Public Health Emergency - Leading a Nation Prepared
Author: Mark Albrecht, Project Officer, Biomedical Advanced Research and Development Authority, HHS Office of the Assistant Secretary for Preparedness and Response Published Date: 8/30/2017 1:21:00 PM
Category: Medical Countermeasures; Public Health Preparedness; Innovations; National Health Security;
Antibiotics underpin nearly every facet of modern medicine. You can’t have a hip replacement or a caesarean section without effective antibiotics to prevent or treat bacterial infections. The same holds true in a mass public health emergency involving a chemical, biological, radiological or nuclear (CBRN) threat. During a biodefense emergency, people may be hospitalized for prolonged periods, potentially exposing them to secondary infections including drug-resistant infections that are occurring at an alarming rate.
That’s why BARDA is focused on development and approval of new antibiotics. Over the last 10 years, 32 BARDA-supported medical countermeasures have achieved licensure or approval from the U.S. Food and Drug Administration. Now, FDA has approved VABOMERE, the first antibiotic drug in BARDA’s antimicrobial portfolio.
FDA approved VABOMERE to treat complicated urinary tract infections and a kidney infection called pyelonephritis in adults. VABOMERE also addresses gram-negative bacteria that produce certain enzymes, called beta-lactamase enzymes, which have spread in the United States and Europe, particularly the Klebsiella pneumoniae carbapenemase (KPC) enzyme. KPC-producing bacteria are responsible for a large majority of all carbapenem-resistant Enterobacteriaceae (CRE) in the United States and are classified by the U.S. Centers for Disease Control (CDC) as an urgent public health threat.
Because drug-resistant infections complicate the medical response in any public health emergency, BARDA sponsors development of new antibacterial products that can be used in an emergency to protect health, save lives, and enhance national security.
Many patients who are treated for diseases, injuries or illnesses resulting from chemical, biological, radiological or nuclear emergencies will need to be put on supportive devices, such as ventilators, urinary catheters, or intravenous catheters. Patients whose care requires these sorts of devices and patients who must take antibiotics for weeks or months are most at risk for hospital-acquired infections such as bacterial pneumonia or infections due to CRE. These infections – particularly those due to CRE – also may be resistant to many different types of antibiotics and are notoriously hard to treat.
Drugs like VABOMERE that address drug-resistant, Gram-negative bacteria, including CRE, can reduce the risks posed by secondary infections that can occur in the wake of a CBRN attack due to the patient’s compromised immune system.
Whenever practical, BARDA and its partners in the Public Health Emergency Medical Countermeasures Enterprise pursue medical products that address multiple high-priority threats and could become commercially available.
Since 2010, BARDA’s Antimicrobial Program has been forming public-private partnerships with industry to develop new antibacterial drugs and diagnostics to combat antibiotic resistant bacteria, including those that could be used in an intentional attack. The program has brought several antibiotic candidates into late stage Phase III clinical development.
In addition to approval of VABOMERE, BARDA has been working with industry partners to achieve FDA approval of more antibiotic candidates in the next one to three years. Last year, BARDA also established
CARB-X, a novel, global public-private partnership aimed at promoting innovation in antibacterial product development. CARB-X will ensure a robust and diverse clinical stage pipeline of new antibacterial candidates that will have the potential to obtain support from BARDA or other stakeholders. Collectively, both BARDA’s clinical stage antibiotic program and CARB-X aim to reduce the barrier of entry to any company willing to innovate in this space.
Drugs that treat antimicrobial infections are important tools in enhancing our national security; drugs that are approved and readily available on the commercial market enable us to respond better to a CBRN attack. However, antimicrobial resistance is a perpetual and ever-evolving threat. Bacteria will always evolve mechanisms to circumvent new antibacterial therapies. We need continued investment in this space in order to maintain a fresh armamentarium of novel antibacterial drugs to treat these infections.
The antibiotic development pipeline does not contain a sufficient number of drugs to keep up with the rapid rise of antibiotic resistance. The private sector’s declining interest in developing novel antimicrobial drugs is attributed to the low return on investment and uncertainty in the marketplace uptake at the product launch. Research associated with identifying and developing new drugs is risky and uncertain.
BARDA’s antimicrobials program, in collaboration with other public and private partners, helps shift the return-on-investment equation which encourages corporate participation. While BARDA support is helpful, robust innovation likely will not return to antibacterial drug development without a known and definitive return on investment for bringing one of these products to market.
We are excited about the FDA approval of the first BARDA-supported antibiotic. We also know that much work still needs to be done to combat the drug-resistant bacteria that place our nation at risk. BARDA continues to seek proposals for the advanced development of novel antimicrobials to treat illness caused by biological threat agents and address the growing threat of antimicrobial resistance.
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