FY 2017 Annual Performance Plan and Report - Goal 3 Objective F
Goal 3. Objective F: Protect Americans’ health and safety during emergencies, and foster resilience to withstand and respond to emergencies
Over the past decade, our nation has renewed its efforts to address large-scale incidents that have threatened human health, such as natural disasters, disease outbreaks, and terrorism. Working with its federal, state, local, tribal, and international partners, as well as industry in public-private partnerships, HHS has improved and exercised response capabilities and developed medical countermeasures.
Over the next few years, HHS will work to build community resilience and strengthen health and emergency response systems. In alignment with Presidential Policy Directive 8 (PPD-8) — robust systems are essential to a secure and resilient nation with required capabilities to prevent, protect against, mitigate, respond to, and recover from the threats and hazards that pose the greatest risk. This includes strengthening the federal medical and public health response capability.
Within HHS, improving health security is a shared responsibility. ASPR serves as the Secretary’s principal advisor on matters related to bioterrorism, public health emergencies, and also coordinates interagency activities between HHS, other partners, and officials responsible for emergency preparedness and protection of the civilian population. ACF, ACL, AHRQ, ASA, ASPR, CDC, CMS, FDA, HRSA, NIH, OASH, OCR, and SAMHSA have a role in supporting emergency preparedness. The table below includes performance measures that are indicative of HHS activities to improve the health and safety of Americans during emergencies. The Office of the Secretary led this Objective’s assessment as a part of the Strategic Review.
Objective 3.F: Table of Related Performance Measures
Increase the number of new Chemical, Biological, Radiological, and Nuclear threats (CBRN) medical countermeasures (MCM) under Emergency Use Authority (EUA) or licensed (Lead Agency - ASPR; Measure ID - 2.4.13)
|FY 2012||FY 2013||FY 2014||FY 2015||FY 2016||FY 2017|
Pan Flu/EID Licensed= +1;
Pan Flu/EID Licensed= +3;
Licensed= +4; EUA= +2 (Cumulative 2010-2015)
EUA= +3 (Cumulative 2010-2015)
|CBRN Licensed= +2;
EUA = +1.
EUA = 0
and NDA approvals = 2;
new EUA = 0.
|Results||CBRN EUAs= 1;
CBRN EUA= 1 anti-neutropenia cytokine drug for acute radiation treatment (Neupogen) Pan Flu Licensed = 1 (Simplexa diagnostics device)
BLA Submissions = 2 (vaccines)
Awarded 3 contracts for Centers for Innovation in Advanced Development and Manufacturing (CIADM)
|CBRN EUA= 2;
ST-246 antiviral for smallpox approved by FDA for EUA and Neupogen an anti-neutropenia cytokine for radiation treatment. 2 other packages were submitted but not acted on during the performance period.
Pan Flu licensed=3;
Licensed by FDA are: 1) Flucelvax, the first cell0based seasonal influenza vaccine, 2) FluBlØk, the first recombinant-based seasonal influenza vaccine, and 3) Aura, a next generation portable ventilator for adults.
While not part of the goal, BARDA saw the first anthrax antitoxin and the first botulinum antitoxin licensed by FDA. Both projects were supported by Project BioShield and approved under the FDA’s Animal Efficacy Rule.
|CBRN EUA= 3;
ST-246 antiviral for smallpox became accessible and Neupogen and Leukine, anti-neutropenia cytokines for radiation treatment under EUA by FDA. Another package (Neulasta) was submitted but not acted on during the performance period.
CBRN licensed = 2;
Licensed by FDA are 1) Raxibacumab, the first anthrax antitoxin, and 2) HBAT, the first botulinum antitoxin. Both projects were supported by Project BioShield and approved under the FDA’s Animal Efficacy Rule.
Pan Flu licensed=5;
Licensed by FDA are: 1) Flucelvax, the first cell-based seasonal influenza vaccine, 2) FluBlØk, the first recombinant-based seasonal influenza vaccine, 3) QPAN H5N1 vaccine, the first adjuvanted pandemic influenza vaccine in the U.S. 4) Aura, a next generation portable ventilator for adults, 5) Simplexa, PCR-based point-of-care diagnostic for influenza and respiratory syncytial virus, and 6) Rapivab (peramivir), the first intravenously-administered single dose influenza antiviral drug; had been available under EUA previously
|CBRN EUA= 4: New in FY 15: OraSure Ebola rapid diagnostic
CBRN Licensed= 5:
New in FY 15: Neupogen anti-neutropenia cytokine (Amgen) approved by for ARS treatment indication (March 2015); AIG anthrax antitoxin (Emergent) approved by FDA for treatment of inhalation anthrax (March 2015).
