Overview. A View of the Flu, 2009 H1N1. Timeline, Ground Zero. What is this virus? Influenza Virus 101

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Overview A View of the Flu, 2009 H1N1 Greg Pratt RPh Michigan Pharmacists Association Emergency Preparedness Coordinator 1. Discuss the virology of the influenza virus 2.

Organize a response plan based upon decisions made in 2009, that can be applied to future crisis events of this nature, Ground Zero What is this virus?

Mexico is reporting 16 confirmed deaths, 44 additional suspected deaths, and over 950 more suspected cases nationally. April is not Flu Season!

1 Overview A View of the Flu, 2009 H1N1 Greg Pratt RPh Michigan Pharmacists Association Emergency Preparedness Coordinator 1. Discuss the virology of the influenza virus 2. Analyze the decision making sequence of events pertaining to the outbreak of Novel H1N1 and the outcomes of those decisions 3. Organize a response plan based upon decisions made in 2009, that can be applied to future crisis events of this nature, Ground Zero What is this virus? Friday, April 24 th, 2009 Details from Mexico are emerging regarding a swine type flu that seems to have sustained human-to-human transmission. There are 8 confirmed cases in the US. Mexico is reporting 16 confirmed deaths, 44 additional suspected deaths, and over 950 more suspected cases nationally. April is not Flu Season! A mix of swine, human, and bird flu This combination made for a Novel strain Already proof of sustained humanhuman transmission 3 Conditions needed for a Pandemic Influenza Virus 101 From the Orthomyxoviridae family of virus Primarily spread via respiratory droplets Spread dependant upon temperature and humidity Millions of virus particles per ml are shed Time from entry into cell, until release of new virus; about 6 hours A single human infectious dose of the virus might be between 100 and 1000 particles 1

Features Host Range Epidemiology Clinical features Influenza Virus 101 A Humans, pigs, horses, birds, marine mammals (mixing vessels) Antigenic shift and drift May cause pandemics with significant

2 Features Host Range Epidemiology Clinical features Influenza Virus 101 A Humans, pigs, horses, birds, marine mammals (mixing vessels) Antigenic shift and drift May cause pandemics with significant mortalities in affected young people B Humans only Antigenic drift only Severe disease, generally confined to elderly or highrisk, pandemics not seen C Humans and pigs Antigenic drift only Mild disease, common in children, without seasonality Hemagglutinin (HA) vs. Neuraminidase (NA) Antibodies to HA are considered protection against disease They prevent attachment, therefore infectivity Antibodies to NA reduce disease severity Four major shifts in last 90+ years: H1 in 1918 H2 in 1957 H3 in 1968 H1 in 2009 WHO Phase 3, an animal or human-animal influenza reassortment virus has caused sporadic cases or small clusters of disease in people, but has not resulted in human-to-human transmission sufficient to sustain community-level outbreaks. Acting Secretary of HHS Declares Public Health Emergency WHO Phase 4 is characterized by verified human-to-human transmission of an animal or human-animal influenza reassortment virus able to cause community-level outbreaks. Sunday, April 26 th, 2009 Monday, April 27 th, 2009 Positive reports from New York, Kansas, England, New Zealand. The numbers reported from Mexico include 81 dead, and 1324 sick. Premature declaration? The CDC makes the call! WHO moves to Pandemic Alert Phase 4 Confirmed cases in United States have increased to 40 Supply chain issues regarding oral antivirals Allocation decisions SNS Supply Chain Dashboard Population, State of Michigan: 10,082,364 Antiviral Cache s Strategic National Stockpile (SNS) Cache 1,502,498 State of Michigan Cache 1,079,450 Totals: 2,581,948 Federal SNS goal is to obtain courses sufficient to treat 25% of population during a pandemic plus 6 million courses for containment of initial outbreak Antiviral Cache-Tamiflu Tamiflu Treatment: 75mg twice daily for 5 days Prophylaxis: 75mg once daily for 10 days Weight based dosing under 90lbs No suspension provided to Michigan 2

Antiviral Cache-Relenza Treatment: Two puffs (2 x 5mg capsules) twice daily for 5 days 7 years and older Prophylaxis: Two puffs once daily for 10 days 5 years and older Prophylaxis: Two puffs once

