in , , , ,

Health and Human Services Biodefense Budget Oversight

ASPR Biodefense - Priorities and Budget OversightThe House Appropriations Subcommittee on Labor, Health and Human Services, and Education held an oversight hearing focused on the FY2019 Budget for Health and Human Services Biodefense Activities on April 18, 2018

Subcommittee Chairman Cole presided. Presenters included:

  • Robert Kadlec, M.D., MTM&H, M.S., Assistant Secretary for Preparedness and Response
  • HHS Anthony S. Fauci, M.D., Director of the National Institute of Allergy and Diseases, NIH
  • Stephen Redd, MD (RADM, USPHS), Director, Office of Public Health Preparedness and Response, CDC

Watch the hearing in full and read select highlights below.

Medical Countermeasures Enterprise

In the last decade, BARDA’s strong partnerships with biotechnology and pharmaceutical companies, the National Institutes of Health, and other HHS components, have led to 35 FDA approvals for 31 unique medical countermeasures addressing chemical, biological, radiological and nuclear (CBRN) threats, pandemic influenza, and emerging and re-emerging infectious diseases. This is a staggering accomplishment in just 12 years. BARDA has supported the development of 27 medical countermeasures against Department of Homeland Security-identified national security threats through Project BioShield, including products for smallpox,anthrax, botulinum, radiologic/nuclear emergencies, and chemical events. – Robert Kadlec, M.D., MTM&H, M.S.

Healthcare Readiness to Respond

ASPR would like to thank this committee for its support for HPP (Hospital Preparedness Program) and NDMS (National Disaster Medical System). The Consolidated Appropriations Act of 2018 includes $265 million, an increase of $10 million over FY 2017, for HPP, and more than $57 million, an increase of almost $8 million, for NDMS. This funding will enable ASPR to invest in innovative approaches to building regional health system readiness for complex mass casualty events, and to rebuild NDMS teams and train them to respond to 21st century threats. – Robert Kadlec, M.D., MTM&H, M.S.

NIH Medical Countermeasure Development

Other broad-spectrum approaches are being used to advance the development of therapeutics that could be used against multiple pathogens. For example, NIAID has supported development of broad-spectrum antiviral agents such as BCX4430 (galidesivir), which has demonstrated activity against Ebola and other RNA viruses, and broad-spectrum antibacterial products, including a compound with activity against the two different bacteria that cause tularemia and plague. – Anthony S. Fauci, M.D.

Fauci further outlined specific medical countermeasures being developed for:

Ebola – NIAID partnered with the government of Liberia to establish the Liberia-U.S. clinical research partnership known as PREVAIL. This partnership enabled a series of clinical trials, including studies testing several Ebola virus vaccine and therapeutic candidates, among them ZMappTM and the NIAID-developed cAd3-EBOZ vaccine. Several candidates have transitioned to BARDA for advanced development.

Smallpox – NIAID supported the early-stage development of a novel smallpox vaccine, IMVAMUNE®, and a therapeutic, TPOXX® (tecovirimat), prior to their transition to BARDA for advanced development. IMVAMUNE® was shown to produce a superior immune response compared to the currently licensed smallpox vaccine. TPOXX® currently is under consideration for FDA approval pursuant to the Animal Rule, using pivotal animal model data supported by NIAID.

Anthrax – NIAID supported the preclinical and clinical development of the anthrax countermeasure ANTHIM® (obiltoxaximab), prior to its transition to BARDA for advanced development. ANTHIM® was approved by the FDA in 2016 for the treatment and prevention of inhalational anthrax, the deadliest form of the disease. NIAID also has supported the development of AV7909, a third-generation anthrax vaccine with a dry formulation that is easy  to store and has increased shelf life. AV7909 has been transitioned to BARDA for further development.

Pneumonic Plague – NIAID supported critical animal model studies of ciprofloxacin and levofloxacin for FDA approval, pursuant to the Animal Rule, as treatments for pneumonic plague. In addition, NIAID scientists conduct foundational research on the bacteria that cause plague, and the fleas that transmit them, to understand plague biology and to aid in the design of new MCMs.

Pandemic Influenza – NIAID is partnering with BARDA to support the development of vaccine candidates for influenza strains with the potential to cause a pandemic, including H7N9 avian influenza. NIAID also is working to develop broadly protective, or “universal,” influenza vaccines that could protect against multiple strains of seasonal and pandemic influenza. NIAID recently developed a Strategic Plan to guide research efforts focused on the design and development of universal influenza vaccines.

Radiological/Nuclear Threats – NIH investment in radiation/nuclear research revitalized physician training and infrastructure for studying radiation injury and developing effective medical countermeasures. Since 2005, NIAID has transitioned 29 radiation/nuclear countermeasure candidates to BARDA for advanced development. Recent successes include FDA approval of NEUPOGEN® (filgrastim) and Neulasta® (pegfilgrastim) to treat radiological or nuclear injuries. In addition, NIAID is funding animal studies of Nplate® (romiplostim) for acute radiation syndrome for consideration for FDA approval under the Animal Rule.

Chemical Threats – NIAID administers a trans-NIH chemical countermeasures program that supports the development of therapeutics for people exposed to dangerous chemicals, including nerve agents, metabolic poisons, and toxic industrial chemicals. NIH recently transitioned several candidate therapeutics to BARDA for advanced development, including those for nerve agent poisoning (midazolam and galantamine), sulfur mustard exposure (tissue plasminogen activator), and inhalation chlorine exposure (R-107 and GSK2798745).

Detection of Biological Threats

Congress’s support of our Advanced Molecular Detection investments allows CDC to detect
outbreaks faster, before they have become widespread. These improvements are being applied in
dozens of areas such as foodborne disease, influenza, antimicrobial resistance, hepatitis,
pneumonia, and meningitis. Moreover, CDC shares genetic sequencing technologies with state
and local health departments, and funds them to acquire new technology that helps them respond
quicker and more efficiently at the local level. – Stephen Redd, MD

A Strong Laboratory Response Network

Rapid identification of disease is critical to addressing public health threats before they become a crisis. CDC’s Laboratory Response Network (LRN) is an integrated system of Federal, state, local, and international laboratories that is scalable and flexible enough to respond to biological, chemical, and other public health threats. The linking of these laboratories over the last 15 years with the LRN advanced our preparedness capabilities and provided for rapid testing, timely notification, and secure communication of laboratory results. – Stephen Redd, MD

Public Health Surveillance

To ensure a nationwide surveillance capability, CDC supports surveillance infrastructure and practice at the state and local level through the National Notifiable Disease Surveillance System (NNDSS), the National Syndromic Surveillance Program (NSSP), the National Healthcare Safety Network (NHSN), the Emerging Infections Program Active Bacterial Core Surveillance (EIP ABCS), and components of national influenza surveillance. As part of CDC’s Surveillance Strategy, we are modernizing the tools and services used in the NNDSS and the NSSP and are implementing standards for exchanging data. – Stephen Redd, MD

Source: U.S. House of Representatives

Anthrax countermeasure for BioShield

Project BioShield: HHS Purchases Anthrax Countermeasure from Elusys Therapeutics

Biomedical Countermeasures

DRIVe: Accelerating National Health Security Innovation