Public Health Emergency - Leading a Nation Prepared
Author: Mark Albrecht, PhD, Chief, Antibacterials Branch, Division of Chemical, Biological, Radiological, and Nuclear (CBRN) Medical Countermeasures, HHS/ASPR/Biomedical Advanced Research and Development Authority (BARDA); Jessica Swenson, MPH, Program Analyst, Antibacterials Branch, Division of CBRN Medical Countermeasures, HHS/ASPR/BARDA Published Date: 11/18/2020 8:46:00 AM
Category: Medical Countermeasures;
Antibiotic resistance is one of the greatest global health threats of our time. Antibiotics are vital tools for addressing bacterial infections and save untold millions of lives each year. However, the increasing prevalence of resistant strains of bacteria threatens the usefulness of antibiotics and can cause untreatable infections. CDC’s 2019 Report on Antibiotic Resistance Threats estimates indicate that each year, more than 2.8 million Americans develop a drug-resistant infection, and more than 35,000 die from them.
Globally, drug-resistant infections kill over 700,000 people every year, and in the United Nations’ report No Time to Wait, the United Nations warns that without a sustained effort to contain antimicrobial resistance, this figure could increase to 10 million lives lost per year by 2050, with 2.4 million deaths occurring in high-income countries between 2015 and 2050.
Last month, the U.S. government released the National Action Plan for Combatting Antibiotic-Resistant Bacteria (CARB), 2020-2025. This pivotal strategy lays the foundation for how agencies across the U.S. Government will collaborate over the next five years to equip the United States to continue its One Health response to the antibiotic resistance threats of today and prepare for new resistance that might emerge tomorrow.
The new plan builds on the successes realized under the 2015 National Action Plan for CARB. After five years of coordinated federal response, the nation is better positioned to combat the emergence, spread, and impact of antibiotic resistance, but more can and needs to be done during the next five years.
BARDA plays a critical role in the federal government’s response to combatting antibiotic-resistant bacteria and is responsible for targeted actions to meet multiple objectives within the National Action Plan for CARB. BARDA serves as the lead agency for investing in the innovation, advanced research and development (R&D), manufacturing, and procurement of medical countermeasures – vaccines, drugs, therapeutics, diagnostic tools, and non-pharmaceutical products – needed to combat health security threats and save lives.
Currently the private sector has too few innovative antibacterial products in development to address highly resistant infections. Making new antibiotics is difficult and expensive, and many manufacturers have shifted their efforts away from developing new antibiotics, which typically have a low return on investment, to more profitable products. BARDA is supporting the world’s largest antibacterial portfolio by incentivizing companies to focus on antibiotic development by providing non-dilutive funding to offset high R&D costs and technical assistance to reduce R&D risk. These critical attributes, along with BARDA’s flexible and nimble authorities, enable BARDA to enter into public-private partnerships that bring critical new antimicrobial products to market.
Together with our counterparts at the National Institutes of Health, Centers for Disease Control and Prevention, and the Department of Defense, BARDA will continue to invest in projects to propel research and development for therapeutic, diagnostic, and preventative products. BARDA will support antimicrobial products from development all the way through marketing approval and will work to ensure that antibiotics used to treat infections from biothreat pathogens are appropriately stockpiled. Our efforts recognize the importance of preparing for all public health emergencies, and we seek to reduce the morbidity and mortality caused by antimicrobial-resistant bacterial infections that stem from mass casualty incidents and disease outbreaks.
Preparing for the threats of tomorrow means investing in transformative, next-generation antibacterial approaches. Having recently celebrated our 10-year anniversary, the BARDA Antibacterials program is proud of having invested over $1.3 billion dollars thus far, with partner cost-share in excess of $3.5 billion, and seeing 3 FDA approvals of new antibiotics.
Our strategy is a holistic one in terms of product type. In seeking to maximize the impact of our investments, we emphasize innovation, new classes of antibiotics, novel mechanisms of action, host-directed therapeutics, small molecules that address priority forms of resistance or unmet clinical needs, and vaccines. We are currently funding development of 60 antibacterial therapeutics, diagnostics, and vaccines: 45 in early stages of development through the CARB-X program and 15 in BARDA's antibacterial portfolio for advanced R&D, which includes 7 products in Phase 2 or Phase 3 clinical development.
BARDA also supports non-traditional approaches, which have the potential to open up new modes of treatment, circumvent known forms of resistance, reduce side effects, and augment existing medical practice. This year, we are pleased to welcome two new partners to BARDA’s antibacterial portfolio, both of whom are developing nontraditional candidates that represent firsts for us: Vedanta Biosciences for BARDA’s first live bio-therapeutic product and Locus Biosciences for a CRISPR-engineered bacteriophage therapy.
As we look to the future, we also recognize that preparedness does not stop with U.S. Food and Drug Administration (FDA) approval. As always, we must continue to improve on our existing preparedness posture. Last year we awarded our first Project BioShield contract in the antibacterials program to Paratek Pharmaceuticals, supporting both the acquisition of their FDA-approved antibiotic NUZYRA for the national preparedness and its continued development as a countermeasure for biothreats. BARDA anticipates making a second Project BioShield award in FY2021, increasing our preparedness to treat biothreat pathogens.
Antibiotic resistance continues to harm hundreds of thousands of American lives every year, and combating this health security threat remains a priority for the U.S. government even amid the current COVID-19 pandemic. As we have seen with the response to COVID-19, tools for surveillance, early detection, containment, treatment, and prevention are key to addressing the spread of infections and treating disease. BARDA remains as committed as ever to fostering public-private partnerships to revitalize the antibacterial pipeline and combat antibiotic resistance.
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