Childhood Vaccines

Educational Learning ObjectivesAt the conclusion of this presentation, the participant should be able to:

• Discuss the indications and recommendations for the most current immunization schedules for childhood, adolescent, and adult populations

• Respond to frequently encountered questions and situations during patient discussions including safety, efficacy, and possible misinformation

• Implement strategies for improving immunization rates within one’s clinical practice, taking into account current immunization schedules and guidelines

Routine Childhood Immunization Schedule, 1983

Birth 1 mo

2 mo

4 mo

6 mo

12 mo 15 mo 18 mo

24 mo

4-6 y

11-12 y

14-16 y

DTP DTPDTP DTP DTP

MMR

OPV OPV OPV* OPV OPV

Td

*A third dose of OPV is optional but may be given in areas of high endemicity for poliomyelitis

CDC. MMWR Morb Mortal Wkly Rep. 1983;32(1):1-8,13-17.

DTP = Diphtheria, tetanus, pertussisOPV = Oral polio (trivalent)MMR = Measles, mumps, rubella

VAC

CIN

E

2010 Child Immunization Schedule

HepB = Hepatitis B; RV = Rotavirus; DTaP = Diphtheria, Tetanus, Pertussis; Hib = Haemophilus influenzae type b; PCV = Pneumococcal; IPV = Inactivated Poliovirus; MMR = Measles, Mumps, Rubella; HepA = Hepatitis A; MCV = Meningococcal; PPSV = Pneumococcal Polysaccharide

ACIP Schedules. http://www.cdc.gov/vaccines/recs/schedules/default.htm. Accessed Jan 2010.

Childhood Catch-up Schedule

ACIP Schedules. http://www.cdc.gov/vaccines/recs/schedules/default.htm. Accessed Jan 2010.

Vaccination Coverage Children 19–35 Months, United States, N = 18,430

CDC. MMWR Morb Mortal Wkly Rep. 2009;58(33):913-940.

0

10

20

30

40

50

60

70

80

90

100

DTaP/DT≥ 3 Doses

Poliovirus MMR ≥ 1 Dose

Hib ≥ 3 Doses

Hepatitis B≥ 3 Doses

Varicella≥ 1 Dose

PCV7 PCV7 ≥ 4 Doses

Hepatitis A≥ 2 Doses

Vacc

inat

ion

Cov

erag

e (%

)

20042005200620072008

≥ 3 Doses≥ 4 Doses

*

*Data for previous years not available

DTaP/DT

2008–2010 Changes in Child Schedule

• Influenza – Universal annual vaccination ≥ 6 months

• Rotavirus – Two schedules available: age 2, 4 mos and age 2, 4, and 6 months

• Polio– Emphasize importance of booster dose at age ≥ 4 yrs

• Meningococcal Conjugate Vaccine– Two vaccines now approved; MCV4-D (Menactra®) and MenACWY-

CRM197 (Menveo®)– Booster

• Hib– Booster reinstatement, shortage issues are over

• Pneumococcal– Addition of PCV13– Booster for PPSV23

Immunization Timelines

• 8% of children immunized too early to be valid • 58% of children received at least one vaccine later

than recommended• Thirty-five million adolescents may be missing at

least one recommended vaccination

Luman ET, et al. Pediatrics. 2002;110:935-939.

Hepatitis B

Dose # Recommended Age

Minimum Age

Recommended Interval

Minimum Interval

1 Birth* Birth 1-4 mo 4 wk2 1-2 mo 4 wk 2-17 mo 8 wk3 6-18 mo 24 wk

• Dose 3 should be administered ≥ 16 wk after dose 1• Combination vaccines cannot be used for the birth

dose

Adapted from Table 1, ACIP General Recommendations on Immunization: MMWR Recomm Rep. 2006;55(RR-15):1-48.

* HB Immunoglobulin should also be administered at birth for infants whose mothers are HBsAg positive

Hepatitis B Perinatal Transmission*

• If mother positive for HBsAg and HBeAg– 70%–90% of infants infected– 90% of infected infants become chronically infected

• If positive for HBsAg only– 5%–20% of infants infected– 90% of infected infants become chronically infected

*in the absence of postexposure prophylaxis

Why Rotavirus?

• > 400,000 physician visits• > 200,000 ED visits• > 50,000 hospitalizations• > $1 billion in total health care costs

CDC. MMWR Recomm Rep. 2006;55(RR12):1-13.

Rotavirus Vaccines and Schedules



Rotavirus Vaccine Harmonized Recommendations

Dose # RV1(Rotarix)

RV5(RotaTeq)

ACIPRecommendation

Usual schedule 2, 4 mo 2, 4, 6 mo Same1

Earliest Latest

6 wk20 wk

6 wk12 wk

6 wk14 wk 6 day

2 Earliest Latest

10 wk24 wk

10 wk32 wk

10 wk8 mo 0 day

3 Earliest Latest

------

14 wk32 wk

14 wk8 mo 0 day

“..vaccination should not be deferred because the product used for previous dose(s) is not available or is unknown. In these situations, the provider should continue or complete the series with the product available. If any dose in the series was RV5, or the vaccine product is unknown for any dose in the series, a total of 3 doses of rotavirus vaccine should be administered.”

