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Webinar Objectives

Discuss messaging that responds to concerns about the effectiveness of 2012-2013 influenza vaccine

Review the new influenza vaccine options that will be available during the 2013-2014 influenza season

Provide a brief update on the current H7N9 situation

.

Looking Ahead to the Next Flu Season: Vaccine Options and Messages

Polling Question

A nationwide ‘virtual’ immunization community of health educators, public health communicators and others who promote immunizations.

Is there any way to put a screen shot in here to help people know where / how they can ask a question?

Polling Results

Lisa Grohskopf, MD Medical Officer, Influenza Division, National Center for Immunization and Respiratory Diseases

TITLE of PRESENATION New Influenza Vaccines

For 2013-2014

Lisa A. Grohskopf, MD, MPH Medical Officer

Influenza Division, CDC

New Influenza Vaccines for 2013-2014

National Center for Immunization and Respiratory Diseases Influenza Division

Influenza Vaccines Available for 2012-2013

MMWR 2012; 61(32):613-618. (See also Table footnotes).

Influenza Vaccine Abbreviations

TIV (Trivalent Influenza Vaccine) replaced with IIV (Inactivated Influenza Vaccine): IIV refers to inactivated influenza vaccines as a class Includes trivalent (IIV3), both egg-based and cell-culture-based,

and quadrivalent (IIV4) inactivated vaccines; Cell-culture-based IIV is referred to as ccIIV/ccIIV3;

RIV refers to recombinant HA influenza vaccine (available as a trivalent, RIV3, for 2013-14);

LAIV refers to Live-Attenuated Influenza Vaccine (available as a quadrivalent, LAIV4, for 2013-14).

Overview of 2013-2014 Influenza Vaccines As in previous seasons, a variety of options for many recipients No preferential recommendations Inactivated Influenza Vaccine (IIV), Standard dose

Formulations available for person 6 mos. and older BUT age indications differ by brand—consult package inserts) Trivalent and quadrivalent available for 2013-14 Contain 15 mcg of hemagglutinin (HA) per vaccine virus strain (total of 45 mcg for

trivalent, 60 for quadrivalent)

High dose IIV Contains 60 mcg of HA per vaccine virus strain Trivalent only

Intradermal IIV For persons aged 18 through 64 yrs. Trivalent only

LAIV For healthy, non-pregnant persons 2 through 49 yrs. Quadrivalent only for 2013-14

Recently-approved Influenza Vaccines

Quadrivalent vaccines: Contain 2 Influenza B vaccine virus strains (one from each lineage) Quadrivalent Live-attenuated Influenza Vaccine (LAIV4)—Flumist®

Quadrivalent (MedImmune) Quadrivalent Inactivated Influenza Vaccine (IIV4)—Fluarix®

Quadrivalent (GSK)

Vaccines using non-egg-based production methods: Cell-culture based inactivated influenza vaccine (ccIIV3)—Flucelvax®

(Novartis) Recombinant hemagglutinin vaccine (RIV3)—FluBlok® (Protein

Sciences)

Recently-approved Influenza Vaccines All newly approved influenza vaccines expected to be

available for 2013-2014 are acceptable alternatives to the other licensed vaccine products, within specified indications.

No formal preferential recommendation is proposed for one vaccine product over another where more than one is appropriate for a given recipient.

Quadrivalent LAIV (LAIV4) Flumist Quadrivalent (MedImmune)

Recommendations same as those for trivalent LAIV

• Healthy, non-pregnant persons aged 2-49 years • Persons caring for individuals who are severely immunosuppressed (e.g.,

requiring a protective environment, such as bone marrow transplant patients) should receive IIV, or avoid contact for 7 days following vaccination

Acceptable alternative to other licensed influenza vaccines within the recommended groups

Quadrivalent IIV (IIV4) Fluarix Quadrivalent (GSK)

Approved for persons aged 3 years and older

Both trivalent and quadrivalent formulations of Fluarix® are expected to

be available for 2013-2014, as well as the many previously available brands of trivalent inactivated influenza vaccines

Acceptable alternative to other licensed products, used within indications

Cell-culture Based IIV (ccIIV3) Flucelvax (Novartis)

Indicated for persons aged 18 years and older

Vaccine viruses propagated in cell culture rather than eggs

Vaccine viruses for ccIIV are not propagated in eggs; however, initial

reference strains provided by WHO have been passaged in eggs • Cannot be considered egg-free, though expected to contain considerably

less egg protein than other IIVs

Acceptable alternative to other licensed products, used within indications

Recombinant HA Vaccine (RIV3) FluBlok (Protein Sciences).

