# Presentation: 150544

## 2008-09 Seasonal Influenza Update

**Carolyn B. Bridges, MD **
**Influenza Division**
**National Center for Immunization and Respiratory Diseases**
**Centers for Disease Control and Prevention**

## 	Continuing Education Credits DISCLAIMER:In compliance with continuing education requirements, all presenters must disclose any financial or other relationships with the manufacturers of commercial products, suppliers of commercial services, or commercial supporters as well as any use of unlabeled product(s) or product(s) under investigational use. CDC, our planners, and the presenters for this seminar do not have financial or other relationships with the manufacturers of commercial products, suppliers of commercial services, or commercial supporters. This presentation does not involve the unlabeled use of a product or product under investigational use.

## Thanks to my many colleagues who contributed data and slides to my presentation, especially
Lyn Finelli
Tony Fiore
Lene Blanton
Scott Epperson
Lynnette Brammer
Gary Euler
Laura Williams
Alicia Fry
Larissa Gubareva

This presentation represents the views of the presenter and may not represent the views of CDC. 

- Lyn Finelli
- Tony Fiore
- Lene Blanton
- Scott Epperson
- Lynnette Brammer
- Gary Euler
- Laura Williams
- Alicia Fry
- Larissa Gubareva
- This presentation represents the views of the presenter and may not represent the views of CDC.

## Human Influenza

- Contagious respiratory illness caused by influenza virus
- Characterized fever (often high), cough, body aches, headache, malaise, rhinnitis
- Yearly winter epidemics
- Peak activity usually in January and February
- Sporadic, unpredictable pandemics

## Burden of Influenza

- Seasonal in U.S.
- Average 6-7% adults and up to 30% children ill
- 36,000 deaths, >200,000 hospitalizations
- 20,000 hospitalizations in <5 year olds
- Pandemic
- 30% illness rates across age groups

|  | Moderate (1957-like) | Severe (1918-like) |
| --- | --- | --- |
| Illness | 90 million (30%) | 90 million (30%) |
| Outpatient medical care | 45 million (50%) | 45 million (50%) |
| Hospitalization | 865,000 | 9, 900,000 |
| Deaths | 209,000 | 1,903,000 |

## Average influenza-associated illness rates by age group*

***Low estimate based on Tecumseh community**** ****studies. High estimate based on Houston family studies. Adapted from Sullivan KM.  PharmacoEconomics**** ****1996;9 Suppl.3:26-33.**

## Influenza-Associated Hospitalizations

**By Age Group  ****(Thompson, JAMA, 2004)**

## Influenza-Associated Deaths By Age Group, 1990-2001  (Thompson, JAMA 2003)

## Influenza Surveillance Activities for 2008-09 Season

## Goals of Influenza Surveillance

**Describe the onset and duration of the season**
**Identify and characterize viruses/strains**
**Vaccine strain selection**
**Antiviral resistance**
**Track geographic spread**
**Monitor severity**
**Provide information to partners**

## Types of Influenza Surveillance in US	

- Virologic
- Morbidity
- Mortality
- Influenza activity
- Novel influenza A virus infection

## 2008-2009 Influenza Season

**2008-2009 Influenza Season**
**Week 42, ending October 18, 2008**
*(All data are preliminary and may change as more reports are received.)*
**Synopsis:**  During week 42 (October 12-18, 2008), a low level of influenza activity was reported in the United States.
- - Ten (1.0%) specimens tested by US World Health Organization (WHO) and National Respiratory and Enteric Virus Surveillance System (NREVSS) collaborating laboratories and reported to CDC/Influenza Division were positive for influenza.
- - The proportion of deaths attributed to pneumonia and influenza (P&I) was below the epidemic threshold.
- - The proportion of outpatient visits for influenza-like illness (ILI) was below national and region-specific baseline levels.
- - Eleven states, the District of Columbia, and Puerto Rico reported sporadic influenza activity; 38 states reported no influenza activity; and one state did not report.