• In March 2010, the FDA recommended that health care providers temporarily suspend the use of Rotarix vaccine for rotavirus immunization in the United States while the agency learned more about components of an extraneous virus detected in the vaccine

• An independent research team using a novel technique found DNA from PCV1 in Rotarix

• Fragments of PCV1 and PCV2 DNA were subsequently detected in RotaTeq using sensitive assay methods

• The FDA has no evidence that PCV1 or PCV2 present a safety risk for humans; PCV1 and PCV2 are not known to cause infection or illness in humans

• Both rotavirus vaccines have strong safety records, including clinical trials (tens of thousands of patients) and clinical experience with millions of vaccine recipients

• The benefits of the vaccines are substantial, including prevention of death in some parts of the world and hospitalization for severe rotavirus disease in the US

• The FDA now recommends that health care providers resume use of Rotarix and continue use of RotaTeq

Rotavirus Vaccines – Porcine Circovirus (PCV)

FDA. http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm205539.htm. Accessed May 2010.

Rotavirus• Contraindications

– History of serious allergic reaction to a previous dose of vaccine

– History of severe hypersensitivity to any component of the vaccine

• Precautions – Altered immunocompetence – Moderate to severe illness, including acute gastroenteritis – Preexisting chronic gastrointestinal disease – Previous history of intussusception


Family Physicians and Rotavirus Vaccine

• 2008 Survey* – 45% provided rotavirus vaccine on site

• ½ rate of other vaccines– 35% referred elsewhere– 24% did neither

• 3x rate of other vaccines

*Campos-Outcalt D, et al. Immunization Practices of Family Physicians.43rd National Immunization Conference, Dallas TX, March 31, 2009. Abstract PS19.

DTaP

Dose #Recommended

AgeMinimum

AgeRecommended

IntervalMinimum Interval

1 2 mo 6 wk 2 mo 4 wk2 4 mo 10 wk 2 mo 4 wk

3 6 mo 14 wk 6-12 mo 6 mo4 15-18 mo 12 mo 3 yr 6 mo5 4-6 yr 4 yr

• Dose 5 not needed if dose 4 is given after age 4 yrs

Adapted from Table 1, ACIP General Recommendations on Immunization. CDC. MMWR Recomm Rep. 2006;55(RR15):1-48.

Hib

Dose #Recommended

AgeMinimum

AgeRecommende

d IntervalMinimum Interval

1 2 mo 6 wk 2 mo 4 wk

2 4 mo 10 wk 2 mo 4 wk

3 6 mo 14 wk 6-9 mo 8 wk

4 12-15 mo 12 mo

• Dose at 6 mo of age not necessary if first 2 doses are PRP-OMP• Fewer doses required if series initiated at ≥ 7 mo of age• Supply shortage over, reinstate 12-15 mo booster and catch-up• Approved products

– PedvaxHib (Merck)– ActHIB (Sanofi)– Hiberix (GSK)---booster only


Summer 2009 HIB Updated Recommendations

• Re-institute routine booster• Catch up on those who missed their booster

at their next regular check up• No recall of all those who missed booster

immediately • Changed in late summer to recall of those

who missed

CDC. http://www.cdc.gov/vaccines/vac-gen/shortages/downloads/hib-hcp-ltr-7-30-09.pdf. Accessed September 2009.CDC, personal communication.

Hib Products

Product Description Primary Series Booster

PedvaxHIB (Merck) Monovalent Hib vaccine 2,4 months 12-15 months*

Comvax(Merck)

Combined Hib/hepatitis B vaccine 2,4 months 12-15 months*

Act HIB (Sanofi Pasteur) Monovalent Hib vaccine 2,4,6 months 12-15 months*

TriHIBit (Sanofi Pasteur) DTaP/Hib vaccine Not licensed for this

age group 15-18 months*

HIBERIX(GSK)

Hib conjugate (tetanus toxoid conjugate) --- 15 months*

*Can immunize through age 59 months

Haemophilus influenzae type b. http://www.cdc.gov/vaccines/pubs/pinkbook/downloads/hib.pdf. Accessed September 2009.HIBERIX PI. http://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM179530.pdf. Accessed September 2009.

PCV7

Dose #Recommended

AgeMinimum

AgeRecommended


1 2 mo 6 wk 2 mo 4 wk

2 4 mo 10 wk 2 mo 4 wk

3 6 mo 14 wk 6 mo 8 wk

4 12-15 mo 12 mo

ACIP Schedules. http://www.cdc.gov/vaccines/recs/schedules/default.htm. Accessed Sept 2009.