Indicated for persons aged 18 through 49 years.

Contains recombinant hemagglutinin (HA) produced in an insect cell

line using a baculovirus vector

RIV3 is an acceptable alternative to other licensed products, used within indications.

For more information please contact Centers for Disease Control and Prevention 1600 Clifton Road NE, Atlanta, GA 30333 Telephone, 1-800-CDC-INFO (232-4636)/TTY: 1-888-232-6348 E-mail: cdcinfo@cdc.gov Web: www.cdc.gov

Thank You

National Center for Immunization and Respiratory Diseases Influenza Division.

Joseph Bresee, MD Chief, Epidemiology and Prevention Branch, Influenza Division, at the Centers for Disease Control and Prevention

Measurement of Vaccine Effectiveness Against Influenza in

the United States

April 2013

Joseph Bresee Epidemiology and Prevention Branch

Influenza Division National Center for Immunization and Respiratory Diseases

CDC

Measurement of vaccine effectiveness against

influenza in the United States

CDC’s Influenza Division program to measure influenza vaccine effectiveness in the U.S.

Emerging Infections Program

New Vaccine Surv. Network

US VE Network - 1

US VE Network - 2

03-04 05-06 09-10 11-12 07-08

6 – 23 m Hosp.

Adults >18 y Hosp.

ACIP recommended groups MAARI

All Ages MAARI

6–59m Hosp.

6 – 59 mo. OP, Hosp.

Marshfield Clinic, WI

ACIP recommended groups - MAARI

Adults > 50 y Hosp.

Special studies HCWs, Peds. ICU, Pregnant

08-09 06-07 04-05 10-11

Influenza season

12-13

School Household

VE

US Flu VE Network

Sites Five medical systems and geographic regions:

– Group Health Cooperative (WA) – Marshfield Clinic (WI) – Scott & White Healthcare (TX) – University of Michigan (MI) – University of Pittsburgh (PA)

Enrollees Children and adults with medically attended acute respiratory illness (MAARI)

Purpose Estimate VE for prevention of healthcare visits due to influenza, by age group and type/subtype • Not designed to develop product-specific estimates

Mid-season Adjusted Estimates of Seasonal Influenza Vaccine Effectiveness — United

States, February 2013

Influenza Division

ACIP February 21, 2013

National Center for Immunization & Respiratory Diseases Influenza Division

US Flu VE Network: Methods Purpose: Estimate VE for prevention of outpatient

healthcare visits due to influenza Design: Prospective case-control study Cases: Medically attended ARI and RT-PCR influenza Controls: Medically attended ARI but negative for

influenza Sites: 5 sites in the US (WA, TX, PA, MI, WI) Interim vaccination status: Confirmed by medical record

or registry (3 sites) and by self-report (2 sites) Immunization: 1+ dose of vaccine ≥14 from illness onset Analysis: VE = (1 – adjusted OR) x 100% Standard covariates: age, site, and days from illness onset

to enrollment Adjusted for potential confounding by race/ethnicity and

lf d h l h

Numbers of influenza-positive medically attended ARI cases (orange bars) and influenza-negative controls (blue bars) by

week of illness onset

Week 3 only includes patients with completed laboratory tests and thus does not reflect all enrolled patients during that week across study sites.

