Immunizations 2010; Infants and Children, Parents and

Grandparents

Richard M. Lampe M.D.Professor and Chairman of Pediatrics

Texas Tech University School of Medicine

Objectives

• Apply the current recommendations for immunizations in infants and children.

• Implement recommendations for their parents and grandparents and legal guardians

• Recognize importance of immunization of healthcare workers

Baseline 20th Century Annual Morbidity and 2007 Morbidity From

10 Infectious Diseases With Vaccines Recommended Before 1990 for

Universal Use in Children: United Statesa

Disease Baseline 20th Century Annual Morbidity

2007 Morbidity % Decrease

Smallpox 48,164 0 100

Diphtheria 175,885 0 100

Pertussis 147,271 10,454 93

Tetanus 1,314 28 98

Poliomyelitis (paralytic)

16,316 0 100

Measles 503,282 43 >99

Mumps 152,209 800 >99

Rubella 47,745 12 >99

Congenital Rubella syndrome

823 0 100

Haemophilus influenzae b

20,000 22 >99

2010 Birth through 6 years

2010 Age 7 through 18

2010 Adults

2010 Adults medical and other indications

0

50000

100000

150000

200000

250000

1940 1950 1960 1970 1980 1990 2000

Ca

ses

Pertussis—United States, 1940-2007

Year

0

5000

10000

15000

20000

25000

30000

1980 1985 1990 1995 2000 2005

Ca

se

sPertussis—United States, 1980-2007

Year

Reported Pertussis by Age Group, 1990-2007

0

5000

10000

15000

20000

25000

30000

1990 1995 2000 2005

Year

Ca

se

s

<11 11-18 >18

Pertussis Complications by Age

0

10

20

30

40

50

60

70

<6 m 6-11 m 1-4 y 5-9 y 10-19 y 20+ y

Age group

Perc

en

t

Pneumonia Hospitalization

*Cases reported to CDC 1997-2000 (N=28,187)

Pertussis Complications*

ConditionPneumoniaSeizuresEncephalopathyHospitalizationDeath

Percent reported4.90.70.1160.2

*Cases reported to CDC 2001-2003 (N=28,998)

Pertussis Deaths in the United States, 2004-2006

2004

2005

2006

Total

CDC, unpublished data, 2007

<3 mos

24

32

13

69

(84%)

>3 mos

3

7

3

13

(16%)

Total

27

39

16

82

Age at onset

Pertussis Among Adolescentsand Adults

• Prolonged cough (3 months or longer)

• Post-tussive vomiting

• Multiple medical visits and extensive medical evaluations

• Complications

• Hospitalization

• Medical costs

• Missed school and work

• Impact on public health system

Composition* of Acellular Pertussis Vaccines

Product

Tripedia

Infanrix

Daptacel

Boostrix

Adacel

PT

23

25

10

8

2.5

PERT

--

8

3

2.5

3

FHA

23

25

5

8

5

*mcg per dose

FIM

--

--

5

--

5

Tdap Vaccines

• Boostrix (GlaxoSmithKline)

–Approved for persons 10 through 64 years of age

• Adacel (sanofi pasteur)

–Approved for persons 11 through 64 years of age

Cocoon

Adolescent and Adult Pertussis Vaccination

• Primary objective

–protect the vaccinated adolescent or adult

• Secondary objective

–reduce reservoir of B. pertussis

–potentially reduce incidence of pertussis in other age groups and settings

Recommendations for Tdap Vaccination of Adolescents

• Adolescents 11-12 years of age should receive a single dose of Tdap instead of Td*

• Adolescents 13-18 years who have not received Tdap should receive a single dose of Tdap as their catch-up booster instead of Td*

*if the person has completed the recommended childhood DTaP/DTP vaccination series, and has not yet received a Td booster

MMWR 2006;55(RR-3):1-43.

• Healthcare personnel who work in hospitals or ambulatory care settings and have direct patient contact should receive a single dose of Tdap as soon as feasible

• Priority should be given to vaccination of healthcare personnel who have direct contact with infants 12 months of age and younger

• An interval as short as 2 years (or less) from the last dose of Td is recommended for the Tdap dose

*if they have not previously received Tdap. MMWR 2006;55(RR-17):1-37.

