New Vaccine

Recommendations

Mark H. Sawyer, MD

University of California, San Diego

Rady Children’s Hospital San Diego

What has happened with vaccines

in the past year?

Influenza vaccine-new products

Tdap vaccination for each pregnancy

Meningococcal conjugate vaccine use in

infants and young children

Meningococcal conjugate vaccine booster for

adolescents

Conjugated pneumococcal vaccine for high

risk older children and adults

Should you take the stairs or the

elevator?

Everyone 6 months of age

and older!

Who should get a flu vaccine?

Who is not getting a flu vaccine?

Group 2011-2012 Coverage

Seniors 70.8%

High Risk Adults 19-64 yo 50%

African American Adults 36%

Hispanic Seniors Adults 39%

Non-Hispanic, White Adults 49%

Pregnant women 49%*

Children 49%

*2010-2011 data

Influenza Vaccines

How do you keep them straight?

Is it an injectable vaccine or a nasal

vaccine?

Is it trivalent or quadrivalent?

Is it made in eggs or in cell culture?

Is it a special product?

What are its age restrictions?

Who makes it/brand name?

Is it injectable or nasal?

IIV-injectable influenza vaccine (TIV is out!)

– Includes both trivalent (IIV3) and quadrivalent

(IIV4) vaccines

– Includes cell culture vaccines

– Includes high dose and intradermal

LAIV-live attenuated influenza vaccine

– Includes both trivalent (LAIV3) and quadrivalent

(LAIV4)

– Only one manufacturer

Strains for the vaccine picked in February for

the coming year

Strain selection based on virus strains circulating

recently around the world

When they are wrong, influenza B strain is often

to blame

Quadrivalent (4 strains) vaccine coming next

year to minimize this problem

They guess the wrong strains to

put in the vaccine half the time

What is a quadrivalent influenza

vaccine? Contains 4 strains of influenza

All current influenza vaccines contain 3 strains; 2 influenza A strains (H1N1, H3N2) and 1 influenza B strain

There are two influenza B strains circulating; Victoria and Yamagata

When the influenza vaccine “doesn’t work” it is often because the influenza B strain is not matched with the predominant strain in the community

New LAIV now FDA approved with 4 strains; 2 influenza A and both Victoria and Yamagata influenza B strains but not available this year

Is it trivalent or quadrivalent?

Currently there are 3 quadrivalent IIV

vaccines expected for 2013-2014.

Companies making IIV4 vaccines will also

have their old IIV3 vaccines on the market

– Fluarix (GSK)

– FluLaval (ID Biomedical Corp)

– Fluzone (Sanofi Pasteur)

LAIV will only be available as quadrivalent

Is it made in eggs?

All are except FluBlok/Protein Sciences

Corp and Flucelvax/Novartis

Flublok is a recombinant vaccine (like Hep

B vaccine) and may be referred to as RIV

Flucelvax is a whole virus vaccine but

made in cells and may be referred to as

ccIIV

Is it a special product?

IIV High dose-Fluzone High Dose/Sanofi

– Recommended for those 65 years of age and

over

– More antigen

– Possibly more local side effects

– No data yet on vaccine efficacy compared to

conventional dose vaccine

IIV Intradermal-Fluzone Intradermal/Sanofi

– Licensed for 18-64 years of age

Influenza Vaccine Abbreviations

Abbreviation

Old

Abbreviation

Vaccine

IIV3 TIV Injectable trivalent

(multiple)

IIV4 TIV Injectable quadrivalent

(multiple)

ccIV3 N/A Cell culture based vaccine/Flucelvax

RIV3 N/A Recombinant/FluBlok

LAIV LAIV Live attenuated

nasal/FluMist

Influenza Vaccines 2013-2014 What are the age restrictions?

Vaccine >6 mos

>3 yrs

>4 yrs

>9 yrs*

>18 yrs

2-49 yrs

18-49 yrs

18-64 yrs

>65 yrs

Fluzone/Sanofi X

Fluarix/GSK X

Fluvirin/Novartis X

Afluria/CSL X

Agriflu/Novartis X

Flucelvax/Novartis X

FluLaval/ID Biomed X

FluMist/MedImmune X

FluBlok/Protein Sciences

X

Fluzone-Intradermal X

Fluzone-High dose X

X=minimum recommended age at which vaccine should be given * FDA approved for >5 years but recommended for >9 years Please see reverse side for sources. (3/13)

I can’t get a flu shot because

I’m allergic to eggs….

WRONG!

Influenza

Vaccine

and Egg

Allergy

Healthy Populations under 65: 50-70%

Seniors 65 years of age and older:

Influenza A Pandemics

Year Subtype Severity of

Pandemic

1889 H3N2 Moderate

1918 H1N1 Severe

1957 H2N2 Severe

1968 H3N2 Moderate

1977 H1N1 Mild

2009 H1N1 Mild

???? ???? ????

What will cause the next

pandemic?