Pan Flu licensed=11; New in FY 15: Rapivab antiviral drug (BioCryst) for treatment of influenza (December 2014); Cobas liat PCR system (Roche) for diagnostic detection of influenza A/B was CLIA-waived by FDA (September 2015).
Pan Flu EUA=3
|Dec 31, 2016||Dec 31, 2017|
|Status||Target Met||Target Not Met but Improved||Target Exceeded||Target Met||Pending||Pending|
Influenza vaccine production (Lead Agency - FDA; Measure ID - 234101)
|FY 2012||FY 2013||FY 2014||FY 2015||FY 2016||FY 2017|
|Target||Evaluate and compare new methods to determine the potency of influenza vaccines.||Develop and evaluate new methods to produce high-yield influenza vaccine reference strains||Continue evaluation of new methods to produce high-yield influenza vaccine reference strains||Continue evaluation of new methods to produce high-yield influenza vaccine reference strains.||Continue evaluation of new methods to produce high-yield influenza vaccine reference strains||Continue evaluation of new methods to produce high-yield influenza vaccine reference strains|
|Result||In FY 2012 CBER met the goal by evaluating three new methods for the determina-tion of influenza vaccine potency. These methods (ELISA using monoclonal antibodies to capture antigen, Surface Plasmon Resonance, and label-free, antibody-free mass spectro-metry) were used to measure the potency of inactivated influenza vaccines from several manufacturers. In each case, the results demonstrated the potential of each method and indicated that further development and evaluation was warranted.||In FY 2013, CBER met the target to develop and evaluate new methods to produce high-yield influenza vaccine reference strains. Activities to meet this target include:
• Multiple assays were evaluated to determine the best methods for assessing vaccine reference strain yield. This is a critical issue for comparing different virus reference strains that might be available to manufacturers for vaccine production. The growth and HA yield of eight H5N1 influenza reference strains, representing 8 distinct H5 sub-clades, were compared for HA yield (enzyme activity and HA protein), total infectious virus titer, total viral protein, and HA/ nucleoprotein ratio in eggs. The results indicated that a single method was insufficient for an accurate assessment of a candidate vaccine’s potential for vaccine manufacturing and that multiple methods should be utilized.
|In FY 2014, FDA met the target to develop, evaluate, and standardize new methods to produce high-yield influenza vaccine reference strains. Activities to meet this target include the following:
• FDA continued evaluation and standardization of multiple assays, such as total viral protein yield and HA antigen by HPLC-based analysis. In addition, FDA included a new technology, Virus Counter platform, to quantify the virus particles in the virus preparation.
FDA developed a H7N9 influenza vaccine candidate virus. The vaccine candidate virus was optimized by introduction of targeted mutations in the viral genome to increase its protein yield, measured using the methods described above.
|In FY 2015, FDA met the target to continue evaluation of new methods to produce high-yield influenza vaccine reference strains. Activities to meet this target included the following:
• FDA continued efforts to develop new methods for determining influenza vaccine potency, an important component in the evaluation of high-yield influenza vaccine viruses. An international collaborative study, involving multiple manufacturers and regulatory agencies, was initiated to compare several alternative methods. The study will continue in FY 2016. In addition, improvements were made to the alternative potency assays under development at FDA that included the ability to accurately measure the potency of influenza B vaccines in addition to influenza A vaccines. Assay development and evaluation will continue in FY 2016.
|Dec 31, 2017||Dec 31, 2018|
|Result||• Further modifications were made to previously developed influenza vaccine reference strains for the 2009 H1N1 pandemic strain, which is now included in the seasonal vaccine. Increased hemagglutinin (HA) content of the reference virus was achieved by modification of the viral neuraminidase (NA) gene to include portions of the A/Puerto Rico/8/34 donor NA trans-membrane and stalk regions. Further increases in HA yield were obtained for this influenza reference strain by genetic modification of the virus PB1gene. HA yield is important to produce the needed quantity of vaccine and helps to ensure rapid availability of vaccines.