27

81

126

192 215

325

149

112

198 181

234

321 348

188

0

50

100

150

200

250

300

350

400

49 50 51 52 1 2 3

Num

ber E

nrol

led

MMWR Week, 2012-13

Cases Controls

Cases enrolled by (sub)type to date

Among the 751 influenza A virus infections, 560 (75%) have been subtyped to date; 546 (98%) were due to A(H3N2) viruses.

Influenza B, 366

Influenza A(H1N1)pdm, 14

Influenza A(H3N2), 546

Influenza A subtype pending,

191

Mid-season adjusted VE (95% CI) against A and B

64%

52%

63%

27%

0% 10% 20% 30% 40% 50% 60% 70% 80% 90%

6 mo. - 17 years

18-49 years

50-64 years

65+ years

Interim Season 2012-13

Mid-season adjusted VE (95% CI) against A(H3N2) only and B only by age

58%

46% 50%

9%

64% 68% 75%

67%

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

6 mo. – 17 years

(179; 565)

18 – 49 years

(183; 604)

50-64 years

(96; 248)

65+ years

(86; 165)

6 mo. – 17 years

(59; 565)

18 – 49 years

(17; 604)

50-64 years

(8; 248)

65+ years

(6; 165)

Influenza A(H3N2) only Influenza B only

Age: (cases; controls)

Conclusions Adjusted VE against influenza A and B was 56% (47-63%)

• Similar to earlier unadjusted VE of 62% (51-71%) against A and B

Vaccination reduced the risk of outpatient medical visits: • Due to influenza A(H3N2) by half (47%); consistent for ages <65

• Due to influenza B by two-thirds (67%); consistent for all ages

Similar to other interim estimates from this season • Canada: VE against A(H3N2) = 45% (13%–66%)

• UK: VE against A = 49% (-2%-75%) and against B = 52% (23%-70%)

• I-MOVE: VE against A and B = 62% (21%-82%)

Conclusions Sub-optimal VE against A(H3N2) among adults aged 65+

• Similar to interim VE against A(H3N2) among elderly in Denmark

Limits and next steps • Pending full enrollment from entire season • Missing chronic medical conditions, vaccine type, and prior

vaccination status until final data set • Additional potential confounders will be considered

Implications • Opportunity to expand beneficial vaccination, especially among

younger age groups • Important to recognize illness and treat with antiviral medications,

especially among older adults • Need more effective vaccines and vaccination strategies • Need better understanding of factors that modify VE • VE this season has to be considered in the context of other

seasons, strains, and outcomes

Adjusted VE (95% CI) against circulating strains by season in US Flu VE Network

58%

69%

51% 51%

36% 45%

58%

44%

54%

43%

64%

52%

63%

27%

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

6 mo. - 2

years

3-8 years

9-49 years

50-64 years

65+ years

6 mo. - 8

years

9-17 years

18-49 years

50-64 years

65+ years

6 mo. - 17

years

18-49 years

50-64 years

65+ years

Season 2010-11 Season 2011-12 Interim Season 2012-13

Key points related to Influenza Vaccine Effectiveness Program at CDC

• Robust system for measuring VE • Most seasons, able to estimate overall VE as well as age group-

specific VE • Able to formulate rapid (intra-season) VE estimates

• Important for seasonal and pandemic communications • Geographically dispersed sites – so mitigates risk of

geographic variability in disease occurrence • During 2009 H1N1 pandemic

• Sites mobilized quickly and effectively despite early onset of disease

• Able to initiate special project to address VE in specific populations to augment understanding of vaccine performance

• Late arrival of vaccine compared to disease limited ability to conduct subgroup analyses

Conclusions • CDC plans to estimate overall and age-group-specific VE for

pandemic vaccine during the next pandemic – Using existing seasonal VE program platforms, primarily

• CDC can’t guarantee that product-specific VE estimates will be derived from its work during the next pandemic – Sample size available:

• number of sites/cases in current systems • late delivery of vaccines compared with disease • Limited ability to expand during a severe pandemic • Limited ability to maintain a larger system in advance of a

pandemic • Human resource challenges during a severe pandemic

– Distribution of vaccine products uncertain • Will continue to plan for pandemic VE work, and this

conclusion could be modified in the future – Ex. VE among first responders

THANK YOU

Q & A Session

Kris Sheedy, PhD Associate Director for Communication Science at the Centers for Disease Control and Prevention

