# Presentation: 590252

## Seasonal Influenza Vaccination:  Looking Ahead Toward the 2007-08 Season

**Jeanne M. Santoli (jsantoli@cdc.gov)**
**Immunization Services Division**
**National Center for Immunization and Respiratory Diseases**
**June 7, 2007**

## Outline

**Recommendations**
**Anticipated supply**
**Promotional activities**
**Annual campaign**
**National Influenza Vaccination Week**

## Highlights of the 2007 Recommendations

_**Change to vaccine composition (new H1N1 component)**_
- Continue to recommend against the use of adamantanes (amantadine, rimantadine)
- No change in the groups recommended for vaccination
- Change in recommendations for children ages 6 months to <9 years who received a single dose during their first (previous) year of vaccination
- New: recommended to receive 2 doses in second year of vaccination
- Emphasize the need to continue vaccination beyond the traditional months of October and November
- Emphasize the importance of vaccinating healthcare workers

**Notes:**
A/Solomon Islands/3/2006-like (H1N1)* 

A/Wisconsin/67/2005-like (H3N2)

B/Malaysia/2506/2004-like

Feb 20, 2007 (CIDRAP News) – Because of changes in the influenza viruses now in circulation, the World Health Organization (WHO) has recommended changing one of the three viral strains to be used in flu vaccines in the Northern Hemisphere next fall and winter. 
The WHO is recommending changing the influenza A/H1N1 strain in the vaccine for the first time since the 2000-01 season. The agency recommends a Solomon Islands strain of H1N1, replacing a New Caledonia strain. The New Caledonia strain of H1N1 had been recommended for the previous 7 years. 
The other two recommended strains remain the same as last year. They are a Wisconsin strain of influenza A/H3N2 and a Malaysia strain of influenza B. The WHO had changed the H3N2 strain the past 3 years and changed the B strain last year. 

## Highlights of the 2007 Recommendations

- Change to vaccine composition (new H1N1 component)
_**Continue to recommend against the use of adamantanes (amantadine, rimantadine)**_
- No change in the groups recommended for vaccination
- Change in recommendations for children ages 6 months to <9 years who received a single dose during their first (previous) year of vaccination
- New: recommended to receive 2 doses in second year of vaccination
- Emphasize the need to continue vaccination beyond the traditional months of October and November
- Emphasize the importance of vaccinating healthcare workers

**Notes:**
Oseltamivir and zanamivir (neuraminidase inhibitors) can still be used if antiviral treatment is indicated.

For treatment:
Oseltamivir is approved for children >= 1 year, Zanamivir for children >= 7 years 
For prophylaxis:
Oseltamivir is approved for children >= 1 year, Zanamivir for children >= 5 years

## Highlights of the 2007 Recommendations

- Change to vaccine composition (new H1N1 component)
- Continue to recommend against the use of adamantanes (amantadine, rimantadine)
_**No change in the groups recommended for vaccination**_
- Change in recommendations for children ages 6 months to <9 years who received a single dose during their first (previous) year of vaccination
- New: recommended to receive 2 doses in second year of vaccination
- Emphasize the need to continue vaccination beyond the traditional months of October and November
- Emphasize the importance of vaccinating healthcare workers

## Recommended Groups, I

*Efforts should target these groups  *_*if vaccine supply is limited*_*:*
- Children aged 6–59 months
- All persons aged _>_50 years
- Household contacts (including children) and caregivers of infants who are younger than 6 months old
- Children and adolescents on long-term aspirin therapy
- Pregnant women
- Adults and children who have chronic diseases
- Immunosuppressed adults and children
- Adults and children with a condition that can compromise respiratory function, handling of respiratory secretion, or increase the risk for aspiration
- Residents of nursing homes and other chronic-care facilities.