• One new influenza reference strain was developed as a possible vaccine candidate for the H7N9 influenza virus that emerged in China during 2013. This reference strain has passed all tests for attenuation and has been shared with the WHO collaborating centers.
|• FDA continued evaluation of methods to assess the relative yields of candidate vaccine viruses. FDA participated in an international collaborative study that compared the influenza virus yields and virus hemagglutinin (HA) production from several candidate vaccine strains. This study is ongoing and will continue in FY 2016. Studies at FDA, designed to increase the yields of candidate vaccines by targeted manipulation of the virus genome, demonstrated the feasibility of improving virus yields for H1N1 vaccine viruses. These studies will continue in FY 2016.|
|Status||Target Met||Target Met||Target Met||Target Met||Pending||Pending|
Increase laboratory surge capacity in the event of terrorist attack on the food supply. (Radiological and chemical samples/week). (Lead Agency - FDA; Measure ID - 214305)
|FY 2012||FY 2013||FY 2014||FY 2015||FY 2016||FY 2017|
|Target||2,500 rad & 2,100 chem||2,500 rad & 2,100 chem||2,500 rad & 2,100 chem||2,500 rad & 2,100 chem||2,500 rad & 2,100 chem||2,500 rad & 2,100 chem|
|Result||2,500 rad & 2,100 chem||2,500 rad & 2,100 chem||2,500 rad & 2,100 chem||2,500 rad & 2,100 chem||Dec 31, 2016||Dec 31, 2017|
|Status||Target Met||Target Met||Target Met||Target Met||In Progress||In Progress|
Increase the percentage of public health agencies that directly receive CDC Public Health Emergency Preparedness funding that can convene within 60 minutes of notification a team of trained staff that can make decisions about appropriate response and interaction with partners. (Lead Agency - CDC; Measure ID - 13.5.3)
|FY 2012||FY 2013||FY 2014||FY 2015||FY 2016||FY 2017|
|Target||91 %||94 %||95 %||95 %||96 %||96 %|
|Result||89 %||96 %1||96 %||Dec 31, 2016||Dec 31, 2017||N/A|
|Status||Target Not Met but Improved||Target Exceeded||Target Exceeded||Pending||Pending||Not Collected|
Analysis of Results
HHS is expanding diagnostic, preparation, response, and treatment options to deal with both natural and man-made disasters. To do this, both the FDA and ASPR are striving to have more options available to handle a crisis. For example, through the Office of Biomedical Advanced Research and Development Authority (BARDA), ASPR is working to increase the development of medical countermeasures for pandemic influenza as well as chemical, biological, radiological, and nuclear agents through public-private partnerships. The intent is to develop countermeasures, facilitate licensure of these producers, and build domestic countermeasure manufacturing capacity to address these threats. The establishment of three Centers for Innovation in Advanced Development and Manufacturing in the U.S. in 2012 has greatly impacted the nation’s ability to produce vaccine. A two-fold increase in our domestic pandemic influenza vaccine manufacturing surge capacity was realized in 2013 with the commercial scale production of H7N9 vaccines at Novartis’ cell-based vaccine manufacturing facility in North Carolina, which became a CIADM in 2012. In FY 2015, the program exceeded its target its target, producing an additional 2 EUA and 4 licensed medical countermeasures in the CBRN area and an additional 3 EUA and 5 licensed products in the pandemic influenza portfolio.
The FDA is diversifying flu vaccine production and increasing laboratory surge capacity for testing potentially contaminated foods. The FDA seeks to ensure continued progress in preparation for new influenza strains, to strengthen vaccine safety monitoring, and to advance the detection of possible adverse events of new licensed vaccines through the use of large population databases. FDA achieved its FY 2015 target to continue evaluation of new methods to produce high-yield influenza vaccine reference strains. Activities to meet this target include the following: FDA continued efforts to develop new methods for determining influenza vaccine potency, an important component in the evaluation of high-yield influenza vaccine viruses. An international collaborative study, involving multiple manufacturers and regulatory agencies, was initiated to compare several alternative methods. In addition, improvements were made to the alternative potency assays under development at FDA that included the ability to accurately measure the potency of influenza B vaccines in addition to influenza A vaccines. FDA also continued evaluation of methods to assess the relative yields of candidate vaccine viruses. FDA participated in an international collaborative study that compared the influenza virus yields and virus hemagglutinin (HA) production from several candidate vaccine strains. Studies at FDA, designed to increase the yields of candidate vaccines by targeted manipulation of the virus genome, demonstrated the feasibility of improving virus yields for H1N1 vaccine viruses. Also, in the event of a terrorist attack on the food supply, the FDA seeks to increase its ability to rapidly test large numbers of samples of potentially contaminated foods through a focus of laboratory capacity, achieving its target every year since 2010.
