# Presentation: 371210

## 2006-07 Influenza Season Update

- Abigail Shefer, MD
- National Center for Immunization and Respiratory Diseases (proposed)
- Centers for Disease Control and Prevention
- October 2006

**Notes:**
Slide 1:  Good morning and thanks for the inviting me to take part in this COCA presentation.  For the next few minutes, I’ll be talking about the 2006-07 influenza season.

## Outline

- Burden of Influenza Disease
- Recommendations
- Vaccine Supply and Distribution
- Communications

**Notes:**
I am going to talk about ...

## Burden of Disease

## Interpandemic Influenza Impact

- Annual US. winter epidemics
-  5-20% of US population
- Highest illness rates in children
- Highest complication rates in elderly and infants
-  >36,000 deaths
- >90% in those >64 years
-  >200,000 hospitalizations
- ~50% in those >64 years

## Burden of Influenza: Children

**Attack rate: Can range substantially from year to year (<5% to >30%)**
**Hospitalization rate among children <5 years old:**
**High risk 500/100,000**
**Healthy 100/100,000**

## 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.

## Recommendations

## Recommended Groups 2006-2007

_**Recommended Groups for Vaccination**_
**Children 6-59 months of age**
**Adults 50 years old and older**
**Residents of nursing homes**
**Persons 5 – 49 years old at high risk for complications**
**Household contacts of persons at high risk for complications**
**Health care workers**
**Pregnant women**
**Anyone wishing to decrease their risk of illness**
** **

**Notes:**
Because of this burden of disease, we recommend influenza vaccination for the following groups of patients.  Children 6-59 months old, adults fifty years old and older, residents of nursing homes, adults (and children) 5-49 years old at high risk for complications of influenza, adults (and children) that are household contacts of persons at high risk of complication from influenza, health care workers, and adult (and adolescent) women that are pregnant.  We ask providers to consider vaccinating anyone wishing to decrease their risk of illness with influenza vaccine.  

## Medical Conditions Among >6 Months for Which Influenza Vaccine 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
- Pregnancy at any stage

## Expanded Recommendations:  Annual Vaccination of 24-59 month old children

- Beginning with the 2006-07 season
- Based upon increased risk of clinic and ED visits
- Includes household contacts and out-of-home caregivers
- Timing of the recommendation and limited supply of vaccine for young children will impact implementation

## Vaccination of Children

**All children < 9 years old vaccinated for first time require 2 doses to be protected**
**Optimal to complete vaccination before influenza season**

## Estimated Size of ACIP Recommended Groups

**Estimated Size of ****ACIP Recommended Groups**

**Notes:**
Annual influenza vaccination is recommended for high risk persons, their household contacts and caregivers, and health care personnel.  This slide depicts the changes in the estimated size of ACIP recommended target groups beginning in 1964 [79 M].  The total number of persons targeted for routine influenza vaccination in the US is now approximately 218 million persons or 73% of the population. 

As we strive to decrease influenza-associated morbidity and mortality, we are considering different options for recommendations:  Should we expand to have universal vaccination recommendations that include an additional 78 million people?  Should we strive toward better coverage levels among the existing target populations that already number 218 million?  Should we consider taking a more focused approach, such as vaccinating school children?  Or, some combination of these approaches.

I don’t have the answers to these questions for you today; but I hope that you’ll continue to be interested in these issues as we work toward improving the prevention and control of influenza.

Thank you.

## Inactivated Vaccine Effectiveness by Age and Risk Group 

| Age/Risk group | Outcome | Effectiveness* |  |
| --- | --- | --- | --- |
| 6m-16 years | Influenza |  | 70-90% |
| 18-64 years | Influenza  |  | 70-90% |
| >65 years, community | Influenza |  | 30-70% |
| Elderly, nursing home | Influenza  |  | 30-40% |
| Elderly, nursing home | Hospitalization |  | 50-60% |
| Elderly, nursing home | Death |  | 80% |

***Overall range from studies conducted when good antigenic match between vaccine**
** ****and circulating strains.  **

## Receipt of influenza vaccination during the previous 12 months by race/ethnicity among persons >65, 1989-2005, National Health Interview Survey

**Healthy People 2010 Goal**

**Survey Year**

**Notes:**
This figure shows coverage by race/ethnicity with whites in blue, Hispanics in green and African Americans in orange. As you can see the differences are substantial and the gap has not narrowed over time.

## Receipt of pneumococcal vaccination among persons >65 by race/ethnicity, 1989-2005, National Health Interview Survey

**Healthy People 2010 Goal**

- White

- Black

- Hispanic

**Survey year**

**Notes:**
As with influenza, differences by race/ethnicity exist and are even more marked for pneumococcal than for influenza vaccine.
In general the gap has not narrowed over time, though it does look like the possible plateauing is occuring more for whites than Hispanics or African Americans. 