## Virologic Surveillance

**~140 participating laboratories from two networks (WHO, NREVSS)**
**Weekly reports**
**80 WHO collaborating labs**
**65 NREVSS labs**
**# specimens tested**
**# positive for influenza: type, subtype, age**
**Analyzed weekly and included in weekly report of influenza activity October through May**
**National and regional level analysis**

## WHO/NREVSS Collaborating LaboratoriesNational Summary, 2007-08

## Virus Type/Subtype by Region2007-08

## Types of Influenza Surveillance	

- Virologic
- Morbidity
- Mortality
- Influenza activity
- Novel influenza A virus infection

## Influenza-like Illness Surveillance in the U.S.

- ~2,400 physicians/clinics enrolled for the 2007-08 season
- Weekly reports
- Total # of patient visits
- # visits for influenza-like illness (ILI) by age group
- ILI = fever  100 F (38 C) and cough or sore throat, in absence of a known cause
- Data weighted by state population for analysis

## Percentage of Visits for Influenza-like IllnessReported by Sentinel Providers, National Summary 2007-08 and Previous 3 Seasons

## Hospitalization Surveillance

## Hospitalization Surveillance

- Two Networks
- Emerging Infections Program (EIP) – 10 sites
- Persons hospitalized with laboratory-confirmed influenza infection
- New Vaccine Surveillance Network (NVSN) – 3 sites
- children <5 yrs hospitalized with laboratory-confirmed influenza infection

## NVSN Influenza Laboratory-Confirmed Cumulative Hospitalization Rates for Children 0 - 4 Years, 2007- 08 and Previous 4 Seasons

## EIP Influenza Laboratory-Confirmed Cumulative Hospitalization Rates for Children Aged 0-4 and 5-17 yrs, 2007-2008 and Previous 4 Seasons

## Types of Influenza Surveillance	

- Virologic
- Morbidity
- Mortality
- Influenza activity
- Novel influenza A virus infection

## 122 Cities Mortality Reporting System

- Purpose:
- Monitor P&I related mortality in a timely manner
- Weekly reports from vital statistics offices in 122 US cities
- Total # of death certificates filed
- # with pneumonia or influenza listed anywhere
- ~ 1/4 of US deaths
- Timely
- Reporting lag 1-2 weeks

## Pneumonia and Influenza Mortalityfor 122 U.S. CitiesWeek Ending 08/02/2008

- Epidemic Threshold*

- Seasonal Baseline†

**Pneumonia and Influenza Mortality****for 122 U.S. Cities****Week Ending 08/02/2008**

- 2005

- 2006

** ****50     10      20      30     40       50      10       20      30     40      50     10     20     30     40      50     10     20     30     40      50    10    20  30**

- 2007

- 2004

- 2008

## Influenza-Associated Pediatric Mortality 

- Initiated during the 2003-04 season
- 153 deaths in 40 States
- In June 2004, CSTE recommended influenza-associated pediatric mortality become a nationally notifiable condition.
- Reporting began in October 2004
- Data reported weekly in MMWR and influenza update
- All influenza pediatric deaths asked to be reported to state/local health departments

## Influenza-Associated Pediatric Mortality Case Definition

- Death resulting from a clinically compatible illness that was confirmed to be influenza by an appropriate laboratory or rapid diagnostic test
- Age <18 years
- Case report form also requests information on bacterial co-infections

## Number of Influenza-Associated Pediatric Deaths by Week of Death:2005-06 season to October 2008

## Influenza Associated Pediatric Mortality  2007-08 Season

- As of August 2, 2008, received 85 reports of influenza-associated pediatric deaths
- Median age 5 years (range = 29 days – 17 years)
- Of 67 tested for bacterial co-infection, 43 positive, 28 (42%) had *S. aureus* infection
- 15 MRSA
- Increasing proportion of cases with *Staph. aureus*  co-infections concerning
- 2% in 2004-05
- 6% in 2005-06
- 30% in 2006-07

## Types of Influenza Surveillance	

- Virologic
- Morbidity
- Mortality
- Influenza activity
- Novel influenza A virus infection