13-Valent Pneumococcal Conjugate Vaccine(PCV13)

• Licensed by FDA on February 24, 2010• Serotypes in PCV13

– PCV7 types: 4, 6B, 9V, 14, 18C, 19F, 23F– Additional serotypes: 1, 3, 5, 6A, 7F, 19A

• Approved for use in children 6 weeks through 5 years (before the 6th birthday) – 4-dose series at ages 2, 4, 6, and 12-15 months

• Indications– Prevention of invasive pneumococcal disease (IPD) caused

by the 13 vaccine serotypes– Prevention of otitis media caused by PCV7 serotypes


PCV13 Recommended Schedules for Children < 24 Months

CDC. http://www.cdc.gov/vaccines/recs/provisional/downloads/pcv13-mar-2010-508.pdf. Accessed March 2010.

Age at Examination (mos)

Vaccination History: Total PCV7 and/or PCV13 Doses

Received PreviouslyRecommended PCV13 Regimen

2 through 6 mos

0 doses 3 doses, 8 wks apart; 4th dose at age 12-15 mos

1 dose 2 doses, 8 wks apart; 4th dose at age 12-15 mos

2 doses 1 dose, 8 wks after the most recent dose; 4th dose at age 12-15 mos

7 through 11 mos0 doses 2 doses, 8 wks apart; 3rd dose at 12-15 mos

1 or 2 doses before age 7 mo 1 dose at age 7-11 mos, 2nd dose at 12-15 mos, ≥ 8 wks later

12 through 23 mos

0 doses 2 doses, ≥ 8 wks apart

1 dose before age 12 mo 2 doses, ≥ 8 wks apart

1 dose at ≥ 12 mo 1 dose, ≥ 8 wks after the most recent dose

2 or 3 doses before age 12 mo 1 dose, ≥ 8 wks after the most recent dose

4 doses of PCV 7 or other age-appropriate, complete PCV7 schedule

1 supplemental dose, ≥ 8 wks after the most recent dose

Transition from PCV7 to PCV13 According to Number of Doses Previously Received

Primary Infant Series Booster Dose Supplemental PCV13 Dose

2 mos 4 mos 6 mos ≥ 12 mos* 14-59 mos**

PCV7 PCV13 PCV13 PCV13 --



PCV7 PCV7 PCV7 PCV7 PCV13

*No additional PCV13 doses are indicated for children 12-23 months who received 2 or 3 doses or PCV7 before age 12 months and at least 1 dose of PCV13 at age ≥ 12months**For children with underlying medical conditions, a supplemental PCV13 dose is recommended through 71 months of age


PCV13 Recommended Schedules for Children ≥ 24 Months


Age at Examination (mos)

Vaccination History: Total PCV7 and/or PCV13 Doses Received

PreviouslyRecommended PCV13 Regimen

Healthy children 24 through 59 mos

Unvaccinated or any incomplete schedule 1 dose, ≥ 8 wks after the most recent dose

4 doses of PCV7 or other age-appropriate, complete PCV7 schedule

1 supplemental dose, ≥ 8 wks after the most recent dose

Children 24 through 71 mos with

underlying medical conditions

Unvaccinated or any incomplete schedule of < 3 doses

2 doses, one ≥ 8 wks after the most recent dose and another dose ≥ 8 wks later

Any incomplete schedule of 3 doses 1 dose, ≥ 8 wks after the most recent dose

4 doses of PCV 7 or other age-appropriate, complete PCV7 schedule

1 supplemental dose, ≥ 8 wks after the most recent dose*

*For children who have underlying medical conditions, a supplemental PCV13 dose is recommended through 71 months of age

PCV13 – Children 6 through 18 Years of Age with High-risk Conditions

• A single dose of PCV13 may be administered for children 6 through 18 years of age who are at increased risk for invasive pneumococcal disease because of their sickle cell disease, HIV infection or other immunocompromising condition, cochlear implant or cerebrospinal fluid leaks, regardless of whether they have previously received PCV7 or PPSV23


This recommendation is an off-label use of PCV13, which is indicated for children 6 weeks through 5 years of age (prior to the 6th birthday)

PPSV23 After PCV13 for Children ≥ 2 Years of Age with Underlying Medical Conditions

Group Schedule for PPSV23 Revaccination with PPSV23

Children who have sickle cell disease, functional or anatomic asplenia, HIV-infection, or other immunocompromising condition

1 dose of PPSV23 administered at age ≥ 2 yrs and ≥ 8 weeks after last indicated dose of PCV13

1 dose 5 years after the 1st dose of PPSV23

Immunocompetent children with chronic illness

1 dose of PPSV23 administered at age ≥ 2 yrs and ≥ 8 weeks after last indicated dose of PCV13

Not recommended

Doses of PCV13 should be completed before PPSV23is given. No more than 2 PPSV23 doses are recommended.