## Vaccine Supply and Distribution

**Current Influenza Vaccine Production Timeline: 6-9 months**

**Notes:**
If a pandemic strain were to appear, it would take time to develop and distribute large quantities of  vaccine that could protect humans against a pandemic influenza strain. Development and distribution of vaccine for a pandemic strain of influenza cannot fully begin until the actual pandemic strain is identified. In addition, vaccine would likely not be available to most countries (resource rich vs. resource poor countries). Even production and distribution of current, seasonal vaccine takes many months from discovery of strain to licensure.

## Projected Production

|  | # manufacturers | # 
presentations | # 
doses |
| --- | --- | --- | --- |
| Current 
(as of 10/2006) | 4 | 7 | ~110-115 million doses |

**Notes:**
In terms of the supply we’ll have available to reach these recommended groups, we anticipate a range of 95-120 million doses being available, depending upon yields.

50 sanofi, 35 novartis, 7 GSK, 3 MedImmune, IDB 15-20 if licensed

The lower end of the range is derived from the projections for the 7 currently licensed formulations produced by the four licensed US influenza vaccine manufacturers, and represents about 10% more doses than last year.

An additional 15-20 million doses may be available if a new vaccine is licensed by GSK.

## Influenza Vaccine Manufacturers  and Products for the 2006-07 Influenza Season 

| Manufacturer | Vaccine | Presentation | Thimerosal preservative | Age indication |
| --- | --- | --- | --- | --- |
| sanofi pasteur, Inc. | Fluzone ®
Inactivated TIV | Multi-dose vial | Yes | > 6 mo |
|  |  | Single-dose, 0.5 mL (syringe/vial) | None | > 36 mo |
|  |  | Single-dose, 0.25 mL (syringe) | None | 6-35 mo |
| MedImmune Vaccines, Inc. | FluMist TM LAIV | Single dose sprayer | None | Healthy, 5-49 yrs |
| Novartis Vaccine | Fluvirin TM
Inactivated TIV | Multi-dose vial | Yes | >4 yrs |
| GSK
 | Fluarix TM
Inactivated TIV | Single-dose, 0.5 mL (syringe)
 | < 1 ug/0.5mL | > 18 yrs |
|  | FluLaval TM
Inactivated TIV | Multi-dose vial | Yes | > 18 yrs |

## Timing of Vaccine Distribution (Products Currently Licensed)

- Majority of doses to be distributed by the end of October
- 40 million doses by October 13
- 75 million doses by end of October (est.)
- This is ~15 million doses more than were delivered by the end of October in 2005
- Goal:  Provide some vaccine to all who ordered it (by the end of October)
- Virtually all doses distributed by end of Nov/Dec

**Notes:**
26 million doses distributed by end Sept.  

## Vaccination

- Vaccine available in communities in Oct
- Optimal time to vaccinate is Oct and Nov
- High risk and children needing 2 doses should start in September
- Vaccination should continue in Dec and later (flu season Oct-May)
- To ensure supply, schedule additional vaccination clinics in Nov and Dec

**Notes:**
We expect that you will all have influenza vaccine by October, and perhaps earlier.  The optimal time to vaccinate is October and November.  One priority group in particular we have always recommended waiting until October, those in nursing homes.  We recommended continuation of vaccination in December and later (we made a specific recommendation this year, directed to those who organize influenza clinics, to schedule one such clinic in December).   Do we want to add something about: Medicare covering the cost of the vaccine for Medicare beneficiaries?  (Per partnership communication with Administration on Aging)

## Gallup Survey 2005

- Among those who received the flu shot, Where did you get your flu shot?
- 39% Dr office/HMO
- 17% Workplace
- 10% Other clinic/health center
- 10% Store (grocery/pharmacy)
- 8% Health Department
- 6% Hospital
- 4% Senior/Recreation center
- 4% Other
- 2% School

**Notes:**
Slide 5:  The data in this slide come from a telephone survey of adults conducted in the fall of 2005 and illustrate the fact that physician offices are the most commonly reported place of influenza vaccination, but that a large number of other venues are reported as well.  
Before leaving this slide, I also wanted to point out that, during the 2005-06 season, 10% of adults surveyed reporting receiving their influenza vaccination in a store.

## Influenza Vaccine:Medicare

**Medicare covers flu vaccine for free**
**Beneficiaries in managed care plan - ~15% pop (e.g., Medicare Advantage)**
**	****	****- need to receive shots within plan **
**Beneficiaries in fee for service can receive in any setting that takes Medicare**

**Notes:**
For adults that receive Medicare, Medicare will cover influenza vaccine for free.  It is important to note that fifteen percent of Medicare beneficiaries belong to Medicare Advantage, a joint Medicare/managed care plan.  If patients in this plan want Medicare to cover the cost of their vaccine they must receive their vaccine within the plan (in the managed care clinic).  Beneficiaries in the fee-for service Medicare plan can receive their vaccine in any setting that takes Medicare.  