## Influenza Activity Report(State Epidemiologist’s Report)

- Assessment of overall influenza activity at state level
- None, sporadic, local, regional, widespread
- Overall impression of virus circulation, outbreaks & illness
- Only system reporting state-level data

## Slide 32

## Types of Influenza Surveillance	

- Virologic
- Morbidity
- Mortality
- Influenza activity
- Novel influenza A virus infection

## Novel Influenza A Virus Infections

- Novel influenza A virus infections are human infections with influenza A virus subtypes that are different from the currently circulating human subtypes (A/H1 and A/H3)
- Human infections with novel influenza A viruses transmissible person to person may signal the beginning of an influenza pandemic
- Require rapid evaluation to assess risk of spread among humans

## New Reporting Requirements for Novel Influenza A Virus Infections

- June 2007, CSTE added novel influenza A infections to the National Notifiable Diseases Surveillance System (NNDSS)
- Reporting of new subtypes of influenza in people also required under International Health Regulations (IHR) 2005

## H5N1 Avian Influenza

- Currently spreading through Asia, Africa, Europe, Middle East
- Highly lethal to domestic poultry and other animal species
- 387 humans cases, including 245 deaths since 2003*
- No efficient human to human transmission
- Virus of greatest concern for pandemic potential, but other viruses in animals also of concern

- *As of Oct. 20, 2008

## Recent Improvements in Influenza Diagnostic Capabilities

- Substantial pandemic planning resources devoted to improving PCR-testing capacity for novel influenza A at public health laboratories
- APHL provided public health labs with RT-PCR procedures and training for differential detection and characterization of human A/H1, A/H3 and Asian avian H5N1 (2004-2005)
- Approximately 140 labs with RT-PCR capacity
- More labs can do subtyping than ever before
- Labs advised to quickly forward any “unsubtypables” to CDC to confirm

## Novel influenza A reportingin the US

- Increase in the number of unsubtypable isolates submitted to the CDC laboratory that are classified as non-circulating subtypes
- Swine influenza virus infection being identified more frequently than before

## Swine Influenza Virus (SIV)

- Swine influenza virus (SIV) first identified in 1930
- Human influenza identified 3 years later
- Endemic in pig herds throughout world
- Causes respiratory symptoms (cough, runny nose, lethargy, decreased feeding)
- Secondary bacterial infections common
- Herds often vaccinated in U.S.

## Interspecies Transmission of SIV

- Interspecies transmission well documented
- Recent review of 37 human civilian cases from 1976 though 2006 (Myers KP, et al.  CID 2007)
- CFR 6/35 (17%)
- H9N2 avian influenza found among pigs in  Southern China and confirmed in 2 humans in HK
- 5 possible cases, S. China(Peiris Lancet 1999, Peiris J Virology 2001, Cong J Virology 2007 )

## Swine Influenza in North America

**1930**

- Slide courtesy of Dr. Amy Vincent, USDA

## Recent Swine Influenza Infections in the United States

- 9 human cases of swine influenza identified since December 2005
- Previously ~1 case every 1-2 years
- All triple reassortant viruses
- Varying exposures and levels
- 		of investigation

## Non-occupational Exposures to Pigs

- Non-work venues provide potential for exposure by persons
- Without pre-existing immunity
- Immune compromised
- E.g. fairs, petting zoos

**Non-occupational Exposures to Pigs**

## USDA Swine Influenza Surveillance Pilot Project

- Interagency Agreement between CDC and  US Department of Agriculture (USDA) signed in September 2008
- Objectives
- Identify antigenic variation among SIV circulating in US
- Increase testing and reporting of outbreaks in swine associated with
- Novel subtypes in pigs
- Unusually severe disease in pigs
- Suspected or confirmed human illness
- Improve understanding of risk of interspecies transmission

## Influenza Vaccine and Antiviral Medication Recommendations for United States

## Influenza Vaccines

- Live and inactivated vaccines available for seasonal influenza
- Live, intranasal spray vaccine for healthy persons 2-49 years
- No asthma or recurrent wheezing in 2-4 year olds
- Inactivated, injectable vaccine for persons 6 months and older
- Primary influenza prevention tool
- More than 140 million doses anticipated for US market this year