H3N2 Variant

Associated with state fairs in U.S. in 2012

H5N1-Avian influenza

Circulating since 2003

32 cases in 2012

H7N9

Identified in China in 2013

131 cases so far

Expected ACIP Influenza

Recommendations 2013-2014

Continue to support annual

immunization for everyone 6

months of age and older

All available vaccine products are

acceptable for indicated age groups

No preference for any one vaccine

product

Ample supply of vaccine

Meningococcemia

Caused by Neisseria

meningitidis

Licensed Meningococcal

Conjugate Vaccines Vaccine Licensed Age

Group

Serogroups Dose(s)

Menactra®

(MenACWY-D)

Sanofi Pasteur

9 months - 55 years

A, C, W-135 and Y

Single dose (2-55 years)

2 doses (9-23 months)

Menveo®

(Men ACWY-CRM)

Novartis*

2 - 55 years

A, C, W-135, and Y

Single dose

MenHibrix ®

(Hib-MenCY-TT)

GlaxoSmithKline

6 weeks – 18 months

C and Y

4-dose series

*Menveo®: FDA review pending (2, 4, 6, 12 through 16 months)

From: http://aapredbook.aappublications.org/site/news/vaccstatus.xhtml

Should we give conjugated

meningococcal vaccine to

infants?

No current recommendation

for routine use of conjugated

meningococcal vaccines in

children

What about the 2nd dose of

conjugated meningococcal

vaccine in adolescents?

The problem

Meningococcal infection is the most rapidly

fatal infection known

There is no time for your immune system to

react

There is no time for your memory T cells to

remember

You have to have circulating levels of

antibody all the time to be protected

New 2nd dose of conjugated

meningococcal vaccine

Routine booster dose at age 16 for those

immunized at 11-12 years of age

For those immunized at age 13-15, booster at

16-18 (particularly before college)

No booster for those first immunized at age

16 or above

No vaccine at age 22 or above

Current Recommendations for use of

Conjugate Meningococcal Vaccines

Routine immunization at age 11-12 with a second

booster dose beginning at age 16

No routine immunization recommendation for those

less than 11 years of age or for those 21 years or

older

High risk individuals (asplenia, compliment

deficiency) should be immunized beginning at 2

months of age

Vaccine may be used in outbreak situations for all

ages 2 months-55 years

Number of doses needed depends on age at

vaccination

Booster doses for high risk needed every 5 years

California 2010: Highest number of pertussis cases in 63 years

Annual incidence by State, 2010

Incidence is per 100,000 population

Source : CDC National Notifiable Disease Surveillance System, *2010 data accessed July 22, 2011

CDC Wonder Population Estimates (Vintage 2009) ; Courtesy of Tom Clark, MD

1.1-3.6

3.7-6.5

6.6-10.2

10.3-23.2

Incidence

2010* incidence 9.0

(n-27,555)

Annual Incidence by State, 2012*

1.4 – 5.2

5.3 – 8.5

8.6 – 24.2

24.3 – 104.9

Incidence

*2012 data are provisional.

Source : CDC National Notifiable Disease Surveillance System, 2012

2011 Census data used for population estimates; Incidence is per 100,000 population

2012 incidence = 13.4 (n=41,880)

Changes in Pertussis Reporting by State from 2011 to 2012* †

*Data for 2012 are provisional.

†Cases reported through Week 52 in 2011 were compared with cases reported through Week 52 in 2012; fold-changes were calculated for each state.

Decrease/No change

< 2-fold increase

2 to 3-fold increase

≥ 3-fold increase

Reasons for outbreaks of

Pertussis

Pertussis is very contagious

People who have pertussis can be

contagious for up to 3 weeks

Pertussis is difficult for doctors to recognize

and diagnose

Even after someone begins treatment for

pertussis they are contagious for up to 5 days

Immunity from prior vaccination or disease

wanes over time so people become

susceptible again.

Pertussis rates by age — United States, 2012

0

5

10

15

20

25

30

35

DTaP Vaccine Efficacy

Misegades L et al, JAMA. 2012;308(20):2126-2132

Tdap Vaccine Effectiveness Studies

Author Year Country Age Range Study Design VE (Confidence Interval)

Pichichero 2005 US 11-64 Immunogenicity 85-89*

Ward 2005 US 15-65 Randomized Clinical Trial 92 (32-99)

Rank 2009 Australia 12-19 Screening 78 (61-88)

Wei 2010 St. Croix 11-18 Cohort 66 (-36-91)

CDC 2011 US 11-17 Case-Control 72 (38-87)

CDC 2012 US 11-19 Cohort 69 (38-86)

*Gustafsson et al. NEJM 1996; 334: 349-55. Rank C, et al. Pediatr Infect Dis J. 2009 Feb;28(2):152-3. *Schmitt et al. JAMA 1996; 275: 37-41. Wei SC, et al. CID 2010; 51(3):315-321. Pichichero et al. JAMA 2005; 293: 3003-11. Skoff et al. NIC 2011, Washington, DC. Ward JI et al. N Engl J Med. 2005 Oct 13;353(15):1555-63. Terranella et al. EIS Conference 2012, Atlanta. CDC unpublished data.