Tdap Vaccine and Healthcare Personnel

Use of Tdap Among Pregnant Women

• Td is generally preferred during pregnancy• Women who have not received Tdap should receive a dose

in the immediate post-partum period• Any woman who might become pregnant is encouraged to

receive a single dose of Tdap• Clinician may choose to administer Tdap to a pregnant

woman in certain circumstances (such as during a community pertussis outbreak)

• Pregnancy is not a contraindication for Tdap

MMWR 2008;57 (No. RR-4)

Conditions NOT Precautions for Tdap• Following a dose of DTaP/DTP:

– temperature 105oF (40.5oC) or higher– collapse or shock-like state– persistent crying lasting 3 hours or longer– convulsions with or without fever– history of an extensive limb swelling reaction

• Stable neurologic disorder • Pregnancy• Breastfeeding• Immunosuppression including• HIV infection• Concurrent minor illness• Antimicrobial use

2010 Birth through 6 years

2010 Age 7 through 18

2010 Adults

2010 Adults medical and other indications

Impact of Influenza on Children

• School absenteeism• Parental work loss• Medical care visits

– 5 to 7 influenza-related outpatient visits per 100 children

– children frequently receive antibiotics

MMWR 2009;58 (RR-8)

Composition of the 2010-11 Influenza Vaccine:

• WHO has recommended vaccine strains for the 2010-11 Northern Hemisphere trivalent influenza vaccine, and FDA has made the same recommendations for the U.S. influenza vaccine. Both agencies recommend that the vaccine contain A/California/7/2009-like (2009 H1N1), A/Perth/16/2009-like (H3N2), and B/Brisbane/60/2008-like (B/Victoria lineage) viruses. A seasonal influenza A (H1N1) component is not included in the 2010-11 formulation and the A (H3N2) component has been changed from the 2009-10 Northern Hemisphere vaccine formulation. This recommendation was based on surveillance data related to epidemiology and antigenic characteristics, serological responses to 2009-10 trivalent seasonal and 2009 H1N1 monovalent vaccines, and the availability of candidate strains and reagents.

Influenza Vaccines

• Inactivated subunit (TIV)– intramuscular– trivalent– contains egg protein

• Live attenuated vaccine (LAIV)– intranasal– trivalent– contains egg protein

MMWR 2009;58 (RR-8)

Trivalent Inactivated Influenza Vaccine (TIV) Schedule

Age Group6-35 mos

3-8 yrs

9 years or older

Dose0.25 mL

0.50 mL

0.50 mL

# Doses1 or 2*

1 or 2*

1

TIV should only be administered by the intramuscular route.*Doses should be separated by at least 4 weeks. MMWR 2009;58 (RR-8)

Live Attenuated Influenza Vaccine (LAIV)

• Approved only for healthy persons 2 years through 49 years of age who are not pregnant– healthcare personnel– persons in close contact with high-risk groups– persons who want to reduce their risk of influenza

MMWR 2009;58 (RR-8)

(LAIV) ScheduleAge Group2 through 8 years -no previous influenza vaccine -previous influenza vaccine 9 through 49 years

Number of Doses

2

(separated by 4 weeks)

1 or 2

1

MMWR 2009;58 (RR-8)

2010 Birth through 6 years

2010 Age 7 through 18

2010 Adults

2010 Adults medical and other indications

ACIP recommends annual flu shots for almost all

• Feb 24, 2010 (CIDRAP News) – In the wake of the H1N1 influenza pandemic, the US Advisory Committee on Immunization Practices (ACIP) today took the long-discussed step of recommending seasonal flu immunizations for nearly everyone, leaving out only small babies.

• Younger adults mortality• 85% recommended anyway• Obesity and minority mortality• Pandemic H1N1 in 2010-2011 seasonal vaccine

0

5

10

15

20

25

<1 1-4 5-9 10-14 15-19 20+

Age group (yrs)

Rate

per

100,0

00 c

ases

Varicella Fatality Rate-United States, 1990-1994

*Deaths per 100,000 cases. Meyer et al, J Infect Dis 2000;182:383-90

0

20

40

60

80

100

120

<1 1-4 5-9 10-14 15-19 20+

Age group (yrs)

Rate

*Varicella Age-Specific Incidence United

States, 1990-1994

*Rate per 100,000 population. National Health Interview Survey data

Varicella Vaccine RecommendationsChildren

• Routine vaccination at 12-15 months of age

• Routine second dose at 4-6 years of age

• Minimum interval between doses of varicella vaccine for children younger than 13 years of age is 3 months

MMWR 2007; 56 (No. RR-4);1-40

Varicella Vaccine RecommendationsOlder Children and Adults

• 2 doses recommended for all persons older than 4 to 6 years who do not have evidence of varicella immunity