## U.S. Influenza Vaccine Recommendations

- Recommended annually for persons
- Increased risk influenza-related complications
- _>_65 years
- 6 months-64 years with high risk conditions
- Close contact with high risk
- Household members
- Health care workers
- 50-64 year old persons
- 24-32% have high risk conditions
- Anyone else who wish to decrease risk of influenza
- 2008: 6 months through 18 years

## Medical Conditions for Which Influenza Vaccination Recommended

- Residents of long-term care facilities
- Chronic heart or lung disease
- Metabolic disease, including diabetes
- Renal disease
- Hemoglobinopathies
- Weakened immune system due to illness or medication, including HIV/AIDS
- Conditions that interfere with lung function/control of secretions, e.g. neurologic or neuromuscular disorders
- 6m – 18 years on chronic aspirin therapy
- Pregnant during influenza season

## Self-Reported Influenza Vaccination Coverage Levels Among Selected Priority U.S. Adult Populations, 1989-2007*, National Health Interview Survey

- Self-Reported Influenza Vaccination Coverage Levels Among Selected Priority U.S. Adult Populations, 1989-2007*, National Health Interview Survey

- Vaccine shortage: 2004-05 season

- Source: CDC, NHIS. _[http://www.cdc.gov/flu/professionals/vaccination/pdf/vaccinetrend.pdf](http://www.cdc.gov/flu/professionals/vaccination/pdf/vaccinetrend.pdf)_
- *Preliminary data from 2006-07 influenza season

**Notes:**
This slow rate of increase in coverage is not just among 6-23 month olds, and not just for newly recommended age or risk groups. We have minimal increases or even decreases in coverage in each of the priority groups shown here.

## Percentage of children fully vaccinated (i.e., 1 or 2 doses as appropriate) against influenza among children 6-23 months of age, IIS Sentinel Site Project, 2004-05 through 2007-08 influenza seasons

**IIS Sentinel Site**

**Percent (%)**

**Preliminary Data**

**Percentage of children fully vaccinated (i.e., 1 or 2 doses as appropriate) against influenza among children 6-23 months of age, IIS Sentinel Site Project, 2004-05 through 2007-08 influenza seasons**

***Note: OR sentinel site expanded from Washington County in 2004-5 through 2006-7 seasons to include**
**Multnomah county in 2007-8 season.  Michigan added one county to its sentinel site region in 2007-8 season.**

**Notes:**
OR, MI, and AZ also participated in the IIS Sentinel Site Project from 2004-2007.  This slides shows the same vaccination coverage rates from the 2007-8 influenza season in blue and vaccination coverage rates from the 2006-7 influenza season in purple for the OR, MI, and AZ sentinel sites. Coverage rates were slightly lower in OR in the 2007-8 influenza season compared to 2006-7; rates remained stable in MI and AZ.

For the 2006-7 influenza season full vaccination was defined* as children who had:
Received no dose of influenza vaccine before September 1, 2006 but then received 2 doses during September 1, 2006-March 31, 2007 or,
Received at least 1 dose of influenza vaccine before September 1, 2006, and then received at least 1 dose during September 1, 2006-March 31, 2007.

* CDC. Influenza Vaccination Coverage Among Children Aged 6-59 Months – Six Immunization Information System Sentinel Sites, United States, 2006-07 Influenza Season.  MMWR 2007; 56:963-965.