Have you received a Tdap

immunization?

1) Yes

2) No

3) Don’t know

4) I don’t want to tell you

Pertussis Vaccine Coverage Rate Data

Population Coverage Level Source

DTaP 19-35 months

84.4±1.0 NIS Infant 2010

Tdap, teens 13-17 years

78.2 (77.3-79.1) NIS Teen 2011

Tdap, adults 19-64 years

12.5 (11.8-13.2) NHIS 2011

http://www.cdc.gov/vaccines/stats-surv/default.htm

http://www.cdc.gov/vaccines/stats-surv/default.htmhttp://www.cdc.gov/vaccines/stats-surv/default.htmhttp://www.cdc.gov/vaccines/stats-surv/default.htm

Tdap vaccine during

pregnancy

Reported pertussis-related deaths by age-groups, U.S., 1980-2009

Age-group 1980-19891 1990-19991 2000-20092

0-1 month 38 68 152

2-3 month 11 16 23

4-5 month 5 5 2

6-11 month 7 4 1

1-4 years 13 2 2

5-10 years 1 6 3

11-18 years 0 0 3

>18 years 1 2 8

Total 77* 103 194

1 Vitek CR et al. Pediatr Infect Dis J 2003; 22(7):628-34.

2 National Notifiable Diseases Surveillance System, CDC, 2009

* Includes one case with unknown age

Parents are the most common source of pertussis infection in infants

Bisgard, K. PIDJ. 2004;23:985-9. n=264 cases

Tdap safety during pregnancy

Data Source Observations

General experience with inactivated

vaccines including Td

n=millions. No pregnancy related

adverse events observed

Vaccine manufacturer pregnancy

registries

n=hundreds; no signal to suggest

pregnancy related adverse events

VAERS data over 6 years n=hundreds/thousands. No signal to

suggest pregnancy related adverse

events

Specific clinical trials n=hundreds. No adverse events

New Tdap Pregnancy

Recommendation

ACIP recommends that providers of prenatal

care implement a Tdap immunization program

for all pregnant women. Healthcare providers

should administer a dose of Tdap during each

pregnancy irrespective of the patient’s prior

history of receiving Tdap. If not administered

during pregnancy, Tdap should be administered

immediately postpartum.

MMWR 2013; 62(07):131-135

Two goals for maternal Tdap immunization

Protect the mother from getting pertussis and

transmitting it to her baby

Prenatal, intrapartum, post-natal maternal immunization

Re-immunization not recommended

Generating maternal antibody so that she transfers it

to her baby in utero thus protecting the baby

beginning at day one of life

Immunization during pregnancy

Re-immunization with each pregnancy

Tom Clark, CDC, ACIP presentation Feb

2013

Rationale for Tdap during pregnancy

Tdap immunization related to pregnancy

Do re-immunize pregnant women at

every pregnancy to protect their

infants

Do not re-immunize women

prenatally or post-partum

Do not re-immunize the cocoon

Do immunize the cocoon and

everyone else 11 years of age and

older one time with Tdap

Cocooning Recommendation

Adolescents and adults who have or who

anticipate having close contact with an infant

aged less than 12 months (e.g., parents,

siblings, grandparents, child-care providers

and healthcare providers) and who previously

have not received Tdap should receive a

single dose of Tdap.

Should we be giving a Tdap

Booster?

Tdap boosters may be needed based on

waning immunity

Interval between Tdap vaccines uncertain

Growing experience in Canada, Australia,

and other countries with a 10 year interval

Limited experience with a 5 year interval

May not be cost effective

Should we give HPV vaccine to

males?

Should I give PCV13 vaccine to

adults?

Pneumococcus causes

pneumonia and other

serious infections in

adults

Adults who are

immunocompromised are

at greatest risk

Currently use

PPSV23/polysaccharide

vaccine for most adults

ACIP recommendation, February 2013

What will ACIP be up to next?

Conjugated pneumococcal vaccine for adults

in general

Tdap revaccination for the general population

?Product preference for some influenza

vaccines

?Zoster vaccine at age 50

Summary

Lots of new influenza vaccines

Large outbreaks of pertussis has led to an

expansion of the groups who should receive

pertussis vaccine

Second dose of meningococcal vaccine for

adolescents based on waning antibody levels

HPV vaccine now routine for boys and girls

PCV13 now for children and some adults

Information for Health-Care Professionals

San Diego HHSA (sdiz.org) CDPH EZ-IZ (eziz.org)

Shots for Schools (shotsforschool.org)

NNII (immunizationinfo.org)

VEC (vaccine.chop.edu)

IAC (immunize.org)

CDC/NIP (cdc.gov/nip)

AAP (aap.org)

AAFP (aafp.org/)

IVS (vaccinesafety.edu)

Vaccine Page (vaccines.org)

Every Child by Two (www.ecbt.org)