Transition from PCV7 to PCV13• When PCV13 is available in office, unvaccinated and

incompletely vaccinated children should receive PCV13 (not PCV7)

• If only PCV7 is available in office, unvaccinated and incompletely vaccinated children should receive PCV7; these children should complete the series with PCV13 at subsequent visits

• Children for whom the supplemental PCV13 dose is recommended should receive it at their next medical visit. Active recall is not being recommended


PPSV23

Dose #Recommended

AgeMinimum

AgeRecommended


1 2 yr 5 yr 5 yr2 7 yr

• Second dose recommended for individuals at highest risk

• Second dose is recommended 5 years after first dose in age ≥ 2 years who are immunocompromised, have sickle cell disease, or

functional or anatomic asplenia

• Routine use not recommended for Alaskan Native or American Indian children ages 24-59 months

– May be recommended by local health departments based on community epidemiology

Adapted from Table 1, ACIP General Recommendations on Immunization.MMWR Recomm Rep.2006;55(RR15):1-48.ACIP Provisional Recommendations.www.cdc.gov/vaccines/recs/provisional/downloads/pneumo-Oct-2008-508.pdf. Accessed September 2009.

IPV

Dose #Recommended

AgeMinimum

AgeRecommende


1 2 mo 6 wk 2 mo 4 wk*2 4 mo 10 wk 2-14 mo 4 wk*3 6-18 mo 14 wk 3-5 yr 6 mo4 4-6 yr 18 wk

*In first 6 months of age, 2 mo intervals are recommended unless accelerated dosing is needed (eg, travel)

• Last dose after age 4 - 6 mo minimum interval from penultimate dose

• DTaP-IPV-Hib (Pentacel): 4 doses at age 2, 4, 6, and 15-18 mos will require a 5th dose at 4-6 years with an age-appropriate IPV vaccine

Adapted from Table 1, ACIP General Recommendations on Immunization.MMWR Recomm Rep.2006;55(RR15):1-48.CDC. MMWR Morb Mortal Wkly Rep. 2009;58(30):829-830.

Annual Influenza Vaccine is Recommended for:

• All people age 6 months and older!

CDC. http://www.cdc.gov/vaccines/recs/provisional/downloads/flu-vac-mar-2010-508.pdf. Accessed March 2010.

Seasonal Influenza Vaccination Status of Children 6–23 mos & 2–4 yrs, United States


2007–08 season: 6–23 months, N = 302,333; 2–4 years, N = 808,7112008–09 season: 6–23 months, N = 263,597; 2–4 years, N = 767,422

TIV

Dose #Recommended

AgeMinimum

AgeRecommended


1 Yearly 6 mo 4 wk 4 wk*2

*Two doses (4 wks apart) are given for children 6 mo through 8 yr of age who are receiving influenza vaccine for the first time

– If 2nd dose is missed during first vaccination season, administer two doses during next season

• Seasonal influenza products will not confer protection against pandemic H1N1 strains

– Pandemic H1N1 vaccine available


LAIV

Dose #Recommended

AgeMinimum

AgeRecommended


1 Yearly 2 yr 4 wk 4 wk*2

* Two doses are given for children 2 through 8 yr of age who are receiving influenza vaccine for the first time

– If 2nd dose is missed during first vaccination season, administer two doses during next season


Trivalent Inactivated (TIV) and Live Attenuated Influenza Virus (LAIV) Vaccines

Category TIV LAIV

Administration IM Intranasal

Primary immune response Serum antibodiesSerum & mucosal antibodies

Formulation Inactivated Live attenuated

Approved age and risk groups ≥ 6 mo (healthy & high risk)

2–49 yrs (healthy)

Storage Refrigerated Refrigerated


Two Doses for Children Under 9 Years of Age

• Regardless of whether a child receives LAIV or TIV, those younger than 9 years of age who are receiving influenza vaccine for the first time should receive 2 doses, 4 weeks apart. If a child received only 1 dose in the first year, he or she should receive 2 doses, 4 weeks apart, the following year.


Trivalent Inactivated Virus (TIV) versus Live Attenuated Influenza Virus (LAIV) Vaccines

TIV• Licensed for use in persons age ≥6 mos• Intramuscular injection• TIV contains purified viral particles that have been chemically

inactivated– Purified components from 3 WHO-recommended annual strains– Immunity developed against disrupted/denatured viral proteins, not against

intact virus

LAIV• Licensed for use among nonpregnant persons aged 2-49 years• Administered by nasal spray• LAIV contains intact virus that has been propogated in eggs at 25ºC

– Cold-adaptation results in restricted replication at body temp– More mild flu symptoms– Contains same 3 WHO-recommended annual strains as TIV

CDC. MMWR Recomm Rep. 2009;58(RR8):1-52. Flumist Prescribing Information. www.flumist.com. Accessed Oct 2009.

