U.S. Readiness for Pandemics
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1 0 U.S. Readiness for Pandemics 5 th National Emergency Management Summit Brooklyn, NY September 15, 2011 Robin Robinson, Ph.D. Deputy Assistant Secretary for Preparedness & Response (HHS/ASPR) Director of Biomedical Advanced Research & Development Authority
2 Overview Previous pandemics Pandemic Readiness H1N1 Pandemic Pandemic Readiness Today Pandemic Readiness 2015
3 Flu pandemics in the 20 th Century Credit: US National Museum of Health and Medicine 1918: Spanish Flu 1957: Asian Flu 1968: Hong Kong Flu A(H1N1) A(H2N2) A(H3N2) m deaths 1 4 m deaths 1 4 m deaths ~500,000 in US 60 80,000 in US 1976 Swine Flu (U.S.) non-pandemic ~30,000 in US
4 Other Pandemic Alerts Avian H5N1 Influenza re-emergence 2003 U.S. Seasonal Influenza vaccine Shortage Hurricane Katrina 2005
5 PANDEMIC READINESS
6 U.S. Pandemic Influenza Plans State Pandemic Preparedness & Response Plans
7 U.S. Influenza Antiviral Drugs Antiviral drug development program Peramivir IV acute, complicated cases Others AVs under consideration Longer lasting NAI Host membrane inhibitor Federal and State antiviral drug stockpile program (75 M regimens) Completed 2007 Tamiflu & Relenza (licensed) Peramivir IV (EUA)
8 Next-Generation Influenza Vaccine Strategy Egg-based Vaccines Cell-based Vaccines Antigen-sparing Influenza Vaccines with Adjuvants Recombinant and Molecular Vaccines Universal Influenza Vaccines
9 U.S. Pandemic Flu Vaccine Manufacturing Infrastructure Building Retrofitting existing facilities (MedImmune & sanofi pasteur) Constructing new cell-based vaccine mfg facilities (Novartis) 8
10 U.S. Influenza Diagnostics Advanced Development Projects Point-of Care (POC) Tests (5) Laboratory Influenza Tests (LIT) (3) Rapid RT-PCR tests (2) Rapid Immunity Tests (4) Novel pathogen recognition detection (4) Reagent Production/Validation (10) Independent Government Evaluation resource (2)
11 10 Pre-2009 Pandemic Influenza MCM Supply-Demand Gap Closure Reduce Demand: Pre-Pandemic Vaccines, Community Mitigation, Antivirals, Vaccines, Masks Increase Capacity: Ventilators, Oxygen, Antivirals, Pandemic Vaccines, Masks, H5N1 Pre-Pandemic Vaccines Egg-based Vaccines Demand for Healthcare Services weeks Increase Supplies of Critical Materiel Current Healthcare Capacity
12 2009 H1N1 PANDEMIC
13 2009 H1N1 National Framework for Response Surveillance: Enhanced efforts to achieve timely and accurate situational awareness of evolving disease to inform policy and operational decisions; Mitigation Measures: Interventions to slow the spread of illness and reduce the impact of illness on communities; Vaccination: Actions to secure an available vaccine and to ready a national vaccination campaign poised to begin immunization upon a decision to execute; and Messaging/Communications: A coordinated campaign aimed at a convergence of action across all levels of government, the private sector, and faith-based and community-based organizations.