## Percentage of children fully vaccinated (i.e., 1 or 2 doses as appropriate) against influenza among children 24-59 months of age, IIS Sentinel Site Project, 2006-07 & 2007-08 influenza seasons

**IIS Sentinel Site**

**Percent (%)**

**Preliminary Data**

**Percentage of children fully vaccinated (i.e., 1 or 2 doses as appropriate) against influenza among children 24-59 months of age, IIS Sentinel Site Project, 2006-07 & 2007-08 influenza seasons**

***Note: OR sentinel site expanded from Washington County in 2004-5 through 2006-7 seasons to include**
**Multnomah county in 2007-8 season.  Michigan added one county to its sentinel site region in 2007-8 season.**

**Notes:**
OR, MI, and AZ also participated in the IIS Sentinel Site Project from 2004-2007.  This slides shows the same vaccination coverage rates for 24-59 month olds from the 2007-8 influenza season in blue and vaccination coverage rates from the 2006-7 influenza season in purple for the OR, MI, and AZ sentinel sites.  Coverage rates were slightly lower in AZ in the 2007-8 influenza season compared to 2006-7; rates remained stable in OR and MI.

For the 2006-7 influenza season full vaccination was defined* as children who had:
Received no dose of influenza vaccine before September 1, 2006 but then received 2 doses during September 1, 2006-March 31, 2007 or,
Received at least 1 dose of influenza vaccine before September 1, 2006, and then received at least 1 dose during September 1, 2006-March 31, 2007.

* CDC. Influenza Vaccination Coverage Among Children Aged 6-59 Months – Six Immunization Information System Sentinel Sites, United States, 2006-07 Influenza Season.  MMWR 2007; 56:963-965.

## Influenza Antiviral Medications

- Two classes
- Adamantanes – rimatadine and amantadine
*Currently not recommended for use due to high level of resistance among circulating influenza A viruses*
- Neuraminidae inhibitors
- Oseltamivir and zanamivir
- Used for both prevention and for treatment

## Neuraminidase Inhibitors

**Neuraminidase Inhibitors**

- Oseltamivir (Tamiflu - Roche) and Zanamivir (Relenza - GSK)
- Used for the treatment and prevention of seasonal influenza A and B virus infections
- Treatment should begin as soon as possible after symptom onset
- Ideally within first 2 days of illness

**Notes:**
Two neuraminidase inhibitor antiviral drugs are available: Oseltamivir (Tamiflu®) and Zanamivir (Relenza ®):

-These drugs are used for treatment and  prevention of seasonal human influenza A and B virus infections.  

-Their effectiveness for H5N1 treatment is unknown, however they are the WHO recommended first line antivirals for the treatment and prevention of human H5N1 virus infections.

-It is very important to remember that you should not wait for laboratory diagnosis before initiating treatment with oseltamivir or zanamivir if you are concerned about H5N1 virus infection; all suspected H5N1 patients should begin treatment as soon as possible if available. 

-Antivirals can also be given as chemoprophylaxis to prevent the development of H5N1 disease in persons who have been exposed to H5N1 virus

## Neuraminidase Inhibitors

**Neuraminidase Inhibitors**

- Reduces duration of influenza symptoms by average of 1-1.5 days when administered within 2 days of illness onset
- Recent observational study by McGeer, et al showed benefit even when treatment started >48 hours after onset*
- Reduces lower respiratory tract complications, pneumonia, and hospitalization in some studies
- McGeer study also suggests oseltamivir reduces mortality among hospitalized patients with lab-confirmed seasonal influenza A*
- Effective in preventing seasonal influenza
- 70-90% effectiveness when started within 48 hours of exposure in RCT

***McGeer et al. Clin Infect Dis 2007 **

**Notes:**
The effectiveness of oseltamivir in treating human influenza A (H1) or (H3) has been studied and the following has been found:
Effectiveness in seasonal human influenza:
Reduces influenza symptoms by 1 day when administered within 2 days of illness onset
May reduce lower respiratory tract complications and hospitalization due to seasonal influenza
-Recall that the effectiveness of treatment for H5N1 virus infection is unknown, nonetheless, oseltamivir is currently recommended as first line therapy for H5N1 virus infections

-Precautions should be taken when oseltamivir is administered to the following groups of patients:
-For people with kidney disease, the dose should be reduced
-Oseltamivir is normally not recommended for use during pregnancy or nursing, as the effects on the unborn child or nursing infant are unknown, however, if there is strong suspicion for H5N1 virus infection, the benefits may outweigh the risks
-There have been some reports from Japan of self-injury and delirium with the use of oseltamivir in patients with seasonal influenza 
-The relationship of these reported events to oseltamivir is not known. 