## Influenza Vaccine Supply

**More vaccine available this season compared to any previous season**

**Notes:**
Take home message, we expect to have more vaccine available this season compared to any previous season.  

## Influenza Vaccine Production and Distribution, US, 1980-2005

|  | Doses Produced (millions) | Doses Distributed (millions)  |
| --- | --- | --- |
| 1980 | 15.7 | 12.4 |
| 1985 | 23.1 | 20.1 |
| 1990 | 32.3 | 28.3 |
| 1995 | 71.5 | 54.9 |
| 1999 | 77.2 | 76.8 |
| 2000 | 77.9 | 70.4 |
| 2001 | 87.7 | 77.7 |
| 2002 | 95.0 | 83.0 |
| 2003 | 86.9 | 83.1 |
| 2004 | 61.0 | 56.5 |
| 2005 | 86.0 | 81.2 |

**Notes:**

Slide 3:  As this group is well-aware, influenza vaccine production and distribution in the US is largely a private sector activity.  The primary exception to this being state-distribution of publicly purchased influenza vaccine, which as we’ll discuss in a minute, represents a relatively modest amount of the annual influenza vaccine sold each year. 
This slide illustrates influenza vaccine production and distribution totals during the past 25 years.  As you can see, total production has increased substantially since 1980.  In addition, you’ll see that, in any given year, a percentage of doses remain undistributed at the end of the year.  In the past five years, this percentage has ranged between 4-13%.

## Cumulative Monthly Influenza Vaccine Distribution

- Doses (Millions)

**83**

**81.2**

**Notes:**
This graph, produced by Greg Wallace at CDC, shows the timing of influenza vaccine distribution by month for 2000, 2002, 2004, and 2005.  The white dotted oval will help you to focus on the month of October, a time when vaccination activities are solidly underway and when delays in vaccine arrival begin to become increasingly problematic.

The light blue line represents 2000, a season in which there was a delay that resulted in only about 30% of doses being delivered by the end of October.  In contrast, the orange line represents 2002, a season in which nearly 100% of doses were distributed by the end of October.  

The most recent season, shown in yellow, falls somewhat between 2000 and 2002 in terms of vaccine availability during October.

## Anticipated Supply Problem:  Vaccine for 3 Year Old Cohort 

- CDC anticipates that providers may be unable to obtain sufficient vaccine for their 3 year old patients
- Single supplier of vaccine for this age-group (sanofi)
- Timing of expanded recommendation (occurred after pre-booking period)
- For providers without sufficient vaccine for all 6-59 month olds, CDC recommends providers consider prioritizing 6-23 months olds.

**Notes:**
The yes part of the answer is based on CDC’s anticipation that providers may be unable to obtain sufficient vaccine for their 3 year old patients, both because there is only a single supplier of vaccine for this age group and because the formulations indicated for this group were largely pre-booked at the time the recommendation was made.

ACIP has added healthy 24-59 month olds into the priority table, as I mentioned earlier, and CDC recommends that providers without sufficient vaccine for all 6-59 month olds consider prioritizing healthy 6-23 month olds over healthy 24-59 month olds because of the increased risk of hospitalizations in the younger group.

## Key Concepts in the Development of Messages about  Supply/Distribution

- Talk about distribution in terms of actual timing, rather than using terms like “delay”
- What is a “normal” or “good season” is ambiguous
- Setting realistic expectations
- Don’t want to deter the public from seeking vaccination
- Address the misconception that it is too late to be vaccinated in** **December and beyond, while still emphasizing the benefits of October/November vaccination

**Notes:**
Jeanne, you can say that our campaign involves ongoing media outreach that will continue into December -- and January if necessary.  

## Communications  

## Reasons Why People Don’t Get Flu Vaccinations– Even if they should

**“****Influenza vaccination is for ‘other’ people.”**
**“****Influenza isn’t a very serious illness or disease.”**
**“****I got the flu shot and I got the flu” or “I got the flu shot and I got sick shortly thereafter.”**
**“****I wasn’t aware I needed a flu vaccination.”**
**“****My doctor didn’t recommend one.”**
**Concerns about vaccine safety.**

**Notes:**
We have also learned that several messages we have used to increase influenza immunization among people at high risk for severe illness have had unintended consequences. Through focus groups conducted over the past several years, we have found that many people who do not usually receive an annual influenza vaccination nevertheless recognize that immunization vaccine is recommended for people 65 and older and for younger people with certain medical conditions. However, in their mind, these messages fostered the perception that immunization was recommended for seniors and people in generally poor health. If they weren't elderly, or didn't perceive themselves to be elderly, or if they considered themselves to be healthy and active, people tended not to think that they ought to get vaccinated. These included participants in focus groups of people with chronic health conditions and of people who were 65 and older, who often said that influenza vaccination is for older people, but upon questioning defined “older” as people in their 80s. 