14 Advisory Panels After Action Review Vaccine Recovery
15 H1N1 Vaccine Products Monovalent vaccine U.S.-licensed CSL Multi-dose vial GSK 3.4% Novartis sanofi pastuer Single-dose Syringe GSK Inactivated, subunit vaccine Intranasal Sprayer MedImmune Live, attenuated vaccine
16 U.S. H1N1 Vaccine Manufacturing Distribution Vaccine Manufacturers Central Distributor States & Locals Sites American Public 5 4 distrb. sites ~120,000 Up to 300 million sanofi pasteur State Health Depts Children Novartis GlaxoSmithKline McKesson PODs County Public Health Depts Healthcare Workers Children Caregivers MedImmune Other Public Sites Pregnant Women CSL A n c i l l a r y Ancillary Product Suppliers N = 4 S u School clinics Private Providers Underlying Chronic Disease General Public BARDA CDC STATES LOCALS
17 16
18 2009 H1N1 Pandemic Results H1N1 virus affected children, pregnant women, & chronically ill disproportionately No Third Wave Licensed monovalent vaccine w/o adjuvant 185 million doses manufactured for U.S million H1N1 vaccine doses administered > 100 million seasonal vaccine doses administered 25 million H1N1 vaccine doses U.S. donation to WHO No significant adverse events
19 H1N1 Vaccine Lessons Learned Vaccine Development HHS experience with manufacturers & VTEUs paid off well Vaccine Manufacturing Existing contracts provided early start to production & greater availability Reduce time to produce first dose and last dose Increase domestic vaccine manufacturing capacity Better emergency vaccine manufacturing practices Support final development of vaccines with adjuvants towards licensure Clear communication of vaccine capacity vs. actual vaccine production when potency assay data needed to set more reasonable expectations on vaccine availability
20 PANDEMIC READINESS TODAY
21 Pandemic Readiness Today Surveillance & Diagnostics Two new POC and LRN diagnostic devices licensed & 3 rd device under review LRN lab funding limited Antiviral Drugs Federal stockpile replenished State stockpiles product expiring in need of SLEP & funding NAI AVs under advanced development for severe cases & longer lasting Respirator Devices Prototype next generation ventilator under clinical testing 20
22 Pandemic Readiness Today Vaccine Stockpiling H5N1 vaccine & adjuvants maintained Vaccine Development BLAs submitted for cell- & recombinant-based vaccines BLAs submissions soon for pandemic vaccines formulated with adjuvants Multiple recombinant-based vaccines in Phase 2 clinical trials Universal vaccines in Phase 1 clinical trials 21
23 U.S. Pandemic Flu Vaccine Stockpiling & Manufacturing Today Retrofitted mfg. facilities (MedImmune & sanofi pasteur) New cell-based influenza vaccine mfg. facilities (Novartis) 22
24 Improving Influenza Vaccine Manufacturing Initiative HHS-interagency team (BARDA, CDC/ID, NIH/NIAID & FDA/CBER) with industry effort to shorten timeline for pandemic influenza vaccine availability Three projects Vaccine virus seed optimization for high growth & library of influenza strains to reduce initial virus adaptation time period Potency assays: SRID assay new methods (e.g., mass spec) reduce from 8-12 weeks days and weeks Sterility assays: std. 14 day 5 day assay
25 PANDEMIC READINESS 2015
26 Pandemic Readiness 2015 Diagnostics/Ventilators Licensed diagnostic devices with greater speed, thru put, & sensitivity in following areas: Point-of Care (POC) Tests Laboratory Influenza Tests (LIT) Rapid RT-PCR tests Rapid Immunity Tests Antiviral Drug Resistance Tests Novel pathogen recognition detection Reagent Production/Validation/Library Unknown respiratory pathogen test in clinical development CDC GHSI sustainability? Licensed next generation ventilators
27 Pandemic Readiness 2015 Antivirals Licensed federal antiviral drug stockpiles maintained with longer expiry dates Licensed single, longer-lasting use & IV formulated NAI AVs Development Broad spectrum antiviral drugs Non-NAI antiviral drug and Ab candidates for novel viral targets & host targets Non-specific host defense modulators as first-line responses to known and unknown threats State AV stockpile sustainability? Domestic production capability?
28 Pandemic Readiness Vaccines Development of universal flu vaccines continues Stockpiles of H5N1 vaccine & adjuvants maintained Licensed cell- & recombinant-based vaccines & pandemic vaccines formulated with adjuvants Shorter vaccine manufacturing cycle by weeks U.S. vaccine mfg. capacity augmented by Centers for Innovation in Advanced Development & Mfg. using faster recombinant-based and flexible technologies Fill finish manufacturing network & product tracking system operative International vaccine mfg. capacity in developing countries increased through U.S. assistance Production & distribution infrastructure Sustainability?
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