5 days Decreased severity of illness Decreased incidence of secondary complications, and use of antibacterial s Decreased transmission of virus in household, community Oral Antivirals-What don t they

3 Antiviral Cache-Relenza Treatment: Two puffs (2 x 5mg capsules) twice daily for 5 days 7 years and older Prophylaxis: Two puffs once daily for 10 days 5 years and older Prophylaxis: Two puffs once daily for 28 days Oral Antivirals, What do they do? Quickly begin to reduce (not eliminate) quantity and duration of viral shedding Reduce duration of disease by ~1.5 days Decreased severity of illness Decreased incidence of secondary complications, and use of antibacterial s Decreased transmission of virus in household, community Oral Antivirals-What don t they do? Not much, if not given within 48 hours of onset of symptoms Don t make you feel better right away Summary of antiviral resistance Influenza viruses Antiviral 2009 H1N1 Seasonal Seasonal H1N1 H3N2 B Adamantanes Resistant Susceptible Resistant N/A Oseltamivir Susceptible Resistant Susceptible Susceptible Zanamivir Susceptible Susceptible Susceptible Susceptible Phase 4 is characterized by verified human-to-human transmission of an animal or human-animal influenza reassortment virus able to cause community-level outbreaks. Mexico reports 149 deaths, 1995 people admitted to hospitals with severe pneumonia Number of confirmed cases in US still 40, but numbers of probable" cases increasing Numbers untested? Tuesday, April 28 th,

4 What have we done so far? Continuation of Operation Plan Is it living document, or cut in stone? Individual Surveillance Planning Employee Health Benefits Give back sick days? Increase Hygiene messages at workplace Review cleaning procedures Contact lists up to date? May not be meeting face to face Family contact information Ready for school closure or children sick days? Supplies at home Contact time Phase 4 is characterized by verified human-to-human transmission of an animal or human-animal influenza reassortment virus able to cause community-level outbreaks. Wednesday April 29th, 2009 Number of US positive cases has risen to 66 First death in US recorded First Emergency Use Authorization by FDA First CDC shipment of antivirals arrives, and continues to arrive at all hours of day and night until May 2nd Logistics 45 Health Departments 8 Biodefense Regions 180 Hospitals Tracking of lot numbers Population based deployment 4

5 Emergency Use Authorizations (EUA) PREP Act Coverage EUA s by FDA Emergency an Emergency by: Health and Human Services Department Of Defense Department of Homeland Security EUA is Authorized by FDA, in consultation with CDC and NIH There is an emergency, based upon current science these are best countermeasures, and there is no better alternative What does an EUA do? EUA s 2009 Novel H1N1 Allows use of unapproved drug, or unapproved use of approved drug Outside of traditional Dr.-Pt-Rx relationship Allows us to skip IRB process, IND protocols Relenza Use at later time point FDA labeling requirements suspended Patient Fact Sheet Alternative distribution methods Suspension of CGMP for up to 90 days Peramivir? IV, IM Neuraminidase inhibitor Tamiflu Use at later time point Use in patient less than 1 year old Allowed use of expired oral solution Patient Fact Sheet Alternative distribution methods Suspension of CGMP for up to 90 days The Public Readiness and Emergency Preparedness (PREP) Act PREP Act Coverage EUA s by FDA Emergency The PREP Act authorizes the Secretary of the Department of Health and Human Services ( Secretary ) to issue a declaration ( PREP Act declaration ) that provides immunity from tort liability (except for willful misconduct) for claims of loss caused, arising out of, relating to, or resulting from administration or use of countermeasures to diseases, threats and conditions determined by the Secretary to constitute a present, or credible risk of a future public health emergency to entities and individuals involved in the development, manufacture, testing, distribution, administration, and use of such countermeasures. 5

PREP Act Declarations H5N1, January 26 th, 2007 Amended June 15 th, 2009 to add Novel H1N1 Anthrax, October 1, 2008 Botulism, October 10 th, 2008 Pandemic Antiviral Countermeasures, October 10 th,