• Second dose recommended for persons of any age who have only received one dose

Varicella Vaccine Immunogenicity and Efficacy

• Detectable antibody

–97% of children 12 months-12 years following 1 dose

–99% of persons 13 years and older after 2 doses

• 70%-90% effective against any varicella disease

• 95%-100% effective against severe varicella disease

Varicella Breakthrough Infection

• Immunity appears to be long-lasting for most recipients

• Breakthrough disease much milder than in unvaccinated persons

• No consistent evidence that risk of breakthrough infection increases with time since vaccination

Varicella Immunity

• Written documentation of age-appropriate vaccination

• Laboratory evidence of immunity or laboratory confirmation of disease

• Born in the United States before 1980*

• Healthcare provider diagnosis or verification of varicella disease

• History of herpes zoster based on healthcare provider diagnosis

*except healthcare personnel and pregnant women. MMWR 2007;56(No. RR-4)

Varicella VaccinePostexposure Prophylaxis

• Varicella vaccine is recommended for use in persons without evidence of varicella immunity after exposure to varicella

–70%-100% effective if given within 72 hours of exposure

–not effective if administered more than 5 days after exposure but will produce immunity if not infected

Varicella-Containing Vaccines

• Varicella vaccine (Varivax)

–approved for persons 12 months and older

• Measles-mumps-rubella-varicella vaccine (ProQuad)

–approved for children 12 months through 12 years

• Herpes zoster vaccine (Zostavax)

–approved for persons 60 years and older

Herpes Zoster

• 500,000 to 1 million episodes occur annually in the United States

• Lifetime risk of zoster estimated to be at least 30%

• 50% of persons living until age 85 years will develop zoster

Herpes Zoster Vaccine

• Approved for a single dose among persons 60 years and older

• May vaccinate regardless of prior history of herpes zoster (shingles)

• Persons with a chronic medical condition may be vaccinated unless a contraindication or precaution exists for the condition

Herpes Zoster Vaccine Efficacy

• Compared to the placebo group the vaccine group had:

–51% fewer episodes of zoster

–Lower efficacy for older recipients

–Less severe disease

–66% less postherpetic neuralgia

• Duration of immunity unknownNEJM 2005;352(22):2271-84.

2010 Birth through 6 years

2010 Age 7 through 18

2010 Adults

2010 Adults medical and other indications

Pneumococcal Disease

• Second most common cause of vaccine-preventable death in the U.S. (after influenza)

• Major clinical syndromes include pneumonia, bacteremia, and meningitis

Pneumococcal Bacteremia

• More than 50,000 cases per year in the United States

• Rates higher among elderly and very young infants

• Case-fatality rate ~20%; up to 60% among the elderly

Pneumococcal Meningitis

• Estimated 3,000 - 6,000 cases per year in the United States

• Case-fatality rate ~30%, up to 80% in the elderly

• Neurologic sequelae common among survivors

• Increased risk in persons with cochlear implant

Bacteremia 13,000

Meningitis 700

Death 200

Otitis media 5,000,000

Syndrome Cases

Burden of Pneumococcal Disease in Children*

*Prior to routine use of pneumococcal conjugate vaccine

Pneumococcal Vaccines

• 1977 14-valent polysaccharide vaccine licensed

• 1983 23-valent polysaccharide vaccine licensed (PPV23)

• 2000 7-valent polysaccharide conjugate vaccine licensed (PCV7)

Pneumococcal Polysaccharide Vaccine

• Purified capsular polysaccharide antigen from 23 types of pneumococcus

• Account for 88% of bacteremic pneumococcal disease

• Cross-react with types causing additional 8% of disease

Pneumococcal Conjugate Vaccine

• Pneumococcal polysaccharide conjugated to nontoxic diphtheria toxin (7 serotypes)

• Vaccine serotypes account for 86% of bacteremia and 83% of meningitis among children younger than 6 years of age

Pneumococcal Conjugate Vaccine

• Highly immunogenic in infants and young children, including those with high-risk medical conditions

• 97% effective against invasive disease caused by vaccine serotypes

• 73% effective against pneumonia

• 7% reduction in all episodes of acute otitis media

Pneumococcal Conjugate Vaccine Recommendations

• All children 24 months of age

• Unvaccinated children 24-59 months with a high-risk medical condition

MMWR 2000;49(RR-9):1-35

"PCV13 will be replacing PCV7"

• February 25, 2010 — The Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) voted yesterday to recommend the use of a 13-valent pneumococcal conjugate vaccine (PCV13), which provides broader protection for young children against pneumococcal diseases.