-Antiviral resistance can develop with treatment, but the frequency of resistance to oseltamivir appears to be low

## Oseltamivir

**Oseltamivir**

- Available as a capsule or suspension administered by mouth
- Approved in the U.S. for treatment or prevention of influenza in persons aged ≥1 year
- Treatment for 5 days
- Prevention regimen typically for 10 days after exposure
- Pediatric dosage depends on age and weight
- For treatment of seasonal influenza, administered twice a day for 5 days
- Side effects: nausea, vomiting in some persons
- Reports of delirium in pediatric patients (adolescents, most reports from from Japan)
- Warning added to label in 2007

**Notes:**
Oseltamivir, the most widely available neuraminidase inhibitor drugs is: 

-Available as a capsule or suspension administered by mouth

-Oseltamivir is approved in the U.S. for treatment of human influenza in children aged one year and older

-For pediatric patients, the dosage depends on age and weight

-For treatment of human influenza A (H1), A (H3), or B virus infection, oseltamivir is administered twice a day, for 5 days

-Side effects are generally mild, and may include nausea, vomiting

## Antiviral Resistance Patterns—United States and Global, 2007-2008

| Virus | Oseltamivir resistance |  | Zanamivir resistance |  | Adamantane resistance |  |
| --- | --- | --- | --- | --- | --- | --- |
|  | US | Global | US | Global | US | Global |
| A(H1N1) | 12% | 16% | 0% | 0% | 10.6% | Variable |
| A(H3N2) | 0% | Rare | 0% | 0% | 99.8% | High |
| B | 0% | Rare | 0% | 0% | N/A | N/A |

- http://www.who.int/csr/disease/influenza/H1N1webupdate20082008_kf.pdf.

- *Global average. NAI resistance varies by country from 0-100%. Resistant A(H1N1) viruses retained sensitivity to zanamivir, amantadine, and rimantadine; N/A = not applicable.

## Antiviral Resistance to Oseltamivir in H1N1 Strains—Global, 2007-2008

- http://www.who.int/csr/disease/influenza/Global_H5N1Resistance_20080701.jpg
- See also Sheu TG, et al. *Antimicrob Agents Chemother*. 2008 Jul 14. [epub].

## Zanamivir

**Zanamivir**

- Orally inhaled powder – administered by mouth via special device
- Approved in the U.S. for
- Treatment of seasonal influenza (aged _>_7 years)
- Prevention of seasonal influenza (aged _>_5 years)
- Treatment dosage: two puffs in the morning and two at night for 5 days (5 days)
- Prevention dosage: 2 puffs once a day (typically for 10 days after exposure)
- Side effects
- Wheezing, and breathing problems
- Precautions
- Persons with chronic respiratory disease
- Pregnant women
- Resistance rare

**Notes:**
Zanamivir is a neuraminidase inhibitor that is not widely available for the treatment of influenza:

- It is an orally inhaled powder (shown here) – which is administered by mouth via a special inhaler device

- It is approved in the U.S. for treatment of seasonal influenza in patients aged 7 years and older, and for the prevention of seasonal influenza in patients aged 5 years and older

- Treatment dosage is one puff in the morning and one at night for 5 days
-Side effects may include wheezing and breathing problems

## ACIP Recommendations 2008: Antiviral Dosage by Age

## Conclusions

- Influenza causes substantial morbidity and mortality yearly in US
- Influenza activity low as typical for October, but expected to increase
- Surveillance updated weekly
- Updates on pediatric deaths and bacterial co-infections
- Antiviral resistance
- Any reports of novel influenza A infections
- Vaccine is primary prevention tool
- Oseltamivir and zanamivir are currently recommended influenza antiviral medications
- Recommendations for antiviral use will be updated based on surveillance data during the season
- Will depend on
- Proportion A/H1N1 viruses that are resistant
- Proportion of all influenza viruses that are A/H1N1 versus A/H3N2 or B

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