Public Health Emergency - Leading a Nation Prepared
BARDA will pursue its strategic goals through an approach comprised of the following core principles.
Goal 1 | Goal 2 | Goal 3 | Goal 4 | Goal 5
An advanced development pipeline replete with medical countermeasures and platforms to address unmet public health needs, emphasizing innovation, flexibility, multi-purpose and broad spectrum application, and long-term sustainability
Since its inception, BARDA has prioritized the development and procurement of medical countermeasures for the highest risk threats, including pandemic influenza and terrorist use of chemical, biological, radiological, or nuclear materials. The Pandemic and All-Hazards Preparedness Act additionally called for the public health and medical needs of at-risk individuals to be taken into account in developing a national stockpile of medical countermeasures. Consistent with statutory requirements, BARDA supports the advanced development of medical countermeasures for all populations, with the goal of making them available for use as needed during public health emergencies.
BARDA's CBRN programs have focused on developing medical countermeasures to meet the requirements determined to be necessary to address the 13 Material Threats identified by the DHS in accordance with Project BioShield. BARDA's influenza program has contributed to pandemic preparedness by supporting the development of improved and/or next-generation influenza vaccines, antiviral medications, ventilators, and other non-pharmaceutical countermeasures; stockpiles of pre-pandemic vaccines and antiviral medications; and increased domestic influenza vaccine manufacturing capacity. More recently, BARDA has begun to address the threat of antimicrobial resistance, emerging infectious diseases, and other novel threats by initiating programs supporting the development of broad-spectrum antimicrobials and technologies and platforms with multi-use potential. BARDA will maintain this three-pronged focus on CBRN threats, pandemic influenza, and emerging infectious diseases, modifying its current portfolio as needed to (1) ensure that the medical countermeasure needs of all populations are addressed and (2) enhance long-term sustainability of our preparedness posture.
A capability base to provide enabling core services to medical countermeasure innovators
Considerable expertise and capabilities are required to overcome the technical, regulatory, manufacturing, commercialization, and business challenges inherent in the development of innovative medical countermeasure candidates. Over the past ten years, innovative companies developing CBRN medical countermeasures have encountered many challenges moving products along the process development, manufacturing, and regulatory pathways. BARDA already provides an array of services to manufacturers and innovators of medical countermeasures but has observed that many of these companies would benefit from additional support in moving from laboratory to commercial scale production and clinical evaluation through the regulatory approval process.
Agile, robust and sustainable U.S. manufacturing infrastructure capable of rapidly producing vaccines and other biologics against pandemic influenza and other emerging threats
The 2005 National Strategy for Pandemic Influenza established a commitment to making vaccine available for all Americans within six months of the emergence of a virus with pandemic potential. BARDA has made significant progress towards increasing and securing domestic manufacturing capacity for pandemic influenza vaccine development. However, the recent response to 2009 H1N1 shows that we are still hampered by the limits of current technology. The first domestic cases of 2009 H1N1 influenza were identified in April and the pandemic peaked about six months later, in late October. Despite an intensive effort to develop a pandemic vaccine, the 2009 H1N1 vaccine arrived too late to have a significant effect on the dynamics of the fall disease wave. Influenza vaccines licensed in the U.S. use egg-based technology that is more than 50 years old and a substantial portion of the manufacturing capacity is based overseas.
Consistent with recommendations from the President's Council of Advisors on Science and Technology in its August 2010 Report to the President on Reengineering the Influenza Vaccine Production Enterprise to Meet the Challenges of Pandemic Influenza BARDA is working with several partners to develop more modern platforms for manufacturing influenza vaccines and this investment is beginning to pay off. In 2011, two manufacturers plan to file Biologic License Applications (BLAs) for cell-based influenza vaccines, with new vaccines based on recombinant technologies to come in following years. Products based on these newer, faster, more scalable technologies will move the field forward and significantly increase the flexibility, surge capacity, and reliability of influenza vaccine production increasing and securing domestic manufacturing capacity for pandemic influenza vaccine development.
Responsive and nimble programs and capabilities to address novel and emerging threats
The Pandemic and All-Hazards Preparedness Act charges BARDA with the advanced development of medical countermeasures for emerging infectious disease threats, which come in many forms. New and lethal infectious diseases, such as MRSA, Dengue, Ebola, SARS, and Nipah virus, continue to emerge in nature. The extensive use of antiviral and antibacterial agents has resulted in the propagation of drug resistant strains of bacteria and viruses and promoted the evolution of extensively drug-resistant strains of many common pathogens. As has been the case with past influenza pandemics where secondary infections with resistant organisms accounted for a significant proportion of deaths, drug-resistant strains are likely to complicate the treatment of CBRN-caused illnesses. Where deliberate threats are concerned, advances in genetic engineering and synthetic biology may provide a means for bioterrorists to generate more dangerous pathogens through the insertion of virulence factors or drug-resistance genes.
Preparing for the threat of previously unknown emerging diseases, whatever the source, requires a different approach than preparing for known threats or pathogens. To address these evolving threats to public health, acquisition of broad spectrum antibiotic and antiviral medications and new classes of antimicrobials, including host-directed therapeutics and small molecule immune modulators, will be a major focus of BARDA's efforts in coming years.
Over the next five years, building on the experiences of the CBRN, Influenza, and Strategic Science and Technology Divisions, BARDA will enhance its efforts to provide solutions to the growing problem of emerging pathogens and antimicrobial resistance. In the near term, BARDA is developing programs to address the threat posed by multidrug-resistant pathogens and future unknown biological threats. A key element of this effort is identifying and supporting the development of broad spectrum antimicrobials. In addition, BARDA's next-generation influenza antiviral drug advanced development program is pursuing new classes of drugs and innovative candidate antiviral therapies that will be less susceptible to viral resistance.
A ready capability to develop, manufacture and facilitate distribution of medical countermeasures during public health emergencies
Ensuring the availability of safe and effective medical countermeasures during public health emergencies is BARDA's core mission. Supporting the scientific development of vaccines, therapeutics, and diagnostics is only one aspect of BARDA's role in promoting pandemic influenza and public health preparedness. The 2009 H1N1 pandemic underscored the critical importance of advanced development, manufacturing, and distribution planning. During the pandemic, BARDA worked in coordination with the NIH, FDA and CDC to procure, test, license and deliver the vaccines and antiviral drugs deployed as part of the U.S. Government response.
Ultimately, 138 million doses of licensed 2009 H1N1 vaccine were produced and distributed for use by the U.S. civilian population, 2.7 million doses for DoD, and 16.9 million doses for international assistance. As part of a contingency-based public health response, BARDA also purchased supplies of adjuvants to be used, if necessary, as part of a pandemic vaccine and additional supplies of antiviral medications to replenish treatment courses that were distributed from the Strategic National Stockpile, focusing on pediatric formulations to address critical needs for this population. BARDA's collaborations with domestic vaccine manufacturers and coordination with the response activities of CDC and industry partners to ensure effective and timely distribution of pandemic countermeasures within regional, state, and tribal jurisdictions were critical enablers of the overall response to the pandemic.
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