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 States a DiseaseBaseline 20 th Century Annual Morbidity 2007 Morbidity% Decrease Smallpox48, Diphtheria175, Pertussis147,27110,45493 Tetanus1, Poliomyelitis (paralytic) 16, Measles503,28243>99 Mumps152,209800>99 Rubella47,74512>99 Congenital Rubella syndrome Haemophilus influenzae b 20,00022>99

2010 Birth through 6 years

2010 Age 7 through 18

2010 Adults

2010 Adults medical and other indications

Pertussis—United States, Year

Pertussis—United States, Year

Reported Pertussis by Age Group,

Pertussis Complications by Age *Cases reported to CDC (N=28,187)

Pertussis Complications* Condition Pneumonia Seizures Encephalopathy Hospitalization Death Percent reported *Cases reported to CDC (N=28,998)

Pertussis Deaths in the United States, Total CDC, unpublished data, 2007 <3 mos (84%) >3 mos (16%) Total Age at onset

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 PT PERT FHA *mcg per dose FIM

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 years of age should receive a single dose of Tdap instead of Td* Adolescents 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 Influenza Vaccine: WHO has recommended vaccine strains for the 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 formulation and the A (H3N2) component has been changed from the Northern Hemisphere vaccine formulation. This recommendation was based on surveillance data related to epidemiology and antigenic characteristics, serological responses to 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 Group 6-35 mos 3-8 yrs 9 years or older Dose 0.25 mL 0.50 mL # Doses 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 seasonal vaccine

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

Varicella Age-Specific Incidence United States, *Rate per 100,000 population. National Health Interview Survey data

Varicella Vaccine Recommendations Children Routine vaccination at 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):

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 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 valent polysaccharide vaccine licensed valent polysaccharide vaccine licensed (PPV23) 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 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 Disease Incidence by Age Group, 1998 and 2002 * Rate per 100,000 population Source: Active Bacterial Core Surveillance/EIP Network

Rate/100,000 children younger than 5 years Before vaccine All IPD Vaccine serotypes Source: Active Bacterial Core Surveillance/EIP Network Direct Benefit of Vaccination: Invasive Pneumococcal Disease (IPD) Among Children Younger Than 5 Years of Age

PCV7 intro- duction Direct Effect of Vaccination: Invasive Pneumococcal Disease Among Children <5 Years of Age, 1998/

Rates of PCV7-type Invasive Pneumococcal Disease among Adults, U.S., 1998/ 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 yrs yrs 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):

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

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

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