2009–2010 Seasonal Influenza Vaccines

• 2009–2010 seasonal influenza vaccine formulation:– A/Brisbane/59/2007(H1N1)-like virus– A/Brisbane/10/2007 (H3N2)-like virus – B/Brisbane/60/2008-like antigens

• VaccinesTrivalent Inactivated, Injectable Influenza Vaccine

Fluzone® (sanofi): age ≥ 6 months Fluvirin® (Novartis): age ≥ 4 years Fluarix® (GSK): age ≥ 3 years FluLaval™ (ID Biomedical/GSK): age ≥ 18 years Afluria® (CSL): age ≥ 6 months

Live Attenuated, Nasal Spray Influenza Vaccine FluMist ® (MedImmune): age 2 through 49 years (healthy, non-pregnant)

• Seasonal 2009 influenza vaccine does not protect against 2009 (pandemic) H1N1 influenza

CDC. MMWR Recomm Rep. 2009;58(RR8):1-52.CDC. http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm094045.htm. Accessed March 2010.

2009 H1N1 (Pandemic) Influenza VaccinesAs of November 11, 2009: 4 monovalent inactivated vaccines approved• CSL Limited

– Age 6-35 mos: Two 0.25 mL IM doses (4 wk interval)– Age 36 mos to 9 yrs: Two 0.5 mL IM doses (4 wk interval)– Age ≥ 10 yrs: Single 0.5 mL IM injection– Adults ≥ 18 yrs: Single 0.5 mL IM injection

• Novartis Vaccines and Diagnostics Limited– Age 4-9 yrs: Two 0.5 mL IM doses (4 wk interval)– Age 10-17 yrs: Single 0.5 mL IM injection– Age ≥ 18 yrs: Single 0.5 mL IM injection

• Sanofi Pasteur, Inc.– Age 6-35 mos: Two 0.25 mL IM doses (4 wk interval)– Age 36 mos to 9 yrs: Two 0.5 mL IM doses (4 wk interval)– Age ≥ 10 yrs: Single 0.5 mL IM injection– Adults ≥ 18 yrs: Single 0.5 mL IM injection

• ID Biomedical/GSK– Adults ≥ 18 yrs: Single 0.5 mL IM injection

1 live attenuated (nasal administration)• MedImmune LLC

– Age 2-9 yrs: Two 0.2 mL doses (0.1 mL per nostril), 4 week interval– Age 10-49 yrs: Single 0.2 mL dose (0.1 mL per nostril)Prescribing information available at:

http://www.cdc.gov/h1n1flu/vaccination/dosage.htm#table1. Accessed December 2009.

2010–2011 Influenza Season• Universal Influenza Vaccination

– All people 6 months and older are now recommended to receive annual influenza vaccination

• 2010-2011 Trivalent Influenza Vaccines:– A/California/7/2009(H1N1)-like virus

• Same strain as in the 2009 H1N1 monovalent vaccine– A/Perth/16/2009(H3N2)-like virus

• New strain for northern hemisphere vaccine• Same strain as 2010 southern hemisphere seasonal strain

– B/Brisbane/60/2008-like virus• No change

CDC. http://www.cdc.gov/vaccines/recs/provisional/downloads/flu-vac-mar-2010-508.pdf. Accessed March 2010.

Continued Emphasis on High-risk Groups:– Children aged 6 months through 4 years– Adults ≥ 50 years– Women who will be pregnant during the influenza season– Persons who have chronic pulmonary, cardiovascular, renal,

hepatic, neurological, neuromuscular, hematological or metabolic disorders

– Persons who have immunosuppression (including caused by medication or HIV)

– Residents of nursing homes and other chronic-care facilities– Health care personnel– Household contacts and caregivers of children aged < 5 year and

adults aged ≥ 50 years, with particular emphasis on vaccinating contacts of children < 6 months

– Household contacts and caregivers of persons with medical conditions that put them at higher risk for severe complications from influenza

2010–2011 Influenza Season

CDC. http://www.cdc.gov/vaccines/recs/acip/downloads/mtg-slides-feb10/05-7-flu-vac.pdf. Accessed March 2010.

MMR

Dose #Recommended

AgeMinimum

AgeRecommended


1 12-15 mo 12 mo 3-5 yr 4 wk2 4-6 yr 13 mo

• May be administered as MMRV if 12 mo-12 yr of age, but minimal interval

is 3 mo

ACIP Summary Recommendations. www.immunize.org/catg.d/p2010.pdf. Accessed Oct 2009.

Varicella

Varicella photo. http://www.cdc.gov/vaccines/vpd-vac/varicella/photos.htm. Accessed September 2009.