TITLE of PRESENATION Communicating About Current Influenza

and Seasonal Flu Vaccine Issues

Kristine Sheedy, PhD Associate Director for Communication Science

April 16, 2013

National Center for Immunization & Respiratory Diseases Health Communication Science Office

Communicating about Current Influenza and Seasonal Flu Vaccine

Communication Issues

Objectives

Describe current H7N9 communication priorities and activities

Share seasonal flu vaccine effectiveness and quadrivalent vaccine messages

Discuss CDC 2013-14 seasonal influenza communications planning activities

H7N9 Current Communication Priorities and Considerations

• Sharing what we know when we know it • Communicating the many uncertainties that exist and

steps we are taking • Striking a balance - must continue to avoid temptation to

over-reassure, but must also avoid being alarmist • Responding to high media interest (public interest lower)

– US public interest may increase significantly and quickly if domestic cases are identified or in the event of sustained human-to-human transmission

• Foreshadowing (or responding to) news of limited human-to-human transmission and providing perspective

• Providing updates on CDC’s work with virus isolate

Current H7N9 Communication Channels and Resources

• Primary channels being used at this time to share information about H7N9: – Distribution of key points

• To be added to our distribution list, please write to us at fluuinbox@cdc.gov

– News media • Transcripts of media briefings are posted on our news

media website (cdc.gov/media)

– CDC website (cdc.gov/flu) – Social media (mainly Twitter) – Conference calls and webinars for partners

2012-13 Seasonal Flu Vaccine Effectiveness

• Last season, vaccination provided moderate protection against influenza illness, reducing the risk of having to go to the doctor from flu by more than half across all age groups. – Flu vaccination, even with moderate effectiveness, can also

reduce: flu-related illness, antibiotic use, time lost from work and school, hospitalizations, and deaths.

• Unfortunately, last season’s vaccine worked much less well in people 65 and older against influenza A H3N2. – It’s possible that people 65 and older did not mount a good

immune response to the H3N2 antibody in the 2012-2013 vaccine.

Seasonal Flu Vaccine Effectiveness: February 2013 Headlines

• “Flu shot doing poor job of protecting elderly” Associated Press

• “CDC says flu vaccine barely worked in over-65s this year” - NBC News

• “Flu vaccine barely worked in people 65 and older” – USA Today

• “Flu vaccine worked in just over half of Americans who got it” - Reuters

Flu Vaccine Effectiveness Messages: Communicating Variability

• How well the flu vaccine works can vary by year. • The two biggest factors impacting how well the vaccine

works are – if the vaccine viruses are matched to viruses causing illness – the health of the person being vaccinated.

• Studies show that with a good match, flu vaccine can reduce the risk of having to go to the doctor for flu by about 60% among the overall population. – This number may be higher for some groups of people and lower

for others. For example, older people with weaker immune systems may respond less well to vaccination.

• When the flu vaccine is not well matched to circulating viruses, possible that no benefit may be observed.

Flu Vaccine Effectiveness: Messages for Older Adults

• We are concerned that the news about last season’s vaccine may keep some older adults from seeking vaccination during the upcoming season.

• It has been recognized for many years that people 65 years and older are at greater risk of serious complications from the flu compared with young, healthy adults.

• It's estimated that 90 percent of seasonal flu-related deaths and more than 60 percent of seasonal flu-related hospitalizations in the US each year occur in people 65 years and older.

• The best way to prevent the flu is with a flu vaccine. • People 65 years and older may choose a regular dose flu

vaccine or a newer flu vaccine designed for people 65 and older with a higher dose.

Flu Vaccine Effectiveness: Messages for Older Adults

• Unlike the 2012-13 season, during other seasons, studies have measured a reduced risk among vaccinated people 65 and older of having to go to the doctor from flu.