6 PREP Act Declarations H5N1, January 26 th, 2007 Amended June 15 th, 2009 to add Novel H1N1 Anthrax, October 1, 2008 Botulism, October 10 th, 2008 Pandemic Antiviral Countermeasures, October 10 th, WHO Phase 5 Characterized by human-tohuman spread of the virus into at least two countries in one WHO region. Thursday, April 30, 2009 What did we plan for? (6 week lead time) Pandemic Alert Phase 3 to 5 in 5 days? SNS Deployment Spread and severity will never be known initially That s why they call it a crisis! WHO phases refer to how widespread the virus in not how severe it is Antiviral Distribution Plan labeling dispensing Relenza teaching Tamiflu compounding Long term dispensing? Record keeping MCIR Phase 5 is characterized by human-to-human spread of the virus into at least two countries in one WHO region. 985 confirmed cases in 20 countries Vaccine decisions must now be made Stop seasonal? How much Novel H1N1 to anticipate? Mortality data now published, median age of confirmed sick is 17 years old Monday, May 4 th, 2009 Phase 5 is characterized by human-to-human spread of the virus into at least two countries in one WHO region. Monday, May 18 th, 2009 The number of cases of H1N1 in Japan jump over the weekend from 5 on Friday to 135 on Monday morning The WHO reports 8829 cases in 40 countries CDC reports 4714 confirmed cases and 6 deaths Closure of 11 schools in New York City, and death of a school official Most cases are mild and resolve WHO Pandemic Level 6 Community level outbreaks in at least one other country in a different WHO region June 9 th, 2009 WHO reports 25,288 confirmed cases in 78 countries What took so long? How solid are the numbers? For every 1 confirmed, probably 10 unconfirmed 60% of cases, and 42% of hospitalized patients are in people 5-24 years of age 6

FLAARDS Most still report mild disease, but some are susceptible to lower airway attachment of the virus Morbid obesity Type 2 Diabetics Cancer Weakened immune system Chronic lung disease Pregnancy

Permanent scarring and overproduction of fluids by immune response lead to further damage WHO Pandemic Level 6 Community level outbreaks in at least one other country in a different WHO region The

US July 13 th, 2009 Summer camps are canceled due to continued presence of circulating H1N1 Surveillance Four Pillars of Response Flu View-National Focus Mi Flu Focus-Michigan Focus Daily school

7 FLAARDS Most still report mild disease, but some are susceptible to lower airway attachment of the virus Morbid obesity Type 2 Diabetics Cancer Weakened immune system Chronic lung disease Pregnancy (Especially 3 rd Trimester) FLAARDS (Flu A Acute Respiratory Distress Syndrome) 2009 H1N1 may be up to 1000 times more adept at infiltrating lower branches of the airway Alveolar capillary damage Permanent scarring and overproduction of fluids by immune response lead to further damage WHO Pandemic Level 6 Community level outbreaks in at least one other country in a different WHO region The H1N1 novel virus is the dominant circulating virus in the Southern Hemisphere flu season Early vaccine production is slower than anticipated Sporadic cases of Tamiflu resistance 35 total, 13 in the US July 13 th, 2009 Summer camps are canceled due to continued presence of circulating H1N1 Surveillance Four Pillars of Response Flu View-National Focus Mi Flu Focus-Michigan Focus Daily school closure information reported to CDC Community Mitigation Stay home if your ill Educated proper hygiene Vaccination Communication The more good information they know, the more they will cooperate Now is the time to exchange business cards! Ongoing Surveillance-FluView Viral surveillance, which monitors The percentage of specimens tested for influenza that are positive for influenza; The types and subtypes of influenza viruses circulating; Resistance to influenza antiviral medications, and The emergence of new strains Sentinel physician surveillance for influenza-like illness (ILI), which monitors the percentage of doctor visits for symptoms that could be the flu. Hospitalization surveillance, which tracks numbers of hospitalizations with laboratory-confirmed flu infections among adults and children. Summary of the geographic spread of flu, which tracks the number of states affected by flu and the degree to which they are affected. Deaths from 122 Cities that report the total number of deaths and the percentage of those that are coded as influenza or pneumonia. The number of laboratory-confirmed deaths from influenza among children. Surveillance: School Dismissal Monitoring System Name of school or school district Zip code of school, or school district Date school, or school district dismissed Date school or school district is projected to reopen (if known) 7