The CDC is helping public health agencies rapidly convene key management staff (within 60 minutes of being notified of an emergency) so that they can integrate information, prioritize resources, and effectively coordinate with key response partners. Since FY 2009, the CDC’s 62 grantees (which include states, territories and four major metropolitan U.S. cities) that successfully convened key staff within 60 minutes of notification increased from 68 percent to 96 percent in FY 2014, exceeding the target. CDC will continue to work with grantees to improve results and achieve future targets.
Plans for the Future
For FY 2016, ASPR plans to continue manage the procurement and advanced development of medical countermeasures for chemical, biological, radiological, and nuclear agents (referred to as CBRN); Project BioShield procurements; and the advanced development and procurement of medical countermeasures for pandemic influenza and other emerging infectious diseases, with acquisitions to meet the requirements.
FDA will continue evaluation of new methods to produce high-yield influenza vaccine reference strains.
The CDC will work to increase the percentage of public health agencies that can assemble, make key decisions, and quickly respond during an emergency. Because many emergencies provide little to no notice but still require a rapid response, the CDC will sustain the percentage of grantees who can convene key staff within 60 minutes of notification.
FY 2014 Strategic Review Objective Progress Update Summary
Please note that this section summarizes the result of the FY 2014 HHS Strategic Review process, limiting the scope of content to that available prior to spring of 2015. Due to this constraint, the following may not be the most current information available.
Analysis: HHS’s submission to Congress in 2014 of the statutorily required National Health Security Strategy (2015 – 2018) provides overarching national guidance on enhancing our nation’s health security. However, there are three themes from 2014 that best characterize HHS’s achievements and support the above rating for Objective 3F of the HHS Strategic Plan:
- The frequency and variety of public health and medical emergency incidents/events for which HHS responds demonstrates an expanding mission and near constant emergency posture for some components;
- HHS has built a national public health and medical emergency response core infrastructure and capabilities by developing state and local public health capacity, building regional coalitions of healthcare providers, and preparing the National Disaster Medical System (NDMS) to respond; and
- HHS demonstrated a model interagency collaboration and public private partnership in mobilizing the medical countermeasures (MCM) enterprise in response to Ebola.
While Ebola response efforts were the most highly visible in 2014, HHS prepared for, responded to, and supported recovery from a range of public health threats and emergencies. These investments helped Bellevue hospital develop and maintain its quarantine and isolation unit and exercise their clinical procedures, protocols, and plans which prepared Bellevue to receive and monitor a suspected Ebola case in a doctor who was exposed in West Africa while maintaining regular, day-to day-care in the facility. Likewise, a HPP funded healthcare coalition in West Virginia was poised to respond to a large chemical spill and the coalition’s hospitals, long-term care facilities, poison centers, and behavioral health facilities came together to share resources and ensure that clean water, behavioral health, and other services were made available. The frequency of these incidents and events means that some components of HHS are in a near constant emergency posture.
Although HHS’s emergency resources and expertise can augment services during emergencies, the success with which these needs are met during and after an emergency largely relies on the strength of the systems in communities that provide these services in routine, day-to-day settings. Emergency care requirements should be aligned with efforts to strengthen the healthcare, public health, human services and emergency management systems that provide routine care day-to-day so that these systems are able to provide appropriate care during emergencies. HHS plans to continue to invest in federal, state and local response tools such as such as public health emergency response core infrastructure, regional coalitions of healthcare providers, and the National Disaster Medical System to ensure capabilities to meet national disaster response needs. In addition, the Department will continue to invest in and enhance the Medical Counter Measure enterprise – a model of interagency collaboration and public-private partnership.
1The 98% result previously reported in the 2016 Congressional Justification was based on preliminary data. The result has been updated to reflect final data.