PCV 13

• Unvaccinated infants and children: PCV13 is recommended for all children aged 2 through 59 months. In the United States, infants receive a "3 plus 1" dosing schedule, with doses at 2, 4, and 6 months and a booster dose at 12 to 15 months. Older children will follow the schedule currently recommended for PCV7.

• Children incompletely vaccinated with PCV7: Children aged 24 to 59 months who received 1 or more doses of PCV7 should complete their vaccine series with PCV13. The age may be extended to 71 months for children with an underlying medical condition, such as sickle cell disease, HIV, or asplenia.

• Children completely vaccinated with PCV7: Those children 14 to 59 months of age who have received all 4 doses of PCV7 should receive a single supplemental dose of PCV13. The age may be extended to 71 months for children with an underlying medical condition.

Children at Increased Risk of Invasive Pneumococcal Disease

• Functional or anatomic asplenia, especially sickle cell disease

• HIV infection• Recipient of cochlear implant• Out-of-home group child care• African American children• Alaska Native and American Indian

children who live in Alaska, Arizona, or New Mexico

• Navaho children who live in Colorado and Utah

Conditions That Increase Risk for Invasive Pneumococcal Disease

• Decreased immune function• Asplenia (functional or anatomic)• Chronic heart, pulmonary, liver or

renal disease• Cigarette smoking• Cerebrospinal fluid (CSF) leak• Cochlear implant

Invasive Pneumococcal DiseaseIncidence by Age Group, 1998 and 2002

0

50

100

150

200

250

<1 1 2-4 5-17 18-34 35-49 50-64 65+

Age Group (Yrs)

Rat

e *

1998 2002

* Rate per 100,000 populationSource: Active Bacterial Core Surveillance/EIP Network

Rate/100,000 childrenyounger than 5 years

Before vaccine100

80

200624

0.5

All IPD

Vaccineserotypes

Source: Active Bacterial Core Surveillance/EIP Network

Direct Benefit of Vaccination: Invasive Pneumococcal Disease (IPD) Among

Children Younger Than 5 Years of Age

0

20

40

60

80

100

120

1998 1999 2000 2001 2002 2003 2004 2005 2006

Cas

es p

er 1

00,0

00

Overall PCV7 type

PCV7 intro-

duction

Direct Effect of Vaccination: Invasive Pneumococcal Disease Among Children

<5 Years of Age, 1998/99-2006

Rates of PCV7-type Invasive Pneumococcal Disease among Adults, U.S., 1998/99-2006

0

10

20

30

40

50

60

70

1998 1999 2000 2001 2002 2003 2004 2005 2006

Cas

es p

er 1

00,0

00

2006 vs. baseline

>80: -90% (-93,-86)

65-79: -88% (-91,-83)

50-64: -84% (-87,-79)

18-49: -88% (-91,-86)

CDC, unpublished data 2008

>80 yrs

65-79 yrs

50-64 yrs

18-49 yrs

Risk Factors for Invasive Pneumococcal Disease (IPD)

• Asthma has now been identified as an independent risk factor for invasive pneumococcal disease

• Adults with asthma had at least double the risk of IPD compared with adults of similar age without asthma

N Engl J Med 2005; 352(20): 2082-90

New Pneumococcal Polysaccharide Vaccine (PPSV) Recommendation

• All adults 19 years of age and older with asthma regardless of severity

• Available data do not support asthma as an indication for PPSV among persons younger than 19 years

http://www.cdc.gov/vaccines/recs/provisional/default.htm#acip

Cigarette Smoking and IPD

• Approximately half of adults 65 years of age or younger who develop severe pneumococcal disease are smokers

• Cigarette smoking is a strong risk factor for severe disease

• Many adults who smoke cigarettes also have another condition for which PPSV is already recommended

• Cigarette smoking is a risk behavior that is easy to identify among patients in clinical practice

• Smoking cessation should be part of the therapeutic plan regardless of immunization

New Pneumococcal Polysaccharide Vaccine (PPSV) Recommendation

• All adults 19 years of age and older who smoke cigarettes

• Available data do not support smoking as an indication for PPSV among persons younger than 19 years

http://www.cdc.gov/vaccines/recs/provisional/default.htm#acip

2010 Birth through 6 years

2010 Age 7 through 18

2010 Adults

2010 Adults medical and other indications

Conclusion

• Changes every year

• Resources

–CDC.GOV

–AAP.ORG

• Life long learning opportunity