• There also is some data that vaccination can make your illness milder if you do get sick.

• Vaccination also can reduce the risk of more serious flu outcomes like hospitalizations and deaths.

• Even if you’ve been vaccinated, – take everyday preventive actions including covering coughs,

washing hands often, and avoiding people who are sick. – seek medical advice quickly if you develop flu symptoms to see

whether you might need medical evaluation or treatment with antiviral drugs.

Sample Quadrivalent Flu Vaccine Messages

• Quadrivalent flu vaccines are designed to protect against four different flu viruses. For years, flu vaccines have been trivalent, or designed to protect against three different flu viruses.

• Adding an extra virus to the vaccine should give broader protection against influenza each season.

• There are many different flu viruses that spread each season. Most fall into four main groups: two “influenza A” groups and two “influenza B” groups. Trivalent flu vaccines protect against the two A viruses and one of the B viruses.

• For years, experts had to choose between the two very different B viruses to add to trivalent vaccines, even though both groups of B viruses spread every year. This left people unprotected against the second group of B viruses. By adding another B virus to the vaccine, quadrivalent vaccine may give broader protection.

Sample Quadrivalent Flu Vaccine Messages

• Quadrivalent flu vaccines are available as both a nasal spray and a shot. – In 2012, the FDA approved FluMist® Quadrivalent; approved for

healthy people 2 through 49 years of age who are not pregnant – In 2012, the FDA approved Fluarix® Quadrivalent; approved for

people 3 years of age and older

• Quadrivalent vaccines are made in the same way that trivalent flu vaccines have been made for many years. The only difference is the addition of another vaccine virus.

• Studies have shown that quadrivalent vaccines have a similar safety profile as seasonal trivalent flu vaccines, with similar—mostly mild—side effects. Hundreds of millions of people have safely gotten trivalent flu vaccines.

Sample Quadrivalent Flu Vaccine Messages

• Most flu vaccines available during the 2013–14 flu season will still be trivalent.

• All nasal spray vaccine will be quadrivalent vaccine.

• Some quadrivalent flu shots will be available, but most will still be trivalent.

• Additional quadrivalent vaccines are being developed.

• In the future, quadrivalent flu vaccines may replace trivalent vaccines.

Preparing for the 2013-14 Influenza Season

• Conducting a nationally representative survey to assess – Perceptions of this past flu season, vaccination

behaviors, beliefs and attitudes toward flu vaccine, and more

• Will conduct on-line and limited in-person focus groups to – Explore knowledge, attitudes and beliefs about

influenza and flu vaccines – Test flu vaccine effectiveness and quadrivalent flu

vaccine messages – Test creative concepts for flu vaccine promotion

campaign • Will share results and plans

Preparing for the 2013-14 Influenza Season

• Planning to participate in National Foundation for Infectious Diseases (NFID) annual influenza vaccination press event in late September

• 2013 National Influenza Vaccination Week (NIVW) will be held December 8-14

• Free evergreen flu vaccine promotional materials are for use/download/order now at cdc.gov/flu/freeresources – Print – Video/audio – Web tools – Mobile content and apps – Images

fluinbox@cdc.gov

1600 Clifton Road NE, Atlanta, GA 30333 Telephone: 1-800-CDC-INFO (232-4636)/TTY: 1-888-232-6348 E-mail: cdcinfo@cdc.gov Web: http://www.cdc.gov The findings and conclusions in this report are those of the authors and do not necessarily represent the official position of the Centers for Disease Control and Prevention.

National Center for Immunization & Respiratory Diseases Health Communication Science Office

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Resources

National Influenza Vaccination Disparities Partnership

www.cdc.gov/flu/nivw/disparities.htm

National Adult and Influenza Immunization Summit www.preventinfluenza.org

Resources

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www.familiesfightingflu.org

Resources

www.immunize.org

Immunization Action Coalition

www.shotbyshot.org Shot by Shot – Stories of Vaccine Preventable Diseases

National Public Health Information Coalition www.nphic.org

California Immunization Coalition www.immunizeca.org

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