Varicella

Dose #Recommended

AgeMinimum

AgeRecommende


1 12-15 mo 12 mo 3-5 yr 12 wk (age < 13)4-8 wk (age ≥

13)2 4-6 yr 15 mo• Second dose

At ≥ 3 months if 1st dose for age < 13 yrsAt ≥ 4 weeks if 1st dose for age > 13 yrs

“MMRV vaccine can be used in place of trivalent MMR vaccine and monovalent varicella vaccine to implement the recommended 2-dose vaccine policies for prevention of measles, mumps, rubella, and varicella”

Note: a two-fold increase in the risk of febrile seizures is associated with MMRV versus MMR and Varicella vaccines administered separately and simultaneously

CDC MMWR Recomm Rep. 2007;56(RR04):1-40.CDC. MMWR Morb Mortal Wkly Rep. 2008;57(10);258-260Broder K, et al. Presented at the ACIP June 25, 2009.

Hepatitis A

Dose #Recommended

AgeMinimum

AgeRecommended


1 12-23 mo 12 mo 6-18 mo 6 mo2 18-41 mo 18 mo

• New recommendations for families of international adoptees

ACIP Summary Recommendations. http://www.immunize.org/catg.d/p2010.pdf.Accessed September 2009.CDC. MMWR Morb Mortal Wkly Rep. 2009;58(36):1006-1007.

Hepatitis A: Families of International Adoptees

– Hepatitis A vaccination is recommended for all previously unvaccinated persons who anticipate close personal contact with an international adoptee from countries of high or intermediate endemicity during the first 60 days following arrival in the US.

– The first dose of hepatitis A vaccine should be administered as soon as adoption is planned. Ideally, the first dose of hepatitis A vaccine should be administered at least two weeks prior to the arrival of the adoptee.


General Principles• The only vaccines that cannot be given at the same time are

smallpox and varicella• Minimal intervals apply to

– Doses of the same inactivated vaccine– Doses of the same live vaccine– Doses of different live vaccines not given simultaneously, except

• Oral typhoid Ty21a vaccine • Rotavirus vaccine

• Minimal intervals do not apply to doses of different inactivated vaccines

• Minimal intervals define catch-up schedules• A 4-day grace period is granted to all vaccine doses

– Rabies vaccine is an exception– Local regulations may not allow a grace period

Marshall, GS. The Vaccine Handbook: A Practical Guide for Clinicians. West Islip, NY: Professional Communications, Inc.;2008.

Principles of Catch-up Schedules• Age

– Doses administered prior to minimum age should not be considered valid

– Reduce number of doses according to age and schedule (eg, Hib, PCV)

– Do not administer beyond maximum age• Dose intervals

– Minimum• Do not administer subsequent doses at less than minimum

intervals• Unnecessary to repeat series; diminution of immunity is not

expected in the short term• Check formula interchangeability

Erroneous ContraindicationsThe following are NOT contraindications:• Mild acute illness• Mild-moderate local reaction• Concurrent antibiotic therapy• Convalescent phase of illness• Prematurity• Recent exposure to illness• History of non-vaccine allergies• Family history of allergies, SIDS, seizures• Desensitization shots• Breastfeeding• Positive TST• Pregnant household contact (except OPV and smallpox)• Asymptomatic or mildly symptomatic HIV infection• Allergic to eggs but can eat egg-containing products• Mild latex allergy• Autoimmune disease

Combination Vaccines

MMRV: New Issues• Increased risk of febrile seizures among 12- to 23-month-olds receiving dose 1

of MMRV vs MMR and varicella vaccines at the same visit• Limited availability of MMRV due to manufacturing constraints• ACIP position

– Age 12 through 47 months for first dose: no preference– Dose 2 and any dose at age > 48 months

• The use of combinations generally is preferred. Considerations should include provider assessment, patient preference, and the potential for adverse events. Footnote= Provider assessment should include storage costs, number of injections, vaccine availability, vaccination status, likelihood of improved coverage, and likelihood of patient return visits.

CDC. MMWR Morb Mortal Wkly Rep. 2008;57(10):258-260.Resolution No. 06/09-3. http://www.cdc.gov/vaccines/programs/vfc/downloads/resolutions/0606mmrv.pdf. Accessed September 2009.

Current US Combination VaccinesProduct TriHIBit Comvax Twinrix Pediarix ProQuad

DTaP Tripedia Infanrix

IPV IPV

Hib conj ActHIB PedvaxHIB

Hep-A Havrix

Hep-B Recom-HB Engerix-B Engerix-B

Measles

MMRIIMumps

Rubella

Varicella Varivax

Current US Combination VaccinesProduct Pentacel Kinrix

DTaP (Daptacel) Infanrix

IPV Poliovax IPV

Hib conj ActHIB

Hep-A

Hep-B

Measles

Mumps

Rubella

Varicella

Combination Vaccine Rule

• The minimum intervals between doses of a combination vaccine are dictated by the single antigen with the longest minimum intervals

Addressing Parental Concerns

Safety

Public Confidence in Vaccines

• Public confidence in vaccines is affected by a number of factors, including:– Product safety and efficacy– Anecdotal experience/information– Prevalence of disease– Recommendations by governmental committees

and professional societies– Physician recommendations– Media coverage– Vaccine monitoring and surveillance systems

Alternative Vaccination Schedules

• The Dr. Bob Sears’ alternative schedule– Dr. Bob Sears’ strategy for addressing parent concerns– Dr. Paul Offit’s analysis of this strategy

Dr. Bob Sears’ Alternative Vaccine Schedule

Sears RW. The Vaccine Book. New York, NY: Little Brown & Company: 2007.