**Notes:**
All persons in the following groups should receive annual influenza vaccination.  Efforts
should focus on delivering vaccination to these persons if vaccine supply is limited:
•	All children aged 6–59 months (i.e., 6 months to <5 years of age);
•	All persons aged >50 years;
Healthy household contacts (including children) and caregivers of infants who are younger than 6 months old
•	Children and adolescents (aged 6 months–18 years) who are receiving long-term aspirin therapy
•	Women who will be pregnant during the influenza season; 
•	Adults and children who have chronic diseases, including pulmonary (including asthma), cardiovascular (except hypertension), renal, hepatic, hematological or metabolic disorders (including diabetes mellitus); 
•	Immunosuppressed adults and children (including immunosuppression caused by medications or by human immunodeficiency virus [HIV]);
•	Adults and children who have any condition (e.g., cognitive dysfunction, spinal cord injuries, seizure disorders, or other neuromuscular disorders) that can compromise respiratory function, handling of respiratory secretion, or increase the risk for aspiration
•	Residents of nursing homes and other chronic-care facilities.

## Recommended Groups, II

- In addition, _to prevent transmission_ to persons such as those at increased risk of complications, the following groups are recommended for annual influenza vaccination with TIV or LAIV unless contraindicated:
- Healthcare Workers
- Healthy household contacts (including children) and caregivers of
- Children 6-59 months of age, adults _>_50 years
- Children and adults with medical conditions that put them at increased risk for severe complications from influenza

## Emphasizing the Permissive Component of the Seasonal Recommendations  

- 	Vaccination is recommended for persons, including school-age children, _who want to reduce the likelihood of becoming ill with influenza or transmitting influenza to others_ should they become infected.

**Notes:**
Change this year is emphasis on permissive component of recs, placed up front, before listed priority groups on past two slides.

## Highlights of the 2007 Recommendations

- Change to vaccine composition (new H1N1 component)
- Continue to recommend against the use of adamantanes (amantadine, rimantadine)
- No change in the groups recommended for vaccination
_**Change in recommendations for children ages 6 months to <9 years who received a single dose during their first (previous) year of vaccination**_
_**New: recommended to receive 2 doses in second year of vaccination**_
- Emphasize the need to continue vaccination beyond the traditional months of October and November
- Emphasize the importance of vaccinating healthcare workers

## Recommendations for Childhood Vaccination

- Longstanding recommendation:  first time vaccinees less than 9 years of age should receive two doses, spaced 4-6 weeks apart
- Those who only received one dose in the first year should receive only one dose the following year
- New data suggests that these children have less benefit (when strains change and when they don’t)
- Beginning with 2007-08 season:  Children who didn’t receive two doses during their initial year of vaccination, should receive two doses the next year.

**Notes:**
Evidence supporting use of 2 doses in second year of vaccination for children ages 6 months to <9 years who received only 1 dose in their first year of vaccination:
Englund et al, Pediatrics 2006: When the influenza B antigen was changed for the second season, children who only received 1 dose in their first season of being vaccinated and 1 dose in second season had decreased immunologic response to the influenza B antigen compared to children who received 2 doses

Allison et al J Pediatr 2006: In consecutive seasons when the influenza vaccine antigens were unchanged, effectiveness against ILI in second season was significantly less for 6-21 month old children being vaccinated for the first time who received 1 dose in both seasons compared to 6-21 month old children in their first season who received 1 dose in first season and 2 doses in second season

## Highlights of the 2007 Recommendations

- Change to vaccine composition (new H1N1 component)
- Continue to recommend against the use of adamantanes (amantadine, rimantadine)
- No change in the groups recommended for vaccination
- Change in recommendations for children ages 6 months to <9 years who received a single dose during their first (previous) year of vaccination
- New: recommended to receive 2 doses in second year of vaccination
_**Emphasize the need to continue vaccination beyond the traditional months of October and November**_
- Emphasize the importance of vaccinating healthcare workers

## Month of Peak Influenza Activity, US 1976-2006

**US WHO Collaborating Centers (CDC, unpublished data).  Peak week defined as week with greatest % of positive specimens for influenza on basis of three-week moving average.**

**Notes:**
As these data indicate, peak has been Jan or later in 80% of seasons and Feb or later in 60% of seasons.

Prior recommendations indicated that optimal timing for vaccination was October and November

Timing of vaccine production and distribution has been increasingly challenging for many of the past seven seasons

ACIP recommendations this year emphasize that vaccination should start as soon as vaccine becomes available and extend into December, January and beyond.  Optimal months not listed. 