## Even among health-care workers. . .

- Reasons registered nurses cited for not getting an influenza vaccination:
- “If you get the flu, your body will work it out, and then you’ll have the antibody.”
- “We are people who aren’t often ill. . .We get immune by being around sick people– we work with all these sick people and don’t get sick.”
- “They just want to keep the workforce healthy.  They don’t want lots of healthcare workers out sick.”

**Notes:**
Perhaps the most troubling mixed message related to annual influenza immunization is its relatively low uptake among health care professionals3 (42% coverage rate in 2004)

##   Characteristics of a “Crisis”

-   Characteristics of a “Crisis”

##  Characteristics of an Influenza Season

-  Characteristics of an Influenza Season

## Utilize Crisis Communication “Best Practices”

**Acknowledge uncertainty**** (e.g., “as we’ve learned in the past few years, there is always some uncertainty regarding influenza vaccine supplies”)**
**Share dilemmas**** (e.g., “We want and need your help”)**
**Express empathy**** (e.g., “We are sorry this is frustrating for so many people.”)**
**Tolerate uncertainty**** (e.g., “Life is unpredictable. We don’t know what is going to happen, so we’re developing a number of plans.”)**
**Model desired responses and behaviors**** (e.g., “The situation will evolve– and so will our advice.” “We all need to be flexible, patient, and persistent.”)**

## Use Communication Strategies and Messages that are Characterized by. . .

- Mutual respect and empathy
- Language, images, and viewpoints that audience members use and understand
- Commitment to helping people achieve and maintain good health – even if they aren’t favorably predisposed to flu vaccination
- Recognition that individual health-related decisions may be based more on values than on evidence

## Key Messages

**Influenza is a serious disease**
**Influenza related deaths average 36,000 per year and hospitalizations average 200,000 per year**
**Getting an influenza vaccination every year is your best protection against a serious disease**
**Who should get vaccinated**
**Anyone who wants to reduce their chances of getting the flu can get vaccinated**
**Your flu vaccination helps protect others**
**October and November are the best months to get vaccinated – however, vaccination in December or later can also be beneficial**

## Influenza Vaccine: Communication with Patients (adults)

**It takes two weeks for the vaccine to become protective**
**It is possible to be infected with influenza virus after vaccination**
**Therefore, people can develop influenza disease after being vaccinated**
**Other microbes besides influenza cause influenza-like illness**

**Notes:**
We feel that the following communication points are particularly effective on this point.  First, it takes two weeks for the influenza vaccine to stimulate an antibody response so that a patient is protected from influenza virus.  It is definitely possible to become infected with influenza virus after vaccination within this two week period, remember, it is possible that the peak of the influenza-disease season could occur concurrently with our vaccination season.    Therefore, people can develop influenza disease after being vaccinated, and it has nothing to do with the vaccine nor a lack of vaccine effectiveness.  Lastly, it’s important to convey that other microbes besides influenza can cause influenza-like illness, and it’s possible that some patients reporting quote-influenza following vaccination may have been infected with another microbe.  

## Influenza Vaccine: Communication with Patients (parents of children)

**It takes two weeks for the vaccine to become protective**
**Other microbes besides influenza cause influenza-like illness, but the vaccine only prevents illness caused by the influenza virus**
**Children <6 month of age are the pediatric group at highest risk of influenza complications, but this group cannot receive the vaccine.  Therefore, it is particularly important to vaccinate all household contacts and other caregivers of children <6 months.**
**Vaccination is also recommended for household contacts and out-of-home caregivers of ALL children 6-59 months and of older children and adults at increased risk of influenza complications**

## Influenza Vaccine:

***Begin vaccinating when you have vaccine!***
***Get vaccinated yourself!***

**Notes:**
Based on our anticipation of ample vaccine supply our take home message is: begin vaccinating when you have vaccine.  And, because the group listening today are among the health care providers most likely to see patients in need of influenza vaccine because of the high risk of morbidity and mortality, please, vaccinate yourself before you see your first patient!

## Influenza Vaccine: Communication with Patients

***Influenza vaccine cannot cause influenza****** ***

**Notes:**
Lastly, when communicating with your patients, we hope you relay the important message that the influenza vaccine cannot cause influenza.  The fear of acquiring influenza disease from influenza vaccine is a common myth that requires education every year. 

##  Free Posters and Flyerswww.cdc.gov/flu/gallery

## Posters Targeting Children

- www.cdc.gov/flu/gallery