Production of a New Live Attenuated Bacterial Vaccine, SCHU S4 ΔclpB, to Prevent Tularemia, is available on the Pathogens website.
"Our continuing efforts include the demonstration of vaccine effectiveness, safety, and immune response. We aim to obtain FDA approval for human clinical trials in the near future," concluded Dr. Gelhaus.