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

Disease

Smallpox

Children: United States Baseline 20 th Century Annual Morbidity

48,164

2007 Morbidity

0

% Decrease

100 Diphtheria Pertussis Tetanus Poliomyelitis (paralytic) 175,885 147,271 1,314 16,316 0 10,454 28 0 100 93 98 100 Measles Mumps 503,282 152,209 Rubella Haemophilus influenzae b 47,745 Congenital Rubella syndrome 823 20,000 43 800 12 0 22 >99 >99 >99 100 >99

2010 Birth through 6 years

2010 Age 7 through 18

2010 Adults

2010 Adults medical and other indications

Pertussis—United States, 1940-2007

250000 200000 150000 100000 50000 0 1940 1950 1960 1970 1980 1990 2000 Year

Pertussis—United States, 1980-2007

30000 25000 20000 15000 10000 5000 0 1980 1985 1990 1995 2000 2005 Year

Reported Pertussis by Age Group, 1990-2007

<11 11-18 >18 30000 25000 20000 15000 10000 5000 0 1990 1995 Year 2000 2005

Pertussis Complications by Age

Pneumonia Hospitalization 70 60 50 40 30 20 10 0 <6 m 6-11 m 1-4 y 5-9 y Age group *Cases reported to CDC 1997-2000 (N=28,187) 10-19 y 20+ y

Pertussis Complications* Condition Pneumonia Seizures Encephalopathy Hospitalization Death Percent reported 4.9

0.7

0.1

16 0.2

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

Pertussis Deaths in the United States, 2004-2006 Age at onset <3 mos >3 mos Total 2004 24 2005 32 2006 13 69 Total (84%) 3 7 3 13 (16%) 27 39 16 82 CDC, unpublished data, 2007

• • • • • • • •

Pertussis Among Adolescents and 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 *mcg per dose PT 23 25 10 8 2.5

FHA 23 25 5 8 5 PERT - 8 3 2.5

3 FIM - - 5 - 5

Tdap Vaccines

•

Boostrix (GlaxoSmithKline)

–

Approved for persons 10 through 64 years of age

•

Adacel (sanofi pasteur)

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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.

Tdap Vaccine and Healthcare Personnel

• • • 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.

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.

strains and reagents.

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

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 Group 6-35 mos 3-8 yrs 9 years or older Dose 0.25 mL 0.50 mL 0.50 mL # Doses 1 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) Schedule

Age Group 2 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

Varicella Fatality Rate-United States, 1990-1994 25 20 15 10 5 0 <1 1-4 5-9 10-14 15-19 Age group (yrs) *Deaths per 100,000 cases. Meyer et al, J Infect Dis 2000;182:383-90 20+

Varicella Age-Specific Incidence United States, 1990-1994 120 100 80 60 40 20 0 <1 1-4 5-9 10-14 Age group (yrs) 15-19 20+ *Rate per 100,000 population. National Health Interview Survey data

Varicella Vaccine Recommendations Children

• • •

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 Recommendations Older 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 Vaccine Postexposure 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 unknown NEJM 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

Burden of Pneumococcal Disease in Children* Syndrome

Bacteremia Meningitis

Cases

13,000 700 Death 200 Otitis media 5,000,000 *Prior to routine use of pneumococcal conjugate vaccine

Pneumococcal Vaccines

•

1977 14-valent polysaccharide vaccine licensed

•

1983 23-valent polysaccharide vaccine licensed (PPV23)

•

2000 licensed 7-valent polysaccharide conjugate vaccine (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

recommended for PCV7. : 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

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

medical condition. : 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

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 Disease Incidence by Age Group, 1998 and 2002 1998 2002 250 200 150 100 50 0 <1 1 2-4 5-17 18-34 Age Group (Yrs) 35-49 50-64 65+ * Rate per 100,000 population Source: Active Bacterial Core Surveillance/EIP Network

Direct Benefit of Vaccination: Invasive Pneumococcal Disease (IPD) Among Children Younger Than 5 Years of Age Rate/100,000 children younger than 5 years All IPD Before vaccine 100 2006 24 Vaccine serotypes 80 0.5

Source: Active Bacterial Core Surveillance/EIP Network

Direct Effect of Vaccination: Invasive Pneumococcal Disease Among Children <5 Years of Age, 1998/99 2006 Overall PCV7 type 120 100 80 60 40 20 0 PCV7 intro duction 1998 1999 2000 2001 2002 2003 2004 2005 2006

Rates of PCV7-type Invasive Pneumococcal Disease among Adults, U.S., 1998/99-2006 70 60 50 40 >80 yrs 30 65-79 yrs 20 50-64 yrs 10 18-49 yrs 0 1998 1999 2000 CDC, unpublished data 2008 2001 2002 2003 2006 vs. baseline >80: -90% (-93,-86) 65-79: -88% (-91,-83) 50-64: -84% (-87,-79) 18-49: -88% (-91,-86) 2004 2005 2006

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

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CDC.GOV

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AAP.ORG

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Life long learning opportunity