Health care providers should be alert to potential vaccination opportunities during all healthcare encounters 

Organized campaigns should be scheduled through December and later if feasible

## Highlights of the 2007 Recommendations

- Change to vaccine composition (new H1N1 component)
- Continue to recommend against the use of adamantanes (amantadine, rimantadine)
- No change in the groups recommended for vaccination
- Change in recommendations for children ages 6 months to <9 years who received a single dose during their first (previous) year of vaccination
- New: recommended to receive 2 doses in second year of vaccination
- Emphasize the need to continue vaccination beyond the traditional months of October and November
_**Emphasize the importance of vaccinating healthcare workers**_

**Notes:**
Key points:

All HCWs and trainees should be vaccinated

Facilities that employ HCWs should use strategies to enhance vaccination uptake and should consider HCW vaccination as a measure of patient safety

HCW vaccination rates should be measured, reported, and disseminated to staff, administration

LAIV can be used in HCW, except for those in contact with severely immunosuppressed patients cared for in specialized patient-care areas

## Recommendations for the Prevention and Control of Influenza are NOT Static

## Recommendation Changes for Influenza Vaccination: Recent Milestones

**2000: ****	**All adults 50 and older
**2004: ****	**All children aged 6--23 months
- 		All contacts of children aged 0--23 months
- 		All women who will be pregnant during influenza 	season
**2005: ****	**All persons with any condition that can 	compromise respiratory function or the handling 	of respiratory secretions** **
**2006: ****	**All children aged 24---59 months and their 	household contacts and out-of-home caregivers

## Potential Time-Frame for Modifying Recommendations

**2007-2008:**  Consider expanding recommendations to include all children (6 months-18 years)
- Address scientific and implementation issues
- Summarize results for the October 2007 ACIP meeting
**2010-2011:**  Possible expansion of recommendations to include household contacts and caregivers of school-aged children
**2012-2013:**  Possible expansion to universal vaccination (extend recommendations to persons 19-49 years)
- Each time recommendations are changed:
- need to assist manufacturers, immunization programs, and public health communication experts in planning implementation

## Meeting to Examine Issues Around Vaccination of School-age Children

**September 10-11 in Atlanta, GA**
**Objectives**
**Review the evidence base supporting expansion of recommendations **
**Identify key data gaps**
**Discuss implementation strategies**
**Meeting summary to be presented to the ACIP in October 2007**

## Projected Production of Influenza Vaccine for 2007-08, US

| Manufacturer | Doses Projected* |
| --- | --- |
| GSK | 30-35 million |
| MedImmune | 7 million |
| Novartis | Up to 40 million |
| sanofi pasteur | 50 million |
| CSL | No estimate provided |
| Total | Up to 127-130 million |

***These estimates are based on presentation made at the National Influenza Vaccine Summit Meeting, Atlanta, GA, April 19, 2007 by the manufacturers listed and reflect upper estimates of production contingent upon consumer demand.**

## More on Supply for 2007-08

**Projections from the 4 currently licensed manufacturers exceed the 2006-07 production by approximately 10 million doses**
**An additional manufacturer has applied for licensure**
**In terms of vaccine for young children**
**Likely to be a similar amount of injectable, p-free vaccine for young children this season**
**An increased amount of LAIV projected, MedImmune has applied for a lower age indication**

## Overall Campaign Goals for the 2007-08 Season

**Promote vaccination to ACIP recommended groups **
**Generate vaccine demand and encourage anyone in the general population who wants to be protected against influenza to be vaccinated**
**Continue to work toward changing public and provider attitudes and behaviors related to vaccination in December, January, and beyond.**

**Notes:**

Traditionally, CDC has focused on outreach to seniors, high risk individuals and household contacts. Our qualitative and survey data show that the public has heard this message. In order to reduce the burden of influenza disease, we continue to recommend this focus and expand our outreach to parents, household contacts and even the general public in anticipation of another year of ample vaccine supply.