Mi FluFocus Michigan Disease Surveillance System Emergency Department Surveillance OTC Product Surveillance Sentinel Provider Surveillance Resistance Data Antigenic characterization Laboratory

8 Mi FluFocus Michigan Disease Surveillance System Emergency Department Surveillance OTC Product Surveillance Sentinel Provider Surveillance Resistance Data Antigenic characterization Laboratory Surveillance Pediatric mortality Mi FluFocus National outlook International outlook look under Michigan Seasonal Flu WHO Pandemic Level 6 Community level outbreaks in at least one other country in a different WHO region September 7 th, 2009 Schools are back in session, and some colleges are reporting thousands of ill students Healthcare systems already reaching surge capacity in ER and ICU s CDC reports 3205 fatal cases worldwide, average age of 37, and 51% of deaths in persons between years of age Half of fatalities also had underlying disease states Surveillance Four Pillars of Response Flu View-National Focus Mi Flu Focus-Michigan Focus Daily school closure information reported to CDC Community Mitigation Stay home if your ill Educated proper hygiene Vaccination Communication The more good information they know, the more they will cooperate Now is the time to exchange business cards! The H1N1 Monovalent Vaccine A/California/7/2009(H1N1) Ends production of seasonal flu vaccine Five manufacturers, so finite amount of manufacturing capacity It s a response asset New dose reporting requirements (MCIR) Reimbursement confusion The H1N1 Monovalent Vaccine Safety Guillain-Barre Issues from 1976 (30 cases out of 40 million doses administered) The H1N1 component has been changed 8 times since 1977 to accommodate antigenic drift within the HA component For H3N2, 5 vaccine strain changes in last 10 years Effectiveness studies TIV 80%, LAIV 85% when well matched 8

Vaccination received by 30% of all persons in target groups January 10 th, 2010 29% of adults aged 25-64 years of age with underlying disease state 39% of Healthcare workers Vaccine Clinic Locator

9 Vaccination received by 30% of all persons in target groups January 10 th, % of adults aged years of age with underlying disease state 39% of Healthcare workers Vaccine Clinic Locator Grand Rapids, Michigan -Today 334 children and teenagers have died due to Influenza infection since April 280 Deaths lab confirmed Novel H1N1 30% had no underlying complications Bacterial co-infections very prevalent in this group CDC Estimates: 59 million persons infected 265,000 hospitalizations 12,000 deaths How has behavior changed? Is this the positive outcome of this event? The Future? Re-assortment possibilities Novel H1N1 with 2008 H1N1 98% resistance Novel H1N1 with Avian H5N1 Virulent return in future wave? Continue to circulate as a mildly virulent Influenza A Replace H1N1 in current Seasonal Flu TIV New ACIP Recommendations for all > 6 months The Classic Approach to Decision Making H1N1 Keep your own history of decisions, guidance released Keep your own history of surveillance data Pre-event decision making works Transparent decisions With individual input comes ownership Start with a good checklist-but keep it flexible and adaptable Fall back on what works! 9

"Policy decisions regarding influenza rest on judgments about the behavior of the virus, the impact of the disease and our ability to interdict its

But the virus is capricious, the disease elusive, and our remedies imperfect" References From a Swine Flu epidemic report in 1976 at Fort Dix World

10 "Policy decisions regarding influenza rest on judgments about the behavior of the virus, the impact of the disease and our ability to interdict its course. But the virus is capricious, the disease elusive, and our remedies imperfect" References From a Swine Flu epidemic report in 1976 at Fort Dix World Health Organization Michigan Pandemic Influenza Community Health Plan Clinical Infectious Diseases 2009;49: PRO/AH/EDR> Influenza pandemic (H1N1) 2009 (61): FLAARDS Neustadt RE, Fineberg HV. The swine flu affair: decision-making on a slippery disease INFLUENZA PANDEMIC (H1N1) 2009 (61): FLU A-ASSOCIATED ACUTE RESPIRATORY DISEASE SYNDROME gpratt@michiganpharmacists.org 10

H1N1 Response and Vaccination Campaign

2009-2010 H1N1 Response and Vaccination Campaign Stephanie A. Dopson, MSW, MPH, ScD. Candidate Influenza Coordination Unit Centers for Disease Control and Prevention CDC H1N1 Response In late March and