Dr. Bob Sears’ Alternative Vaccine Schedule

Parameter Dr. Bob Sears ACIPTotal visits to completion 15 visits 4 or 5 visits

Age at completion 42 months 15 or 18 months

Marshall G. The Vaccine Quarterly. 2009;3[1]:17.

Argument The TruthDoctors do not understand vaccines. Parents can educate themselves to know more than doctors.

Doctors may not always review the primary data, but the advisory committees that do are composed of experts whose record has been spot-on.

Government and pharmaceutical companies conspire to misrepresent data.

There is no evidence of conspiracy.

Vaccine-preventable diseases are not that serious and are often not seen in practice.

Vaccine-preventable diseases are serious and can result in death. Anecdotal experience in practice does not trump national surveillance data.

Natural immunity is better than vaccine-induced immunity.

The cost of natural immunity is the risk of serious disease or death.

Vaccines are not adequately tested for safety. Vaccines are among the most thoroughly tested pharmaceuticals. The post-licensure safety net is robust.

Offit PA, Moser CA. Pediatrics. 2009;123(1):e164-e169.

Critique of Dr. Bob Sears’ Alternative Schedule

Argument The TruthVaccines are recommended for protection of the

public at large, not individuals. Every individual benefits from receiving

vaccines– they become immune to the disease and, as long as others are immunized, they have

less chance of exposure. Parents’ fears should be indulged by offering

alternative schedules. Parents’ fears should be assuaged by explaining

the scientific findings. Reports in VAERS and language in the Package Insert (PI) constitute accurate profiles of vaccine

side effects.

VAERS reports do not establish causality and the PI lists any reported events, whether

causally related or not. There is a middle ground between causality and

coincidence. This logic is flawed–either vaccines do or don’t

cause certain adverse events. Science fails because it cannot prove there is no

connection between vaccines and certain adverse events.

Science doesn’t work that way– one can only reject or fail to reject the null hypothesis.

Offit PA, Moser CA. Pediatrics. 2009;123(1):e164-e169.

Critique of Dr. Bob Sears’ Alternative Schedule

For more discussion on this alternative schedule, visithttp://www.immunize.org/concerns/drsears.asp

Institute of Medicine Immunization Safety Reviews

2004• “…the body of epidemiological evidence favors

rejection of a causal relationship between the MMR vaccine and autism… [and] favors rejection of a causal relationship between thimerosal-containing vaccines and autism.”

1. Immunization Safety Review: http://www.nap.edu/catalog.php?record_id=10101#toc. Accessed September 2009.



US Measles Cases

• Measles increase in 2008 not due to a greater number of imported cases, but was the result of greater transmission after importation

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Cases of imported measles* as a proportion of all measles cases–US 1997 to July 2008

Cases of measles by vaccination status (2008)

Madsen KM, et al. N Engl J Med. 2002;347:1477-1482.

Danish Cohort Study

Population of Denmark

Children born between01/01/91 and 12/31/98

The Past

MMR1,647,504 person-yr

No MMR482,360 person-yr

The Present

Autism: 263ASD: 345

Autism: 53ASD: 77

Relative risk:Autism: 0.92 (0.68-1.24)ASD: 0.83 (0.65-1.07)

Hviid A, et al. JAMA. 2003;290:1763-1766.

Danish Cohort Study

Population of Denmark

Children born between01/01/90 and 12/31/96

The Past

Thimerosal1,220,006 person-yr

No thimerosal1,660,159 person-yr

The Present

Autism: 104ASD: 321

Autism: 303ASD: 430

Relative risk:Autism: 0.85 (0.60-1.20)ASD: 1.12 (0.88-1.43)

2-month-old infantsPichichero ME, et al. Pediatrics. 2008;121:e208-e214.

Mercury Levels After Thimerosal-Containing Vaccines

Madsen KM, et al. Pediatrics. 2003;112:604-606.

Autism Incidence After Vaccine Formulation Changes

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Schechter R, Grether JK. Arch Gen Psychiatry. 2008;65:19-24.

Autism in California

Thimerosal in Vaccines. www.fda.gov/cber/vaccine/thimerosal.htm.Accessed September 2009.