Similarly we have encouraged Americans to get vaccinated in October and November. This message has also gotten through well. Given the challenges of the manufacturing and distribution process, and now that our supply is likely to be over 100 million annually, it makes sense to extend the length of the season as much as possible. Last year and over the next few years we will be working through communication to try to expand the public’s perception of when is the right time to get vaccinated.

## Target Audiences: Priority Groups

**Persons 50 and older**
**Hispanic/Latino and African American seniors**
**Persons with chronic disease**
**Moms of preschool age children**
**Close contacts**

**Notes:**

Next year’s campaign will continue to focus efforts on increasing vaccine uptake among those groups recommended by ACIP who are traditionally undervaccinated including persons over 50, minority seniors, and children and adults with chronic diseases

## Target Audiences: Growing Market Share

**Working adults**
**Work through CEOs, CFOs and HR professionals**
**Commuters and travelers**
**Mothers **

**Notes:**

Assuming another year of ample vaccine supply, we plan to build on the work started last year during the National Influenza Vaccination Week to increase substantially the number of adults 18-49 who seek vaccination. 

We believe great opportunity for substantial increase in vaccine uptake is among working adults, particularly by outreach to senior management in the corporate sector and providing tools and resources to employers to help them arrange workplace clinics.

## Annual Campaign Core Elements

**Media outreach and activities**
**NFID press “kick-off” in DC on Sept. 19**
**Radio and television PSAs, matte articles, print ads, media tours**
**Print materials**
**Partnerships**
**Education and outreach to clinicians**
**Web content **_**[www.cdc.gov](http://www.cdc.gov/flu)**__**[/flu](http://www.cdc.gov/flu)**_** and new media outreach**
**Communications research**

## Formative Research

**Explore new late season messages **
**Encourage the public to get their vaccination later without implying they should put it off**
**Assess messages related to vaccine mismatch **
**Test new print materials targeted to healthy adults who have household contact s at high risk**

## Preliminary Focus Group Results

**Participants heard and remember our past messages **
**Messages about vaccination in December and later and about timing of the peak of disease raised several unexpected questions **
**Emphasis on the permissive component of the seasonal recommendations raised skepticism among  many  participants**
**Draft posters with messages about getting vaccinated to protect vulnerable loved ones (particularly babies and children) were highly motivating **
**In the event of a mismatch -  as always - simple and straight-forward recommendations from CDC and providers for people to continue to seek vaccination will be important**

## National Influenza Vaccination Week (NIVW)

**Goal:  Annual event to help raise awareness of the importance of influenza vaccination and the importance of continuing vaccination throughout November and beyond  **
**Planning for 2007-08 NIVW is now underway**
**Designated dates are Nov 26-Dec 2, 2007**

## NIVW Activities

**Flu-mobile stops**
**Arrange public clinics/media events at malls, airports,etc.**
**Audio, video news releases; media tours for CDC spokespersons**
**NIVW on-line toolkit and calendar of events**

**Notes:**
Flu-Mobile – Before, during and following NIVW, the Flu Mobile would visit various states. At key sites, the governor, mayor, a CDC spokesperson and others such as representatives of Families Fighting Flu could address the press, provide data on current disease activity and promote vaccination.

Mall Events – We recommend tapping into the biggest shopping week of the year by partnering with malls and other retailers to conduct flu clinics during NIVW.

Additional NIVW Media Outreach
Video bites and cover package release
Audio bites release
Satellite (video) media tour

## Summing Up, I

**Primary changes to the annual recommendations include**
**Emphasis on permissive recommendation**
**Changes to 2-dose recs for children not fully vaccinated the first year**
**Changes in language about timing of vaccination**
**Meeting in September 2007 to examine issues around expanding childhood vaccination recommendations **

## Summing Up, II

**Vaccine supply for 2007-08 is projected at record high levels (if demand remains high)**
**CDC’s campaign will continue to emphasize and promote late season vaccination to make optimal use of available vaccine to protect children, adolescents, and adults**