Thimerosal Status of Current VaccinesVaccine Trade Name Status

Diphtheria, tetanus, pertussis

InfanrixDaptacelTripedia

FreeFree≤ 0.3 mcg Hg/0.5mL

PCV-7 Prevnar Free

Polio IPOL Free

Hepatitis B Recombivax HBEngerix-B

FreeFree

Hib conjugate ActHIBPedvaxHIBHibTITER

FreeFreeFree (single dose)

Hib/Hepatitis B Comvax Free

MMR M-M-R-II Free

Varicella Varivax Free

DTaP/Hep-B/IPV Pediarix Free

Influenza Fluzone T-free Free

Fluvirin P-free < 1.0 mcg Hg/0.5 mL

FluMist Free

Hepatitis A**updated 3/14/08

Vaqta Free

Havrix Free

Marshall GS, et al. The Vaccine Handbook. Lippincott Williams + Wilkins; 2004. VAERS reporting. http://www.cdc.gov/vaccines/Pubs/surv-manual/chpt21-surv-adverse-events.htm#4.Accessed September 2009.CDC. MMWR Morb Mortal Wkly Rep. 1988;37(13):197-200.

Vaccine Adverse Event Reporting System

• Postmarketing surveillance system• Mandatory reporting by health care providers

– Occurrence of events listed as contraindications– Occurrence of events listed in the Reportable

Events Table• Voluntary reporting: any event by any one• Intent: hypothesis generation not hypothesis

testing

Vaccine Safety Datalink Study

MMRV MMR plus V

Number of subjects 43,353 314,599

Rate of febrile seizures 9 per 10,000 4 per 10,000


Adjudication of Febrile Seizure Incidence Following MMRVPre-adjudicated Seizure Reports Adjudicated Seizure Data

Adjudication panel: Drs S. Michael Marcy, Robert Riewerts, and Suresh Gurbani– Reviewed medical records (blinded to vaccination dates)– Confirmed seizure diagnosis based on Brighton Collaboration criteria

Post-adjudication seizure data for days 5-12 postvaccination:– MMRV: 0.70/1000 – MMR + V: 0.32/1000 – Relative risk = 2.2 (95% CI = 1.04, 4.65)

Jacobsen SJ, et al. Vaccine. 2009;27:4656-4661.

Aluminum Adjuvants: Review of the Evidence

Jefferson T, et al. Lancet Infect Dis. 2004;4:84-90.

Aluminum HydroxidevsNo Adjuvant(children up to 18 months of age)

Any AluminumvsNo Adjuvants(children 10-16 years)

Strategies for Improving Childhood Immunization Rates

The Community Guide.http://www.thecommunityguide.org/vaccines/universally/index.html. Accessed September 2009.Briss PA, et al. Am J Prev Med. 2000;18(suppl 1):35-43.

Evidence-based Methods for Improving Immunization Rates

• Community Preventive Services Task Force Recommended Strategies– Reducing client out-of-pocket costs – Vaccination programs in schools– Vaccination programs in WIC settings – Client reminder and recall systems – Vaccination requirements for child care, school, and college attendance– Provider reminder systems when used alone – Standing orders when used alone – Provider assessment and feedback

• The above recommendations have all been upgraded to ‘strong evidence’ based on systematic reviews

Resources

PROTECTTM Website:http://www.francefoundation.com/protect/

Resources for Patients and Parents• Guide to evaluating information on the web

www.cdc.gov/vaccines/vac-gen/evalwebs.htm

• CDC Vaccine Information Statements (VISs) http://www.cdc.gov/vaccines/pubs/vis/default.htm

• Vaccine Safety www.cdc.gov/Features/VaccineSafety

• National Network for Immunization Information (NNII) www.immunizationinfo.org

• Allied Vaccine Group www.vaccine.org

• Immunization Action Coalition (IAC) www.immunize.org • Vaccine Education Center at CHOP www.vaccine.chop.edu

• TCH Center for Vaccine Awareness and Research www.texaschildrens.org/carecenters/vaccine/default.aspx

Resources for Providers• Immunization Schedules

www.cdc.gov/vaccines/recs/schedules/

• ACIP recommendations & provisional recommendationswww.cdc.gov/vaccines/pubs/ACIP-list.htmwww.cdc.gov/vaccines/recs/provisional/default.htm

• The Guide to Community Preventive Services. Vaccine recommendationswww.thecommunityguide.org/vaccines/index.html

• Assessment, Feedback, Incentives, and Exchange (AFIX) www.cdc.gov/vaccines/programs/afix/default.htm

• National Foundation for Infectious Diseaseswww.nfid.org

• Centers for Medicare & Medicaid Serviceswww.cms.hhs.gov

Resources for Providers, Parents, and Patients

• The Immunization Action Coalition: vaccine information for the public and health professionals

www.vaccineinformation.org

• The Immunization Action Coalition: directory of immunization coalitions

www.izcoalitions.org

Childhood Vaccines

Documents

Transcript of Childhood Vaccines